Adjustable Continence Therapy (ACT) for the Treatment of Female SUI

Launched by UROMEDICA · Jan 27, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Adjustable Continence Therapy (ACT) for women who experience stress urinary incontinence, which is when urine leaks during activities like coughing, sneezing, or exercise. The goal of the trial is to show whether this treatment can safely and effectively improve this condition. The trial is currently recruiting women aged 22 and older who have been diagnosed with stress urinary incontinence and have not found relief from other treatments for at least six months.

To participate, women must meet certain criteria, including having a specific type of urinary incontinence and being eligible for surgery. Participants will receive the ACT treatment and will be monitored throughout the trial to see how well it works. It's important for potential participants to know that they will need to agree to follow-up visits and provide informed consent to join the study. This trial aims to provide a new option for women struggling with this common issue, and your participation could help improve treatment options for others in the future.

Gender

FEMALE

Eligibility 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