doxazosin and Urinary Incontinence studies

Doxazosin: A prazosin-related compound that is a selective alpha-1-adrenergic blocker.
doxazosin : A member of the class of quinazolines that is quinazoline substituted by an amino group at position 4, methoxy groups at positions 6 and 7 and a piperazin-1-yl group at position 2 which in turn is substituted by a 2,3-dihydro-1,4-benzodioxin-2-ylcarbonyl group at position 4. An antihypertensive agent, it is used in the treatment of high blood pressure.

Urinary Incontinence: Involuntary loss of URINE, such as leaking of urine. It is a symptom of various underlying pathological processes. Major types of incontinence include URINARY URGE INCONTINENCE and URINARY STRESS INCONTINENCE.

Research Excerpts

Excerpt	Relevance	Reference
"Doxazosin was usually added as the fifth antihypertensive drug in individuals who were either unresponsive to or intolerant of the combination of other antihypertensives."	5.35	Doxazosin: safety and efficacy in the treatment of resistant arterial hypertension. ( Ceral, J; Solar, M, 2009)
" However, the incidence of nocturnal enuresis, urgency attacks, and daytime incontinence were significantly reduced compared with baseline in the tizanidine group (P=."	5.16	Doxazosin versus tizanidine for treatment of dysfunctional voiding in children: a prospective randomized open-labeled trial. ( Dawaba, M; El-Assmy, MM; El-Hefnawy, AS; Hafez, AT; Helmy, T; Sarhan, O, 2012)
"Compared to placebo, doxazosin did not demonstrate a significant objective benefit, but produced a significant subjective benefit in the treatment of urinary incontinence secondary to voiding dysfunction."	5.11	Double-blind placebo controlled study of alpha-adrenergic receptor antagonists (doxazosin) for treatment of voiding dysfunction in the pediatric population. ( Elkins, D; Husmann, DA; Karnes, RJ; Kramer, SA; Rathbun, SR, 2005)
" All patients received a selective α1-blocker (doxazosin) for 6-8 weeks with an initial dosage of 0."	1.43	An Evaluation of the Efficacy of Selective Alpha-Blockers in the Treatment of Children with Neurogenic Bladder Dysfunction--Preliminary Findings. ( Gajewska, E; Kroll, P; Mańkowski, P; Sobieska, M; Zachwieja, J, 2016)
"Doxazosin was usually added as the fifth antihypertensive drug in individuals who were either unresponsive to or intolerant of the combination of other antihypertensives."	1.35	Doxazosin: safety and efficacy in the treatment of resistant arterial hypertension. ( Ceral, J; Solar, M, 2009)

Research

Studies (15)

Authors

Clinical Trials (2)

Trial Overview

Trial Outcomes

Change From Baseline in Urinary Growth Factor to Creatinine Ratio (GF/Cr)

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	2 (13.33)	18.2507
2000's	10 (66.67)	29.6817
2010's	3 (20.00)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Sarkar, D	1
Kumar, M	1
Kroll, P	1
Gajewska, E	1
Zachwieja, J	1
Sobieska, M	1
Mańkowski, P	1
Ceral, J	1
Solar, M	1
El-Hefnawy, AS	1
Helmy, T	1
El-Assmy, MM	1
Sarhan, O	1
Hafez, AT	1
Dawaba, M	1
Camarasa García, F	1
García Herola, A	1
de Teresa Parreño, L	1
Cain, MP	1
Wu, SD	1
Austin, PF	1
Herndon, CD	1
Rink, RC	1
Yang, SS	1
Wang, CC	1
Chen, YT	1
Lee, JY	1
Kim, HW	1
Lee, SJ	1
Koh, JS	1
Suh, HJ	1
Chancellor, MB	1
Athanasopoulos, AA	1
Perimenis, PS	1
Kramer, SA	1
Rathbun, SR	1
Elkins, D	1
Karnes, RJ	1
Husmann, DA	1
Slavov, Ch	1
Dimitrov, R	1
Lee, KS	1
Choo, MS	1
Kim, DY	1
Kim, JC	1
Kim, HJ	1
Min, KS	1
Lee, JB	1
Jeong, HJ	1
Lee, T	1
Park, WH	1
Athanasopoulos, A	1
Perimenis, P	1
Marshall, HJ	1
Beevers, DG	1
Serels, S	1
Stein, M	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Urinary Nerve Growth Factor as a Biomarker for Medical Treatment of Male Lower Urinary Tract Symptoms: A Pilot Trial[NCT01457573]	Phase 4	10 participants (Actual)	Interventional	2011-10-31	Completed
Antimuscarinics as the First-line Treatment for Male With International Prostate Symptom Score (IPSS) Voiding-to-storage Subscore Rati (IPSS-V/S)≤1-- A Prospective Randomized Study Comparing With α-blockers[NCT01661621]	Phase 4	395 participants (Actual)	Interventional	2012-08-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

