NCT04248283 · Uromedica
Adjustable Continence Therapy (ACT) for the Treatment of Female SUI
What this study is about
A forward-looking, single treatment group$1, non-randomly assigned, conducted at multiple hospitals, forward-looking 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.
View original scientific description
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 participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Female at least 22 years old
- Diagnosed with stress urinary incontinence with primary Intrinsic Sphincter Deficiency
- Provocative pad weight of 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 (e.g., exercise regimen, electrical stimulation, surgical procedures, etc). Note: patients may have failed prior anti-incontinence procedures for SUI (e.g., suspension, sling, or urethral bulking agent)
- Willing and able to sign informed consent and comply with trial follow-up requirements
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
- Urethral stricture evidenced during cystourethroscopy
- Has a neurogenic bladder that is atonic or has detrusor sphincter dyssynergia
- Has a diathesis, hemophilia, or a bleeding disorder
- Has a rectocele, cystocele, urethrocele, enterocele, or pelvic prolapse of grade 3 or higher
- Had prior pelvic radiotherapy
- Had a prior artificial urinary sphincter implanted
- Has a neurogenic condition known to affect bladder/sphincter function
Where
- Denver, Colorado
- Omaha, Nebraska
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 17, 2026 · Source of record for eligibility and locations