|
Title
|
|
|
|
A prospective, multicenter study of a novel, miniaturized rechargeable sacral neuromodulation system : 12-month results from the RELAX-OAB study
| |
|
Author
|
|
|
|
| |
|
Abstract
|
|
|
|
| Aims Historically, providing SNM therapy required use of a non-rechargeable implantable pulse generator (IPG) with an average device lifespan of 4.4 years. Multiple device replacement surgeries are necessary with this device for long-term overactive bladder (OAB) management. A longer-lived device can reduce and potentially eliminate the need for replacement surgeries, thereby improving the long-term safety and cost-effectiveness of SNM therapy. The objective of this study was to evaluate the safety and efficacy of a miniaturized, rechargeable SNM system. Methods This prospective, multi-center study implanted 51 subjects with the SNM system in a single stage procedure without an external trial period. Subjects had overactive bladder as demonstrated on a 3-day voiding diary (>= 8 voids/day and/or >= 2 incontinence episodes over 72-h). Outcome measures at 1-year follow-up included quality of life (evaluated by ICIQ-OABqol questionnaire), therapy responder rates (>= 50% reduction in voids and/or leaks or <8 voids per day), subject satisfaction questionnaire, and adverse events (AEs). Results At 1-year, 94% of Test Responders continued to respond to r-SNM therapy based on bladder diary criteria. Subjects experienced significant improvement of 21.1 points on the ICIQ-OABqol. 84% of subjects were satisfied with r-SNM therapy and 98% found their charging experience acceptable. Device-related AEs occurred in 21% of subjects, with discomfort due to stimulation occurring in 20% of subjects. This AE was resolved with reprogramming in all instances. Conclusions The Axonics r-SNM System provides sustained clinically significant improvements in OAB subjects after 1-year. Subjects were satisfied with r-SNM therapy and reported an easy and acceptable recharging experience. |
| |
|
Language
|
|
|
|
English
| |
|
Source (journal)
|
|
|
|
Neurourology and urodynamics. - New York
| |
|
Publication
|
|
|
|
New York
:
2019
| |
|
ISSN
|
|
|
|
0733-2467
| |
|
DOI
|
|
|
|
10.1002/NAU.23892
| |
|
Volume/pages
|
|
|
|
38
:2
(2019)
, p. 689-695
| |
|
ISI
|
|
|
|
000460665400026
| |
|
Pubmed ID
|
|
|
|
30592526
| |
|
Full text (Publisher's DOI)
|
|
|
|
| |
|
Full text (publisher's version - intranet only)
|
|
|
|
| |
|