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

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02143570
• Other study ID #: 635
• Status: Completed
• Phase: Phase 3
• First received: May 18, 2014
• Last updated: April 29, 2016
• Start date: May 2014
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Universidad de Valparaiso
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Comité de Ética Científico
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

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.

Locations

Country	Name	City	State
Chile	Hospital Carlos Van Buren	Valparaiso

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Valparaiso	Recalcine (GynoPharm)

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life	Overall quality of life as established by the Overactive Bladder Questionnaire.	12 weeks	No
Secondary	Overactive Bladder Symptoms	Presence of symptoms of overactive bladder, as established by the King's Health Questionnaire and the International Consultation on Incontinence Questionnaire.	12 weeks	No
Secondary	Adverse Events	Development of any adverse event attributable to darifenacin and as established by a standardised questionnaire.	12 weeks	No