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OpenTrials
Completed

NCT Number: NCT00143481

Effect of Detrol LA on Overactive Bladder Symptoms, Sexual Quality of Life and Sexual Function in Women

The purpose of the study is to assess the impact of treatment with tolterodine ER versus placebo on Urgency Urinary Incontinence in sexually active women with OAB symptoms.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Chandler, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female outpatients 18 years or older.
  • Overactive bladder symptoms (subject-reported) for greater than or equal to 3 months.
  • Currently sexually active with a male partner.

Exclusion criteria

  • Diagnosed or suspected interstitial cystitis, uninvestigated hematuria, urogenital cancer, and interstitial or external radiation to the pelvis or external genitalia or clinically significant bladder outlet obstruction.
  • Symptoms of incontinence being predominately stress urinary incontinence as determined by the investigator.
  • Treated with antimuscarinic/ anticholinergic medication, for any reason including OAB, within the last 3 months or are expected to start therapy during the study treatment period.
  • Any drug for urgency urinary incontinence (UUI) initiated within the past 3 months prior to Visit 1, with the exception of estrogen (topical or systemic) as long as treatment is not initiated within 4 weeks prior to Visit 1 (screening)

Treatment and study plan

Tolterodine ER 4mg QD

Drug

Primary outcomes

  1. Change in number of episodes of urgency urinary incontinence (UUI) at week 12 compared with baseline.

Secondary outcomes

  1. Change in total number of urgency urinary incontinence (UUI) episodes at weeks 4 and 24 compared with baseline

  2. Change in total number of daytime urgency urinary incontinence (UUI) episodes at week 4, week 12, and week 24 compared with baseline

  3. Change in total number of pads used per 24 hours at weeks 4, 12, and 24 compared with baseline

  4. Reasons for treatment withdrawal

  5. Adverse Events during the 24 week treatment period.

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Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study title

A Multi-Center, Double-Phase, Randomized, Double-Blind, Placebo Controlled (12-Week Double-Blind Followed by 12-Week Open-Label) Study Evaluating the Effect of Tolterodine ER on Urgency Urinary Incontinence (UUI), Urgency, Frequency, Sexual Quality of Life and Sexual Function in Women With Overactive Bladder

Important dates

Study start
2005
Primary completion
2006
First posted
Sep 2, 2005
Registry last updated
Jan 27, 2021

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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