Actively Recruiting
Adjustable Continence Therapy (ACT) for the Treatment of Female SUI
Led by Uromedica · Updated on 2024-07-23
167
Participants Needed
2
Research Sites
257 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A prospective, single arm, non-randomized, multicenter, prospective case-series trial. The purpose of this trial is to demonstrate the safety and effectiveness of using the Adjustable Continence Therapy (ACT) to provide a clinically relevant improvement in stress urinary incontinence.
CONDITIONS
Official 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 treatment(s) 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 (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 by cystometrogram
- Significant residual urine volume (>100 ml) with weak detrusor contraction at bladder volume 250 ml
- Has, had, or suspected bladder cancer
- History of bladder stones
- Urethral stricture seen during cystourethroscopy
- Neurogenic bladder that is atonic or has detrusor sphincter dyssynergia
- Diathesis, hemophilia, or bleeding disorder
- Rectocele, cystocele, urethrocele, enterocele, or pelvic prolapse grade 3 or higher
- Prior pelvic radiotherapy
- Prior artificial urinary sphincter implant
- Neurogenic condition affecting bladder/sphincter function
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
T
Timothy C Cook, PhD
CONTACT
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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