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Prospective Randomized Feasibility Study Assessing the Effect of Cyclic Sacral Neuromodulation on Urinary Urge Incontinence in Women

Siegel, Steven, MD*; Kreder, Karl, MD; Takacs, Elizabeth, MD; McNamara, Rachael, BA; Kan, Fangyu, MS

Female Pelvic Medicine & Reconstructive Surgery: July/August 2018 - Volume 24 - Issue 4 - p 267–271
doi: 10.1097/SPV.0000000000000457
Original Articles

Objectives The aim of this prospective, randomized, multicenter, single-blind, 4 × 4 crossover study was to estimate the effect of 4 InterStim cycling settings (continuous, 16 seconds on/8 seconds off, 10 minutes on/10 minutes off, and 30 minutes on/23.5 hours off) on efficacy, Global Response Assessment, and safety.

Methods Eligible women implanted for at least 3 months for urgency urinary incontinence (UI) were enrolled, and daily diaries were collected. General linear mixed models were used to estimate the cycling effect on efficacy. Quality of life measured by Global Response Assessment (subjects’ perception of effectiveness) and safety were summarized.

Results Primary efficacy analysis was based on the first 24 subjects who completed unique randomization sequences. Mean age was 64 years, and mean implant duration was 2.8 years. Results showed no significant cycling (P = 0.3773) or period (P = 0.0800) effect on UI. There was a statistically significant interaction between cycling and period (P = 0.0032). In the first period, subjects on 10 minutes on/10 minutes off had significantly fewer UI episodes compared with subjects on 16 seconds on/8 seconds off (P = 0.0026); this difference was not observed in any other period or sensitivity analyses. No cycling effect was found on urgency or pad usage. When programmed to 10 minutes on/10 minutes off, 54% of subjects felt their incontinence symptoms improved compared with when they entered the study, followed by 42% on 30 minutes on/23.5 hours off, 38% on 16 seconds on/8 seconds off, and 29% on continuous. Safety was similar across cycling settings.

Conclusions The results suggest that patients with overactive bladder who have been implanted with sacral neuromodulation devices and are receiving substantial benefit may perceive further optimization by switching to cycling settings.

This prospective, randomized, multicenter, single-blind, 4 × 4 crossover study estimated the effect of 4 different cycling settings (continuous, 16 seconds on/8 seconds off, 10 minutes on/10 minutes off, and 30 minutes on/23.5 hours off) on sacral neuromodulation efficacy, Global Response Assessment, and safety, and the results suggest that among implanted patients who are already receiving substantial benefit further optimization may be achieved by switching to cycling settings.

From *Metro Urology, Woodbury, MN;

University of Iowa, Iowa City, IA; and

Medtronic, Minneapolis, MN.

Correspondence: Steven Siegel, MD, Metro Urology, 6025 Lake Rd Ste 200, Woodbury, MN 55125. E-mail: ssiegel@metro-urology.com.

ClinicalTrials.gov identifier: InterStim Sacral Nerve Modulation Cycling Study NCT01957137.

Medtronic sponsored this trial in full.

The authors have declared they have no conflicts of interest.

Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.