Effects of a Gentle, Self-Administered Stimulation of Perineal Skin for Nocturia in Elderly Women: A Randomized, Placebo-Controlled, Double-Blind Crossover Trial.

Kaori Iimura,Koichi Masunaga,Nobuhiro Watanabe,Hidenori Takahashi,Tatsuya Hisajima,Hunkyung Kim,Harumi Hotta,Yutaka Kasuya,Shogo Miyazaki,Neal Shore

doi:10.1371/journal.pone.0151726

Abstract

BackgroundSomatic afferent nerve stimuli are used for treating an overactive bladder (OAB), a major cause of nocturia in the elderly. Clinical evidence for this treatment is insufficient because of the lack of appropriate control stimuli. Recent studies on anesthetized animals show that gentle stimuli applied to perineal skin with a roller could inhibit micturition contractions depending on the roller’s surface material. We examined the efficacy of gentle skin stimuli for treating nocturia.MethodsThe study was a cross-over, placebo-controlled, double-blind randomized clinical study using two rollers with different effects on micturition contractions. Participants were elderly women (79–89 years) with nocturia. Active (soft elastomer roller) or placebo (hard polystyrene roller) stimuli were applied to perineal skin by participants for 1 min at bedtime. A 3-day baseline assessment period was followed by 3-day stimulation and 4-day resting periods, after which the participants were subjected to other stimuli for another 3 days. The primary outcome was change in the frequency of nighttime urination, for which charts were maintained during each 3-day period.ResultsTwenty-four participants were randomized, of which 22 completed all study protocols. One participant discontinued treatment because of an adverse event (abdominal discomfort). In participants with OAB (n = 9), change from baseline in the mean frequency of urination per night during the active stimuli period (mean ± standard deviation, −0.74 ± 0.7 times) was significantly greater than that during placebo stimuli periods (−0.15 ± 0.8 times [p < 0.05]). In contrast, this difference was not observed in participants without OAB (n = 13).ConclusionsThese results suggest that gentle perineal stimulation with an elastomer roller is effective for treating OAB-associated nocturia in elderly women. Here the limitation was a study period too short to assess changes in the quality of sleep and life.Trial RegistrationUMIN Clinical Trial Registry (CTR) UMIN000015809

Highlights

Many elderly people have bladder problems such as frequent urination, incontinence, or nocturia [1]
Gentle Skin Stimulation for Nocturia in the Elderly application on skin stimulation roller (Name: Urination suppression device, Patent application number: JP,2010-251392), the rollers that were kindly gifted by Toyoresin Co. and research grant (Translation research fund in Tokyo Metropolitan Institute of Gerontology)
Significantly greater than that during placebo stimuli periods (−0.15 ± 0.8 times [p < 0.05]). This difference was not observed in participants without overactive bladder (OAB) (n = 13). These results suggest that gentle perineal stimulation with an elastomer roller is effective for treating OAB-associated nocturia in elderly women

Summary

Introduction

Many elderly people have bladder problems such as frequent urination, incontinence, or nocturia [1]. As non-pharmacological methods, somatic afferent stimuli such as acupuncture [8] and transcutaneous electrical nerve stimulation [9] have been used clinically for the treatment of OAB. Somatic afferent nerve stimuli are used for treating an overactive bladder (OAB), a major cause of nocturia in the elderly. Clinical evidence for this treatment is insufficient because of the lack of appropriate control stimuli. Recent studies on anesthetized animals show that gentle stimuli applied to perineal skin with a roller could inhibit micturition contractions depending on the roller’s surface material. We examined the efficacy of gentle skin stimuli for treating nocturia

Objectives

Methods

Results

Conclusion