Autologous Muscle Derived Cells for Female Urinary Sphincter Repair

Sponsor

Cook MyoSite (Industry)

Overall Status

Completed

CT.gov ID

NCT01893138

Collaborator

(none)

311

Enrollment

Locations

Arms

83.6

Actual Duration (Months)

10.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence	Biological: Roll-in: AMDC for USR Other: Placebo Biological: AMDC for USR Other: Roll in: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

311 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Double-blind, Randomized, Controlled Trial Comparing the Safety and Efficacy of AMDC-USR With Placebo in Female Subjects With Stress Urinary Incontinence

Actual Study Start Date :

Nov 21, 2013

Actual Primary Completion Date :

Nov 1, 2019

Actual Study Completion Date :

Nov 10, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Roll-in: AMDC for USR Roll-in patients are allowed in the study (up to 12 per site) and are randomized and treated exactly the same as standard study patients.	Biological: Roll-in: AMDC for USR AMDC for USR is the study product (autologous muscle derived cells for urinary sphincter repair).
Placebo Comparator: Placebo Placebo control is the vehicle solution used for the study product.	Other: Placebo Placebo control is the vehicle solution used for the study product.
Experimental: AMDC for USR AMDC for USR is the study product (autologous muscle derived cells for urinary sphincter repair).	Biological: AMDC for USR AMDC for USR is the study product (autologous muscle derived cells for urinary sphincter repair). Other Names: Autologous muscle derived cells for urinary sphincter repair
Placebo Comparator: Roll in: Placebo Roll-in patients are allowed in the study (up to 12 per site) and are randomized and treated exactly the same as standard study patients.	Other: Roll in: Placebo Placebo control is the vehicle solution used for the study product.

Outcome Measures

Primary Outcome Measures

Number of leaks due to stress incontinence episodes, as recorded in a diary [12 months]

Secondary Outcome Measures

Stress leak frequency [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Female patient has primary symptoms of SUI, as confirmed by patient medical history and clinical symptoms, including a focused incontinence evaluation.

Exclusion Criteria:

Patient has symptoms of pure urge incontinence as confirmed by basic evaluation of etiology from a patient medical history, including a focused incontinence history.
Patient has symptoms of mixed urinary incontinence where urge incontinence is the predominant factor.
Patient has had stress urinary incontinence symptoms less than 6 months prior to signing the informed consent.
Patient has not previously attempted conservative treatment prior to signing the informed consent. (Examples of conservative treatment include behavior modifications, bladder exercises, biofeedback, etc.)
Patient has more than 2 episode of awakening to void during normal sleeping hours.
Patient cannot be maintained on a stable dose and/or frequency of medication (including diuretics) known to affect lower urinary tract function, including but not limited to, anticholinergics, tricyclic antidepressants or alpha-adrenergic blockers, for at least 2 weeks prior to screening or is likely to change during the course of the study.
Patient is pregnant, lactating, or plans to become pregnant during the course of the study.
Patient refuses to provide written informed consent.
Patient is not at least 18 years of age.
Patient is not available for the follow-up evaluations as required by the protocol.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Arizona Phoenix Campus	Phoenix	Arizona	United States	85054
2	The American Association of Female Pelvic Medicine Specialists	Agoura Hills	California	United States	91301
3	Ronald Reagan UCLA Medical Center	Los Angeles	California	United States	90024
4	Stanford University	Stanford	California	United States	94304
5	Cleveland Clinic Florida	Weston	Florida	United States	33331
6	Emory University	Atlanta	Georgia	United States	30033
7	NorthShore University HealthSystem	Skokie	Illinois	United States	60076
8	IU Health Physicians Urogynecology	Indianapolis	Indiana	United States	46202
9	Female Pelvic Medicine & Urogynecology Institute of Michigan	Grand Rapids	Michigan	United States	49503
10	Mercy Health Saint Mary's Campus	Grand Rapids	Michigan	United States	49503
11	William Beaumont Hospital	Royal Oak	Michigan	United States	48073
12	Montefiore Medical Center	Bronx	New York	United States	10467
13	NYU Urology Associates	New York	New York	United States	10016
14	Premier Medical Group of the Hudson Valley PC	Poughkeepsie	New York	United States	12601
15	McKay Urology	Charlotte	North Carolina	United States	28207
16	The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital	Cincinnati	Ohio	United States	45242
17	Cleveland Clinic	Cleveland	Ohio	United States	44195
18	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104
19	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
20	Medical University of South Carolina	Charleston	South Carolina	United States	29425
21	Greenville Health System	Greenville	South Carolina	United States	29607
22	Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic	Sioux Falls	South Dakota	United States	57105
23	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
24	Methodist Urology Associates	Houston	Texas	United States	77030
25	Inova Fairfax Hospital	Falls Church	Virginia	United States	22042
26	Benaroya Research Institute at Virginia Mason	Seattle	Washington	United States	98101
27	University Hospital Leuven	Leuven		Belgium	3000
28	Universitätsklinikum Essen	Essen		Germany	45147
29	Praxisklinik Urologie Rhein-Ruhr (PUR/R)	Mülheim		Germany	45468