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NCT01323426 Clinical Trial

Treatment of Stress Urinary Incontinence by Injection of Autologous Muscle Fibers Into the Urethral Sphincter.

Urinary Incontinence, Stress Clinical Trial

Official title:
Autologous Muscle Fiber Transplantation for Repair of the Urethral Sphincter in Patients With Stress Urinary Incontinence

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01323426
Other study ID # H-1-2009-079 and H-1-2011-032
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received March 21, 2011
Last updated January 23, 2013
Start date May 2010
Est. completion date September 2013

Study information
Verified date January 2013
Source Copenhagen University Hospital at Herlev
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines Agency
Study type Interventional

Clinical Trial Summary

This pilot study examines safety and efficacy of a simple procedure for treatment of stress urinary incontinence. A muscle biopsy is taken from the thigh, minced and injected into the urethral sphincter.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 40
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Stress urinary incontinence refractory to conservative treatment.

Exclusion Criteria:

- urge urinary incontinence

- Pregnancy

- Pelvic organ prolapse > grade 1

Study Design

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

Related Conditions & MeSH terms

Intervention

Procedure:
• Periurethral injection
Periurethral injection of autologous muscle fibers

Locations
Country Name City State
Denmark Herlev Hospital Herlev

Sponsors (1)
Lead Sponsor Collaborator
Copenhagen University Hospital at Herlev

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency of incontinence episodes Reduction in the number of leakages in three days 12 months No
Secondary International Consultation on Incontinence (ICIQ)short form incontinence score 12 months No
Secondary Intraurethral pressure measured by reflectometry 12 months No
Secondary Uroflow 12 months Yes
Secondary Adverse events peri- or postoperatively 12 months Yes
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Active, not recruiting NCT02275728 - Pelvic Floor Muscle Training With and Without Biofeedback in Women With Stress Urinary Incontinence N/A
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