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Muscle Fiber Fragment Treatment for Urinary Incontinence

This study is currently recruiting participants.
Verified April 2017 by Wake Forest University Health Sciences ( Wake Forest University )
Sponsor:
ClinicalTrials.gov Identifier:
NCT01953263
First Posted: September 30, 2013
Last Update Posted: November 8, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )
  Purpose
This study is designed to evaluate the safety of autologous muscle fiber fragments for the treatment of urinary incontinence due to incompetent outlet (bladder neck/urethra).

Condition Intervention Phase
Urinary Incontinence Other: Autologous Muscle Fiber Fragments Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of Human Muscle Fiber Fragment (MFF) Treatment for Urinary Incontinence

Resource links provided by NLM:


Further study details as provided by Wake Forest University Health Sciences ( Wake Forest University ):

Primary Outcome Measures:
  • Incidence of treatment-related serious adverse events [ Time Frame: 12 months ]
    the subject/biopsy/treatment sites will be monitored for signs of bleeding, infections, continued pain, prolonged hospitalization


Secondary Outcome Measures:
  • Change in Incontinence Assessment by Pad Test [ Time Frame: baseline, 3, 6, and 12 months post-treatment ]
    Subjects will undergo 1 hour and 24 hour Pad Tests (pads are weighed) at baseline, 3, 6 and 12 months post treatment


Other Outcome Measures:
  • Change in number of incontinence episodes and pads used per day [ Time Frame: baseline, 3, 6 and 12 months post-treatment ]
    voiding diaries and pads used each day will be compared to baseline


Estimated Enrollment: 10
Study Start Date: January 2016
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autologous Muscle Fiber Fragments
Autologous Muscle Fiber Fragments administered via a single,direct injection into the bladder neck sphincter region
Other: Autologous Muscle Fiber Fragments
Autologous muscle fiber fragments administered via a single direct injection into the bladder neck sphincter region

Detailed Description:
Eligible subjects with a diagnosis of urinary incontinence who give consent to take part will undergo a biopsy of the muscle from the inner thigh under anesthesia. During the same procedure, muscle fiber fragments will be obtained from the sample and then immediately delivered via target injected into the bladder neck sphincter region using an endoscopic needle via cystoscope or under ultrasound guidance. All subjects will be followed at 1 week, 6 weeks, 3 months, 6 months and 12 months post-treatment injection.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult female patients who are not pregnant or lactating/breast-feeding and must be either not sexually active, surgically sterilized, or must be practicing an effective method of birth control as determined by the investigator
  • Patients between the ages of 18 and 75 years
  • Patients with positive diagnosis of urinary incontinence due to sphincter insufficiency caused by acquired (e.g., stress urinary incontinence) and/or congenital conditions.
  • Patients with cystometric capacity of bladder > 100 ml
  • Patients with normal renal function
  • Patients with a history of primary incontinence

Exclusion Criteria:

  • Patients with a history of hypercontractile bladder, non-compliant bladder, hydronephrosis or neurogenic bladder
  • Patients with an active urinary tract infection as evidenced by positive urine culture
  • Patients who are taking medication that affect urination such as prescription drugs, over-the-counter drugs, or dietary supplements, including herbal supplements and those taken with teas
  • Patients requiring concomitant use of or treatment with immunosuppressive agents
  • Patients with a history of systemic conditions, including but not limited to HIV, diabetes and chronic liver disease (including Hepatitis B or C), that the Investigator believes may jeopardize the safety of the patient to participate in the study
  • Patients with evidence or diagnosis of any primary muscle disease or coagulation disorder (including concomitant anti-coagulation therapy)
  • Patients who have been treated with any other investigational drug or participated in any investigational study within 30 days prior to enrollment in this study
  • Patients who have been treated with any cellular therapy within 12 months prior to enrollment in this study
  • Patients with urinary incontinence other than the categories being investigated
  • Patients with significant (>grade 2) pelvic organ prolapse
  • Patients with vaginal prolapse beyond introitus
  • Patients with neurological disorders
  • Patients with abnormal bladder capacity (i.e., less than 100 cc)
  • Patients with abnormal urologic conditions, including post-void residual, urethral stricture and bladder neck contracture, spastic bladder, vesicoureteral reflux, bladder stones, bladder tumors, hydronephrosis, other renal impairment
  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): NCT01953263


Contacts
Contact: Mary-Clare Day, RN, BSN 336-713-1343 mday@wakehealth.edu
Contact: Gopal Badlani, MD gbadlani@wakehealth.edu

Locations
United States, North Carolina
Wake Forest Urology Clinic Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Mary-Clare Day, RN, BSN    336-713-1343    mday@wakehealth.edu   
Principal Investigator: Gopal Badlani, MD         
Sponsors and Collaborators
Wake Forest University
Investigators
Principal Investigator: Gopal Badlani, MD Wake Forest School of Medicine, Dept. of Urology
  More Information

Responsible Party: Wake Forest University
ClinicalTrials.gov Identifier: NCT01953263     History of Changes
Other Study ID Numbers: 00025341
First Submitted: September 25, 2013
First Posted: September 30, 2013
Last Update Posted: November 8, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Wake Forest University Health Sciences ( Wake Forest University ):
urinary incontinence, muscle fibers

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