Clinical Trials Logo
  1. Home
  2. Urinary Incontinence, Stress
  3. NCT00190996
  4. Details
NCT00190996 Clinical Trial

Evaluate Safety and Efficacy of Duloxetine in Predominant Stress Urinary Incontinence

Urinary Incontinence, Stress Clinical Trial

Official title:
The Safety and Effectiveness of Duloxetine Compared With Placebo and Its Long-Term Safety and Efficacy in the Treatment of Predominant Stress Urinary Incontinence

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00190996
Other study ID # 8049
Secondary ID F1J-EW-SBCC
Status Completed
Phase Phase 3
First received September 12, 2005
Last updated January 24, 2007
Start date January 2003
Est. completion date June 2006

Study information
Verified date January 2007
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purposes of this study are to determine whether duloxetine can help subjects with stress urinary incontinence and to see whether the effects of duloxetine can be maintained.

Recruitment information / eligibility
Status Completed
Enrollment 2765
Est. completion date June 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Female diagnosed with stress urinary incontinence

Exclusion Criteria:

- Currently taking a monoamine oxidase inhibitor

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Duloxetine Hydrochloride

• placebo

Locations
Country Name City State
United Kingdom For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Surrey

Sponsors (2)
Lead Sponsor Collaborator
Eli Lilly and Company Boehringer Ingelheim

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assess the efficacy of Duloxetine compared with placebo in women with predominant stress urinary incontinence as measured by a reduction in incontinent episode frequency.
Secondary Evaluate the maintenance of effect on IEF in long-term use
Secondary Kings Health Questionnaire
Secondary Patient Global Impression of Improvement Questionnaire
Secondary Safety effects
See also
  Status Clinical Trial Phase
Completed NCT02001714 - Group Learning Achieves Decreased Incidents of Lower Urinary Symptoms N/A
Not yet recruiting NCT00523068 - Pharmacological vs Surgical Treatment for Mixed Incontinence Phase 4
Completed NCT00904969 - A Pre-Market Study of the American Medical Systems (AMS) Transobturator Male Sling System for the Treatment of Male Stress Urinary Incontinence N/A
Completed NCT00190814 - Effectiveness and Safety of Duloxetine in Women Experiencing Urinary Leakage Due to Physical Stress and Urge. Phase 3
Completed NCT00190827 - Effectiveness of Duloxetine in the Treatment of Stress Urinary Incontinence(Uncontrolled Leakage of Urine) Phase 3
Terminated NCT00247286 - Weighted Vaginal Cones Versus Biofeedback in the Treatment of Urodynamic Stress Incontinence: a Randomized Trial. Phase 4
Completed NCT01959347 - Combined Treatment for Mixed Incontinence Phase 3
Completed NCT00244296 - To Determine How Effective Duloxetine is in Treating Women 65 Years and Older With Symptoms of Stress Urinary Incontinence, or With a Combination of Stress Urinary Incontinence and Urge Urinary Incontinence Symptoms Phase 4
Not yet recruiting NCT05570071 - A Study of the Use of Vaginal Radiofrequency Therapy in Treatment of SUI. N/A
Completed NCT02334878 - Stem Cell Therapy for Treatment of Female Stress Urinary Incontinence Phase 3
Completed NCT01382602 - Autologous Muscle Derived Cells Female Stress Urinary Incontinence Clinical Study Phase 3
Completed NCT03296462 - Hip External Rotation Physical Therapy Trial N/A
Recruiting NCT02750878 - Surgical Consent Process for Trans-obturator Tape Slings. N/A
Completed NCT02296099 - Trial Liposomal Bupivacaine Following Retropubic Suburethral Sling for Stress Urinary Incontinence Phase 4
Completed NCT02599051 - Transobturator Verus Single Incision Slings N/A
Completed NCT00138749 - An 8 Week Study Looking At The Efficacy, Toleration And Safety Of SS-RBX For Stress Urinary Incontinence. Phase 2
Terminated NCT03614611 - Canadian Experience With Contiform Intravaginal Device For The Treatment Of Stress Incontinence N/A
Completed NCT03722719 - The Knack on Female Stress Urinary Incontinence N/A
Active, not recruiting NCT02275728 - Pelvic Floor Muscle Training With and Without Biofeedback in Women With Stress Urinary Incontinence N/A
Terminated NCT01358214 - Quality of Life After Tension Free Transvaginal Sling / Tape Operation With a Titanized Surgical Tape (TiLOOP® Tape) N/A