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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT01323426
First received: March 21, 2011
Last updated: January 23, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention Phase
Urinary Incontinence, Stress
 Procedure: Periurethral injection
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Autologous Muscle Fiber Transplantation for Repair of the Urethral Sphincter in Patients With Stress Urinary Incontinence

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Copenhagen University Hospital at Herlev:

Primary Outcome Measures:
  • Frequency of incontinence episodes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Reduction in the number of leakages in three days


Secondary Outcome Measures:
  • International Consultation on Incontinence (ICIQ)short form incontinence score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Intraurethral pressure measured by reflectometry [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Uroflow [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Adverse events peri- or postoperatively [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: May 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: periurethral injection
Periurethral injection of autologous muscle fibers
 Procedure: Periurethral injection
Periurethral injection of autologous muscle fibers

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stress urinary incontinence refractory to conservative treatment.

Exclusion Criteria:

  • urge urinary incontinence
  • Pregnancy
  • Pelvic organ prolapse > grade 1
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01323426

Locations
Denmark
Herlev Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Investigators
Principal Investigator: Søren Gräs, MD Herlev Hospital
  More Information

No publications provided

Responsible Party: Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier: NCT01323426     History of Changes
Other Study ID Numbers: H-1-2009-079 and H-1-2011-032
Study First Received: March 21, 2011
Last Updated: January 23, 2013
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Copenhagen University Hospital at Herlev:
urinary incontinence, stress
autologous

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
 Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013