Muscle Fiber Fragment Treatment for Urinary Incontinence

NCT01953263 | Recruiting Phase 1 DMC

• 1 other identifier: IRB00025341
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Urinary Incontinence

Keywords

urinary incontinence, muscle fibers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Incontinence Assessment by Pad Test

  baseline, 3, 6, and 12 months post-treatment

Other Outcomes (1)

• Change in number of incontinence episodes and pads used per day

  baseline, 3, 6 and 12 months post-treatment

Study Arms (1)

Autologous Muscle Fiber Fragments

EXPERIMENTAL

Autologous Muscle Fiber Fragments administered via a single,direct injection into the bladder neck sphincter region

Other: Autologous Muscle Fiber Fragments

Interventions

Autologous Muscle Fiber Fragments OTHER

Autologous muscle fiber fragments administered via a single direct injection into the bladder neck sphincter region

Autologous Muscle Fiber Fragments

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University: lead

Study Sites (1)

Wake Forest Urology Clinic

Winston-Salem, North Carolina, 27103, United States

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gopal Badlani, MD

  Wake Forest School of Medicine, Dept. of Urology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary-Clare Day, RN, BSN

CONTACT

336-713-1343; mday@wakehealth.edu

Gopal Badlani, MD

CONTACT

gbadlani@wakehealth.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2013
• First Posted: September 30, 2013
• Study Start: January 1, 2016
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)