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NCT00190853 Clinical Trial

Biomechanical and Electrophysiological Effects of Duloxetine in the Treatment of Women With Urinary Stress Incontinence

Urinary Stress Incontinence Clinical Trial

Official title:
Effect of Duloxetine on Valsalva Leak Point Pressure and Quantitative Rhabdosphincter Electromyography Measures in Women With Stress Urinary Incontinence

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00190853
Other study ID # 9587
Secondary ID F1J-MC-SBCT
Status Completed
Phase Phase 3
First received September 12, 2005
Last updated January 24, 2007
Start date January 2005
Est. completion date September 2006

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

Clinical Trial Summary

Biomechanical and electrophysiological effects of duloxetine in the treatment of women with urinary stress incontinence

Recruitment information / eligibility
Status Completed
Enrollment 93
Est. completion date September 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Have a diagnosis of only stress urinary incontinence

- Have no pelvic organ prolapse protruding more than 1 cm beyond the hymen

Exclusion Criteria:

- At visit 1, have a positive urine culture or a history of four or more urinary tract infections in the preceding year.

- Have had more than one continence surgery.

- Have a current or past urogenital cancer.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Duloxetine

Locations
Country Name City State
Slovenia 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 Ljubljana
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 Manchester
United States 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 Annandale Virginia
United States 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 Birmingham Alabama
United States 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 Denver Colorado
United States 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 Durham North Carolina
United States 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 Fort Wayne Indiana
United States 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 Indianapolis Indiana
United States 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 Jeffersonville Indiana
United States 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 Knoxville Tennessee
United States 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 Memphis Tennessee
United States 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 Metairie Louisiana
United States 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 Morganton North Carolina
United States 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 New Bern North Carolina
United States 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 Oak Lawn Illinois
United States 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 Richmond Virginia
United States 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 Salt Lake City Utah
United States 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 West Palm Beach Florida
United States 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 Winston Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Slovenia,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assess the effects of duloxetine in women with urodynamically proved stress urinary incontinence on the within-group change in vesical Valsalva leak point pressure (VLPP) from baseline to endpoint.
Secondary To evaluate the within-group endpoint/baseline ratios of Root Mean Square Voltage and Mean Rectified Voltage from the rhabdosphincter electromyogram (EMG) at rest and with coughing, and the ratio of cough/rest ratios from baseline to endpoint.
Secondary To evaluate the within-group changes in VLPP and ratios of EMG variables from baseline to 6 months and from 4 weeks to 6 months.
Secondary To describe the percent change in incontinence episode frequency (IEF) from baseline to post-baseline and define two groups, responders and non-responders, based on threshold value of < 50% IEF reduction values.
Secondary To compare the changes in VLPP and EMG ratios from baseline to 4 weeks and from baseline to 6 months in responder and non responders
Secondary To evaluate the safety and tolerability of duloxetine for up to 28 weeks in subjects diagnosed with urodynamic stress incontinence.Based on treatment-emergent adverse events, discontinuation rates, vital signs, and laboratory analyses
See also
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Active, not recruiting NCT02538991 - TVT Versus Bulkamid®-Injections in Treatment of Stress Urinary Incontinence N/A
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Terminated NCT02591381 - Transcorporal Versus Standard Artificial Urinary Sphincter Placement N/A
Completed NCT00984958 - Bulkamid Treatment of Stress Incontinence in Women With Urinary Stress Incontinence and Not Suitable to TVT-procedure N/A
Completed NCT00190567 - Biomechanical Effects of Duloxetine on Bladder and Sphincter Muscle Function in Women in Pure Genuine Stress Incontinence Phase 2
Completed NCT02423486 - The Comparison of Efficacy Between Electromagnetic Stimulation Therapy and Electromagnetic Stimulation Therapy With Extracorporeal Biofeedback N/A
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Completed NCT03672461 - A Group-Based Therapeutic Yoga Intervention for Urinary Incontinence in Ambulatory Older Women N/A
Completed NCT02407145 - Safety and Efficacy of PVDF (DynaMesh®-SIS Soft) Retropubic Midurethral Slings in Stress Urinary Incontinence in Women
Completed NCT01784172 - Efficacy and Safety Study of Electroacupuncture for Simple Female Stress Urinary incontinence-a Multicenter Trial Phase 2
Not yet recruiting NCT06469320 - Urinary Incontinence and Other Pelvic Floor Dysfunctions in Trail Runners
Recruiting NCT02935803 - A Study on the Anti-incontinent Effectiveness of the mTVM Method in POPQ Stage II-III Patients N/A
Active, not recruiting NCT02039830 - Group Versus Individual Physiotherapy for Urinary Incontinence in Aging Women N/A
Recruiting NCT04817839 - Optimal Duration of Post-Operative Activity Restriction After Midurethral Sling Procedures N/A