Evaluation of clinical performance and safety for the rechargeable InterStim Micro device in overactive bladder subjects: 6‐month results from the global postmarket ELITE study

Aims Sacral neuromodulation (SNM) is an advanced therapy option for the treatment of overactive bladder (OAB), nonobstructive urinary retention, and fecal incontinence. The aim of this ongoing prospective, multicenter, global, postmarket study is to confirm safety and clinical performance of the Int...

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Published in:Neurourology and urodynamics 2023-04, Vol.42 (4), p.761-769
Main Authors: Goudelocke, Colin, Xavier, Keith, Pecha, Barry, Burgess, Kimberly, Perrouin‐Verbe, Marie‐A., Krlin, Ryan, Michaels, Jodi, Shah, Sagar, Peyronnet, Benoît, Zaslau, Stanley, Champs, Mylène, Papi, Bianca, Bittner, Katie, Elterman, Dean, Nitti, Victor
Format: Article
Language:English
Subjects:
Adverse events
Bladder
Electric stimulation therapy
Fecal incontinence
Humans
Neuromodulation
overactive bladder
Prospective Studies
Quality of Life
rechargeable
sacral neuromodulation
Sacrum
Safety
Statistical analysis
Treatment Outcome
urgency incontinence
Urinary Bladder, Overactive
Urinary Incontinence
Urinary Incontinence, Urge
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Summary:Aims Sacral neuromodulation (SNM) is an advanced therapy option for the treatment of overactive bladder (OAB), nonobstructive urinary retention, and fecal incontinence. The aim of this ongoing prospective, multicenter, global, postmarket study is to confirm safety and clinical performance of the InterStimTM Micro system for SNM in all indications. Reported here are the results for the OAB cohort through 6‐month follow‐up. Methods Eligible OAB subjects that had a successful therapy evaluation were enrolled after implant of an InterStim Micro implantable pulse generator (IPG). Subjects completed voiding diaries and the Overactive Bladder Quality of Life questionnaire (OAB‐q) at baseline and follow‐up visits occurring at 3 months and 6 months postimplant. Safety was evaluated as device‐, procedure‐, or therapy‐related adverse events. The primary objective for the OAB cohort was to demonstrate an improvement in OAB‐q Health Related Quality of Life (HRQL) total score at 3 months postimplant compared to baseline. Results Sixty‐eight OAB subjects were enrolled and implanted with an InterStim Micro IPG. Of those, 67 and 66 subjects completed the 3‐ and 6‐month follow‐up visits, respectively. The OAB‐q HRQL demonstrated a statistically significant improvement from baseline to 3‐month follow‐up with an average increase of 33 ± 24 points (n = 67, p 
ISSN:0733-2467
1520-6777
DOI:10.1002/nau.25171