tolterodine-tartrate and Prostatic-Hyperplasia

We reviewed recent literature and treatment guidelines regarding the prevalence, pathophysiology, and management of BPO related to BPH; and management of lower urinary tract symptoms secondary to BPH.. Published literature and current treatment concepts were reviewed regarding the diagnosis and treatment options for BPO.. BPH is a histological diagnosis that can contribute to medical problems, including enlargement of the prostate and BPO. These conditions should be treated only if the symptoms are troublesome, there is considerable risk of progression, and/or cancer is suspected. Very effective medical and surgical options are available to treat BPO and improve patient quality of life.. BPO is highly treatable, but should be managed in close collaboration with the patient. Pharmacological agents and minimally invasive procedures, when appropriate, are generally preferred to more invasive surgery. Patients with mild or moderate symptoms usually can be treated by a primary care physician; more complicated cases should be referred to a urologist for evaluation and management.

Topics: Age Distribution; Aged; Aged, 80 and over; Benzhydryl Compounds; Biopsy, Needle; Cresols; Humans; Immunohistochemistry; Incidence; Male; Middle Aged; Muscarinic Antagonists; Phenylpropanolamine; Prognosis; Prostatic Hyperplasia; Risk Assessment; Severity of Illness Index; Sulfonamides; Tamsulosin; Tolterodine Tartrate; Transurethral Resection of Prostate; Treatment Outcome; Urinary Bladder Neck Obstruction; Urination Disorders

The combination of an alpha1-blocker with an anticholinergic is a new and promising therapeutic approach for bladder outlet obstruction and detrusor overactivity. Both placebo-controlled and comparative studies have demonstrated that the addition of an anticholinergic in the conventional treatment of patients with bladder outlet obstruction is safe, as the likelihood of acute urinary retention is low. Although the pathophysiology of detrusor overactivity is unknown and most probably multifactorial, it is not expected that the voiding phase is influenced by regular doses of anticholinergics, although high doses may affect detrusor contraction. However, safety issues must be studied further. The combination of tamsulosin with propiverine or tolterodine, and of doxasosin with tolterodine has been shown to cause a significant improvement of lower urinary tract symptoms when compared with alpha1-blocker monotherapy. Indisputably, the existing literature provides clear evidence that the combination of an alpha1-blocker with an anticholinergic extends physicians ability to manage lower urinary tract symptoms caused by bladder outlet obstruction and overactive bladder syndrome.

Topics: Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Benzhydryl Compounds; Benzilates; Cholinergic Antagonists; Cresols; Doxazosin; Drug Therapy, Combination; Humans; Male; Phenylpropanolamine; Prostatic Hyperplasia; Randomized Controlled Trials as Topic; Sulfonamides; Tamsulosin; Tolterodine Tartrate; Urinary Bladder Neck Obstruction; Urinary Incontinence; Urodynamics; Urologic Diseases

To assess the efficacy of mirabegron in the treatment of erectile dysfunction concomitant with lower urinary tract symptoms in benign prostatic obstruction patients.. In this randomized controlled trial, 55 sexually active lower urinary tract symptoms/benign prostatic obstruction patients with concomitant erectile dysfunction were randomly allocated in two groups: the first received mirabegron 50 mg plus doxazosin 2 mg once daily (mirabegron group) and the second received tolterodine 4 mg plus doxazosin 2 mg (tolterodine group) for 12 weeks. The evaluation was based on the International Index of Erectile Function questionnaire, Erection Hardness Score questionnaire, International Prostate Symptom Score, quality of life, uroflowmetry and post-voiding residual. The therapeutic outcomes were assessed at 4 and 12 weeks compared with the baseline.. Only the mirabegron group achieved significant improvement in sexual functions after 4 and 12 weeks. By using ≥5 points difference from the baseline as a cut-off point of change, there was a significant difference in change of direction of the International Index of Erectile Function-15 total score in favor of the mirabegron group; after 12 weeks, the International Index of Erectile Function-15 total score decreased in 0%, was unchanged in 8.3% and improved in 91.7% in the mirabegron group compared with 8.7%, 65.2% and 26.1%, respectively, in the tolterodine group (P < 0.001). Regarding the urinary characteristics, both groups showed significant improvement in the International Prostate Symptom Score, quality of life, and post-voiding residual after 4 and 12 weeks, with no significant difference among them.. Mirabegron improves urinary characteristics and the associated sexual dysfunction in patients with lower urinary tract symptoms/benign prostatic obstruction.

Topics: Acetanilides; Doxazosin; Erectile Dysfunction; Humans; Lower Urinary Tract Symptoms; Male; Prostatic Hyperplasia; Quality of Life; Thiazoles; Tolterodine Tartrate; Treatment Outcome

BACKGROUND Benign prostatic hyperplasia (BPH), a common disease in men over age 50 years, often causes bladder outlet obstruction and lower urinary tract symptoms (LUTS). Alpha blockers in combination with muscarinic receptor antagonists may have the potential to improve symptoms. This study aimed to assess the efficacy and safety of doxazosin or tamsulosin combined with tolterodine extend release (ER) in patients with BPH and LUTS. MATERIAL AND METHODS In a prospective, randomized, open-label study (ChiCTR-IPR-15005763), 220 consecutive men with BPH and LUTS were allocated to receive doxazosin 4 mg and tolterodine ER 4 mg per day (doxazosin group) or tamsulosin 0.2 mg and tolterodine ER 4 mg per day (tamsulosin group). Treatment lasted 12 weeks. The primary endpoint was the international prostatic symptom score (IPSS). Secondary endpoints were quality of life (QoL) and maximum flow rate (Qmax), which were evaluated at 0, 6, and 12 weeks, and urodynamic parameters assessed at 0 and 12 weeks. RESULTS A total of 192 patients completed the trial. Baseline measurements showed no differences between the groups. After 6 weeks, IPSS improved in both groups and QoL was significantly better in the doxazosin group (P=0.01). After 12 weeks, Qmax, IPSS, QoL, intravesical pressure (Pves), and bladder compliance (BC) in the doxazosin group were significantly better than in the tamsulosin group (P=0.03, P<0.001, P<0.001, P=0.027, and P=0.044, respectively). CONCLUSIONS Administration of alpha blockers combined with muscarinic receptor blocker for 12 weeks improved LUTS in men with BPH.

Topics: Adrenergic alpha-Antagonists; Aged; Doxazosin; Drug Therapy, Combination; Humans; Male; Middle Aged; Prospective Studies; Prostatic Hyperplasia; Quality of Life; Sulfonamides; Tamsulosin; Tolterodine Tartrate

The medium-to-long-term use of antimuscarinics alone or in combination with an α-blocker in men with an enlarged prostate is still controversial. This double-blind, placebo-controlled, randomized clinical trial aimed to investigate the efficacy and safety of medium-to-long-term use of tolterodine extended release (ER) with or without tamsulosin in patients with benign prostate hyperplasia (BPH) and larger prostate size.. Totally, 152 patients (age ≥50 years) with BPH, International Prostate Symptom Score (IPSS) ≥12, quality-of-life (QoL) score ≥3, and total prostate volume ≥25 ml were enrolled in this study. The patients were randomized into four groups (n = 38 in each) to receive tolterodine ER placebo plus tamsulosin placebo, 0.2 mg tamsulosin plus tolterodine ER placebo, 4 mg tolterodine ER plus tamsulosin placebo, or tolterodine ER plus tamsulosin once daily for 24 weeks. IPSS (total, storage, and voiding subscales), QoL, maximum urinary flow rate (Qmax), and postvoid residual volume (PVR) were collected at baseline, and at weeks 4, 12, and 24.. Compared with placebo, tolterodine ER plus tamsulosin significantly improved total IPSS (-7.15, -12.20, and -14.66 vs. -3.51, -5.78, and -7.23), storage IPSS (-3.56, -5.63, and -6.66 vs. -1.52, -1.21, and -2.43), voiding IPSS (-2.88, -5.10, and -6.48 vs. -1.52, -3.03, and -2.97), QoL (-1.21, -2.40, and -3.21 vs. -0.39, -1.41, and -1.60), Qmax (2.21, 7.97, and 9.72 ml/s vs. 2.15, 2.44, and 2.73 ml/s), and PVR (-17.88, -26.97, and -27.89 ml vs. -12.03, -11.16, and -16.73 ml) at weeks 4, 12, and 24, respectively; the differences were all statistically significant (P < 0.05). Adverse events (AEs) were not increased with treatment progression. Tolterodine ER alone did not improve total IPSS (-4.61, -6.79, and -5.70), voiding IPSS (-0.64, -1.83, and -1.45), QoL (-0.69, -1.21, and -1.41), or Qmax(-0.79, 2.83, and 1.11 ml/s), compared with placebo (all P > 0.05). However, a gradual increase in PVR (10.03, 10.41, and 12.89 ml) and more urinary AEs suggestive of urinary retention (11/38 vs. 4/38) were observed.. Medium-to-long-term use of tolterodine ER plus tamsulosin should be recommended in patients with BPH and an enlarged prostate volume.. www.chictr.org.cn, ChiCTR-TRC-09000596; http://www.chictr.org.cn/showproj.aspx?proj=8939.

