Adjustable Continence Therapy for treating female stress urinary incontinence
A Clinical Investigation of the Adjustable Continence Therapy (ACT) for Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency
This study is testing a new treatment called Adjustable Continence Therapy to see if it can help women with stress urinary incontinence who haven't had success with other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 167 (estimated) |
| Ages | 22 Years and up |
| Sex | Female |
| Sponsor | Uromedica Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 2 sites (Denver, Colorado and 1 other locations) |
| Trial ID | NCT04248283 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 22 and older who have been diagnosed with stress urinary incontinence and have not found relief from previous treatments.
Not a fit: Patients who are pregnant, have uncontrolled diabetes, or are undergoing radiation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve the quality of life for women suffering from stress urinary incontinence.
How similar studies have performed: Other studies have shown promising results with similar therapeutic approaches, indicating potential for success with this method.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Denver, Colorado and 1 other locations
- University of Colorado — Denver, Colorado, United States (Recruiting)
- CHI Health Research Center — Omaha, Nebraska, United States (Recruiting)
Study contacts
- Study coordinator: Patrick Gora
- Email: pgora@uromedica-inc.com
- Phone: 763-694-9880
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.