Axonics SNM System for Overactive Bladder (OAB)
This study is looking at the Axonics SNM System Model 5101 (R20), a rechargeable device, for people with Overactive Bladder (OAB), which includes urinary urgency incontinence (UUI) and urinary frequency (UF). The goal is to see how well the device continues to work and if it's safe over time. Researchers will measure improvements in your quality of life related to OAB and track any side effects over 3 months. You can join if you are 18 or older, have OAB that hasn't responded to other treatments, and are willing to attend follow-up appointments. The study is currently unclear on its recruitment status and plans to enroll 55 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It is a post-market clinical follow-up study, and it plans to enroll 55 participants.
- What's involved
- You would be treated with the Axonics SNM System Model 5101 (R20) and would need to attend follow-up assessments at clinical centers.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your quality of life and any adverse events will be measured at 3 months after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
PMCF Study of the Axonics SNM System Model 5101 (R20) for the Indication of OAB
At a glance
Conditions
Where it's being run
6 sites across 4 statesStudy leadership
- Mahreen Pakzad, MD · PRINCIPAL_INVESTIGATOR · University College London Hospitals
- Gita Ghadimi, OD · STUDY_DIRECTOR · Boston Scientific Corporation
Who to contact
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What this trial measures
- Performance/Effectiveness - Improvement in Qualify of Life scoring (OAB)3 months
To demonstrate an improvement in Overactive Bladder Quality of Life using the International Consultation of Incontinence Questionnaire Overactive Bladder Qualify of Life (ICIQ-OABqol): questions in each subscale are scored by a summed range of 0 to 100, with a higher score indicating better quality of life. Overall score ≥ 10 points from baseline to follow-up is indicative of a clinically meaningful improvement.
- Adverse event reporting (Safety)3 months
Device related, procedure-related and all serious adverse events