The Efficacy of Solifenacin With or Without Tamsulosin in Adult Women With Overactive Bladder (OAB)

Study Overview
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Brief Summary
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The aim of the study is to investigate if the combination therapy consisting of anticholinergics plus alpha-blockers could be beneficial for women suffering from Overactive Bladder (OAB).

Detailed Description
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Overactive bladder (OAB) describes the symptom complex of urgency, with or without urge incontinence, usually with frequency and nocturia. The lower urinary tract is innervated by both the parasympathetic and the sympathetic nervous system, that act via muscarinic and adrenergic receptors, respectively. Antimuscarinics are mainly used for the treatment of patients with OAB, especially women. Other than antimuscarinics, a1-blockers have been shown in several clinical reports to be useful in treating DO caused by neurological diseases.

Official Title
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Comparison of the Efficacy of Solifenacin With or Without Tamsulosin in Adult Women With OAB: A Prospective Randomized Multicenter Study

Conditions
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Overactive Bladder

Intervention / Treatment
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* Drug: Solifenacin
* Drug: Solifenacin plus Tamsulosin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female aged 20 ≤ and < 70 years History of OAB symptoms for ≥ 3 months International Prostate Symptom Score (IPSS) ≥ 8 points at Screening and more than 3 in total score and 2 in Q 3 index from OABSS questionnaire An average of ≥ 8 micturitions per 24 hours and ≥ 1 urgency (defined as a level of 3 to 5 in a 5 point Urinary Sensation Scale) episode (with or without incontinence) per 24 hours as documented in a 3-day micturition diary Exclusion Criteria: Uroflowmetry - Q max ≤ 10 mL/sec, or Post Void Residual Volume ≥ 15% of voided urine Any condition that would contraindicate their usage of anticholinergics or alpha blockers History of lower urinary tract surgery (e.g. incontinence surgery or electrostimulation) History of stress urinary incontinence or urinary retention History of interstitial cystitis, bladder outlet obstruction or other significant genitourinary disorder Pregnant or nursing women Current urinary tract infection Neurological bladder dysfunction Treatment with drugs that may interfere with CYP3A4 metabolic function Significant hepatic or renal disease Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Solifenacin<br> | Drug: Solifenacin<br>* Solifenacin (5mg, qd, oral)<br>* Other names: Vesicare;|
| Experimental: Solifenacin plus Tamsulosin<br> | Drug: Solifenacin plus Tamsulosin<br>* Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)<br>* Other names: Harnal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Number of Micturition Episodes Per 24 Hours |  | at week 24 relative to baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Change of Urgency Episodes Per 24 Hours |  | at week 24 relative to baseline | 
| Change in Total Score of OABSS | Total Score of OABSS(Overactive Bladder Symptom Score) is the sum of 4 questions, ranging from 0 (best possible outcome) to 15 (worst possible outcome) | at week 24 relative to baseline | 
| Change in Score of IPSS | Total Score of IPSS(International Prostate Symptom Score) is the sum of 7 questions, ranging from 0 (best possible outcome) to 35 (worst possible outcome). The 7 symptom questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each referring to during the last month, and each involving assignment of a score from 0 to 5 for a total of maximum 35 points. | at week 24 relative to baseline | 
| Change of PVR | Change from baseline in Post-Void Residual (PVR) volume | at week 24 relative to baseline | 
| Change of Qmax | maximal urinary flow rate (Qmax) assessed by uroflowmetry | at week 24 relative to baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overactive bladder, Solifenacin succinate, Tamsulosin