Treatment for urinary incontinence using muscle fiber fragments

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety of using autologous muscle fiber fragments to treat urinary incontinence caused by incompetent bladder neck or urethra. Eligible adult female participants will undergo a biopsy to obtain muscle fibers from their inner thigh, which will then be injected into the bladder neck sphincter region. Participants will be monitored for safety and efficacy at various intervals post-treatment, including 1 week, 6 weeks, 3 months, 6 months, and 12 months. The goal is to assess the potential of this innovative approach in improving urinary control.

Why it matters

Who can join: the full rules

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

Where it's running

• Wake Forest Urology Clinic
  Winston-Salem, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Gopal Badlani, MD — Wake Forest School of Medicine, Dept. of Urology
• Study coordinator: Mary-Clare Day, RN, BSN
• Email: mday@wakehealth.edu
• Phone: 336-713-1343

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.