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A Clinical Investigation of the Adjustable Continence Therapy ACT for Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency
Led by Uromedica · Updated on 2024-07-23
167
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Adjustable Continence Therapy ACT device for women with stress urinary incontinence caused by intrinsic sphincter deficiency. This prospective, single arm, non-randomized, multicenter trial aims to assess the safety and effectiveness of ACT in providing meaningful improvement in symptoms for affected women. The study is sponsored by Uromedica and focuses on clinical outcomes related to urinary incontinence. The trial involves implanting two ACT devices in each participant in the paraurethral space near the bladder neck using local, spinal, or general anesthesia. The device includes balloons that are filled with an isotonic solution after implantation via subcutaneous ports placed in the labia majora. This device implantation is the main intervention studied, and participants receive follow-up care to monitor results. Participants will undergo evaluations including provocative pad weight measurement at 12 months to assess urine leakage. Additional assessments include quality of life and urogenital distress questionnaires at 12 months. Researchers will also monitor participants for safety and treatment adherence throughout the study. The trial seeks to gather comprehensive data on symptom improvement and quality of life over the course of a year following device implantation.
CONDITIONS
Brief Title
Adjustable Continence Therapy (ACT) for the Treatment of Female SUI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female at least 22 years old
- Diagnosed with stress urinary incontinence with primary Intrinsic Sphincter Deficiency
- Provocative pad weight greater than 11.0 grams
- Candidate for surgical intervention
- Negative urinalysis
- Normal cystourethroscopy
- Failed at least 6 months of previous treatments for stress urinary incontinence
- Willing and able to sign informed consent and comply with trial follow-up requirements
You will not qualify if you...
- Pregnant or lactating
- Life expectancy less than 5 years
- Uncontrolled diabetes with HbA1c over 6.5% and fasting plasma glucose over 130 mg/dL
- Auto-immune disease
- Undergoing radiation therapy
- Active urinary tract infection
- Detrusor instability refractory to medication
- Reduced bladder compliance as defined by cystometrogram
- Significant residual urine volume over 100 ml with weak detrusor contraction
- Has, had, or suspected bladder cancer
- History of bladder stones
- Urethral stricture
- Neurogenic bladder that is atonic or has detrusor sphincter dyssynergia
- Bleeding disorder such as diathesis or hemophilia
- Rectocele, cystocele, urethrocele, enterocele, or pelvic prolapse grade 3 or higher
- Prior pelvic radiotherapy
- Prior artificial urinary sphincter implant
- Neurogenic condition affecting bladder or sphincter function
Research Team
P
Patrick Gora
T
Timothy C Cook, PhD
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