The urinary growth factor (GF) to creatinine ratio may be potential biomarker for overactive bladder, based on published articles. Measuring the ratio at baseline and Month 3, comparing the difference after treatment with tamsulosin and solifenacin which may provide insight into how lower urinary tract symptoms in men progresses. (NCT01457573)
Timeframe: change from baseline score to Month 3

Change in Urinary Nerve Growth Factor (pg/mL) at Baseline Compared to Post Dose Exposure at Mo.3/Wk12

Intervention	ratio (Mean)
Baseline Characteristics	-19.61

Urine sample tested for urinary Nerve Growth Factor (uNGF as measured in pg/mL), a small secreted protein in the bladder that supports bladder function regulation, at baseline (pre-dose) and week 12/Month 3 post-dose, after using daily tamsulosin and solifenacin. (NCT01457573)
Timeframe: Change from baseline to week 12 (3 months)

Change in ICIQ LUTS QoL -International Consultation on Incontinence Modular Questionnaire LUTS Quality of Life for Male LUTS Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12

Intervention	pg/ml (Mean)
Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg	-10.9

Change in the International Consultation on Incontinence Modular Questionnaire on lower urinary tract symptoms quality of life survey for men, self administered, compared to Month 1, Month 2, and Month 3, after exposure to tamsulosin and solifenacin. The survey scoring is zero to 182, with 182 being the most bothersome and 0 to 1 being the least bothersome. (NCT01457573)
Timeframe: Change from baseline to months 1, 2 and 3

Change in ICIQ-MLUTS - International Consultation on Incontinence Modular Questionnaire for Male LUTS Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12

Intervention	units on a scale (Mean)
	Change at Month 1	Change at Month 2	Change at Month 3
Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg	34.60	38.30	-9.00

Measuring change in the International Consultation on Incontinence Modular Questionnaire for male lower urinary tract symptoms through a self administered survey at baseline compared to Month 1, Month 2, and Month 3, after exposure to tamsulosin and solifenacin. The survey score is a zero to 182 range with 182 being the most bothersome and zero to one being the least bothersome. (NCT01457573)
Timeframe: Change from baseline to months 1, 2 and 3

Change in IPSS-International Prostate Score Scale at Baseline Compared to Post Dose Survey at Month 1, 2, and Month 3/Week12.

Intervention	units on a scale (Mean)
	Change at Month 1	Change at Month 2	Change at Month 3
Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg	-22.40	-22.20	-29.8

The survey, IPSS-International Prostate Score Scale, survey responses measured 0-35, is collected at baseline compared to post dose survey response at Month 1, Month 2, and Month 3/Week12 post-dose. The lower the score is indicative of less or fewer urinary symptoms while 35 is consistent with more bothersome symptoms. (NCT01457573)
Timeframe: Change from baseline to months 1, 2 and 3

Change in Maximum Urinary Flow Rate (ml/s) at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12

Intervention	units on a scale (Mean)
	Change at Month 1	Change at Month 2	Change at Month 3
Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg	-2.00	-5.30	-7.33

Urination flow rate (measured in milliliters per second) at baseline (pre-dose), and Month 1, Month 2, and Month 3/Week 12 pose-dosing with tamsulosin and solifenacin. An average maximum urinary flow rate in males is 21 ml/sec aged 14-45 years-old and 12 ml/sec in males aged 46-65 years-old. (NCT01457573)
Timeframe: Change from baseline to months 1, 2 and 3

Change in PBC-Patient Perception of Bladder Condition at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12

Intervention	ml/s (Mean)
	Change at Month 1	Change at Month 2	Change at Month 3
Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg	-3.20	-3.90	-4.70

Change in the Perception of Bladder through a self administered survey at baseline compared to Month 1, Month 2, and Month 3, following exposure to tamsulosin and solifenacin. The survey score measures from zero to 6, with 6 being the most bothersome bladder symptoms and 0 to 1 being the least bothersome. (NCT01457573)
Timeframe: Change from baseline to months 1, 2 and 3

