Muscle Fiber Fragment Treatment for Urinary Incontinence

NCT ID: NCT01953263

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2026-01-31

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).

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.

Conditions

Urinary Incontinence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Autologous Muscle Fiber Fragments

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

Group Type: EXPERIMENTAL

Autologous Muscle Fiber Fragments

Intervention Type: OTHER

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

Interventions

Autologous Muscle Fiber Fragments

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gopal Badlani, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest School of Medicine, Dept. of Urology

Locations

Wake Forest Urology Clinic

Winston-Salem, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mary-Clare Day, RN, BSN

Role: CONTACT

mday@wakehealth.edu

336-713-1343

Gopal Badlani, MD

Role: CONTACT

gbadlani@wakehealth.edu

Facility Contacts

Mary-Clare Day, RN, BSN

Role: primary

mday@wakehealth.edu

336-713-1343

Other Identifiers

IRB00025341

Identifier Type: -

Identifier Source: org_study_id