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Effect of Detrol LA on Overactive Bladder Symptoms, Sexual Quality of Life and Sexual Function in Women
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00143481
First received: September 1, 2005
Last updated: April 9, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Urinary Incontinence | Drug: Tolterodine ER 4mg QD | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Change in number of episodes of urgency urinary incontinence (UUI) at week 12 compared with baseline.
Secondary Outcome Measures:
- Change in total number of urgency urinary incontinence (UUI) episodes at weeks 4 and 24 compared with baseline
- Change in total number of daytime urgency urinary incontinence (UUI) episodes at week 4, week 12, and week 24 compared with baseline
- Change in total number of pads used per 24 hours at weeks 4, 12, and 24 compared with baseline
- Reasons for treatment withdrawal
- Adverse Events during the 24 week treatment period.
| Estimated Enrollment: | 400 |
| Study Start Date: | March 2005 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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)
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00143481
Show 58 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00143481
Show 58 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00143481 History of Changes |
| Other Study ID Numbers: |
A6121002 |
| Study First Received: | September 1, 2005 |
| Last Updated: | April 9, 2013 |
Additional relevant MeSH terms:
|
Urinary Incontinence Enuresis Urinary Bladder, Overactive Urination Disorders Urologic Diseases Lower Urinary Tract Symptoms Urological Manifestations Signs and Symptoms Behavioral Symptoms Elimination Disorders |
Mental Disorders Urinary Bladder Diseases Tolterodine Tartrate Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urological Agents |
ClinicalTrials.gov processed this record on July 26, 2017