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NCT06789406 · ClinicalTrials.gov registry record · NA
PMCF Study of the Axonics SNM System Model 5101 (R20)
A NA study of Overactive Bladder (OAB) and Urinary Urge Incontinence (UUI), sponsored by Axonics.
- Recruiting
- Registry status
- NA
- Development phase
- 55
- Enrollment target
- 4
- Study locations
NCT06789406: Recruiting NA study of Overactive Bladder (OAB) and Urinary Urge Incontinence (UUI), sponsored by Axonics.
NCT06789406 is a NA study of Overactive Bladder (OAB) and Urinary Urge Incontinence (UUI) that is actively recruiting participants, run by Axonics. The registered enrollment target is 55 participants, below the 284-participant average among 7 other Overactive Bladder (OAB) trials with a reported enrollment target (81% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06789406, a NA study of Overactive Bladder (OAB) and Urinary Urge Incontinence (UUI), is actively recruiting participants, sponsored by Axonics.
- RECRUITING
- Registry status
- NA
- Development phase
- 55 participants
- Enrollment target
- 4
- Study locations
Study Summary
Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the Axonics SNM System INS Model 5101.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Axonics SNM System INS Model 5101 (R20)
Study Locations (4)
West Yorkshire
- Bradford Royal Infirmary - Bradford
- Pinderfields Hospital - Wakefield
Illinois
- University of Chicago - Chicago
Other
- University College London Hospital - London
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2025-09-18 |
| Est. Completion | 2031-10 |
| Phase | NA |
What NCT06789406 shows while recruiting
NCT06789406 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 284-participant average among 7 other Overactive Bladder (OAB) trials with a reported enrollment target (81% lower).
The record links to 3 conditions, with Overactive Bladder (OAB) appearing as the primary indexed condition, and to 1 intervention - of which Axonics SNM System INS Model 5101 (R20) is the first listed.
NCT06789406 reports a single indexed study location in West Yorkshire, Illinois, Other.
Frequently Asked Questions
What is clinical trial NCT06789406 about?
NCT06789406 is a clinical study titled "PMCF Study of the Axonics SNM System Model 5101 (R20)". Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the Axonics SNM System INS Model 5101.
What is the current status of trial NCT06789406?
This trial is currently recruiting. It is a NA study. The enrollment target is 55 participants. The study started on 2025-09-18. Estimated completion is 2031-10.
What conditions does trial NCT06789406 study?
This clinical trial studies the following conditions: Overactive Bladder (OAB), Urinary Urge Incontinence (UUI), Urinary Frequency (UF).
What interventions are being tested in trial NCT06789406?
The interventions under investigation include: Axonics SNM System INS Model 5101 (R20) (DEVICE).
Who is sponsoring clinical trial NCT06789406?
This trial is sponsored by Axonics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06789406 being conducted?
This trial has 4 study locations across Illinois, West Yorkshire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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