Autologous Cell Therapy for Female Stress Urinary Incontinence

Stress Urinary Incontinence Clinical Trial

Official title:

A Canadian Prospective Nonrandomized Study of Autologous Cell Therapy for Female Stress Urinary Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01008943
• Other study ID #: 09-013
• Status: Completed
• Phase: Phase 2
• Start date: June 2, 2010
• Est. completion date: September 21, 2012

Study information

• Verified date: June 2021
• Source: Cook MyoSite
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 21, 2012
• Est. primary completion date: September 21, 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Biological:
• Autologous Muscle Derived Cells
Urethral injection of autologous muscle-derived cells

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	Sunnybrook Health Sciences Center	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Cook MyoSite

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at biopsy or between biopsy and treatment, approximately 6 weeks
Primary	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.	30 days
Primary	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.	30 days
Primary	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.	12 months

External Links

•   Autologous muscle derived cells for treatment of stress urinary incontinence in women