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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-04-30

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.

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Detailed Description

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Conditions

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Darifenacin + Physiotherapy

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.

Group Type EXPERIMENTAL

Darifenacin

Intervention Type DRUG

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.

Physiotherapy

Intervention Type PROCEDURE

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.

Physiotherapy

Patients allocated to this arm will receive a tailored pelvic floor exercise programme in addition to a matching placebo pill.

Group Type ACTIVE_COMPARATOR

Physiotherapy

Intervention Type PROCEDURE

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.

Interventions

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Darifenacin

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.

Intervention Type DRUG

Physiotherapy

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.

Intervention Type PROCEDURE

Other Intervention Names

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Oralafi Darisec Continex Emselex Enablex

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.