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

Phase 3

Completed

• Conditions: Overactive Bladder
• Interventions: Drug: Darifenacin; Procedure: Physiotherapy

• Registration Number: NCT02143570
• Lead Sponsor: Universidad de Valparaiso

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-18
• Study First Submitted QC: 2014-05-18
• Study First Posted: 2014-05-21
• Status Verified: 2016-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Last Update Submitted: 2016-04-29
• Last Update Posted: 2016-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Darifenacin + Physiotherapy	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.
Physiotherapy	Physiotherapy	Patients allocated to this arm will receive a tailored pelvic floor exercise programme in addition to a matching placebo pill.
Darifenacin + Physiotherapy	Darifenacin	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.

Primary Outcome Measures

Name	Time	Method
Quality of Life	12 weeks	Overall quality of life as established by the Overactive Bladder Questionnaire.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Carlos Van Buren; 🇨🇱 Valparaiso, Chile