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Completed

NCT Number: NCT00932022

Trospium Chloride XR in Obese Female Patients With Overactive Bladder

This study evaluated the effectiveness of trospium chloride extended release (XR) in obese female patients with overactive bladder (OAB). Patients received either placebo and trospium chloride XR or placebo only. The study assessed the change from baseline in urinary frequency, urgency, and incontinence for trospium chloride XR versus a placebo-pill. The study was 14 weeks in duration.

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Key information

Conditions

Obesity Body Weight Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Incontinence Lower Urinary Tract Symptoms Male Urogenital Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overactive Bladder Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

La Mesa, California, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • OAB syndrome with Urgency, Urinary frequency and Urgency urinary incontinence
  • Non-smoker (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to the screening visit).
  • Obese

Exclusion criteria

  • Chronic kidney failure
  • Abdominal bypass surgery for obesity
  • Moderate or severe memory impairment
  • Uncontrolled narrow angle glaucoma
  • Uncontrolled systemic disease
  • Concurrent dementia drugs: Aricept (donepezil), Namenda (memantine), Cognex (tacrine), Exelon (rivastigmine), Razadyne (galantamine), or similar drugs for dementia

Treatment and study plan

Trospium Chloride, Extended Release (XR)

Drug

Trospium chloride extended release 60 mg capsule taken orally once daily for 12 weeks.

Other names: Sanctura XR™ 60 mg

Placebo

Other

Placebo capsule taken orally once daily for either 2 weeks or 14 weeks.

Primary outcomes

  1. Percent Change From Baseline in Urinary Urgency Incontinence (UUI)

    Time frame: Baseline (Week 2), Week 14

    Patients recorded information about UUI (accidental leakage, urgency associated with void and urgency severity) in a 3-day diary at Baseline (Week 2) and Week 14. The daily average episodes of UUI was the sum of all UUI episodes over valid diary days during the 3-day diary period divided by the valid number of diary days with at least one valid bladder entry. The percent change from baseline was calculated as (Mean UUI at Week 14- Mean UUI at Week 2)/ Mean UUI at Week 2 X 100. A negative number percent change from baseline indicated an improvement.

Secondary outcomes

  1. Percent Change From Baseline in Urgency Severity Associated With Toilet Voids

    Time frame: Baseline (Week 2), Week 14

    Due to lack of evaluable data, analysis for this outcome measure was not performed.

  2. Percent Change From Baseline in Voided Volume

    Time frame: Baseline (Week 2), Week 14

    Due to lack of evaluable data, analysis for this outcome measure was not performed.

  3. Percent Change From Baseline in Over Active Bladder (OAB)-Symptom Composite Score

    Time frame: Baseline (Week 2), Week 14

    Due to lack of evaluable data, analysis for this outcome measure was not performed.

  4. Percent Change From Baseline in Percentage of Patients Continent

    Time frame: Baseline (Week 2), Week 14

    Due to lack of evaluable data, analysis for this outcome measure was not performed.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 2, 2009
Registry last updated
Jan 21, 2013

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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