Autologous Muscle Derived Cells for Female Urinary Sphincter Repair

Status Completed

Clinical Trial Summary

This randomized, double-blind, placebo-controlled, multicenter, confirmatory study will evaluate the efficacy and safety of Cook MyoSite Incorporated Autologous Muscle-Derived Cells (generic name Iltamiocel) compared to a placebo (vehicle) control dose in the treatment of stress urinary incontinence (SUI) in adult female patients.

Clinical Trial Description

Study comparing intrasphincteric injection of iltamiocel with placebo. Subjects unblinded after 12 month visits, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01893138
Study type	Interventional
Source	Cook MyoSite
Contact
Status	Completed
Phase	Phase 3
Start date	November 21, 2013
Completion date	November 10, 2020

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04829357` - Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System
Completed	`NCT05493735` - Lidocaine for Pessary Check Pain Reduction	Phase 3
Completed	`NCT04512053` - A Phase 2 Study of TAS-303 in Female Patients With Stress Urinary Incontinence	Phase 2
Active, not recruiting	`NCT06224335` - Measurement of Intravaginal and Intra-abdominal Pressure and Pad Test During Sports Activities (SPORTVAGPRES)
Recruiting	`NCT05304312` - The Role of Kegel Exercises Book to Improve Treatment in Stress Urinary Incontinence Women	N/A
Not yet recruiting	`NCT05527665` - Sexual Fonction and Discomfort in Women After Midurethral Sling Surgery, Using PPSSQ
Not yet recruiting	`NCT04558762` - Ten Years Follow-up After Insertion of a MUS (Mid Urethral Sling) Due to Stress Urinary Incontinence
Withdrawn	`NCT02524366` - A Study of Transcorporal Versus Standard Artificial Urinary Sphincter Placement	N/A
Completed	`NCT01924728` - Efficacy of Magnetic Stimulation for Stress Urinary Incontinence	N/A
Completed	`NCT01676662` - Solace European Confirmatory Trial	N/A
Unknown status	`NCT01455779` - Lyrette: Renewing Continence Objective and Subjective Efficacy Study	N/A
Terminated	`NCT01029106` - Gynecare TVT Secur for the Management of Stress Urinary Incontinence (SUI)	N/A
Completed	`NCT01123096` - Is the Cough Stress Test Equivalent to the 24 Hour Pad Test in the Assessment of Stress Incontinence?	N/A
Withdrawn	`NCT00573703` - Laparoscopic Burch Colposuspension Versus Transobturatory Tape for the Treatment of Female Urinary Stress Incontinence	Phase 4
Completed	`NCT01770691` - Preliminary Performance Study of the New TIPI Device in the Prevention of Stress Urinary Incontinence	N/A
Completed	`NCT00234754` - Trans-Obturator Tape Versus Trans-Vaginal Tape for Stress Urinary Incontinence in Women	N/A
Completed	`NCT00441454` - Retropubic vs. Transobturator Tension-free Vaginal Tape	N/A
Completed	`NCT03985345` - Prospective Evaluation of the Connected EMY Biofeedback Probe in the Management of Stress Urinary Incontinence.	N/A
Active, not recruiting	`NCT03671694` - Laser Vaginal Treatment for SUI	N/A
Completed	`NCT04097288` - Effects of Single Dose Citalopram and Reboxetine on Urethral and Anal Closure Function on Healthy Female Subjects	Phase 1