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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Copenhagen University Hospital at Herlev.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Copenhagen University Hospital at Herlev Identifier:
First received: March 21, 2011
Last updated: January 23, 2013
Last verified: January 2013
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: 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:

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

Primary Outcome Measures:
  • Frequency of incontinence episodes [ Time Frame: 12 months ]
    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 ]
  • Intraurethral pressure measured by reflectometry [ Time Frame: 12 months ]
  • Uroflow [ Time Frame: 12 months ]
  • Adverse events peri- or postoperatively [ Time Frame: 12 months ]

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


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
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Please refer to this study by its identifier: 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 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

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 processed this record on April 28, 2017