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

Phase 1

• Conditions: Urinary Incontinence, Stress
• Interventions: Procedure: Periurethral injection

• Registration Number: NCT01323426
• Lead Sponsor: Copenhagen University Hospital at Herlev

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2011-03-21
• Study First Submitted QC: 2011-03-24
• Study First Posted: 2011-03-25
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-23
• Last Update Posted: 2013-01-24
• Primary Completion: 2013-09
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Stress urinary incontinence refractory to conservative treatment.

Exclusion Criteria

• urge urinary incontinence
• Pregnancy
• Pelvic organ prolapse > grade 1

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
periurethral injection	Periurethral injection	Periurethral injection of autologous muscle fibers

Primary Outcome Measures

Name	Time	Method
Frequency of incontinence episodes	12 months	Reduction in the number of leakages in three days

Secondary Outcome Measures

Name	Time	Method
Uroflow	12 months
Adverse events peri- or postoperatively	12 months
International Consultation on Incontinence (ICIQ)short form incontinence score	12 months
Intraurethral pressure measured by reflectometry	12 months

Trial Locations

Locations (1)

Herlev Hospital; 🇩🇰 Herlev, Denmark