Topics: Adrenergic alpha-Antagonists; Aged; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Prostate; Prostatic Hyperplasia; Quality of Life; Sulfonamides; Tamsulosin; Tolterodine Tartrate; Treatment Outcome

To identify predictors of successful first-line antimuscarinic monotherapy for patients with enlarged prostate and predominant storage symptoms.. Men aged ≥ 50 years with total International Prostate Symptom Score (IPSS-T) ≥ 8, total prostate volume (TPV) ≥ 20 mL, IPSS quality of life (QOL) index ≥ 2, IPSS voiding to storage (IPSS-V/S) subscore ratio ≤ 1, and post-void residual (PVR) ≤ 250 mL were recruited into a prospective open-label study. All men received tolterodine ER (4 mg) daily. Global response assessment (GRA) ≥ 1 after treatment was considered successful treatment and an indication for continued antimuscarinic monotherapy.. One hundred ninety-seven men aged 50-89 years (average TPV 44.4 mL) received first-line tolterodine monotherapy. Mean IPSS-T, IPSS storage (IPSS-S) subscore, and QOL improved significantly at 2, 4, and 12 weeks. Average PVR increased significantly; no patient developed acute urinary retention. One hundred thirty-six patients (69.0%) showed improvement (GRA ≥ 1) at both 2 and 4 weeks. Regression analysis showed that IPSS-S (P = .039) and maximum urine flow (Qmax, P = .033) were significant predictors of therapeutic success. Patients with smaller baseline TPV, higher IPSS-S, and higher Qmax had significantly higher treatment success rates.. First-line antimuscarinic monotherapy is safe and effective within 12 weeks in selected patients with benign prostatic hyperplasia (BPH) Higher baseline IPSS-S, higher baseline Qmax, and lower TPV were predictors of successful antimuscarinic monotherapy.

Topics: Aged; Aged, 80 and over; Benzhydryl Compounds; Cresols; Endosonography; Follow-Up Studies; Humans; Male; Middle Aged; Muscarinic Antagonists; Phenylpropanolamine; Prospective Studies; Prostatic Hyperplasia; Quality of Life; Surveys and Questionnaires; Tolterodine Tartrate; Treatment Outcome; Urinary Retention

To evaluate the effectiveness of the monotherapy of Cardura and the combination therapy of Cardura and Tolterodine L-Tartrate Tablets for II° ? benign prostate hyperplasia (BPH) with overactive bladder (OAB).. This study included 87 cases of BPH with OAB, with a disease course > or = 3 months, daily urination > or = 8 times, nocturnal urination > or = 2 times, urine volume < 200 ml per time, International Prostate Symptom Score (IPSS) > or = 8, OAB symptom score (OABS) > or = 3, quality of life score (QOL) > or = 3, post-void residual (PVR) < or = 100 ml, maximum urinary flow (Qmax) > or = 5 ml/s, prostate weight 25-50 g, and PSA < 4 microg/L. We randomized the patients to a monotherapy group (n = 44) and combination group (n = 43), the former treated with Cardura 4 mg qd, and the latter with Cardura 4 mg + Tolterodine L-Tartrate Tablets 4 mg qd, both for 8 weeks. Then we recorded the IPSS, OABS, Qmax, PVR, PSA, and adverse events.. The baseline parameters showed no significant differences between the two groups (P > 0.05). In comparison with the baseline, both the monotherapy group and the combination therapy group showed significant decreased in the IPSS (16.50 +/- 4.27 vs 13.68 +/- 3.69 and 15.51 +/- 3.80 vs 11.49 +/- 2.75), urine storage symptom score (10.48 +/- 2.75 vs 7.98 +/- 2.34 and 9.47 +/- 2.31 vs 5.74 +/- 1.66), OABS (8.55 +/- 2.69 vs 6.32 +/- 1.97 and 8.21 +/- 2.55 vs 4.44 +/- 1.62), urgent micturition score (4.25 +/- 1.06 vs 3.23 +/- 0.99 and 4.07 +/- 0.83 vs 2.26 +/- 1.05), QOL (5.36 +/- 0.72 vs 3.43 +/- 0.66 and 5.07 +/- 0.86 vs 2.37 +/- 0.76) and PVR ([44.55 +/- 22.39] vs [38.30 +/- 20.20] ml and [36.19 +/- 21.21] vs [24.98 +/- 17.60] ml) (P < 0.01). All the six parameters were significantly more improved in the combination therapy group than in the monotherapy group (P < 0.01), but there were no remarkable differences between the groups in Qmax and voiding symptom score (P > 0.05). Neither group exhibited significant changes in the PSA level and prostate weight after treatment as compared with the baseline (P > 0.05). No acute urinary retention and other severe adverse reactions were observed during the medication.. Both Cardura monotherapy and the combination therapy of Cardura + Tolterodine L-Tartrate Tablets can improve II ? BPH with OAB, and the latter has an even better efficacy than the former.

Topics: Aged; Benzhydryl Compounds; Cresols; Doxazosin; Drug Therapy, Combination; Humans; Male; Middle Aged; Phenylpropanolamine; Prostatic Hyperplasia; Tolterodine Tartrate; Treatment Outcome; Urinary Bladder, Overactive

To determine the efficacy of toterodine extended release (ER) treatment for 1 year in older men with benign prostatic hyperplasia (BPH) and storage symptoms treated with alpha-blockers and/or 5-alpha-reductase inhibitors (5ARI).. Men aged over 70 years with BPH/bladder outlet obstruction (BOO) and clinical storage symptoms were randomly treated with or without tolterodine ER in combination with alpha-blockers and/or 5ARI for 12 months. Among them, 50 patients (group 1) received additive tolterodine extended release (ER) 4 mg q.d., another 87 patients (group 2) did not. All patients had a baseline and 12th month post-treatment evaluation, which comprised of uroflowmetry, post-void residual (PVR) volume, International Prostate Symptom Score (IPSS), and quality of life index (QoL-I), transrectal ultrasound of the prostate and serum prostate specific antigen.. One hundred thirty-seven of 153 enrolled patients with a mean age of 74.9 years completed the study. Treatment benefit demonstrated in both groups included deceased total, voiding and storage IPSS scores, increased peak urinary flow rate and deceased QoL-I. Inter-group difference was only observed on the storage domain of IPSS score (P = 0.012). The mean PVR after treatment did not significantly differ between two groups. Two patients of group 1 and three of group 2 developed acute urinary retention. Among group 1, six patients discontinued tolterodine ER for intolerable dry mouth; among group 2, three patients reported dizziness.. This longer comparative study indicated that additive treatment with tolterodine ER in older men with BPH/BOO and significant storage symptoms is a beneficial and safe therapeutic option.

Topics: Aged; Aged, 80 and over; Benzhydryl Compounds; Cresols; Delayed-Action Preparations; Humans; International Cooperation; Male; Muscarinic Antagonists; Phenylpropanolamine; Prostatic Hyperplasia; Quality of Life; Tolterodine Tartrate; Treatment Outcome; Urinary Bladder, Overactive; Urinary Retention

To evaluate the efficacy and safety of Tolterodine Tartrate combined with the alpha-receptor blocker in the treatment of benign prostatic hyperplasia with detrusor overactivity (BPH-DO).. A total of 113 patients with BPH-DO were randomly assigned to receive Tolterodine Tartrate combined with Cardura (Group A) and Cardura alone (Group B), both for 12 weeks. Then we recorded and compared their average 24 h urinary frequency, IPSS and QOL score, maximum urinary flow rate, residual urine volume and urinary retention times before and after the treatment.. After the treatment, Group A showed significantly better improvement in the average 24 h urinary frequency and scores on IPSS and QOL than Group B. No significant differences were found between the two groups in the maximum urinary flow rate and residual urine volume. No acute urinary retention occurred in either group.. The combined use of Tolterodine Tartrate and the alpha-receptor blocker can effectively relieve the symptoms of dysuria, urinary frequency and urinary urgency in patients with BPH-DO, with neither significant adverse effects on the maximum flow rate and residual urine volume nor increase in the incidence of acute urinary retention.

