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

• Register: ClinicalTrials.gov
• Last refreshed on: 9 May 2016
• Main ID: NCT02143570
• Date of registration: 18/05/2014
• Prospective Registration: No
• Primary sponsor: Universidad de Valparaiso
• Public title: Efficacy of Darifenacin and Physiotherapy for the Treatment of Overactive Bladder in Women
• Scientific title: Efficacy of Darifenacin and Physiotherapy for the Treatment of Overactive Bladder in Women
• Date of first enrolment: May 2014
• Target sample size: 80
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02143570
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Chile

Contacts

• Name: Melissa Cifuentes, M.D.
• Affiliation: Senior Urologist

Key inclusion & exclusion 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.



Age minimum: 16 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Overactive Bladder

Intervention(s)

Drug: Darifenacin

Procedure: Physiotherapy

Primary Outcome(s)

Quality of Life [Time Frame: 12 weeks]

Secondary Outcome(s)

Overactive Bladder Symptoms [Time Frame: 12 weeks]

Adverse Events [Time Frame: 12 weeks]

Secondary ID(s)

635

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Recalcine (GynoPharm)