R20 PMCF (Post-Market Follow-up) Study, Version A
Research type
Research Study
Full title
Post-Market Clinical Follow-up Study of the Axonics SNM System Model 5101 (R20)
IRAS ID
353580
Contact name
Mahreen Pakzad
Contact email
Sponsor organisation
Axonics, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Sacral Neuromodulation (SNM) is a recommended treatment for Overactive Bladder (OAB) including urinary urgency incontinence (UUI) and urinary frequency (UF). Long-term data support the safety, performance/effectiveness, and clinical benefit of this type of therapy.
The Axonics SNM system is indicated for the treatment of the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments.
INS Model 5101, also known as R20 is a rechargeable system, programmable device that is connected to the Axonics Tined Lead, which conducts stimulation pulses from the INS to a sacral nerve. The mechanism of action is identical in that the therapy is delivered to the sacral nerve, typically the 3rd sacral nerve root.
Model 5101 (R20) uses the same exact stimulation waveform as the previous Axonics model, Model 1101 (R15). One differing attribute between INS 1101 and INS 5101 is that INS 5101 utilizes updated software and hardware which extends the recharging interval from once every 1 month for 1101 (previous model) to once every 6 to 10 months for 5101 (new model).The objective of this study is to assess the post-market clinical outcomes with use of the Axonics Sacral Neuromodulation System(s) to obtain real world data on the Axonics INS Model 5101 (R20).
REC name
Wales REC 3
REC reference
25/WA/0050
Date of REC Opinion
19 Feb 2025
REC opinion
Favourable Opinion