AUS vs ATOMS for Urinary Incontinence
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares two treatments for men with moderate to severe urinary incontinence (difficulty controlling urination) after prostate surgery. It evaluates the effectiveness of the Adjustable Transobturator Male System (ATOMS) against the Artificial Urinary Sphincter (AUS) to determine if ATOMS performs as well as AUS. Suitable candidates for this trial are men who have undergone prostate surgery and experience moderate to severe urinary incontinence. Participants will be randomly assigned to receive either the ATOMS or AUS treatment. The trial aims to assist doctors and patients in selecting the best treatment for this condition. As an unphased trial, it offers participants the chance to contribute to significant research that could enhance treatment options for future patients.
Do I have to stop taking my current medications for the trial?
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 these devices are safe for treating post-prostatectomy incontinence?
Research has shown that the Adjustable Transobturator Male System (ATOMS) is a safe option for men experiencing urinary leakage after prostate surgery. It effectively addresses moderate to severe cases and is generally well-received by patients. Compared to other treatments, it presents fewer issues, such as damage to the urethra (the tube that carries urine out of the body).
The Artificial Urinary Sphincter (AUS) has been used for over 50 years and is a well-established treatment for urinary leakage. It is widely used and has a long track record of safety. While both devices are considered safe, ATOMS may be easier to use because it requires less manual operation.
In summary, both treatments are safe, but each offers distinct benefits. Consulting a doctor is important to determine the best option.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the Adjustable Transobturator Male System (ATOMS) for urinary incontinence because it offers a unique approach compared to traditional treatments like the Artificial Urinary Sphincter (AUS). Unlike the AUS, which requires a more complex surgical procedure and involves a mechanical pump, ATOMS is designed to be less invasive and provides the ability to adjust the pressure post-surgery without further operations. This adjustability feature allows for greater customization to the patient's needs and can lead to more effective and comfortable outcomes. Additionally, by simplifying the surgical process, ATOMS may reduce recovery time and associated risks.
What evidence suggests that this trial's treatments could be effective for post-prostatectomy incontinence?
This trial will compare the Adjustable Transobturator Male System (ATOMS) with the Artificial Urinary Sphincter (AUS) for treating urinary incontinence. Research has shown that both ATOMS and AUS effectively treat urinary leakage after prostate surgery. Studies have found that ATOMS can help men regain bladder control post-surgery and may be suitable even for those who have undergone radiation therapy. Some evidence suggests that ATOMS might cause less harm to the urinary tract and does not require manual operation by the patient. In contrast, the AUS has been a trusted option for over 50 years and is known for its success in managing moderate to severe leakage. Both treatments work well, but this trial's direct comparison could help determine which is better for certain patients.46789
Are You a Good Fit for This Trial?
Adult men over 18 with moderate-to-severe urinary incontinence after prostate surgery, who are fit for surgery based on AUA/SUFU Guidelines and agree to be randomly assigned to receive either ATOMS or AUS. Excludes those with poor manual dexterity, cognitive issues, unresolved urethral stenosis, mild incontinence, neurogenic incontinence, previous incontinence surgeries, rising PSA levels or allergies to certain antibiotics.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to receive either the ATOMS or AUS device for the treatment of moderate to severe post-prostatectomy incontinence
Follow-up
Participants are monitored for safety and effectiveness after the surgical intervention
What Are the Treatments Tested in This Trial?
Interventions
- Adjustable Transobturator Male System
- Artificial Urinary Sphincter
Find a Clinic Near You
Who Is Running the Clinical Trial?
Université de Sherbrooke
Lead Sponsor