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

Universidad de Valparaiso

Status and phase: Completed; Phase 3

Conditions: Overactive Bladder

Treatments: Procedure: Physiotherapy; Drug: Darifenacin

Study type: Interventional

Funder types: Other

Identifiers

NCT02143570

635

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: Female

Ages: 16+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

Darifenacin + Physiotherapy

Experimental group

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.

Treatment:

Drug: Darifenacin

Procedure: Physiotherapy

Physiotherapy

Active Comparator group

Description:

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

Treatment:

Procedure: Physiotherapy