Topics: Adrenergic alpha-Antagonists; Aged; Benzhydryl Compounds; Cresols; Humans; Male; Muscarinic Antagonists; Phenylpropanolamine; Prostatic Hyperplasia; Tolterodine Tartrate; Treatment Outcome; Urinary Bladder, Overactive

To determine whether the efficacy and safety of a combination of tolterodine extended-release (ER) plus α-blocker treatment varies with high or low levels of serum prostate-specific antigen (PSA) in men who have persistent overactive bladder (OAB) symptoms after any α-blocker monotherapy.. Men aged ≥ 40 years were eligible if they reported ≥ 8 micturitions/24 h, including ≥ 1 urgency episode/24 h with or without urgency urinary incontinence (UUI), and at least some moderate bladder-related problems at baseline despite receiving treatment with an α-blocker for ≥ 1 month. Exclusion criteria included a postvoid residual urine volume (PVR) of ≥ 200 mL and history of acute urinary retention requiring catheterization. Subjects were randomly assigned to tolterodine-ER 4 mg or placebo for 12 weeks; all subjects continued their α-blocker treatment throughout the study. Subjects completed 5-day bladder diaries at baseline and week 12, in which they recorded all micturitions and rated the sensation associated with each micturition using the 5-point Urinary Sensation Scale (USS). For this post hoc analysis, efficacy, safety, and tolerability data were stratified by the study median PSA concentration at baseline (1.41 ng/mL).. In the tolterodine-ER +α-blocker and placebo +α-blocker groups, 160 and 159 men, respectively, had PSA levels of <1.41 ng/mL, and 166 and 160 men, respectively, had PSA levels of ≥ 1.41 ng/mL. Men with higher PSA levels were slightly older and had higher PVR at baseline compared with men with lower PSA levels. At week 12, improvements in daytime micturitions, 24-h urgency episodes, and daytime urgency episodes were significantly greater with tolterodine-ER +α-blocker vs placebo +α-blocker both in men with PSA levels of ≥ 1.41 ng/mL and those with PSA levels of < 1.41 ng/mL (P < 0.05). Among men with PSA levels of < 1.41 ng/mL, improvements in 24-h micturitions and frequency-urgency sum (sum of USS ratings for all micturitions) were also significantly greater with tolterodine-ER +α-blocker vs placebo +α-blocker (P < 0.05). There were no significant treatment differences in change in UUI episodes in either PSA group (although only 19% of subjects reported UUI at baseline), nor in nocturnal micturitions or nocturnal urgency episodes. Among men with PSA levels of ≥ 1.41 ng/mL, there was a statistically significant increase in PVR (P = 0.036) and decrease in maximum urinary flow rate (Q(max); P = 0.038) with tolterodine-ER +α-blocker vs placebo +α-blocker; these changes were not considered clinically meaningful. There were no treatment differences for changes in PVR or Q(max) among men with PSA levels of < 1.41 ng/mL. One subject receiving tolterodine-ER +α-blocker (PSA concentration of ≥ 1.41 ng/mL) and two subjects receiving placebo +α-blocker (one each in the PSA concentration subgroups of ≥ 1.41 ng/mL and < 1.41 ng/mL) had acute urinary retention requiring catheterization.. In a 12-week study, the addition of tolterodine-ER to α-blocker therapy improved key OAB symptoms and appeared to be well tolerated compared with placebo +α-blocker in men with persistent OAB symptoms, regardless of subjects' prostate size as judged by serum PSA concentration.

Topics: Adrenergic alpha-Antagonists; Adult; Aged; Aged, 80 and over; Benzhydryl Compounds; Cresols; Delayed-Action Preparations; Drug Therapy, Combination; Humans; Male; Middle Aged; Muscarinic Antagonists; Phenylpropanolamine; Prostate-Specific Antigen; Prostatic Hyperplasia; Tolterodine Tartrate; Treatment Outcome; Urinary Bladder, Overactive

To evaluate and compare the clinical efficacy and safety of the highly selective alpha receptor antagonist tamsulosin and its combination with the M receptor antagonist tolterodine in the treatment of refractory lower urinary tract symptoms (LUTS) in patients with benign prostatic hyperplasia (BPH).. We included in this study 184 BPH patients with refractory LUTS with the disease course of 4 weeks to 2 years, whose LUTS were not alleviated after a week's treatment with tamsulosin. The patients were randomly divided into Groups A and B, the former (n=89) treated with tamsulosin at 0.2 mg qd and the latter (n=95) given tolterodine at 2 mg bid in addition to tamsulosin medication, both for 4 weeks. Scores on IPSS, QOL and Qmax were obtained before and after the treatment, and the improvement of LUTS evaluated after the medication.. The tamsulosin group showed no significant differences before and after the treatment in the scores on IPSS (13.23 +/- 4.39 vs. 12.21 +/- 4.07), QOL (4.23 +/- 1.27 vs 3.53 +/- 0.95) and Qmax ([12.3 +/- 8.39] ml/s vs. [14.1 +/- 8.62] mls) (P > 0.05), while the combination group exhibited significantly higher scores on IPSS and QOL and lower score on Qmax after the medication than before it (IPSS: 14.45 +/- 5.31 vs. 6.56 +/- 2.03, P < 0.05; QOL: 4.45 +/- 0.79 vs. 2.34 +/- 0.73, P < 0.05; Qmax: [11.4 +/- 9.21] ml/s vs. [15.5 +/- 8.35] ml/s, P < 0.01). No severe complications were found in any of the cases.. Combination of tamsulosin and tolterodine can significantly alleviate refractory LUTS and improve QOL without causing serious adverse events in BPH patients.

Topics: Adrenergic alpha-1 Receptor Antagonists; Aged; Aged, 80 and over; Benzhydryl Compounds; Cresols; Humans; Male; Middle Aged; Muscarinic Antagonists; Phenylpropanolamine; Prostatic Hyperplasia; Sulfonamides; Tamsulosin; Tolterodine Tartrate; Treatment Outcome

Overactive bladder may coexist with bladder outlet obstruction induced by benign prostatic hyperplasia (BPH). This study aimed to evaluate the efficacy of the combined use of tolterodine and tamsulosin in the treatment of BPH accompanied by overactive bladder.. We selected 53 cases of clinically diagnosed BPH, and randomly assigned them to a tamsulosin group (n = 25) to receive 0.2 mg of tamsulosin once a day and a tamsulosin + tolterodine group (n = 28) to be treated with 0.2 mg of tamsulosin once a day plus 2 mg of tolterodine twice a day, both for 12 weeks. Before and after the treatment, we obtained the International Prostate Symptoms Score (IPSS), quality of life (QOL) score and Qmax, and recorded the adverse events.. All the patients accomplished the 12-week treatment. The tamsulosin group showed a significant decrease in IPSS and QOL from 21.50 +/- 5.42 and 4.58 +/- 0.94 before the treatment to 14.80 +/- 4.21 and 2.78 +/- 0.91 after it (P < 0.05), but a significant increase in Qmax from (12.20 +/- 6.60) ml/s to (16.40 +/- 5.13) ml/s (P < 0.05). In the tamsulosin + tolterodine group, IPSS and QOL were decreased from 20.90 +/- 5.15 and 4.61 +/- 0.86 at the baseline to 14.90 +/- 5.32 and 2.12 +/- 0.87 after the medication (P < 0.05), Qmax was increased from (13.30 +/- 7.80) ml/s to (16.70 +/- 6.32) ml/s (P < 0.05), and the score on the urinary storage phase symptoms was reduced from 10.12 +/- 3.10 to 4.77 +/- 0.75 (P < 0.05).. Tamsulosin could quickly relieve BPH-induced lower urinary tract symptoms (LUTS) , while the combined use of tolterodine and tamsulosin could even better alleviate the LUTS and improve the QOL of BPH patients.

Topics: Aged; Benzhydryl Compounds; Cresols; Drug Therapy, Combination; Humans; Male; Middle Aged; Phenylpropanolamine; Prostatic Hyperplasia; Sulfonamides; Tamsulosin; Tolterodine Tartrate; Treatment Outcome

To evaluate the efficacy of tolterodine extended-release (ER) plus tamsulosin on lower urinary tract symptoms (LUTS) as assessed by changes in the International Prostate Symptom Score (IPSS) in men who met symptom entry criteria for both overactive bladder (OAB) and benign prostatic hyperplasia (BPH) trials.. Men aged > or =40 years with an IPSS of > or =12 and diary-documented OAB symptoms (> or =8 voids/24 h and > or =3 urgency episodes/24 h, with or without urgency urinary incontinence) who reported at least moderate problems related to their bladder condition were randomized to receive placebo, tolterodine ER (4 mg), tamsulosin (0.4 mg), or tolterodine ER (4 mg) + tamsulosin (0.4 mg) once daily for 12 weeks. Patients completed the IPSS at baseline and at 1, 6 and 12 weeks.. Patients receiving tolterodine ER + tamsulosin had significantly greater improvements than those taking placebo on IPSS storage subscale scores and scores for all three individual storage items included on the IPSS (urinary frequency, urgency, and nocturnal micturitions) by 12 weeks. Storage subscale and urgency scores were significantly improved vs placebo at 1 and 6 weeks, whereas frequency scores were significantly improved at 6 weeks. Changes in IPSS storage subscale and individual storage item scores in the tolterodine ER and tamsulosin monotherapy groups were not significantly different from placebo at most time points. IPSS voiding subscale scores and scores for three of four individual voiding items (sensation of incomplete emptying, intermittency, and weak stream) were significantly improved by 12 weeks for patients receiving tamsulosin monotherapy vs placebo. Voiding subscale and intermittency scores were significantly improved vs placebo at 1 week; weak stream scores were significantly improved at 1 and 6 weeks. The IPSS voiding subscale and individual voiding item scores in the tolterodine ER + tamsulosin and tolterodine ER groups were not significantly different from placebo at most time points.. In this distinct clinical research population of men who met traditional symptom entry criteria for both OAB and BPH trials, tolterodine ER + tamsulosin was significantly more effective than placebo in treating storage LUTS, including OAB symptoms. Tamsulosin monotherapy produced significant improvements in voiding LUTS.

Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Benzhydryl Compounds; Cresols; Delayed-Action Preparations; Drug Therapy, Combination; Humans; Male; Middle Aged; Muscarinic Antagonists; Phenylpropanolamine; Prostatic Hyperplasia; Prostatism; Quality of Life; Sulfonamides; Surveys and Questionnaires; Tamsulosin; Tolterodine Tartrate; Treatment Outcome; Urinary Bladder, Overactive

We evaluated the efficacy of tolterodine extended release and/or tamsulosin on micturition related urgency episodes, urgency severity and patient reported outcomes in men who met entry criteria for prostatic enlargement and overactive bladder trials.. Men 40 years old or older with an International Prostate Symptom Score of 12 or greater, frequency (8 or more voids per 24 hours) and urgency (3 or more episodes per 24 hours) with or without urgency urinary incontinence were randomized to placebo, 4 mg tolterodine extended release, 0.4 mg tamsulosin or tolterodine extended release plus tamsulosin for 12 weeks. Subjects completed 5-day diaries; the Patient Perception of Bladder Condition and Urgency Perception Scale at baseline, and weeks 1, 6 and 12; Overactive Bladder Questionnaire at baseline, and weeks 6 and 12; Perception of Treatment Satisfaction question at weeks 1, 6 and 12; and Willingness to Continue question at week 12. Subjects rated the urgency associated with each micturition on a 5-point scale and micturition related urgency episodes were those rated 3 or greater. Urgency severity was measured using frequency-urgency sum, defined as the sum of urgency ratings for all micturitions.. Compared with placebo, tolterodine extended release plus tamsulosin significantly reduced daytime and nocturnal micturition related urgency episodes as well as frequency-urgency sum at weeks 1, 6 and 12. It also improved Patient Perception of Bladder Condition scores at weeks 1, 6 and 12; improved Urgency Perception Scale and Overactive Bladder Questionnaire, Symptom Bother and Health Related Quality of Life scores at weeks 6 and 12; and increased the percentage of subjects who reported treatment satisfaction at weeks 6 and 12, and willingness to continue at week 12.. Treatment with tolterodine extended release plus tamsulosin significantly improved urgency variables and patient reported outcomes in men meeting entry criteria for overactive bladder and prostatic enlargement trials.

Topics: Adrenergic alpha-Antagonists; Adult; Analysis of Variance; Benzhydryl Compounds; Cresols; Delayed-Action Preparations; Drug Therapy, Combination; Humans; Male; Middle Aged; Muscarinic Antagonists; Patient Satisfaction; Phenylpropanolamine; Prostatic Hyperplasia; Sulfonamides; Surveys and Questionnaires; Tamsulosin; Tolterodine Tartrate; Treatment Outcome; Urinary Bladder, Overactive; Urinary Incontinence, Urge

To evaluate the efficacy of tolterodine extended release (ER), tamsulosin, and tolterodine ER plus tamsulosin in men with symptoms of overactive bladder and benign prostatic hyperplasia stratified by prostate-specific antigen (PSA) level.. We performed a post hoc analysis of data from men >or=40 years old with frequency and urgency (with or without urge urinary incontinence), postvoid residual urine volume <200 mL, maximal urinary flow rate >5 mL/s, International Prostate Symptom Score (IPSS) of >or=12, and quality-of-life score of >or=3. They had been randomized to placebo, tolterodine ER (4 mg), tamsulosin (0.4 mg), or tolterodine ER plus tamsulosin for 12 weeks. The men were stratified by the median baseline PSA level (>or=1.3 vs <1.3 ng/mL). Assessments included changes in bladder diary variables and IPSSs. The men rated the urgency level of each micturition, and the frequency-urgency sum was defined as the total of these ratings.. The PSA level correlated significantly with prostate size. Men with a PSA level of >or=1.3 ng/mL receiving tolterodine ER plus tamsulosin showed significantly greater improvements in 24-hour frequency, daytime frequency, the frequency-urgency sum, total IPSS, and IPSS storage score compared with those receiving placebo. Tamsulosin significantly improved the IPSS voiding scores, but tolterodine ER was ineffective. In men with a PSA level <1.3 ng/mL, tolterodine ER alone and tolterodine ER plus tamsulosin significantly improved the 24-hour frequency, daytime frequency, frequency-urgency sum, and IPSS storage scores compared with those receiving placebo; tamsulosin alone was ineffective. No significant changes were found in the postvoid residual urine volume or maximal urinary flow rate in any group, and the acute urinary retention rates were low.. The results of our study have shown that tolterodine ER was efficacious in men with lower urinary tract symptoms, including overactive bladder, who had lower PSA levels (<1.3 ng/mL).

Topics: Adrenergic alpha-Antagonists; Aged; Benzhydryl Compounds; Cohort Studies; Cresols; Delayed-Action Preparations; Drug Therapy, Combination; Humans; Male; Middle Aged; Muscarinic Antagonists; Phenylpropanolamine; Predictive Value of Tests; Prostate-Specific Antigen; Prostatic Hyperplasia; Sulfonamides; Tamsulosin; Tolterodine Tartrate; Treatment Outcome; Urinary Bladder, Overactive; Urination Disorders

The primary objectives of the treatment for the lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) are to produce rapid, sustained, and safe improvements in the symptoms that affect the quality of life in the majority of men over 50. In this study, we evaluated the efficacy and safety of the combined therapy with terazosin (apha1-adrenergic receptor antagonist) and tolterodine (anticholinergic agent) for LUTS associated with BPH.. This combination study included 69 patients diagnosed with LUTS associated with BPH based on the International Prostate Symptom Scores (IPSS), urinary flow rate, prostate volume, urinary residual, and their serum prostate-specific antigen levels. Initially, 191 patients were treated with terazosin 2 mg once daily for one week. Those patients with continued LUTS after the initial treatment were allocated randomly into two groups: terazosin group (n = 36) in which patients were treated with terazosin 2 mg once daily for six weeks, and combination group (n = 33) in which patients were treated with both terazosin 2 mg once daily and tolterodine 2 mg twice daily for 6 weeks.. The IPSS were significantly improved in both groups after treatment, and the reduction of IPSS in the combination group was significantly greater than that in the terazosin group (P < 0.01). A decrease in urgency, frequency and nocturia were the main contributory factors causing the reduction of IPSS in the combination group. The differences about the peak urinary flow rate and the residual urine from the baseline values were noted in both groups after treatment, but were not significant between the two groups. The incidence of adverse effects in the combination group was higher than that in the terazosin group. As expected the most common adverse effect was mouth dryness which was associated with anticholinergic drugs such as tolterodine.. Patients with LUTS associated BPH appear the improved IPSS after combined therapy with terazosin and tolterodine. This study, although short term and limited numbers of patients, provides evidence that the combined therapy with terazosin plus tolterodine is a good approach for meeting the objectives of rapid, sustained, and safe improvements in the LUTS associated with BPH. And the profile of patients in this study might be used as the indication of such combined therapy for LUTS associated with BPH without urodynamic evaluation.

Topics: Adrenergic alpha-Antagonists; Aged; Benzhydryl Compounds; Cresols; Drug Therapy, Combination; Humans; Male; Middle Aged; Muscarinic Antagonists; Phenylpropanolamine; Prazosin; Prospective Studies; Prostatic Hyperplasia; Tolterodine Tartrate; Urination Disorders

Patients with presumed non-obstructive BPH (Q (max )>or= 15 ml/s) treated with tolterodine ER 4 mg/day for OAB symptoms, alone or added to unsuccessful alpha-blocker treatment of >or=6 weeks duration, were observed for 12 weeks in a non-interventional study to generate real-life efficacy and safety data. Patients completed the IPSS, the OAB-q and a 2-day micturition diary at baseline and 12 weeks. PVR was determined sonographically. Seven hundred and forty one patients were analysed. Mean PVR did not increase (25.4 +/- 26.5 vs. 29.3 +/- 30.9 ml at baseline). AUR requiring catheterization occurred in two patients, acute UTI in four patients. Median IPSS total scores decreased from 17 to 10, IPSS QoL scores from 4 to 2, OAB-q symptom bother scores from 50.0 to 22.5 and OAB-q HRQL scores increased from 59.2 to 81.6. In men with OAB symptoms and presumed non-obstructive BPH, tolterodine ER provided considerable symptomatic and QoL improvements with a low risk of AUR, acute UTI, or increased PVR.

