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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 2016

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • 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.
  • Active Comparator: Physiotherapy
    • Patients allocated to this arm will receive a tailored pelvic floor exercise programme in addition to a matching placebo pill.

Clinical Trial Outcome Measures

Primary Measures

  • Quality of Life
    • Time Frame: 12 weeks
    • Overall quality of life as established by the Overactive Bladder Questionnaire.

Secondary Measures

  • 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.
  • Adverse Events
    • Time Frame: 12 weeks
    • Development of any adverse event attributable to darifenacin and as established by a standardised questionnaire.

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 16 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universidad de Valparaiso
  • Collaborator
    • Recalcine (GynoPharm)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Felipe Martinez, M.D., M.Sc. – Universidad de Valparaiso
  • Overall Official(s)
    • Melissa Cifuentes, M.D., Principal Investigator, Senior Urologist

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