tolterodine-tartrate and alfuzosin

To evaluate the effects of tolterodine extended release (ER) and alfuzosin for the treatment of Double-J stent-related lower urinary tract symptoms.. Fifty-two patients (33 men and 19 women; mean age 52.0 years) who underwent insertion of a Double-J stent after urological surgery were prospectively randomized into three groups. Group 1 included 20 patients who received 10 mg of alfuzosin, once daily for 6 weeks; group 2 included 20 patients who received 4 mg of tolterodine ER, once daily for 6 weeks; group 3 included 12 patients who received a placebo for the same protocol. All patients completed a validated Ureteral Stent Symptom Questionnaire at 6 weeks after the stent placement.. The mean urinary symptom index was 22.1 in group 1, 22.1 in group 2, and 28.1 in the placebo group (p = 0.032). The mean pain scores were 8.2, 11.7, and 16.2, respectively (p = 0.020). There were no significant differences in urinary symptoms and pain between the alfuzosin and tolterodine ER groups. In addition, there was no significant difference in the general health, work performance, and sexual performance scores among the groups.. Tolterodine ER and alfuzosin improve stent-related urinary symptoms and body pain.

Topics: Adolescent; Adrenergic alpha-Antagonists; Adult; Aged; Aged, 80 and over; Benzhydryl Compounds; Cresols; Delayed-Action Preparations; Demography; Female; Humans; Male; Middle Aged; Muscarinic Antagonists; Phenylpropanolamine; Postoperative Complications; Quinazolines; Stents; Surveys and Questionnaires; Tolterodine Tartrate; Young Adult

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

Pediatric drug development is challenging when a product is studied for a pediatric disease that has a different underlying etiology and pathophysiology compared to the adult disease. Neurogenic bladder dysfunction (NBD) is such a therapeutic area with multiple unsuccessful development programs. The objective of this study was to critically evaluate clinical trial design elements that may have contributed to unsuccessful drug development programs for pediatric NBD. Trial design elements of drugs tested for pediatric NBD were identified from trials submitted to the U.S. Food and Drug Administration. Data were extracted from publically available FDA reviews and labeling and included trial design, primary endpoints, enrollment eligibilities, and pharmacokinetic data. A total of four products were identified. Although all four programs potentially provided clinically useful information, only one drug (oxybutynin) demonstrated efficacy in children with NBD. The lack of demonstrable efficacy for the remainder of the products illustrates that future trials should give careful attention to testing a range of doses, using objectively measured, clinically meaningful endpoints, and selecting clinical trial designs that are both interpretable and feasible. Compiling the drug development experience with pediatric NBD will facilitate an improved approach for future drug development for this, and perhaps other, therapeutic areas.

Topics: Adolescent; Adrenergic alpha-1 Receptor Antagonists; Area Under Curve; Benzhydryl Compounds; Child; Child, Preschool; Cresols; Delayed-Action Preparations; Humans; Infant; Mandelic Acids; Marine Toxins; Muscarinic Antagonists; Oxocins; Phenylpropanolamine; Quinazolines; Tablets; Tolterodine Tartrate; Urinary Bladder, Neurogenic

Large, controlled trials in chronic pelvic pain syndrome (CPPS) have failed due to patient heterogeneity. To phenotype CPPS patients, we developed the UPOINT system with 6 domains (Urinary, Psychosocial, Organ-Specific, Infection, Neurologic/Systemic and Tenderness). In this study, we treated patients with multimodal therapy based on the UPOINT phenotype and measured response after at least 6 months.. Patients with CPPS were offered multimodal therapy based on the UPOINT phenotype (eg, Urinary: alpha blocker or antimuscarinic; Organ-specific: quercetin; Tenderness: physical therapy). One hundred patients agreed to therapy and were reexamined after 26 weeks. Primary endpoint was a minimum 6-point drop in NIH-Chronic Prostatitis Symptom Index (CPSI).. Mean age was 46 years, and median symptom duration was 24 months. A median of 3 UPOINT domains were positive, the most common being Organ-specific (70%), Tenderness (64%), and Urinary (59%). With a median 50-week follow-up, 84% had at least a 6-point fall in CPSI. Number of domains and initial CPSI did not predict response. Mean changes (+/-SD) for CPSI subscores were pain 11.5+/-3.2 to 6.1+/-3.9, urine 4.7+/-3.1 to 2.6+/-2.0, QOL 9.1+/-2.3 to 4.5+/-2.8, and total 25.2+/-6.1 to 13.2+/-7.2 (all P<.0001). No domain predicted outcome; however, quercetin use resulted in a greater CPSI decrease.. Multimodal therapy using UPOINT leads to significant improvement in symptoms and quality of life. Moreover, a placebo-controlled trial for every therapy combination is not feasible, and results using UPOINT compare favorably with all large trials of monotherapy.

Topics: Adolescent; Adrenergic alpha-Antagonists; Adult; Aged; Benzhydryl Compounds; Chronic Disease; Cohort Studies; Cresols; Drug Therapy, Combination; Follow-Up Studies; Humans; Male; Middle Aged; Muscarinic Antagonists; Pain Measurement; Pelvic Pain; Phenotype; Phenylpropanolamine; Probability; Prospective Studies; Prostatitis; Quinazolines; Risk Assessment; Severity of Illness Index; Tolterodine Tartrate; Treatment Outcome; Young Adult