Phase 2 N=16 Treatment

Autologous Cell Therapy for Female Stress Urinary Incontinence

Stress Urinary Incontinence

Bottom Line

View on ClinicalTrials.gov: NCT01008943 ↗

Enrolled (actual)

Serious AEs

6.3%

Results posted

Nov 2015

Primary outcome: Primary: Number of Participants That Experienced Biopsy Procedure-related Adverse Events — 1 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Autologous Muscle Derived Cells (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Cook MyoSite
Primary completion: Sep 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants That Experienced Biopsy Procedure-related Adverse Events	1	—
PRIMARY Number of Participants That Experienced Injection Procedure-related Adverse Events	6	—
PRIMARY Injection Procedure-related Adverse Events	2; 4; 1; 1	—
PRIMARY Number of Participants That Experienced AMDC Product-related Events	—	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01008943). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.