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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:

ClinicalTrials.gov Identifier:

NCT00143481

First Posted: September 2, 2005

Last Update Posted: April 10, 2013

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.

Information provided by:

Pfizer

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 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:

MedlinePlus related topics: Bedwetting Overactive Bladder Urinary Incontinence

Drug Information available for: Tolterodine Tolterodine tartrate

U.S. FDA Resources

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

Information from the National Library of Medicine

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, 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

Information from the National Library of Medicine

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

Show 58 Study Locations

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rogers RG, Bachmann G, Scarpero H, Jumadilova Z, Sun F, Morrow JD, Guan Z, Bavendam T. Effects of tolterodine ER on patient-reported outcomes in sexually active women with overactive bladder and urgency urinary incontinence. Curr Med Res Opin. 2009 Sep;25(9):2159-65. doi: 10.1185/03007990903103279.

Rogers R, Bachmann G, Jumadilova Z, Sun F, Morrow JD, Guan Z, Bavendam T. Efficacy of tolterodine on overactive bladder symptoms and sexual and emotional quality of life in sexually active women. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Nov;19(11):1551-7. doi: 10.1007/s00192-008-0688-6. Epub 2008 Aug 7.


ClinicalTrials.gov Identifier:	NCT00143481 History of Changes
Other Study ID Numbers:	A6121002
First Submitted:	September 1, 2005
First Posted:	September 2, 2005
Last Update Posted:	April 10, 2013
Last Verified:	April 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

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