ProACT Therapy for Stress Urinary Incontinence
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how ProACT Adjustable Continence Therapy functions for men with stress urinary incontinence (unintentional urine leakage when pressure is applied to the bladder). The goal is to determine if ProACT can prevent issues such as urethral stricture (a narrowing of the tube that carries urine out of the body) or device erosion over five years. Researchers also aim to assess the treatment's effectiveness if additional bladder control treatments become necessary later. Men aged 50 or older, who have stress urinary incontinence, have undergone prostate surgery, and are willing to undergo the ProACT procedure may be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to understanding and improving treatment options for stress urinary incontinence.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the ProACT device is safe for treating stress urinary incontinence?
Research has shown that the ProACT Adjustable Continence Therapy for Men has been tested for safety and effectiveness. Studies have found that men using ProACT experienced a noticeable improvement in their quality of life. On average, they used fewer pads each day, indicating the treatment's effectiveness.
However, like any medical procedure, risks exist. Common issues include mechanical problems and device displacement. Despite these concerns, long-term follow-up data suggests that the benefits generally outweigh the risks for treating male stress urinary incontinence after prostate surgery.
The FDA has already approved ProACT therapy for similar conditions, indicating its safety for patients. While no treatment is without risk, existing data provides reassurance about its safety.12345Why are researchers excited about this trial?
Unlike the standard treatments for stress urinary incontinence, which often include lifestyle changes, pelvic floor exercises, or surgery, ProACT Adjustable Continence Therapy for Men offers a minimally invasive option. This therapy involves the implantation of small, adjustable balloons near the bladder neck, which can be tailored to the patient's needs over time. Researchers are excited about this treatment because it allows for personalized adjustments, potentially improving continence without the need for more invasive surgical procedures. Additionally, the ability to modify the therapy post-implantation provides a unique advantage in managing varying degrees of incontinence over time.
What evidence suggests that ProACT Adjustable Continence Therapy for Men is effective for stress urinary incontinence?
Studies have shown that the ProACT Adjustable Continence Therapy for Men can significantly aid those with stress urinary incontinence. Research indicates that patients experienced an average improvement of 30.8 points in their quality of life. Initially, most patients used about four pads per day, but this number decreased after the ProACT device was implanted. Additionally, 81.5% of patients saw at least a 50% improvement in bladder control. About 61.1% of patients achieved complete surgical success, with greatly reduced symptoms. This treatment targets men whose bladder control issues stem from sphincter problems, the muscle that helps control urination.12346
Who Is on the Research Team?
Timothy C Cook, PhD
Principal Investigator
Uromedica, Inc.
Are You a Good Fit for This Trial?
Men over 50 with stress urinary incontinence post-prostate surgery can join this study. They must be able to undergo ProACT device implantation, follow a 5-year study plan including phone interviews, and have no untreated urogenital cancers or bladder conditions. Men with severe allergies, uncontrolled diabetes (A1c >6.5%), recent prostate/anti-incontinence surgeries, or radiation therapy are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are implanted with ProACT Adjustable Continence Therapy for Men
Follow-up
Participants are monitored for urethral stricture, device erosion, and quality of life over 5 years
What Are the Treatments Tested in This Trial?
Interventions
- ProACT Adjustable Continence Therapy for Men
ProACT Adjustable Continence Therapy for Men is already approved in United States, European Union for the following indications:
- Stress urinary incontinence arising from intrinsic sphincter deficiency of at least twelve months duration following radical prostatectomy or transurethral resection of the prostate (TURP) and who have failed to respond adequately to conservative therapy
- Stress urinary incontinence arising from intrinsic sphincter deficiency following radical prostatectomy or transurethral resection of the prostate (TURP)
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Who Is Running the Clinical Trial?
Uromedica
Lead Sponsor