Muscle Fiber Fragment Treatment for Urinary Incontinence

Status Recruiting

Clinical Trial 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).

Clinical Trial Description

Eligible subjects with a diagnosis of urinary incontinence who give consent to take part will undergo a biopsy of the muscle from the inner thigh under anesthesia. During the same procedure, muscle fiber fragments will be obtained from the sample and then immediately delivered via target injected into the bladder neck sphincter region using an endoscopic needle via cystoscope or under ultrasound guidance. All subjects will be followed at 1 week, 6 weeks, 3 months, 6 months and 12 months post-treatment injection. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01953263
Study type	Interventional
Source	Wake Forest University Health Sciences
Contact	Mary-Clare Day, RN, BSN
Phone	336-713-1343
Email	mday@wakehealth.edu
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	January 2016
Completion date	January 2026

View Details

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