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Muscle Fiber Fragment Treatment for Urinary Incontinence

NCT01953263 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-04-23

No results posted yet for this study

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).

Conditions

Interventions

OTHER

Autologous Muscle Fiber Fragments

Autologous muscle fiber fragments administered via a single direct injection into the bladder neck sphincter region

Sponsors & Collaborators

  • Wake Forest University

    lead OTHER

Principal Investigators

  • Gopal Badlani, MD · Wake Forest School of Medicine, Dept. of Urology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01953263 on ClinicalTrials.gov