Axonics SNM System for Overactive Bladder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial evaluates the safety and performance of the Axonics SNM System, a device designed to assist individuals with overactive bladder. Researchers aim to determine if the device maintains its effectiveness over time for those with implants. Individuals with overactive bladder who have not found success with other treatments might be suitable candidates. Participants must be prepared to visit clinical centers for follow-up assessments. As an unphased trial, this study provides a unique opportunity to contribute to the understanding of a promising treatment for overactive bladder.
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 Axonics SNM System is safe for overactive bladder?
Research has shown that the Axonics SNM System, used to treat overactive bladder, is safe for people. In an important study, no serious problems related to the device were reported after two years, indicating that the treatment did not cause major issues for participants during that time.
The FDA has already approved the Axonics SNM System for treating urinary problems, suggesting it is generally well-tolerated. While minor side effects can occur, data indicates that the device usually does not cause significant harm.
In summary, based on existing studies and its current use for similar conditions, the Axonics SNM System appears to be safe.12345Why are researchers excited about this trial?
The Axonics SNM System for overactive bladder is unique because it uses sacral neuromodulation, which involves implanting a small device to regulate nerve activity. Unlike standard treatments like medications or lifestyle changes, which can have variable effectiveness and side effects, this system directly targets the nerves controlling bladder function. Researchers are excited because this approach offers a long-term solution with the potential for fewer side effects, aiming to improve quality of life for individuals with overactive bladder.
What is the effectiveness track record for the Axonics SNM System in treating overactive bladder?
Research has shown that the Axonics SNM System effectively manages overactive bladder symptoms. In one study, 89% of participants experienced significant improvements in bladder control. Another study found that 90% of individuals noticed substantial improvements within six months. Long-term data confirms its safety and effectiveness for over two years. Additionally, up to 82% of patients reported at least a 75% improvement in symptoms, with 37% becoming completely dry. These findings strongly support the Axonics SNM System's effectiveness in treating overactive bladder.678910
Who Is on the Research Team?
Mahreen Pakzad, MD
Principal Investigator
University College London Hospitals
Are You a Good Fit for This Trial?
This trial is for individuals with Overactive Bladder (OAB) symptoms like urge incontinence or frequent urination, who haven't improved with basic treatments. Participants must be able to give written consent and commit to follow-up assessments at clinical centers.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Axonics SNM System Model 5101 and are monitored for safety and performance
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Axonics SNM System INS Model 5101 (R20)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Axonics, Inc.
Lead Sponsor