Actively Recruiting
Muscle Fiber Fragment Treatment for Urinary Incontinence
Led by Wake Forest University · Updated on 2026-04-23
10
Participants Needed
1
Research Sites
674 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Muscle Fiber Fragment Treatment for Urinary Incontinence
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult female patients who are not pregnant or breastfeeding and are either not sexually active, surgically sterilized, or using effective birth control
- Patients aged 18 to 75 years
- Diagnosis of urinary incontinence due to sphincter insufficiency from acquired or congenital causes
- Bladder capacity greater than 100 ml
- Normal kidney function
- History of primary urinary incontinence
You will not qualify if you...
- History of hypercontractile or non-compliant bladder, hydronephrosis, or neurogenic bladder
- Active urinary tract infection confirmed by urine culture
- Taking medications or supplements that affect urination
- Need for immunosuppressive treatment
- History of systemic conditions such as HIV, diabetes, chronic liver disease, or others risking patient safety
- Diagnosis or evidence of muscle disease or bleeding disorders
- Participation in investigational drug studies within 30 days prior to enrollment
- Treatment with cellular therapy within 12 months prior to enrollment
- Urinary incontinence types not included in the study
- Significant pelvic organ prolapse (greater than grade 2)
- Vaginal prolapse beyond the opening
- Neurological disorders
- Abnormal bladder capacity less than 100 cc
- Other abnormal urologic conditions including post-void residual, urethral stricture, bladder neck contracture, spastic bladder, vesicoureteral reflux, bladder stones, tumors, hydronephrosis, or renal impairment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Wake Forest Urology Clinic
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
Research Team
M
Mary-Clare Day, RN, BSN
CONTACT
G
Gopal Badlani, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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