Topics: Aged; Benzhydryl Compounds; Cresols; Delayed-Action Preparations; Humans; Male; Middle Aged; Muscarinic Antagonists; Phenylpropanolamine; Prostatic Hyperplasia; Quality of Life; Regression Analysis; Severity of Illness Index; Tolterodine Tartrate; Treatment Outcome; Urinary Bladder, Overactive; Urinary Incontinence, Urge; Urodynamics

Urgency and urge incontinence are frequently observed after prostatectomy. Although symptoms ameliorate within a relatively short time, they usually cause significant stress and anxiety to the patient as far as their duration is concerned. Aim of our study was to determine the efficacy of tolterodine in preventing urgency and urge incontinence after catheter removal in patients that underwent prostatectomy for benign prostate hyperplasia.. Twenty-seven patients with moderate/severe lower urinary tract symptoms due to benign prostatic enlargement, scheduled for prostatectomy, were randomised into two groups, Group A (14 pts) received tolterodine 2 mg b.i.d starting the day of surgery, while group B patients received no such treatment. Tolterodine treatment was discontinued 15 days after catheter removal. All patients completed the International Prostatic Symptom Score (IPSS) and the International Continence Society (ICS-BPH) forms the day before surgery, and three times more, one, fifteen and thirty days after catheter removal.. Pre-operative total 1PSS and frequency of urgency/urge incontinence as determined by questions 3 and 4 of the ICS-BPH questionnaire were equally distributed between groups. Tolterodine was well tolerated and no adverse effects were reported. Post-operative IPSS and QoL scores did not differ between groups. However, the frequency of urge incontinence both the first day and fifteen days after catheter removal was significantly lower in the tolterodine group (16.6% vs. 69.2%, p=0.004 and 8.3% vs. 38.4%, p=0.039, respectively).. Tolterodine was well tolerated in all patients and had a beneficial effect regarding the postoperative urge incontinence. Trials of a larger scale could determine which patients would benefit more, especially according to the presence of storage lower urinary tract symptoms prior to surgery.

Topics: Aged; Benzhydryl Compounds; Cresols; Humans; Male; Middle Aged; Phenylpropanolamine; Prostatectomy; Prostatic Hyperplasia; Surveys and Questionnaires; Tolterodine Tartrate; Treatment Outcome; Urinary Incontinence, Urge

Men with overactive bladder and other lower urinary tract symptoms may not respond to monotherapy with antimuscarinic agents or alpha-receptor antagonists.. To evaluate the efficacy and safety of tolterodine extended release (ER), tamsulosin, or both in men who met research criteria for both overactive bladder and benign prostatic hyperplasia.. Randomized, double-blind, placebo-controlled trial conducted at 95 urology clinics in the United States involving men 40 years or older who had a total International Prostate Symptom Score of 12 or higher and, an International Prostate Symptom Score quality-of-life (QOL) item score of 3 or higher, a self-rated bladder condition of at least moderate bother, and a bladder diary documenting micturition frequency (>or=8 micturitions per 24 hours) and urgency (>or=3 episodes per 24 hours), with or without urgency urinary incontinence. Patients were recruited between November 2004 and February 2006, and the study was completed May 2006.. Patients were randomly assigned to receive placebo (n = 222), 4 mg of tolterodine ER (n = 217), 0.4 mg of tamsulosin (n = 215), or both tolterodine ER plus tamsulosin (n = 225) for 12 weeks.. Patient perception of treatment benefit, bladder diary variables, International Prostate Symptom Scores, and safety and tolerability were assessed.. A total of 172 men (80%) receiving tolterodine ER plus tamsulosin reported treatment benefit by week 12 compared with 132 patients (62%) receiving placebo (P<.001), 146 (71%) receiving tamsulosin (P=.06 vs placebo), or 135 (65%) receiving tolterodine ER (P=.48 vs placebo). Patients receiving tolterodine ER plus tamsulosin compared with placebo experienced significant reductions in urgency urinary incontinence (-0.88 vs -0.31, P=.005), urgency episodes without incontinence (-3.33 vs -2.54, P=.03), micturitions per 24 hours (-2.54 vs -1.41, P<.001), and micturitions per night (-0.59 vs -0.39, P.02). Patients receiving tolterodine ER plus tamsulosin demonstrated significant improvements on the total International Prostate Symptom Score (-8.02 vs placebo, -6.19, P=.003) and QOL item (-1.61 vs -1.17, P=.003). All interventions were well tolerated. The incidence of acute urinary retention requiring catheterization was low (tolterodine ER plus tamsulosin, 0.4%; tolterodine ER, 0.5%; tamsulosin, 0%; and placebo, 0%).. These results suggest that treatment with tolterodine ER plus tamsulosin for 12 weeks provides benefit for men with moderate to severe lower urinary tract symptoms including overactive bladder. Clinical Trials Registration clinicaltrials.gov Identifier: NCT00147654.

Topics: Adrenergic alpha-Antagonists; Adult; Aged; Aged, 80 and over; Benzhydryl Compounds; Cresols; Delayed-Action Preparations; Double-Blind Method; Drug Therapy, Combination; Humans; Male; Middle Aged; Muscarinic Antagonists; Phenylpropanolamine; Prostatic Hyperplasia; Sulfonamides; Tamsulosin; Tolterodine Tartrate; Urinary Bladder, Overactive; Urinary Incontinence, Urge

We evaluate the effect of tolterodine combined with tamsulosin on quality of life in patients with bladder outlet obstruction and concomitant detrusor instability.. The study included 50 consecutive patients with urodynamically proven mild or moderate bladder outlet obstruction and concomitant detrusor instability. All patients were initially treated with 0.4 mg. tamsulosin orally once a day. A week later the patients were randomly allocated into group 1-25 who continued treatment with tamsulosin only and, group 2-25 who also received 2 mg. tolterodine orally twice daily. Reevaluation with a quality of life questionnaire and urodynamic study was performed after 3 months.. Two patients from group 2 stopped tolterodine while 1 patient from each group stopped tamsulosin because of hypotension. Analysis revealed statistically significant improvement in quality of life scores only in group 2 patients (mean score 525.0 and 628.4 before and after treatment, respectively, 2-sided t test p = 0.0003). A significant difference was noted in both groups after treatment for maximum flow rate and volume at first contraction. Additionally, in group 2, a statistically significant difference was observed for maximum detrusor pressure and maximum unstable contraction pressure after treatment.. Combination treatment with an alpha-blocker (tamsulosin) plus an anticholinergic (tolterodine) improves quality of life in patients with bladder outlet obstruction and concomitant detrusor instability. Interestingly, no acute urinary retention was observed and tolterodine did not affect the quality of urine flow or residual urine volume. The proposed combination appears to be an effective and relatively safe treatment option in patients with bladder outlet obstruction and detrusor instability.

Topics: Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Aged; Benzhydryl Compounds; Cresols; Drug Therapy, Combination; Humans; Male; Middle Aged; Muscarinic Antagonists; Phenylpropanolamine; Prospective Studies; Prostatic Hyperplasia; Quality of Life; Sulfonamides; Tamsulosin; Tolterodine Tartrate; Urinary Bladder Neck Obstruction; Urodynamics

Two novel combination therapies for the treatment of benign prostatic hyperplasia were analyzed using simple and enhanced spectrofluorimetric methods based on derivative and derivative ratio techniques. The two combinations contained tamsulosin hydrochloride (TAM) as a minor component with tolterodine tartrate (TOL) or solifenacin succinate (SOL). The fluorescence of the three drugs under study was measured in methanolic water solution. For the TAM and SOL mixture, successful resolution between both drugs was achieved by derivative manipulation of both ratio and zero-order emission spectra with good linearity in the ranges of 0.75-3.50 and 2.5-15.0 μg ml

Topics: Dose-Response Relationship, Drug; Drug Therapy, Combination; Humans; Male; Molecular Structure; Prostatic Hyperplasia; Solifenacin Succinate; Spectrometry, Fluorescence; Sulfonamides; Tamsulosin; Tolterodine Tartrate

To assess treatment persistence and adherence in men ≥45 years of age with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH), using prescription records from the Netherlands IMS Lifelink™ LRx database.. In this retrospective, observational cohort study, we identified men who received combination therapy with an α-blocker plus an antimuscarinic (e.g. solifenacin or tolterodine) between 1 November 2013 and 31 October 2014. Treatment could be received as a fixed-dose combination (FDC) tablet or as two drugs administered together (concomitant therapy), if both combination drugs were prescribed within 30 days. The primary objective was to assess treatment persistence, defined as the time from initiation of combination therapy until first discontinuation of the FDC or at least one of the drugs given concomitantly (i.e. ≥30 days without prescription renewal). Subgroup and sensitivity analyses were conducted to assess persistence by antimuscarinic agent, and with different gap lengths used to define discontinuation (45, 60 and 90 days), respectively.. A total of 1891 men received an α-blocker plus an antimuscarinic (FDC, N = 665; concomitant therapy, N = 1226). Median time to discontinuation was significantly longer with FDC versus concomitant therapy (414 vs. 112 days; adjusted hazard ratio [HR] 2.04, 95% confidence interval 1.77, 2.35; p < 0.0001). Persistence at 12 months (51.3% vs. 29.9%) was also significantly greater with FDC compared with concomitant therapy. Assessment of antimuscarinic subgroups showed that median time to discontinuation was longest with solifenacin combinations (214 days) compared with other antimuscarinic combinations (range, 47-164 days; adjusted HR range, 1.27-1.77, p = 0.037). No observable impact on treatment persistence was found by adjusting the gaps used to define discontinuation.. This study of real-world evidence of men with LUTS/BPH treated with α-blocker plus antimuscarinic combination therapy in the Netherlands showed that treatment persistence was significantly greater in those who received a FDC tablet compared with combination therapy given concomitantly. The study also shows that treatment persistence was extended in men who received combination therapy containing solifenacin compared with other antimuscarinics.. Overall, these findings may be useful for prescribers, as improved persistence on-treatment may translate into improved outcomes for men with LUTS/BPH. Further study is warranted to establish the key drivers of persistence in men receiving combination therapy for LUTS/BPH.

