Muscle Fiber Fragment Treatment for Urinary Incontinence

Launched by WAKE FOREST UNIVERSITY · Sep 25, 2013

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment for women with urinary incontinence, which is a condition that causes involuntary leakage of urine. The study aims to test the safety of using muscle fiber fragments taken from the patient’s own body to potentially help improve this condition. The trial is currently looking for women aged 18 to 75 who have been diagnosed with urinary incontinence due to issues with their bladder muscles. To participate, women must not be pregnant or breastfeeding, should not have certain medical conditions, and need to be able to effectively control their health with appropriate methods.

Participants in this trial can expect to undergo a procedure where muscle fibers are collected and then used to treat their urinary incontinence. The study is in its early phase, which means it’s primarily focused on ensuring that the treatment is safe. Women interested in joining the study will need to meet specific health criteria and should talk to their doctor to see if they qualify. This trial represents a potential new option for women seeking relief from urinary incontinence.

Gender

FEMALE

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