Back to resultsTreatment of Stress Urinary Incontinence by Injection of Autologous Muscle Fibers Into the Urethral Sphincter.
Primary Purpose
Urinary Incontinence, Stress
Status
Unknown status
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Periurethral injection
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence, Stress focused on measuring urinary incontinence, stress, autologous
Eligibility Criteria
Inclusion Criteria:
- Stress urinary incontinence refractory to conservative treatment.
Exclusion Criteria:
- urge urinary incontinence
- Pregnancy
- Pelvic organ prolapse > grade 1
Sites / Locations
- Herlev Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
periurethral injection
Arm Description
Periurethral injection of autologous muscle fibers
Outcomes
Primary Outcome Measures
Frequency of incontinence episodes
Reduction in the number of leakages in three days
Secondary Outcome Measures
International Consultation on Incontinence (ICIQ)short form incontinence score
Intraurethral pressure measured by reflectometry
Uroflow
Adverse events peri- or postoperatively
Full Information
NCT ID
NCT01323426
First Posted
March 21, 2011
Last Updated
January 23, 2013
Sponsor
Copenhagen University Hospital at Herlev
1. Study Identification
Unique Protocol Identification Number
NCT01323426
Brief Title
Treatment of Stress Urinary Incontinence by Injection of Autologous Muscle Fibers Into the Urethral Sphincter.
Official Title
Autologous Muscle Fiber Transplantation for Repair of the Urethral Sphincter in Patients With Stress Urinary Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
September 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Copenhagen University Hospital at Herlev
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Stress
Keywords
urinary incontinence, stress, autologous
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
periurethral injection
Arm Type
Experimental
Arm Description
Periurethral injection of autologous muscle fibers
Intervention Type
Procedure
Intervention Name(s)
Periurethral injection
Intervention Description
Periurethral injection of autologous muscle fibers
Primary Outcome Measure Information:
Title
Frequency of incontinence episodes
Description
Reduction in the number of leakages in three days
Time Frame
12 months
Secondary Outcome Measure Information:
Title
International Consultation on Incontinence (ICIQ)short form incontinence score
Time Frame
12 months
Title
Intraurethral pressure measured by reflectometry
Time Frame
12 months
Title
Uroflow
Time Frame
12 months
Title
Adverse events peri- or postoperatively
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stress urinary incontinence refractory to conservative treatment.
Exclusion Criteria:
urge urinary incontinence
Pregnancy
Pelvic organ prolapse > grade 1
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Søren Gräs, MD
Organizational Affiliation
Herlev Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Treatment of Stress Urinary Incontinence by Injection of Autologous Muscle Fibers Into the Urethral Sphincter.
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