Actively Recruiting
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with immediate recovery period
Participants undergo implantation of the Adjustable Continence Therapy (ACT) devices, which involves a surgical procedure placing devices near the urethra.
1 surgical visit and several post-operative visits
Duration - 12 months
Participants are monitored after implantation for safety and assessment of therapy effectiveness over time.
Regular follow-up visits over 12 months
Trial Site Locations
Total: 2 locations
1
University of Colorado
Denver, Colorado, United States, 80045
Actively Recruiting
2
CHI Health Research Center
Omaha, Nebraska, United States, 68124
Actively Recruiting
Research Team
P
Patrick Gora
T
Timothy C Cook, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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