Back to resultsAutologous Cell Therapy for Female Stress Urinary Incontinence
Primary Purpose
Stress Urinary Incontinence
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Autologous Muscle Derived Cells
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence
Eligibility Criteria
Inclusion Criteria:
- SUI with normal detrusor activity confirmed with urodynamics
- Bladder capacity >200 ml
- Incontinence has not shown any improvement for at least -6 months
- Failed prior treatments (e.g., behavior modification, bladder exercises, biofeedback, electrical stimulation, bulking injections, urethral suspensions and/or drug therapy)
Exclusion Criteria:
- Known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant pelvic floor abnormalities with high pressure instability
- Neuromuscular disorder (e.g., muscular dystrophy, multiple sclerosis)
- Uncontrolled diabetes
- Pregnant, lactating, or plans to become pregnant during course of the study
- Morbid obesity (defined as 100 pounds over their ideal body weight, or BMI ≥40) and not expected to benefit from treatment
- Current or acute conditions involving cystitis or urethritis
- Scheduled to receive radiation treatment to the vicinity, or history of radiation treatment to the urethra or adjacent structures
Sites / Locations
- Foothills Medical Centre
- Sunnybrook Health Sciences Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants That Experienced Biopsy Procedure-related Adverse Events
Biopsy was required to generate AMDC products. Biopsy procedure-related events were defined as systemic responses to the biopsy procedure or injury at the biopsy site. Since biopsy occurred prior to AMDC treatment, results are presented independent of AMDC dose received. All biopsy procedure-related events either self-resolved or were easily treated.
Number of Participants That Experienced Injection Procedure-related Adverse Events
AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received. All injection procedure-related events self-resolved or were easily treated.
Injection Procedure-related Adverse Events
AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received. All injection procedure-related events self-resolved or were easily treated.
Number of Participants That Experienced AMDC Product-related Events
If an immune response after injection or any urinary retention occurred and seemed suspicious, the physicians were consulted to determine whether the effect was likely related to the AMDC product.
No adverse events reported during the study were adjudicated as AMDC product-related.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01008943
Brief Title
Autologous Cell Therapy for Female Stress Urinary Incontinence
Official Title
A Canadian Prospective Nonrandomized Study of Autologous Cell Therapy for Female Stress Urinary Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 2, 2010 (Actual)
Primary Completion Date
September 21, 2012 (Actual)
Study Completion Date
September 21, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook MyoSite
4. Oversight
5. Study Description
Brief Summary
The Autologous Cell Therapy for Female SUI study is a clinical trial to determine the safety and potential effectiveness of a single dose of 200 million Cook MyoSite Autologous Muscle Derived Cells for treatment of Stress Urinary Incontinence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Autologous Muscle Derived Cells
Intervention Description
Urethral injection of autologous muscle-derived cells
Primary Outcome Measure Information:
Title
Number of Participants That Experienced Biopsy Procedure-related Adverse Events
Description
Biopsy was required to generate AMDC products. Biopsy procedure-related events were defined as systemic responses to the biopsy procedure or injury at the biopsy site. Since biopsy occurred prior to AMDC treatment, results are presented independent of AMDC dose received. All biopsy procedure-related events either self-resolved or were easily treated.
Time Frame
at biopsy or between biopsy and treatment, approximately 6 weeks
Title
Number of Participants That Experienced Injection Procedure-related Adverse Events
Description
AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received. All injection procedure-related events self-resolved or were easily treated.
Time Frame
30 days
Title
Injection Procedure-related Adverse Events
Description
AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received. All injection procedure-related events self-resolved or were easily treated.
Time Frame
30 days
Title
Number of Participants That Experienced AMDC Product-related Events
Description
If an immune response after injection or any urinary retention occurred and seemed suspicious, the physicians were consulted to determine whether the effect was likely related to the AMDC product.
No adverse events reported during the study were adjudicated as AMDC product-related.
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
SUI with normal detrusor activity confirmed with urodynamics
Bladder capacity >200 ml
Incontinence has not shown any improvement for at least -6 months
Failed prior treatments (e.g., behavior modification, bladder exercises, biofeedback, electrical stimulation, bulking injections, urethral suspensions and/or drug therapy)
Exclusion Criteria:
Known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant pelvic floor abnormalities with high pressure instability
Neuromuscular disorder (e.g., muscular dystrophy, multiple sclerosis)
Uncontrolled diabetes
Pregnant, lactating, or plans to become pregnant during course of the study
Morbid obesity (defined as 100 pounds over their ideal body weight, or BMI ≥40) and not expected to benefit from treatment
Current or acute conditions involving cystitis or urethritis
Scheduled to receive radiation treatment to the vicinity, or history of radiation treatment to the urethra or adjacent structures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lesley K. Carr, MD
Organizational Affiliation
Sunnybrook Health Sciences Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N2T9
Country
Canada
Facility Name
Sunnybrook Health Sciences Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3 M5
Country
Canada
12. IPD Sharing Statement
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/24582537
Description
Autologous muscle derived cells for treatment of stress urinary incontinence in women
Learn more about this trial
Autologous Cell Therapy for Female Stress Urinary Incontinence
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