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New treatment option for Urinary Incontinence
Official title Adjustable Continence Therapy (ACT) for the Treatment of Female SUI
ClinicalTrials.gov ID: NCT04248283
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older, women only
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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...
- Willing and able to sign informed consent and comply with trial follow-up requirements
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Denver, Colorado, United States
- Omaha, Nebraska, United States
- Marseille, France
- Nantes, France
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Denver, Colorado, United States; Omaha, Nebraska, United States; Marseille, France; Nantes, France; Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.