Topics: Adrenergic alpha-Antagonists; Aged; Cohort Studies; Drug Therapy, Combination; Humans; Lower Urinary Tract Symptoms; Male; Medication Adherence; Middle Aged; Muscarinic Antagonists; Netherlands; Prostatic Hyperplasia; Retrospective Studies; Solifenacin Succinate; Tolterodine Tartrate

Whether cholinergic innervations and/or autophagy have a role in the etiopathology of benign prostatic hyperplasia (BPH) is still unknown. This study aimed to investigate the role of cholinergic innervation and autophagy in the etiopathology of BPH.. Male, 13-week-old spontaneous hypertension rats (spontaneous BPH animal model) were divided into three groups: an experimental group (EG, n = 24), a control group (CG, n = 24), and a normal control group (NC, n = 10). The EG animals were intragastrically injected with tolterodine (3.5 mg/kg, twice a day), CG animals were intragastrically injected with physiological saline, and the NC animals did not receive any treatment. Rats were sacrificed every 4 weeks, and the prostatic gross morphological changes, wet weight/body weight (ww/bw), dry weight/wet weight (dw/ww), histological changes, ultrastructural changes, and LC3 immunohistochemistry were continuously observed and compared.. The gross morphological and ww/bw changes in the three groups were similar at every stage. The dw/ww (mg/mg) values of the EG at week 17, 21, 25, and 29 were 0.1478 ± 0.0034, 0.1653 ± 0.0036, 0.1668 ± 0.0045, and 0.1755 ± 0.0034, respectively, and the CG values were 0.1511 ± 0.0029, 0.1734 ± 0.0020, 0.1837 ± 0.0052, and 0.1968 ± 0.0045, respectively. The difference between EG and CG for dw/ww showed statistical significance after 21 weeks of age (week 21: P= 0.016, week 25: P= 0.008, and week 29: P= 0.001). Both EG and CG, prostatic glandular epithelial cell proliferation, and secretory function improved with age, but in EG, these improvements were slower than those in CG, and all the differences were statistically significant after 21 weeks. An increasing number of autophagosomes in the prostatic glandular cell cytoplasm, attenuation of LC3-I immunohistochemical staining, enhancement of LC3-II staining, and the ratio of LC3-II/LC3-I staining were all progressive in both groups, but the rate of change in EG was faster than that in CG, and these differences gained statistical significance after 25 weeks. Comparisons with regard to the above indexes between CG and NC showed no statistical significance at any stage.. Cholinergic innervations and activation of autophagy appear to have important functions in the etiopathology of BPH. Drug-mediated blockade of cholinergic innervations could delay the physiopathology processes. Moreover, overactivation of autophagy may also play an important role in this delay.

Topics: Animals; Autophagy; Body Weight; Cell Proliferation; Disease Models, Animal; Immunohistochemistry; Male; Prostate; Prostatic Hyperplasia; Rats; Tolterodine Tartrate

To study the dosage regimen of oral M-receptor blocker following transurethral resection of the prostate (TURP) for severe benign prostate hyperplasia (BPH) with predominant urine storage period symptoms (USPSs) and its clinical effect.. Severe BPH patients with predominant USPSs received oral tolterodine (2 mg q12d or 4 mg qd) 6 hours after TURP for 4 weeks. The medication continued for another 2 weeks in case of recurrence of USPSs or until the 12th week in case of repeated recurrence. Before and at 1, 4, 8 and 12 weeks after TURP, we analyzed the International Prostate Symptoms Score (IPSS), quality of life (QoL) score, maximum urinary flow rate (Qmax), and postvoid residual volume (PVR) of the patients.. Complete clinical data were collected from 106 cases, of which 33 achieved successful drug withdrawal with no aggravation of USPSs at 4 weeks after TURP, 51 at 6－8 weeks, 13 at 10－12 weeks, and 9 needed medication after 12 weeks. Before and at 1, 4, 8 and 12 weeks after TURP, the total IPSSs were 25.33 ± 3.45, 19.33 ± 3.62, 11.56 ± 2.45, 8.38 ± 2.0 and 7.74 ± 1.87, those in the urine storage period were 11.97 ± 1.53, 10.76 ± 1.82, 6.16 ± 1.22, 4.08 ± 1.19 and 3.91 ± 1.15, those at urine voiding were 9.80 ± 1.60, 5.59 ± 1.45, 3.40 ± 0.92, 2.85 ± 0.71, and 2.61 ± 0.67, and the QoL scores were 4.70 ± 0.78, 3.92 ± 0.75, 2.55 ± 0.74, 1.83 ± 0.72 and 1.66 ± 0.75, respectively, with statistically significant differences between the baseline and the scores at 1 and 4 weeks (P <0.01) but not at 8 or 12 weeks (P >0.05). Qmax and PVR were improved progressively and significantly at 1 and 4 weeks (P <0.01) but not at 8 or 12 weeks (P >0.05).. Four to eight weeks of oral administration of M-receptor blocker may be an effective dosage regimen for severe BPH with predominant USPSs after TURP.. 目的： 探讨储尿期症状明显的重度良性前列腺增生（BPH）患者经尿道前列腺电切术（TURP）后口服M-受体阻滞剂的用药方案及其临床效果。方法： 储尿期症状明显的重度BPH患者，TURP 6 h后开始口服酒石酸托特罗定片（2 mg 每12 h 1次或4 mg 1次/d），4周后停药，如储尿期症状加重，继续服药2周再停药观察，如此反复直至术后12周。回顾性分析其术前，术后1、4、8、12周IPSS评分（总分、储尿期、排尿期症状评分）、QoL评分、Qmax和排尿后膀胱残余尿（PVR）。结果： 临床资料完备病例共106例。其中4周停药后储尿期症状未加重（成功停药）者33例，6~8周成功停药者51例，10~12周成功停药者13例，12周后仍需继续服药者9例。术前,术后1、4、8、12周IPSS总分分别为（25.33±3.45）、（19.33±3.62）、（11.56±2.45）、（8.38±2.08）、（7.74±1.87）分；储尿期IPSS分别为（11.97±1.53）、（10.76±1.82）、（6.16±1.22）、（4.08±1.19）、（3.91±1.15）分；排尿期IPSS分别为（9.80±1.60）、（5.59±1.45）、（3.40±0.92）、（2.85±0.71）、（2.61±0.67）分；QoL评分为（4.70±0.78）、（3.92±0.75）、（2.55±0.74）、（1.83±0.72）、（1.66±0.75）分;除术后12周与术后8周比较外，术前、术后各观察点之间，IPSS各项指标均有显著性差异（P均<0.01）。QoL、Qmax、PVR术后1、4周呈现进行性改善（P均<0.01），4周后变化不再显著（P均>0.05）。结论： 储尿期症状明显的重度BPH患者TURP术后持续口服M-受体阻滞剂4~8周可能是治疗其术后储尿期症状的有效方案。.

Topics: Administration, Oral; Clinical Protocols; Drug Administration Schedule; Humans; Male; Muscarinic Antagonists; Postoperative Care; Prostatic Hyperplasia; Quality of Life; Recurrence; Tolterodine Tartrate; Transurethral Resection of Prostate; Treatment Outcome; Urination; Urological Agents

Real-world data on the pharmacological management of men who have lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) are limited.. To characterize men with LUTS/BPH who had both storage and voiding symptoms and to evaluate treatment patterns in UK primary care.. This was an observational study of men aged ≥45 years with a diagnosis, symptoms or therapies indicative of LUTS/BPH with both storage and voiding components. These men were identified from the large Health Improvement Network (THIN) database between 1 January 2004 and 30 September 2011.. Drug prescriptions and switching/discontinuation patterns for α₁-blockers and antimuscarinics.. We identified 8694 men with a median age of 66.0 (interquartile range [IQR], 59.0-74.0) years. Most (7850; 90.3%) received an α₁-blocker, and 2167 (24.9%) received antimuscarinic therapy over a median of 2.1 years. The most commonly prescribed α₁-blocker was tamsulosin (81.8%); most frequent antimuscarinics were tolterodine (41.0%), oxybutynin (37.2%) and solifenacin (35.7%). Concomitant prescription of α1-blocker and antimuscarinic therapy (within 30 days of each other) was received by 1160 men (14.8% of α₁-blocker-treated men). Of α₁-blocker recipients, 3024 (38.5%) discontinued during follow-up, while 1149 (53.0%) discontinued antimuscarinic therapy. Of 2167 men who received an antimuscarinic, 476 (22.0%) switched to another antimuscarinic. Of the three most commonly prescribed antimuscarinics, solifenacin had the lowest proportions of discontinuations (43.0%) and switches (15.3%), and the longest median duration of therapy (90 days, IQR 30-300). General practice consultations accounted for most resource use (5307.9 per 1000 patient-years).. This study presents real-world management of men with LUTS/BPH who have both storage and voiding symptoms. The low proportion of men who received concomitant α₁-blocker and antimuscarinic therapy suggests that some patients are sub-optimally treated in routine clinical practice.

