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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014