Change in Post Void Residual (mL) at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12

Intervention	units on a scale (Mean)
	Change at Month 1	Change at Month 2	Change at Month 3
Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg	1.29	0.29	0.00

Urine sample tested for urinary post void residual (measured in mL) at baseline (pre-dose), Month 1 and Month 2and week 12/Month 3 post-dose, post dose w/tamsulosin and solifenacin. (NCT01457573)
Timeframe: Change from baseline to months 1, 2 and 3

Change in PPUS-Patient Perception of Urinary Urgency Survey Score at Baseline Compared to Post Dose Exposure at Mo.1, Mo, 2, and Mo. 3/Wk12

Intervention	ml (Mean)
	Change at Month 1	Change at Month 2	Change at Month 3
Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg	-6.90	-10.00	-3.60

The Patient Perception of Urinary Urgency self administered survey score has a maximum score 4, zero to four, for how severe a patient describes their urinary voiding frequency. Four is the most bothersome score, 0 or 1 is the least bothersome. Pre-dose / baseline score is compared at Month 1, Month 2, and Month 3, after dosing with tamsulosin and solifenacin. (NCT01457573)
Timeframe: Change from baseline to months 1, 2 and 3

Change in Urinary Growth Factor to Creatinine Ratio (GF/Cr) From Baseline Compared to Month 1/Week4 and Month 2/Week 8.

Intervention	units on a scale (Mean)
	Change at Month 1	Change at Month 2	Change at Month 3
Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg	0.00	0.30	0

Assessing the change from baseline to Month 1/Week 4 and Month 2/Week 8, of the urinary growth factor (GF) to creatinine ratio in men, which may be potential biomarker for overactive bladder, based on published articles. Measuring the ratio at baseline compared to Month 1 and Month 2 may provide insight into how lower urinary tract symptoms in men progresses. (NCT01457573)
Timeframe: change from baseline score to Mo.1/Wk4 and Mo.2/Wk8 scores

Change in Urinary Nerve Growth Factor (pg/mL) at Baseline Compared to Post Dose Exposure at Mo.1/Wk4 and Mo.2/Wk8

Intervention	ratio (Mean)
	Change at Month 1	Change at Month 2
Baseline Characteristics	-21.85	-20.56

Urine sample tested for urinary Nerve Growth Factor (uNGF as measured in pg/mL), a small secreted protein in the bladder that supports bladder function regulation, at baseline (pre-dose) compared to Month 1/Week 4 and Month 2/Week 8, post dosing with tamsulosin and solifenacin. (NCT01457573)
Timeframe: Change from baseline to Mo.1/Wk4 and Mo.2/Wk8

The Global Response Assessment (GRA) After the Treatment Day

Intervention	pg/ml (Mean)
	Change at Month 1	Change at Month 2
Single Arm Receiving Tamsulosin 0.4 mg and Solifenacin 5 mg	11.17	15.64

"Efficacy Using global response assessment (GRA) to compare the efficacy in Group 1 and Group 2 from baseline to 1month.~The global response assessment on a 6-point scale ranging from 1 No problems at all to 6 Many severe problems.~Changes of the global response assessment (GRA) improved or reduction by 1 points.~Change = Baseline minus Month 1 value~Safety:~Systemic adverse events such as difficult urination, dry mouth, dry eye, blurred vision, constipation, dizziness or general weakness" (NCT01661621)
Timeframe: 1 month after initial treatment

The International Prostate Symptom Score (IPSS) Quality of Life (QoL) Score After the Treatment Day

Intervention	participants (Number)
	GRA≥1	GRA<1
Group 1	89	27
Group 2	218	61

"Efficacy:~Using the the the International Prostate Symptom Score (IPSS) quality of life (QoL) score to compare the efficacy in Group 1 and Group 2 from baseline to 1month.~The IPSS quality of life question score on a 7-point scale ranging from 0 Delighted to 6 Terrible.~IPSS-QoL ranges 0 to 6 (Delighted to Terrible)~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness" (NCT01661621)
Timeframe: Baseline and 1 month

The International Prostate Symptom Score (IPSS) Questionnaires After the Treatment Day

Intervention	units on a scale (Mean)
	Baseline	1 month
Group 1	3.91	2.82
Group 2	3.88	2.82