Topics: Adrenergic alpha-1 Receptor Antagonists; Aged; Benzhydryl Compounds; Cresols; Family Practice; Humans; Lower Urinary Tract Symptoms; Male; Mandelic Acids; Middle Aged; Muscarinic Antagonists; Phenylpropanolamine; Primary Health Care; Prostatic Hyperplasia; Quinuclidines; Retrospective Studies; Solifenacin Succinate; Sulfonamides; Tamsulosin; Tetrahydroisoquinolines; Tolterodine Tartrate; United Kingdom

Storage symptoms, associated with benign prostatic hyperplasia (BPH), often co-exist with voiding symptoms in men with lower urinary tract symptoms (LUTS). Storage symptoms are likely to be most bothersome, and may not be adequately resolved by treatment with α-blocker or antimuscarinic monotherapy. A recent randomised controlled phase 3 trial (NEPTUNE) demonstrated that a fixed-dose combination (FDC) of solifenacin 6 mg plus an oral controlled absorption system (OCAS™) formulation of tamsulosin (TOCAS, 0.4 mg) improved storage symptoms, as well as quality of life, compared with TOCAS alone in men with moderate-to-severe storage symptoms and voiding symptoms. This analysis aimed to assess the cost-effectiveness of a FDC tablet of solifenacin 6 mg plus TOCAS relative to tolterodine plus tamsulosin given concomitantly, from the perspective of the UK National Health Service (NHS).. A Markov model was developed for men aged ≥45 years with LUTS/BPH who have moderate-to-severe storage symptoms and voiding symptoms. The model calculated cost-effectiveness over an analytical time horizon of 1 year and estimated total treatment costs, quality adjusted life years (QALYs) and incremental cost-effectiveness ratio.. The FDC tablet of solifenacin 6 mg plus TOCAS was associated with lower total annual costs (£860 versus £959) and increased QALYs (0.839 versus 0.836), and was therefore dominant compared with tolterodine plus tamsulosin. Time horizon, discontinuation or withdrawal rates, drug cost and utility values were the main drivers of cost-effectiveness. The probability that the FDC tablet of solifenacin 6 mg plus TOCAS is cost-effective was 100% versus tolterodine plus tamsulosin, at a willingness-to-pay threshold of £20,000/QALY gained.. The FDC tablet of solifenacin 6 mg plus TOCAS provides important clinical benefits and is a cost-effective treatment strategy in the UK NHS compared with tolterodine plus tamsulosin for men with both storage and voiding LUTS/BPH.

Topics: Administration, Oral; Aged; Aged, 80 and over; Cost-Benefit Analysis; Delayed-Action Preparations; Drug Combinations; Drug Therapy, Combination; Follow-Up Studies; Humans; Lower Urinary Tract Symptoms; Male; Markov Chains; Middle Aged; Prostatic Hyperplasia; Severity of Illness Index; Solifenacin Succinate; Sulfonamides; Tamsulosin; Tolterodine Tartrate; Treatment Outcome; Urodynamics

Patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) often present with voiding and storage symptoms, which may require combination therapy with an alpha blocker and an antimuscarinic (AM). This study compared treatment persistence in LUTS/BPH patients on alpha blocker monotherapy with those using combination alpha blocker and AM therapy (AB/AM).. Retrospective analysis of anonymized patient longitudinal prescription reimbursement claims data. All patients who had claims for any of four alpha blocker medications and six AM agents during an index period from April 1, 2011 to March 31, 2012 were included. For the combination therapy group, the effect of adherence with the AM medication on persistence to the alpha blocker was examined.. Patients on AB/AM combination therapy remained on alpha blockers for longer than those on alpha blocker monotherapy (p = 0.04); 92.4% were persistent at 3 months versus 89.0%, and at 1 year 50.8% were persistent versus 49.6%, respectively. The highest number of days on therapy was reported for tamsulosin plus solifenacin. As confirmed by multivariate analysis, patients with the highest adherence to AM medication (= 80%) persisted on alpha blockers for longer than those with the lowest (< 50%) adherence (p < 0.05).. Patients taking an AM in combination with an alpha blocker showed greater persistence with alpha blocker treatment over a 1 year period. When an AM is combined with an alpha blocker in patients with LUTS/BPH, the additional medication burden does not have a negative impact on persistence and may even improve it.

Topics: Administrative Claims, Healthcare; Adrenergic alpha-Antagonists; Aged; Benzofurans; Doxazosin; Drug Therapy, Combination; Humans; Longitudinal Studies; Male; Mandelic Acids; Medication Adherence; Middle Aged; Muscarinic Antagonists; Ontario; Prazosin; Prostatic Hyperplasia; Prostatism; Pyrrolidines; Quinazolines; Retrospective Studies; Solifenacin Succinate; Sulfonamides; Tamsulosin; Tolterodine Tartrate

To investigate the symptomatic and quality of life (QoL) response to treatment with tolterodine extended release (ER) in subgroups of male patients with Overactive Bladder Syndrome (OAB) and LUTS suggestive of non-obstructive benign prostatic hyperplasia (BPH) according to age, symptom severity, diabetes mellitus status, and concomitant treatment for LUTS.. Patients treated with tolterodine ER 4 mg/day for OAB symptoms, alone or added to unsuccessful alpha-blocker treatment of > or =6 weeks duration, and presumed non-obstructive BPH (Q (max) > or = 15 ml/s) were observed for 12 weeks in a non-interventional study. Patients completed the International Prostate Symptom Score (IPSS) and Overactive Bladder Questionnaire (OAB-q) at baseline and after 12 weeks.. 52.4% of 741 patients were aged < or =65 years; 4, 64, and 32% had mild, moderate, and severe symptoms, respectively, according to IPSS; 14% had diabetes mellitus, and in 42% tolterodine was added to alpha blockers. In the various subgroups, mean IPSS total scores improved by 2.8-11.1 points, IPSS QoL scores by 1.8-2.4 points, and all OAB-q subscores by more than 14 points. Only IPSS and OAB-q baseline scores had a relevant impact on changes during treatment, benefits were greatest in patients with more severe symptoms and bother.. In men with symptoms of OAB and LUTS suggestive of non-obstructive BPH of all IPSS severity classes, aged < or =65 years or above, with or without concomitant diabetes or alpha-blockers, symptoms and QoL improved markedly during treatment with tolterodine ER.

Topics: Adrenergic alpha-Antagonists; Age Factors; Aged; Benzhydryl Compounds; Cresols; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Therapy, Combination; Humans; Male; Middle Aged; Muscarinic Antagonists; Patient Satisfaction; Phenylpropanolamine; Probability; Prospective Studies; Prostatic Hyperplasia; Prostatism; Quality of Life; Regression Analysis; Severity of Illness Index; Statistics, Nonparametric; Tolterodine Tartrate; Treatment Outcome; Urinary Bladder, Overactive; Urodynamics

OBJECTIVES To evaluate the number of medical and urological conditions associated with nocturia in a cohort of older men who were primary-care enrolees, and to assess the feasibility and efficacy of using a multicomponent intervention to reduce nocturia and its bother. SUBJECTS AND METHODS Men aged > or =50 years and with two or more episodes of nocturia were recruited from the primary-care clinics at one Veterans Affairs Medical Center to participate in a 4-week, open-label, prospective pilot study. A multicomponent intervention composed of behavioural therapy and targeted drug therapy was administered according to a specified protocol based upon identified risk factors for nocturia. Outcome measures included self-reported nocturia and bother on the American Urological Association (AUA)-7 Symptom Index, 3-day bladder diaries and self-reported sleep-related measures recorded using 7-day sleep diaries. RESULTS Fifty-five men completed the protocol (mean age 67 years, sd 8.3); they had a mean of 4.5 of nine defined conditions potentially related to nocturia. Highly prevalent conditions included moderate-to-severe benign prostatic hyperplasia (87%), hypertension (86%) and urinary frequency (71%). The mean diary-recorded nocturia decreased from 2.6 to 1.9 (P < 0.001), and bother score reduced from 3.1 to 1.1, representing a change from a 'medium' to a 'very small' problem (on a 5-point scale). Sleep diary-derived measures also improved significantly (time to initiate sleep, time to return to sleep after awakening, quality of sleep). CONCLUSIONS Given that individual older patients often have multiple coexistent risk factors for nocturia, identifying a principal cause of nocturia, a concept emphasized in treatment guidelines, proved to be difficult. Implementing a multicomponent behavioural intervention combined with drug(s) was feasible in older men and reduced nocturia frequency, bother from nocturia, and time to initiate sleep, within 4 weeks. These promising results merit repeating using a randomized, controlled trial.

