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

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Phase 3
Locations
Chile
Study Type
Interventional
Intervention
Darifenacin
Physiotherapy
Sponsored by
Universidad de Valparaiso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Urinary Bladder, Overactive, Darifenacin, Physiotherapy, Quality of Life

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Carlos Van Buren

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Darifenacin + Physiotherapy

Physiotherapy

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Quality of Life
Overall quality of life as established by the Overactive Bladder Questionnaire.

Secondary Outcome Measures

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

Full Information

First Posted
May 18, 2014
Last Updated
April 29, 2016
Sponsor
Universidad de Valparaiso
Collaborators
Recalcine (GynoPharm)
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1. Study Identification

Unique Protocol Identification Number
NCT02143570
Brief Title
Efficacy of Darifenacin and Physiotherapy for the Treatment of Overactive Bladder in Women
Official Title
Efficacy of Darifenacin and Physiotherapy for the Treatment of Overactive Bladder in Women
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Valparaiso
Collaborators
Recalcine (GynoPharm)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
Urinary Bladder, Overactive, Darifenacin, Physiotherapy, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Darifenacin + Physiotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Physiotherapy
Arm Type
Active Comparator
Arm Description
Patients allocated to this arm will receive a tailored pelvic floor exercise programme in addition to a matching placebo pill.
Intervention Type
Drug
Intervention Name(s)
Darifenacin
Other Intervention Name(s)
Oralafi, Darisec, Continex, Emselex, Enablex
Intervention Description
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
Procedure
Intervention Name(s)
Physiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of Life
Description
Overall quality of life as established by the Overactive Bladder Questionnaire.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Overactive Bladder Symptoms
Description
Presence of symptoms of overactive bladder, as established by the King's Health Questionnaire and the International Consultation on Incontinence Questionnaire.
Time Frame
12 weeks
Title
Adverse Events
Description
Development of any adverse event attributable to darifenacin and as established by a standardised questionnaire.
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Cifuentes, M.D.
Organizational Affiliation
Senior Urologist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Carlos Van Buren
City
Valparaiso
ZIP/Postal Code
2341131
Country
Chile

12. IPD Sharing Statement

Learn more about this trial

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

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