"Efficacy:~Using the total International Prostate Symptom Score (IPSS) to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.~The International Prostate Symptom Score (IPSS) is an 7 symptom questions including 4 voiding questions (IPSS-voiding), 3 storage questions (IPSS-Storage) The symptom score have 6-point scale ranging from 0 Not at all to 5 Almost always.~Total IPSS score = IPSS-voiding + IPSS-Storage Rang = 0 to 35 (asymptomatic to very symptomatic). Mild = 0 to 7; Moderate = 8 to 19; Severe = 20 to 35~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness" (NCT01661621)
Timeframe: Baseline and 1 month

The IPSS Subscore (IPSS Storage) Questionnaires After the Treatment Day

Intervention	units on a scale (Mean)
	Baseline	1 month
Group 1	14.8	11.2
Group 2	18.0	10.8

"Efficacy:~Using the the IPSS subscore (IPSS Storage) to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.~The IPSS subscore (IPSS Storage) is a 3 symptom questions. The symptom score have 6-point scale ranging from 0 Not at all to 5 Almost always. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.~The total IPSS Storage score can therefore range from 0 to 15 (asymptomatic to very symptomatic).~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness" (NCT01661621)
Timeframe: Baseline and 1 month

The IPSS Subscore (IPSS Voiding) Questionnaires After the Treatment Day

Intervention	units on a scale (Mean)
	Baseline	1 month
Group 1	9.51	6.40
Group 2	5.70	4.31

"Efficacy:~Using the the IPSS subscore (IPSS Voiding) questionnaires to compare the efficacy in Group 1 and Group 2 from baseline to 1 month.~The IPSS subscore (IPSS Voiding) questionnaires is a 4 symptom questions. The symptom score have 6-point scale ranging from 0 Not at all to 5 Almost always. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom.~The total IPSS Voiding score can therefore range from 0 to 20 (asymptomatic to very symptomatic).~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness" (NCT01661621)
Timeframe: Baseline and 1 month

The Maximum Flow Rate (Qmax) After the Treatment Day

Intervention	units on a scale (Mean)
	Baseline	1 month
Group 1	5.31	4.84
Group 2	12.3	6.49

"Efficacy:~Net change used the the maximum flow rate (Qmax) in Group 1 and Group 2 from baseline to 1 month.~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness" (NCT01661621)
Timeframe: Baseline and 1 month

The Postvoid Residual Volume (PVR) After the Treatment Day

Intervention	mL/s (Mean)
	Baseline	1 month
Group 1	13.1	13.6
Group 2	11.4	13.6

"Efficacy:~Net change used the the postvoid residual volume (PVR) in Group 1 and Group 2 from baseline to 1 month.~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness" (NCT01661621)
Timeframe: Baseline and 1 month

The Voided Volume After the Treatment Day

Intervention	mL (Mean)
	Baseline	1 month
Group 1	50.1	60.4
Group 2	53.9	42.9

"Efficacy:~Net change used the the voided volume in Group 1 and Group 2 from baseline to 1 month.~Safety:~Systemic adverse events such as difficult urination, dry mouth, blurred vision, constipation, dry eye, dizziness, or general weakness" (NCT01661621)
Timeframe: Baseline and 1 month

Article	Year
Doxazosin versus tizanidine for treatment of dysfunctional voiding in children: a prospective randomized open-labeled trial. Urology, 2012, Volume: 79, Issue:2 Topics: Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-2 Receptor Agonists; Anorexia; Child; Chil	2012
Alpha blocker therapy for children with dysfunctional voiding and urinary retention. The Journal of urology, 2003, Volume: 170, Issue:4 Pt 2 Topics: Adolescent; Adrenergic alpha-Antagonists; Antibiotic Prophylaxis; Child; Child, Preschool; Dose-Resp	2003
Double-blind placebo controlled study of alpha-adrenergic receptor antagonists (doxazosin) for treatment of voiding dysfunction in the pediatric population. The Journal of urology, 2005, Volume: 173, Issue:6 Topics: Adolescent; Adrenergic alpha-Antagonists; Child; Double-Blind Method; Doxazosin; Female; Humans; Mal	2005
Combination treatment with propiverine hydrochloride plus doxazosin controlled release gastrointestinal therapeutic system formulation for overactive bladder and coexisting benign prostatic obstruction: a prospective, randomized, controlled multicenter st The Journal of urology, 2005, Volume: 174, Issue:4 Pt 1 Topics: Adrenergic alpha-Antagonists; Aged; Benzilates; Comorbidity; Delayed-Action Preparations; Doxazosin;	2005
Prospective study comparing hyoscyamine, doxazosin, and combination therapy for the treatment of urgency and frequency in women. Neurourology and urodynamics, 1998, Volume: 17, Issue:1 Topics: Adrenergic alpha-Antagonists; Adult; Aged; Aged, 80 and over; Atropine; Cross-Over Studies; Delayed-	1998