Topics: Acetamides; Adrenergic alpha-Antagonists; Aged; Behavior Therapy; Benzhydryl Compounds; Combined Modality Therapy; Cresols; Epidemiologic Methods; Humans; Hypnotics and Sedatives; Male; Middle Aged; Muscarinic Antagonists; Nocturia; Phenylpropanolamine; Prazosin; Prostatic Hyperplasia; Pyrimidines; Tolterodine Tartrate; Treatment Outcome; Urinary Bladder, Overactive

The efficacy of alpha1-adrenoceptor (alpha1-AR) antagonist and anticholinergic agent combined therapy for patients with benign prostatic hyperplasia (BPH) together with overactive bladder (OAB) has been controversial. The purpose of this study was to evaluate the effect of tolterodine combined with alpha1-AR antagonist for patients with BPH and OAB after insufficient efficacy by monotherapy with alpha1-AR antagonist. The adverse event of this combined therapy was also assessed.. The study included 47 patients with BPH, whose OAB symptom persisted (OAB symptom score; OABSS > or =3) after monotherapy with alpha1-AR antagonist for more than 4 weeks. The mean age was 72.9 years and the mean prostate volume was 29.8 ml. Four mg/day of tolterodine with alpha-AR antagonist was administered for 8 weeks to patients. International prostate symptom score (IPSS), quality of life (QOL) index, OABSS, King's Health Questionnaire (KHQ) and residual urine volume (RUV) were assessed before and after combined therapy.. Six patients were dropped out from this study because of dry mouth, constipation, onset of other disease and insufficient efficacy by self-judgment. IPSS (from 15.1 +/- 6.8 to 11.0 +/- 7.9; P < 0.01), QOL index (from 4.3 +/- 1.1 to 3.6 +/- 1.3; P < 0.01) and OABSS (from 7.0 +/- 3.0 to 5.4 +/- 2.9; P < 0.01) of 41 patients improved significantly by combined therapy. The storage symptom of IPSS subscore improved significantly (from 8.0 +/- 2.9 to 6.5 +/- 2.8; P < 0.01), whereas the voiding symptom did not improve. Regarding KHQ, the score of 3 domains (impact on life, role limitation, and physical limitation) improved significantly (P < 0.05). RUV did not change and no serious adverse event including urinary retention was found in this study.. This study reveals that the combined therapy of alpha-AR antagonist and tolterodine represents an effective and safe treatment modality for patients with BPH and OAB, whose OAB symptom was not improved by antecedent monotherapy with alpha-AR antagonist.

Topics: Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Aged; Aged, 80 and over; Benzhydryl Compounds; Cresols; Drug Therapy, Combination; Humans; Male; Middle Aged; Muscarinic Antagonists; Phenylpropanolamine; Prostatic Hyperplasia; Quality of Life; Tolterodine Tartrate; Treatment Outcome; Urinary Bladder, Overactive

Topics: Adrenergic alpha-Antagonists; Benzhydryl Compounds; Cresols; Doxazosin; Drug Therapy, Combination; Enzyme Inhibitors; Erectile Dysfunction; Finasteride; Humans; Imidazoles; Male; Muscarinic Antagonists; Phenylpropanolamine; Piperazines; Prostatic Hyperplasia; Sulfonamides; Sulfones; Tamsulosin; Tolterodine Tartrate; Triazines; Urination Disorders; Vardenafil Dihydrochloride

Topics: Benzhydryl Compounds; Cresols; Humans; Male; Muscarinic Antagonists; Phenylpropanolamine; Prostatic Hyperplasia; Tolterodine Tartrate; Treatment Outcome; Urination Disorders; Urodynamics

Topics: Adrenergic alpha-Antagonists; Aged; Benzhydryl Compounds; Cost-Benefit Analysis; Cresols; Drug Therapy, Combination; Humans; Male; Muscarinic Antagonists; Patient Satisfaction; Phenylpropanolamine; Prostatic Hyperplasia; Sulfonamides; Tamsulosin; Tolterodine Tartrate; Treatment Outcome; Urinary Bladder, Overactive; Urinary Incontinence, Urge

Topics: Adrenergic Agonists; Adrenergic alpha-Antagonists; Aged; Benzhydryl Compounds; Cresols; Drug Interactions; Drug Therapy, Combination; Histamine H1 Antagonists; Humans; Male; Muscarinic Antagonists; Phenylpropanolamine; Prostatic Hyperplasia; Sulfonamides; Tamsulosin; Tolterodine Tartrate; Urinary Bladder, Overactive; Urinary Incontinence, Urge

In this open label, prospective study we determined the efficacy and tolerability of tolterodine extended release (ER) in men with benign prostatic hyperplasia (BPH) and lower urinary tract symptoms (LUTS) in whom previous alpha-blocker therapy had failed.. A total of 43 consecutive men with BPH and LUTS in whom a mean of 5.7 months of alpha-blocker therapy had failed due to adverse events (11) or a lack of efficacy (32) received tolterodine ER (4 mg daily) for 6 months. Primary efficacy end points were American Urological Association symptom score, and mean daytime and nighttime micturition frequency. Secondary end points were the peak urinary flow rate, post-void residual volume, the incidence of urinary retention, total score on the erectile function domain of the International Index of Erectile Function and adverse events.. A total of 39 men (91%) with a mean age of 61 years completed the 6-month trial. Mean 24-hour micturition frequency decreased from 9.8 to 6.3 voids and nocturia decreased from 4.1 to 2.9 episodes nightly. Significant changes in mean American Urological Association symptom scores (-6.1), the peak urinary flow rate (1.9 ml per second) and post-void residual volume (-22 ml) were also observed. Of the men 27 (63%) were potent at baseline and 29 (67%) were potent after 6 months of tolterodine ER treatment. Mean International Index of Erectile Function erectile function domain scores increased (6.9). Four men (9%) discontinued therapy because of intolerable dry mouth. There were no reports of urinary retention.. Treatment with tolterodine ER in men with BPH and LUTS may be a reasonable therapeutic option as initial therapy or after failed treatment with alpha-blockers.

Topics: Adrenergic beta-Antagonists; Aged; Aged, 80 and over; Benzhydryl Compounds; Cresols; Delayed-Action Preparations; Humans; Incidence; Male; Middle Aged; Muscarinic Antagonists; Penile Erection; Phenylpropanolamine; Prospective Studies; Prostatic Hyperplasia; Time Factors; Tolterodine Tartrate; Treatment Outcome; Urinary Retention; Urination

To assess the efficacy of combined treatment with doxazosin and tolterodine, as although alpha-blockers are commonly used and generally effective in men with symptomatic bladder outlet obstruction (BOO), a subset of men with BOO and overactive bladder (OAB) symptoms often complain of persistent symptoms.. In a prospective study of 144 consecutive men with BOO at one tertiary urology centre, all had a baseline pressure-flow urodynamic study and were then subdivided into those with BOO or BOO + OAB, based on absence or presence of involuntary detrusor contractions. The Abrams-Griffiths nomogram was used to determine obstructive BOO. After the initial evaluation, all patients were treated with doxazosin 4 mg/day for 3 months. In patients with no symptomatic improvement, tolterodine 2 mg twice daily was added for an additional 3 months.. Of the 144 patients, 76 (53%) were diagnosed as having BOO and 68 (47%) BOO + OAB. The patients with BOO + OAB were older (P < 0.05) and had a higher International Prostate Symptom Score. After 3 months of treatment with doxazosin, 60 (79%) with BOO and 24 (35%) BOO + OAB reported a symptomatic improvement. In those patients with no improvement, six of 16 with BOO and 32 of 44 (73%) with BOO + OAB improved after adding tolterodine. Acute urinary retention developed in only two of 60 men (3.3%) treated with the combined therapy.. About half of men with symptomatic BOO had an OAB; while about three-quarters of men with symptomatic BOO and no OAB improved with doxazosin, only a third with BOO + OAB were helped with doxazosin alone. Combining tolterodine with doxazosin was effective in three-quarters of men with BOO + OAB. Overall, most men with BOO with or with no OAB were helped with doxazosin alone or with the addition of tolterodine.

Topics: Adrenergic alpha-Antagonists; Benzhydryl Compounds; Cresols; Doxazosin; Humans; Male; Middle Aged; Phenylpropanolamine; Prospective Studies; Prostatic Hyperplasia; Tartrates; Tolterodine Tartrate; Treatment Outcome; Urinary Bladder Neck Obstruction; Urinary Incontinence; Urodynamics