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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01323426
Recruitment Status : Unknown
Verified January 2013 by Copenhagen University Hospital at Herlev.
Recruitment status was:  Active, not recruiting
First Posted : March 25, 2011
Last Update Posted : January 24, 2013
Information provided by (Responsible Party):

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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 2010
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 :
  1. Frequency of incontinence episodes [ Time Frame: 12 months ]
    Reduction in the number of leakages in three days

Secondary Outcome Measures :
  1. International Consultation on Incontinence (ICIQ)short form incontinence score [ Time Frame: 12 months ]
  2. Intraurethral pressure measured by reflectometry [ Time Frame: 12 months ]
  3. Uroflow [ Time Frame: 12 months ]
  4. Adverse events peri- or postoperatively [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01323426

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

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
First Posted: March 25, 2011    Key Record Dates
Last Update Posted: January 24, 2013
Last Verified: January 2013

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

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders