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

April 29, 2016 updated by: Felipe Martinez, Universidad de Valparaiso
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Valparaiso, Chile, 2341131
        • Hospital Carlos Van Buren

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.
Other Names:
  • Enablex
  • Darisec
  • Oralafi
  • Continex
  • Emselex
Procedure: 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.
Active Comparator: Physiotherapy
Patients allocated to this arm will receive a tailored pelvic floor exercise programme in addition to a matching placebo pill.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: 12 weeks
Development of any adverse event attributable to darifenacin and as established by a standardised questionnaire.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Valparaiso

Collaborators

Recalcine (GynoPharm)

Investigators

  • Principal Investigator: Melissa Cifuentes, M.D., Senior Urologist

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

May 18, 2014

First Submitted That Met QC Criteria

May 18, 2014

First Posted (Estimate)

May 21, 2014

Study Record Updates

Last Update Posted (Estimate)

May 2, 2016

Last Update Submitted That Met QC Criteria

April 29, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 635

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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