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OpenTrials
Completed

NCT Number: NCT02143570

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

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.

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Carlos Van Buren

Valparaíso, Valparaiso, 2341131, Chile

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Darifenacin

Drug

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.

Other names: Oralafi, Darisec, Continex, Emselex, Enablex

physiotherapy

Procedure

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 outcomes

  1. Quality of Life

    Time frame: 12 weeks

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

Secondary outcomes

  1. Overactive Bladder Symptoms

    Time frame: 12 weeks

    Presence of symptoms of overactive bladder, as established by the King's Health Questionnaire and the International Consultation on Incontinence Questionnaire.

  2. Adverse Events

    Time frame: 12 weeks

    Development of any adverse event attributable to darifenacin and as established by a standardised questionnaire.

Sponsors and collaborators

Lead sponsor

Universidad de Valparaiso

Other

Collaborators

  • Recalcine (GynoPharm)

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 21, 2014
Registry last updated
May 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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