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New treatment option for Urinary Incontinence
Official title Muscle Fiber Fragment Treatment for Urinary Incontinence
ClinicalTrials.gov ID: NCT01953263
What this study is testing
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- Adult female patients who are not pregnant or lactating/breast-feeding and must be either not sexually active, surgically sterilized, or must be...
- 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...
- Patients with cystometric capacity of bladder \> 100 ml
- Patients with normal renal function
You likely can't join if
- 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...
- 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)...
- Patients with evidence or diagnosis of any primary muscle disease or coagulation disorder (including concomitant anti-coagulation therapy)
See the full eligibility 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...
- 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
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Winston-Salem, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Winston-Salem, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.