Muscle Fiber Fragment Treatment for Urinary Incontinence

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University
Study ID
NCT01953263
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Urinary Incontinence

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Autologous Muscle Fiber Fragments — OTHER
    Autologous muscle fiber fragments administered via a single direct injection into the bladder neck sphincter region

Study Details

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).

Key Dates

Start date
Jan 31, 2016
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Autologous Muscle Fiber Fragments
    Autologous Muscle Fiber Fragments administered via a single,direct injection into the bladder neck sphincter region

Primary Outcome Measure

Incidence of treatment-related serious adverse events [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest Urology ClinicWinston-SalemNorth Carolina27103
Mary-Clare Day, RN, BSN
[email protected]
336-713-1343
Gopal Badlani, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Wake Forest Urology Clinic· Winston-Salem, NC

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