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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02143570

Enrollment

Registered

2014-05-21

Start date

2014-05-31

Completion date

2016-04-30

Last updated

2016-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder

Keywords

Urinary Bladder, Overactive, Darifenacin, Physiotherapy, Quality of Life

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.

Interventions

DRUGDarifenacin

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.

PROCEDUREPhysiotherapy

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

16 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Quality of Life	12 weeks	Overall quality of life as established by the Overactive Bladder Questionnaire.

Secondary

Measure	Time frame	Description
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.

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026