Adjustable Continence Therapy for treating female stress urinary incontinence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the safety and effectiveness of Adjustable Continence Therapy (ACT) in women diagnosed with stress urinary incontinence due to primary Intrinsic Sphincter Deficiency. It is a prospective, single-arm, non-randomized, multicenter case-series trial that will assess the clinical improvement in patients who have not responded to previous treatments. Participants will undergo the ACT procedure and will be monitored for outcomes related to urinary incontinence. The study seeks to provide valuable data on the therapeutic benefits of this innovative approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Female at least 22 years old
2. Diagnosed with stress urinary incontinence with primary Intrinsic Sphincter Deficiency
3. Provocative pad weight of greater than 11.0 grams
4. Candidate for surgical intervention
5. Negative urinalysis
6. Normal cystourethroscopy
7. 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)
8. Willing and able to sign informed consent and comply with trial follow-up requirements

Exclusion Criteria:

1. Pregnant or lactating
2. Life expectancy of less than 5 years
3. Has uncontrolled diabetes as evidenced by HbA1c over 6.5% and fasting plasma glucose over 130 mg/dL
4. Has auto-immune disease
5. Undergoing radiation therapy
6. Active urinary tract infection
7. Detrusor instability refractory to medication
8. Reduced bladder compliance as defined by a cystometrogram
9. 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
10. Has, had, or is suspected of having bladder cancer
11. History of bladder stones
12. Urethral stricture evidenced during cystourethroscopy
13. Has a neurogenic bladder that is atonic or has detrusor sphincter dyssynergia
14. Has a diathesis, hemophilia, or a bleeding disorder
15. Has a rectocele, cystocele, urethrocele, enterocele, or pelvic prolapse of grade 3 or higher
16. Had prior pelvic radiotherapy
17. Had a prior artificial urinary sphincter implanted
18. Has a neurogenic condition known to affect bladder/sphincter function

Where it's running

• University of Colorado
  Denver, Colorado, United States Recruiting
• Idaho Urologic Institute, PA
  Meridian, Idaho, United States Recruiting
• CHI Health Research Center
  Omaha, Nebraska, United States Recruiting
• Penn State University
  Hershey, Pennsylvania, United States Recruiting
• Hôpital de la Conception - Marseille
  Marseille, France Recruiting
• CHU de Nantes
  Nantes, France Recruiting

Study contacts

• Study coordinator: Lisa Draper
• Email: USLDR@COLOPLAST.COM
• Phone: 612-834-7494

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.