Clinical trial NCT01382602: Autologous Muscle Derived Cells Female Stress Urinary Incontinence Clinical Study
Official title: A Double-blind, Randomized, Placebo-Controlled Study Evaluating the Safety and Effectiveness of Cook MyoSite Incorporated AMDC in Female Patients With Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Incontinence, Stress
Keywords: Urinary Incontinence, Stress
Tissue Therapy (Cell Therapy)
Transplantation, Autologous
Lead sponsor: Cook MyoSite
Sponsor class: INDUSTRY
First posted: 2011-06-27
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a clinical trial to study the safety and effectiveness of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) for the treatment of female stress urinary incontinence (SUI).

Detailed description: Study comparing intrasphincteric injection of AMDC-USR with placebo. Subjects unblinded after 12 months visits, but followed for 2 years. Subjects randomized to placebo could elect to receive open-label AMDC-USR after completing 12 months visit.

Eligibility criteria: 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 for at least 1 month 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 randomization 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.

Primary outcomes:
measure: Percentage of Participants With Response (Based on Stress IEF, or In-office Pad Weight Test, or 24-hour Pad Weight Test) at 12 Months
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Center
state: Alberta
city: Calgary
country: Canada
facility: Southern Alberta Institute of Urology
state: Alberta
city: Victoria
country: Canada
facility: Victoria Gynecology and Continence Clinic
state: British Columbia
city: Victoria
country: Canada
facility: Can-Med Clinical Research Inc.
state: British Columbia
city: Kingston
country: Canada
facility: Centre for Applied Urological Research Queens University
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
city: Mülheim
country: Germany
facility: Praxisklinik Urologie Rhein-Ruhr
city: Worthing
country: United Kingdom
facility: Worthing Hospital
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Lesley K. Carr, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fontaine F, Tu LM, Carroll MS, Morin M. Agreement between simple catheter method and 3D transperineal ultrasound for assessing urethral length measurement before stress urinary incontinence treatment. Neurourol Urodyn. 2018 Nov;37(8):2875-2880. doi: 10.1002/nau.23805. Epub 2018 Sep 3.