Treatment of Stress Urinary Incontinence by Injection of Autologous Muscle Fibers Into the Urethral Sphincter.
Sponsor
Copenhagen University Hospital at Herlev (Other)
Overall Status
Unknown status
CT.gov ID
NCT01323426
Collaborator
(none)
40
1
1
40
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Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Autologous Muscle Fiber Transplantation for Repair of the Urethral Sphincter in Patients With Stress Urinary Incontinence
Study Start Date
:
May 1, 2010
Anticipated Primary Completion Date
:
Sep 1, 2013
Anticipated Study Completion Date
:
Sep 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: periurethral injection Periurethral injection of autologous muscle fibers |
Procedure: Periurethral injection
Periurethral injection of autologous muscle fibers
|
Outcome Measures
Primary Outcome Measures
- Frequency of incontinence episodes [12 months]
Reduction in the number of leakages in three days
Secondary Outcome Measures
- International Consultation on Incontinence (ICIQ)short form incontinence score [12 months]
- Intraurethral pressure measured by reflectometry [12 months]
- Uroflow [12 months]
- Adverse events peri- or postoperatively [12 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Stress urinary incontinence refractory to conservative treatment.
Exclusion Criteria:
-
urge urinary incontinence
-
Pregnancy
-
Pelvic organ prolapse > grade 1
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Herlev Hospital | Herlev | Denmark | 2730 |
Sponsors and Collaborators
- Copenhagen University Hospital at Herlev
Investigators
- Principal Investigator: Søren Gräs, MD, Herlev Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT01323426
Other Study ID Numbers:
- H-1-2009-079 and H-1-2011-032
First Posted:
Mar 25, 2011
Last Update Posted:
Jan 24, 2013
Last Verified:
Jan 1, 2013
Keywords provided by Copenhagen University Hospital at Herlev
Additional relevant MeSH terms: