This trial is active, not recruiting.

Condition urinary incontinence, stress
Treatment periurethral injection
Phase phase 1/phase 2
Sponsor Copenhagen University Hospital at Herlev
Start date May 2010
End date September 2013
Trial size 40 participants
Trial identifier NCT01323426, H-1-2009-079 and H-1-2011-032


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Periurethral injection of autologous muscle fibers
periurethral injection
Periurethral injection of autologous muscle fibers

Primary Outcomes

Frequency of incontinence episodes
time frame: 12 months

Secondary Outcomes

International Consultation on Incontinence (ICIQ)short form incontinence score
time frame: 12 months
Intraurethral pressure measured by reflectometry
time frame: 12 months
time frame: 12 months
Adverse events peri- or postoperatively
time frame: 12 months

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Stress urinary incontinence refractory to conservative treatment. Exclusion Criteria: - urge urinary incontinence - Pregnancy - Pelvic organ prolapse > grade 1

Additional Information

Official title Autologous Muscle Fiber Transplantation for Repair of the Urethral Sphincter in Patients With Stress Urinary Incontinence
Principal investigator Søren Gräs, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by Copenhagen University Hospital at Herlev.