Autologous Cell Therapy for Female Stress Urinary Incontinence

Phase 2

Completed

Conditions: Stress Urinary Incontinence

Registration Number: NCT01008943

Lead Sponsor: Cook MyoSite

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 16

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Participants That Experienced Biopsy Procedure-related Adverse Events	at biopsy or between biopsy and treatment, approximately 6 weeks	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.
Injection Procedure-related Adverse Events	30 days	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	12 months	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.
Number of Participants That Experienced Injection Procedure-related Adverse Events	30 days	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (2): Foothills Medical Centre
🇨🇦
Calgary, Alberta, Canada
Sunnybrook Health Sciences Center
🇨🇦
Toronto, Ontario, Canada
Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada