Treatment for urinary incontinence using muscle fiber fragments
A Phase 1 Study of Human Muscle Fiber Fragment (MFF) Treatment for Urinary Incontinence
This study is testing if using muscle fibers from women's thighs can help improve bladder control for those dealing with urinary incontinence.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT01953263 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adult females aged 18 to 75 with a diagnosis of urinary incontinence due to sphincter insufficiency.
Not a fit: Patients with conditions such as hypercontractile bladder, neurogenic bladder, or active urinary tract infections may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for women suffering from urinary incontinence.
How similar studies have performed: While this approach is innovative, similar studies using muscle-derived treatments have shown promise in other areas, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Winston-Salem, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.