Urinary Incontinence Clinical Trial
Official title:
A Multicenter, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder
This is a placebo-controlled, double-blind study to evaluate the safety and efficacy of two doses of DR-3001 in women with overactive bladder who have symptoms of predominant or pure urge incontinence, urinary urgency and elevated urinary frequency
Status | Completed |
Enrollment | 800 |
Est. completion date | December 2006 |
Est. primary completion date | December 2006 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of overactive bladder and incontinence for at least 6 months - Using birth control or menopausal - Willing to discontinue current medication for overactive bladder Exclusion Criteria: - Pregnant or given birth in the last 6 months - Three or more urinary tract infections a year - Uncontrolled glaucoma, hypertension, diabetes or myasthenia gravis - History of bladder cancer, ulcerative colitis or severe constipation - Any contraindication to vaginal delivery systems |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Duramed Investigational Site | Toronto | Ontario |
Canada | Duramed Investigational Site | Vancouver | British Columbia |
United States | Duramed Investigational Site | Aurora | Colorado |
United States | Duramed Investigational Site | Aventura | Florida |
United States | Duramed Investigational Site | Birmingham | Alabama |
United States | Duramed Investigational Site | Boise | Idaho |
United States | Duramed Investigational Site | Boise | Indiana |
United States | Duramed Investigational Site | Charleston | South Carolina |
United States | Duramed Research Site | Colorado Springs | Colorado |
United States | Duramed Investigational Site | Dallas | Texas |
United States | Duramed Investigational Site | Decatur | Georgia |
United States | Duramed Investigational Site | Denver | Colorado |
United States | Duramed Investigational Site | Edison | New Jersey |
United States | Duramed Investigational Site | Evansville | Indiana |
United States | Duramed Investigational Site | Fort Wayne | Indiana |
United States | Duramed Research Site | Gainesville | Florida |
United States | Duramed Research Site | Houston | Texas |
United States | Duramed Investigational Site | Huntsville | Alabama |
United States | Duramed Investigational Site | Indianapolis | Indiana |
United States | Duramed Investigational Site | Jackson | Mississippi |
United States | Duramed Investigational Site | Jackson | Tennessee |
United States | Duramed Investigational Site | Jeffersonville | Indiana |
United States | Duramed Investigational Site | Lancaster | Pennsylvania |
United States | Duramed Investigational Site | Lebanon | New Hampshire |
United States | Duramed Investigational Site | Little Rock | Arkansas |
United States | Duramed Investigational Site | Livingston | New Jersey |
United States | Duramed Investigational Site | Memphis | Tennessee |
United States | Duramed Investigational Site | Meridian | Indiana |
United States | Duramed Investigational Site | Milwaukee | Wisconsin |
United States | Duramed Investigational Site | Mobile | Alabama |
United States | Duramed Investigational Site | Moorestown | New Jersey |
United States | Duramed Investigational Site | Nashville | Tennessee |
United States | Duramed Investigational Site | Philadelphia | Pennsylvania |
United States | Duramed Research Site | Phoenix | Arizona |
United States | Duramed Investigational Site | Portland | Oregon |
United States | Duramed Investigational Site | Providence | Rhode Island |
United States | Duramed Investigational Site | Salt Lake City | Utah |
United States | Duramed Investigational Site | San Antonio | Texas |
United States | Duramed Investigational Site | San Diego | California |
United States | Duremed Research Site | San Diego | California |
United States | Duramed Research Site | Sandy Springs | Georgia |
United States | Duramed Investigational Site | Seattle | Washington |
United States | Duramed Investigational Site | Shreveport | Louisiana |
United States | Duramed Research Site | Tacoma | Washington |
United States | Duramed Research Site | Tucson | Arizona |
United States | Duramed Research Site | Waco | Texas |
United States | Duramed Investigational Site | Waterbury | Connecticut |
United States | Duramed Investigational Site | Williamsville | New York |
Lead Sponsor | Collaborator |
---|---|
Duramed Research |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the total weekly number of incontinence episodes | Baseline to Treatment Week 12/Premature Discontinuation | No | |
Secondary | Average daily urinary frequency | Baseline to Treatment Week 12/Premature Discontinuation | No | |
Secondary | Proportion of patients with no incontinence episodes | Baseline to Treatment Week 12/Premature Discontinuation | No | |
Secondary | Average void volume | Baseline to Treatment Week 12/Premature Discontinuation | No | |
Secondary | Average severity of urgency | Baseline to Treatment Week 12/Premature Discontinuation | No |
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 |
NCT02529371 -
Pre-Marketing Feasibility Evaluation of the UriCap-RM - Urine Collection in Hospitalized Male Patients
|
N/A | |
Enrolling by invitation |
NCT02530372 -
Feasibility of the UriCap-F for Urine Collection in Hospitalized Women
|
N/A | |
Completed |
NCT02338726 -
Pelvic Floor Symptoms and Quality of Life in Elderly Women - a Population-based Pilot Study
|
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 |
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 |