PMID- 30592526
OWN - NLM
STAT- MEDLINE
DCOM- 20200214
LR  - 20200214
IS  - 1520-6777 (Electronic)
IS  - 0733-2467 (Linking)
VI  - 38
IP  - 2
DP  - 2019 Feb
TI  - A prospective, multicenter study of a novel, miniaturized rechargeable sacral 
      neuromodulation system: 12-month results from the RELAX-OAB study.
PG  - 689-695
LID - 10.1002/nau.23892 [doi]
AB  - 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.
CI  - (c) 2018 Wiley Periodicals, Inc.
FAU - Blok, Bertil
AU  - Blok B
AD  - Department of Urology, Erasmus MC, Rotterdam, The Netherlands.
FAU - Van Kerrebroeck, Philip
AU  - Van Kerrebroeck P
AD  - Department of Urology, Maastricht University Medical Centre, Maastricht, The 
      Netherlands.
FAU - de Wachter, Stefan
AU  - de Wachter S
AD  - Department of Urology, University Hospital Antwerpen, Edegem, Belgium.
FAU - Ruffion, Alain
AU  - Ruffion A
AD  - Department of Urology, Hopital Lyon Sud, Pierre Benite, Lyon, France.
FAU - Van der Aa, Frank
AU  - Van der Aa F
AD  - Department of Urology, UZ Leuven, Leuven, Belgium.
FAU - Jairam, Ranjana
AU  - Jairam R
AD  - Department of Urology, Maastricht University Medical Centre, Maastricht, The 
      Netherlands.
FAU - Perrouin-Verbe, Marie Aimee
AU  - Perrouin-Verbe MA
AD  - Department of Urology, University Hospital of Nantes, Nantes, France.
FAU - Elneil, Sohier
AU  - Elneil S
AD  - Department of Uro-Neurology, National Hospital of Neurology and Neurosurgery, 
      London, United Kingdom.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20181228
PL  - United States
TA  - Neurourol Urodyn
JT  - Neurourology and urodynamics
JID - 8303326
SB  - IM
CIN - J Urol. 2020 Mar;203(3):467-468. PMID: 31829816
MH  - Adult
MH  - Aged
MH  - Cost-Benefit Analysis
MH  - Electric Stimulation Therapy/*methods
MH  - Female
MH  - Humans
MH  - *Implantable Neurostimulators
MH  - Lumbosacral Plexus/*physiopathology
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - *Quality of Life
MH  - Sacrum
MH  - Surveys and Questionnaires
MH  - Time Factors
MH  - Treatment Outcome
MH  - Urinary Bladder, Overactive/physiopathology/*therapy
MH  - Urination/*physiology
MH  - Young Adult
OTO - NOTNLM
OT  - overactive bladder
OT  - rechargeable
OT  - sacral neuromodulation
OT  - single stage implant
OT  - urgency frequency
OT  - urinary incontinence
EDAT- 2018/12/29 06:00
MHDA- 2020/02/15 06:00
CRDT- 2018/12/29 06:00
PHST- 2018/08/24 00:00 [received]
PHST- 2018/10/29 00:00 [accepted]
PHST- 2018/12/29 06:00 [pubmed]
PHST- 2020/02/15 06:00 [medline]
PHST- 2018/12/29 06:00 [entrez]
AID - 10.1002/nau.23892 [doi]
PST - ppublish
SO  - Neurourol Urodyn. 2019 Feb;38(2):689-695. doi: 10.1002/nau.23892. Epub 2018 Dec 
      28.