Effect of Detrol LA on Overactive Bladder Symptoms, Sexual Quality of Life and Sexual Function in Women
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00143481 |
Recruitment Status :
Completed
First Posted : September 2, 2005
Last Update Posted : April 10, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Urinary Incontinence | Drug: Tolterodine ER 4mg QD | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 400 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
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 |
Study Start Date : | March 2005 |
Actual Primary Completion Date : | June 2006 |

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00143481

Study Director: | Pfizer CT.gov Call Center | Pfizer |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00143481 |
Other Study ID Numbers: |
A6121002 |
First Posted: | September 2, 2005 Key Record Dates |
Last Update Posted: | April 10, 2013 |
Last Verified: | April 2013 |
Urinary Incontinence Enuresis Urinary Bladder, Overactive Urination Disorders Urologic Diseases Lower Urinary Tract Symptoms Urological Manifestations 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 |