Article	Year
An interesting case of an antihypertensive causing post-prostatectomy incontinence. BMJ case reports, 2015, Sep-30, Volume: 2015 Topics: Aged; Antihypertensive Agents; Doxazosin; Humans; Laparoscopy; Male; Prostate-Specific Antigen; Pros	2015
An Evaluation of the Efficacy of Selective Alpha-Blockers in the Treatment of Children with Neurogenic Bladder Dysfunction--Preliminary Findings. International journal of environmental research and public health, 2016, Mar-15, Volume: 13, Issue:3 Topics: Adolescent; Adrenergic alpha-Antagonists; Child; Child, Preschool; Doxazosin; Female; Humans; Male;	2016
Doxazosin: safety and efficacy in the treatment of resistant arterial hypertension. Blood pressure, 2009, Volume: 18, Issue:1-2 Topics: Adrenergic alpha-Antagonists; Aged; Antihypertensive Agents; Diuretics; Dose-Response Relationship,	2009
[Doxazosin and urinary incontinence]. Anales de medicina interna (Madrid, Spain : 1984), 2002, Volume: 19, Issue:10 Topics: Adrenergic alpha-Antagonists; Doxazosin; Female; Humans; Middle Aged; Urinary Incontinence	2002
Effectiveness of alpha1-adrenergic blockers in boys with low urinary flow rate and urinary incontinence. Journal of the Formosan Medical Association = Taiwan yi zhi, 2003, Volume: 102, Issue:8 Topics: Adolescent; Adrenergic alpha-Antagonists; Child; Child, Preschool; Doxazosin; Humans; Male; Treatmen	2003
Comparison of doxazosin with or without tolterodine in men with symptomatic bladder outlet obstruction and an overactive bladder. BJU international, 2004, Volume: 94, Issue:6 Topics: Adrenergic alpha-Antagonists; Benzhydryl Compounds; Cresols; Doxazosin; Humans; Male; Middle Aged; P	2004
Comparison of doxazosin with or without tolterodine in men with symptomatic bladder outlet obstruction and an overactive bladder. BJU international, 2004, Volume: 94, Issue:6 Topics: Adrenergic alpha-Antagonists; Benzhydryl Compounds; Cresols; Doxazosin; Humans; Male; Middle Aged; P	2004
Comparison of doxazosin with or without tolterodine in men with symptomatic bladder outlet obstruction and an overactive bladder. BJU international, 2004, Volume: 94, Issue:6 Topics: Adrenergic alpha-Antagonists; Benzhydryl Compounds; Cresols; Doxazosin; Humans; Male; Middle Aged; P	2004
Comparison of doxazosin with or without tolterodine in men with symptomatic bladder outlet obstruction and an overactive bladder. BJU international, 2004, Volume: 94, Issue:6 Topics: Adrenergic alpha-Antagonists; Benzhydryl Compounds; Cresols; Doxazosin; Humans; Male; Middle Aged; P	2004
Comparison of doxazosin with or without tolterodine in men with symptomatic bladder outlet obstruction and an overactive bladder. BJU international, 2005, Volume: 95, Issue:7 Topics: Benzhydryl Compounds; Cresols; Doxazosin; Humans; Muscarinic Antagonists; Phenylpropanolamine; Tolte	2005
[LUTS in women and possible therapeutic effects of alfa1-adrenoblockers]. Khirurgiia, 2004, Volume: 60, Issue:4-5 Topics: Adrenergic alpha-Antagonists; Adult; Aged; Doxazosin; Female; Humans; Middle Aged; Receptors, Adrene	2004
Alpha-adrenoceptor blocking drugs and female urinary incontinence: prevalence and reversibility. British journal of clinical pharmacology, 1996, Volume: 42, Issue:4 Topics: Adrenergic alpha-Antagonists; Doxazosin; Female; Humans; Prazosin; Prevalence; Urinary Incontinence	1996

doxazosin and Urinary Incontinence