Adjustable Continence Therapy (ACT) for the Treatment of Female SUI (NCT04248283)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (19 items).
Location: University of Colorado — Denver, Colorado
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Pregnant or lactating
- Life expectancy of less than 5 years
- Has uncontrolled diabetes as evidenced by HbA1c over 6.5% and fasting plasma glucose over 130 mg/dL
- Has auto-immune disease
- Undergoing radiation therapy
- Active urinary tract infection
- Detrusor instability refractory to medication
- Reduced bladder compliance as defined by a cystometrogram
- Significant residual volume (greater than 100 ml) after voiding in which detrusor contraction is weak, when the bladder volume is greater than or equal to 250 ml
- Has, had, or is suspected of having bladder cancer
- History of bladder stones
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (5 Sites)
- University of Colorado — Denver, Colorado
- CHI Health Research Center — Omaha, Nebraska
- Hôpital de la Conception - Marseille — Marseille,
- CHU de Nantes — Nantes,
- Pitié Salpêtrière University Hospital Paris — Paris,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.