Muscle Fiber Fragment Treatment for Urinary Incontinence

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by Wake Forest School of Medicine
Sponsor:
Information provided by (Responsible Party):
Gopal Badlani, MD, Wake Forest University
ClinicalTrials.gov Identifier:
NCT01953263
First received: September 25, 2013
Last updated: NA
Last verified: September 2013
History: No changes posted
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 School of Medicine:

Primary Outcome Measures:
  • Incidence of treatment-related serious adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    voiding diaries and pads used each day will be compared to baseline


Estimated Enrollment: 10
Study Start Date: November 2013
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2016 (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

Ages Eligible for Study:   18 Years to 75 Years
Genders 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
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: 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 Not yet 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 School of Medicine
Investigators
Principal Investigator: Gopal Badlani, MD Wake Forest School of Medicine, Dept. of Urology
  More Information

No publications provided

Responsible Party: Gopal Badlani, MD, Professor, Wake Forest University
ClinicalTrials.gov Identifier: NCT01953263     History of Changes
Other Study ID Numbers: 00025341
Study First Received: September 25, 2013
Last Updated: September 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
urinary incontinence, muscle fibers

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

ClinicalTrials.gov processed this record on October 29, 2014