NCT01953263 Muscle Fiber Fragment Treatment for Urinary Incontinence
| NCT ID | NCT01953263 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Wake Forest University |
| Condition | Urinary Incontinence |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2016-01 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2016-01 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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
Contact & Investigator
Gopal Badlani, MD
PRINCIPAL INVESTIGATOR
Wake Forest School of Medicine, Dept. of Urology
Frequently Asked Questions
Who can join the NCT01953263 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Urinary Incontinence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT01953263 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT01953263 currently recruiting?
Yes, NCT01953263 is actively recruiting participants. Contact the research team at mday@wakehealth.edu for enrollment information.
Where is the NCT01953263 trial being conducted?
This trial is being conducted at Winston-Salem, United States.
Who is sponsoring the NCT01953263 clinical trial?
NCT01953263 is sponsored by Wake Forest University. The principal investigator is Gopal Badlani, MD at Wake Forest School of Medicine, Dept. of Urology. The trial plans to enroll 10 participants.