Back to resultsAutologous Muscle Derived Cells Female Stress Urinary Incontinence Clinical Study
Primary Purpose
Urinary Incontinence, Stress
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
AMDC-USR
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence, Stress focused on measuring Urinary Incontinence, Stress, Tissue Therapy (Cell Therapy), Transplantation, Autologous
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.
Sites / Locations
- Foothills Medical Center
- Southern Alberta Institute of Urology
- Victoria Gynecology and Continence Clinic
- Can-Med Clinical Research Inc.
- Centre for Applied Urological Research Queens University
- Sunnybrook Health Sciences Centre
- Mount Sinai Hospital
- Centre Hospitalier Universitaire de Sherbrooke
- Praxisklinik Urologie Rhein-Ruhr
- Worthing Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AMDC-USR
Placebo
Arm Description
Subjects received 1 or 2 treatments of 150 million AMDC-USR delivered via transurethral intrasphincteric injection. After completing 12 months follow-up subjects were unblinded. Subjects were followed for 2 years after initial AMDC-USR treatment.
Subjects received 1 or 2 treatments of placebo delivered via transurethral intrasphincteric injection. After completing 12 months follow-up subjects were unblinded and could elect to receive open-label AMDC-USR treatment. Subjects that received unblinded AMDC-USR treatment were followed for 2 years after initial placebo treatment.
Outcomes
Primary Outcome Measures
Percentage of Participants With Response (Based on Stress IEF, or In-office Pad Weight Test, or 24-hour Pad Weight Test) at 12 Months
A composite primary endpoint of responder rate was used, where a subject was considered a responder if she had ≥ 50% reduction from baseline in stress Incontinence Episode Frequency (stress IEF; reported stress leaks from 3-day diary) or ≥ 50% reduction in leakage from baseline as determined by either the in-office pad weight test or the 24-hour pad weight test.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01382602
Brief Title
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
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
November 4, 2011 (Actual)
Primary Completion Date
February 3, 2016 (Actual)
Study Completion Date
January 29, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook MyoSite
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Stress
Keywords
Urinary Incontinence, Stress, Tissue Therapy (Cell Therapy), Transplantation, Autologous
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AMDC-USR
Arm Type
Experimental
Arm Description
Subjects received 1 or 2 treatments of 150 million AMDC-USR delivered via transurethral intrasphincteric injection. After completing 12 months follow-up subjects were unblinded. Subjects were followed for 2 years after initial AMDC-USR treatment.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects received 1 or 2 treatments of placebo delivered via transurethral intrasphincteric injection. After completing 12 months follow-up subjects were unblinded and could elect to receive open-label AMDC-USR treatment. Subjects that received unblinded AMDC-USR treatment were followed for 2 years after initial placebo treatment.
Intervention Type
Biological
Intervention Name(s)
AMDC-USR
Intervention Description
AMDC-USR Treatment
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo treatment
Primary Outcome Measure Information:
Title
Percentage of Participants With Response (Based on Stress IEF, or In-office Pad Weight Test, or 24-hour Pad Weight Test) at 12 Months
Description
A composite primary endpoint of responder rate was used, where a subject was considered a responder if she had ≥ 50% reduction from baseline in stress Incontinence Episode Frequency (stress IEF; reported stress leaks from 3-day diary) or ≥ 50% reduction in leakage from baseline as determined by either the in-office pad weight test or the 24-hour pad weight test.
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lesley K. Carr, MD, FRCSC
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foothills Medical Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Southern Alberta Institute of Urology
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2V 1P9
Country
Canada
Facility Name
Victoria Gynecology and Continence Clinic
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6R3
Country
Canada
Facility Name
Can-Med Clinical Research Inc.
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8T 5G1
Country
Canada
Facility Name
Centre for Applied Urological Research Queens University
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1Z5
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Praxisklinik Urologie Rhein-Ruhr
City
Mülheim
ZIP/Postal Code
45468
Country
Germany
Facility Name
Worthing Hospital
City
Worthing
ZIP/Postal Code
BN11 2DH
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
30178605
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.
Results Reference
derived
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Autologous Muscle Derived Cells Female Stress Urinary Incontinence Clinical Study
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