Urinary Incontinence Clinical Trial
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
| NCT number | NCT00143481 |
| Other study ID # | A6121002 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 4 |
| First received | |
| Last updated | |
| Start date | March 2005 |
| Verified date | January 2021 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 400 |
| Est. completion date | |
| Est. primary completion date | June 2006 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| United States | Pfizer Investigational Site | Albuquerque | New Mexico |
| United States | Pfizer Investigational Site | Allentown | Pennsylvania |
| United States | Pfizer Investigational Site | Alpharetta | Georgia |
| United States | Pfizer Investigational Site | Austin | Texas |
| United States | Pfizer Investigational Site | Austin | Texas |
| United States | Pfizer Investigational Site | Austin | Texas |
| United States | Pfizer Investigational Site | Baltimore | Maryland |
| United States | Pfizer Investigational Site | Baton Rouge | Louisiana |
| United States | Pfizer Investigational Site | Berkeley | California |
| United States | Pfizer Investigational Site | Bryan | Texas |
| United States | Pfizer Investigational Site | Chandler | Arizona |
| United States | Pfizer Investigational Site | Cincinnati | Ohio |
| United States | Pfizer Investigational Site | Cincinnati | Ohio |
| United States | Pfizer Investigational Site | Clearwater | Florida |
| United States | Pfizer Investigational Site | Cleveland | Ohio |
| United States | Pfizer Investigational Site | Cleveland | Ohio |
| United States | Pfizer Investigational Site | Columbia | South Carolina |
| United States | Pfizer Investigational Site | Columbus | Ohio |
| United States | Pfizer Investigational Site | Conroe | Texas |
| United States | Pfizer Investigational Site | Creve Coeur | Missouri |
| United States | Pfizer Investigational Site | Denver | Colorado |
| United States | Pfizer Investigational Site | Denver | Colorado |
| United States | Pfizer Investigational Site | Evansville | Indiana |
| United States | Pfizer Investigational Site | Farmington | Connecticut |
| United States | Pfizer Investigational Site | Gallipolis | Ohio |
| United States | Pfizer Investigational Site | Irving | Texas |
| United States | Pfizer Investigational Site | Lakewood | Colorado |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Leesburg | Florida |
| United States | Pfizer Investigational Site | Little Rock | Arkansas |
| United States | Pfizer Investigational Site | Metairie | Louisiana |
| United States | Pfizer Investigational Site | Metairie | Louisiana |
| United States | Pfizer Investigational Site | Miami | Florida |
| United States | Pfizer Investigational Site | Morgantown | West Virginia |
| United States | Pfizer Investigational Site | Morgantown | West Virginia |
| United States | Pfizer Investigational Site | New Bern | North Carolina |
| United States | Pfizer Investigational Site | New Brunswick | New Jersey |
| United States | Pfizer Investigational Site | Newburgh | Indiana |
| United States | Pfizer Investigational Site | North Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Oakland | California |
| United States | Pfizer Investigational Site | Olean | New York |
| United States | Pfizer Investigational Site | Pembroke Pines | Florida |
| United States | Pfizer Investigational Site | Philadelphia | Pennsylvania |
| United States | Pfizer Investigational Site | Phoenix | Arizona |
| United States | Pfizer Investigational Site | Saginaw | Michigan |
| United States | Pfizer Investigational Site | Salt Lake City | Utah |
| United States | Pfizer Investigational Site | Salt Lake City | Utah |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | San Diego | California |
| United States | Pfizer Investigational Site | San Francisco | California |
| United States | Pfizer Investigational Site | Santa Rosa | California |
| United States | Pfizer Investigational Site | Seattle | Washington |
| United States | Pfizer Investigational Site | South Bend | Indiana |
| United States | Pfizer Investigational Site | West Hartford | Connecticut |
| United States | Pfizer Investigational Site | West Palm Beach | Florida |
| United States | Pfizer Investigational Site | Weston | Florida |
| United States | Pfizer Investigational Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in number of episodes of urgency urinary incontinence (UUI) at week 12 compared with baseline. | |||
| Secondary | Change in total number of urgency urinary incontinence (UUI) episodes at weeks 4 and 24 compared with baseline | |||
| Secondary | Change in total number of daytime urgency urinary incontinence (UUI) episodes at week 4, week 12, and week 24 compared with baseline | |||
| Secondary | Change in total number of pads used per 24 hours at weeks 4, 12, and 24 compared with baseline | |||
| Secondary | Reasons for treatment withdrawal | |||
| Secondary | Adverse Events during the 24 week treatment period. |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05534412 -
A Practice-Based Intervention To Improve Care for a Diverse Population Of Women With Urinary Incontinence
|
N/A | |
| Recruiting |
NCT05515198 -
Improving Care for Women With Urinary Incontinence (EMPOWER)
|
N/A | |
| Completed |
NCT04071301 -
Collection of Real-life Measurement Data for TENA SmartCare Change Indicator in Subjects With Urinary Incontinence
|
N/A | |
| Completed |
NCT03623880 -
Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders
|
N/A | |
| Recruiting |
NCT05880862 -
Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls
|
Early Phase 1 | |
| Recruiting |
NCT04159467 -
Effect of Pelvic Floor Muscle Training on Urinary Incontinence Reports in Obese Women Undergoing a Low Calorie Diet
|
N/A | |
| Completed |
NCT05485922 -
Performance of a Single-use Intermittent Micro-hole Zone Catheter
|
N/A | |
| Completed |
NCT06268782 -
The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women
|
N/A | |
| Not yet recruiting |
NCT03027986 -
Evaluation of a Postural Rehabilitation Program Based on Sensory-motor Control in Men With Urinary Incontinence After Prostatectomy
|
N/A | |
| Recruiting |
NCT02490917 -
ACT™ Balloons Versus Artificial Urinary Sphincter (AMS800™) for the Treatment of Female Stress Urinary Incontinence
|
N/A | |
| Enrolling by invitation |
NCT02530372 -
Feasibility of the UriCap-F for Urine Collection in Hospitalized Women
|
N/A | |
| Enrolling by invitation |
NCT02529371 -
Pre-Marketing Feasibility Evaluation of the UriCap-RM - Urine Collection in Hospitalized Male Patients
|
N/A | |
| Completed |
NCT02549729 -
Effect of the Pelvic Floor Training in Postmenopausal Women With or Without Hormonal Therapy
|
N/A | |
| Completed |
NCT02600676 -
Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis
|
N/A | |
| Completed |
NCT02338726 -
Pelvic Floor Symptoms and Quality of Life in Elderly Women - a Population-based Pilot Study
|
N/A | |
| Completed |
NCT02239796 -
Feasibility Controlled Trial of Tibial Nerve Stimulation for Stroke Related Urinary Incontinence
|
N/A | |
| Completed |
NCT02368262 -
Prevalence of Incontinence and Risk Factors in Children With Cerebral Palsy
|
N/A | |
| Completed |
NCT01942681 -
Female Patients With Signs of uRgE and Stress Urinary Incontinence Study of Propiverine Hydrochloride
|
N/A | |
| Recruiting |
NCT01804153 -
Stem Cells Tratment for the Local Feminine Stress Urinary Incontinence Treatment (HULPURO)
|
Phase 1/Phase 2 | |
| Completed |
NCT01520948 -
Behavioral Therapy to Treat Urinary Symptoms in Parkinson Disease
|
Phase 3 |