Muscle Fiber Fragment Treatment for Urinary Incontinence

A Phase 1 Study of Human Muscle Fiber Fragment (MFF) Treatment for Urinary Incontinence

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).

Study Overview

• Status: Recruiting
• Conditions: Urinary Incontinence
• Intervention / Treatment: Other: Autologous Muscle Fiber Fragments

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Mary-Clare Day, RN, BSN; Phone Number: 336-713-1343; Email: mday@wakehealth.edu
• Study Contact Backup: Name: Gopal Badlani, MD; Email: gbadlani@wakehealth.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Recruiting
      • Wake Forest Urology Clinic
      • Contact: Mary-Clare Day, RN, BSN; Phone Number: 336-713-1343; Email: mday@wakehealth.edu
      • Principal Investigator: Gopal Badlani, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment-related serious adverse events	the subject/biopsy/treatment sites will be monitored for signs of bleeding, infections, continued pain, prolonged hospitalization	12 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in number of incontinence episodes and pads used per day	voiding diaries and pads used each day will be compared to baseline	baseline, 3, 6 and 12 months post-treatment

Collaborators and Investigators

• Sponsor: Wake Forest University
• Investigators: Principal Investigator: Gopal Badlani, MD, Wake Forest School of Medicine, Dept. of Urology

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: September 25, 2013
• First Submitted That Met QC Criteria: September 25, 2013
• First Posted (Estimated): September 30, 2013

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: urinary incontinence, muscle fibers
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis
• Other Study ID Numbers: IRB00025341

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No