At a glance
ClinicalIndex Comparison Record- ✓Female, age 18 or older
- ✓Diagnosed with stress urinary incontinence with or without urethral hypermobility
- ✓Candidate for surgical intervention for stress incontinence
- ✓Failed at least 6 months of previous conservative or surgical treatments (e.g., pelvic floor exercises, electrical stimulation, prior surgical procedures)
- ✕Pregnant or lactating
- ✕Life expectancy less than one year
- ✕Insulin-dependent diabetic
- ✕Auto-immune disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Investigation of an Adjustable Continence Therapy (ACT) Periurethral Prosthetic System for Treatment of Female Stress Urinary Incontinence With or Without Hypermobility
In Brief
A clinical study evaluating ACT (Adjustable Continence Therapy) for Urinary Incontinence. Completed, enrolled 221 participants across 7 sites in 2 countries.
Detailed Summary
The purpose of this study is to evaluate the safety and effectiveness of a minimally invasive surgical procedure in up to 160 implanted female patients in which two adjustable balloons (one on each side of the urethra) are implanted to treat urinary stress incontinence. The results will be analyzed to demonstrate the effects of the device as well as its associated risks. Therapeutic success will be based on whether the patients demonstrate at least a one-grade (mean) reduction in the Stamey score at 12 months.
Study Details
Timeline
Interventions
surgically implanted device