Efficacy of Darifenacin and Physiotherapy for the Treatment of Overactive Bladder in Women

Study Overview
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Brief Summary
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Overactive bladder is a common problem among adult women. Darifenacin is an antimuscarinic drug that is frequently used as part of the management of the condition. However, current evidence backing its use is limited. This study aims to address Darifenacin's effectiveness in adjunct to physiotherapy in treating symptoms due to overactive bladder.

Official Title
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Efficacy of Darifenacin and Physiotherapy for the Treatment of Overactive Bladder in Women

Conditions
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Overactive Bladder

Intervention / Treatment
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* Drug: Darifenacin
* Procedure: Physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with overactive bladder as diagnosed and confirmed by a urologist. Able to answer the ICIC, King's Health Questionnaire and Overactive Bladder Questionnaire. Able and willing to receive urodynamic studies. Exclusion Criteria: History of pelvic radiotherapy. Recent pelvic surgery (<1 year). History of anti-incontinence surgery. Pregnancy.

Ages Eligible for Study
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Minimum Age: 16 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Darifenacin + Physiotherapy<br>Patients allocated to this group will receive Darifenacin 7.5mg daily in addition to physiotherapy for 12 weeks. This dose may be increased up to 7.5mg twice daily in follow-up visits in cases of refractory symptoms. | Drug: Darifenacin<br>* Darifenacin will be prescribed in a starting dose of 7.5mg, once daily. This dose may be increased to 15mg a day in cases with refractory symptoms.<br>* Other names: Enablex;Procedure: Physiotherapy<br>* All patients will received a tailored pelvic floor exercise programme as part of the standard of care of overactive bladder at the study centre. This intervention will be mainly comprised of biofeedback stimulation techniques.<br>|
| Active Comparator: Physiotherapy<br>Patients allocated to this arm will receive a tailored pelvic floor exercise programme in addition to a matching placebo pill. | Procedure: Physiotherapy<br>* All patients will received a tailored pelvic floor exercise programme as part of the standard of care of overactive bladder at the study centre. This intervention will be mainly comprised of biofeedback stimulation techniques.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Overall quality of life as established by the Overactive Bladder Questionnaire. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overactive Bladder Symptoms | Presence of symptoms of overactive bladder, as established by the King's Health Questionnaire and the International Consultation on Incontinence Questionnaire. | 12 weeks | 
| Adverse Events | Development of any adverse event attributable to darifenacin and as established by a standardised questionnaire. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physiotherapy, Urinary Bladder, Overactive, Darifenacin, Quality of Life