title: Effects of a Gentle, Self-Administered Stimulation of Perineal Skin for Nocturia in Elderly Women: A Randomized, Placebo-Controlled, Double-Blind Crossover Trial.
abstract: BACKGROUND
  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.
  
  
  METHODS
  The 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.
  
  
  RESULTS
  Twenty-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).
  
  
  CONCLUSIONS
  These 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.
  
  
  BACKGROUND
  UMIN Clinical Trial Registry (CTR) UMIN000015809.
authors.affiliation: Graduate School of Health Science, Teikyo Heisei University, Tokyo, Japan.|Department of Autonomic Neuroscience, Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan.
authors.forename: Kaori
authors.initials: K
authors.lastname: Iimura
authors.affiliation: Department of Autonomic Neuroscience, Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan.
authors.forename: Nobuhiro
authors.initials: N
authors.lastname: Watanabe
authors.affiliation: Department of Urology, Tokyo Metropolitan Geriatric Hospital, Tokyo, Japan.
authors.forename: Koichi
authors.initials: K
authors.lastname: Masunaga
authors.affiliation: Graduate School of Health Science, Teikyo Heisei University, Tokyo, Japan.|Department of Autonomic Neuroscience, Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan.|Department of Acupuncture and Moxibustion, Faculty of Health Care, Teikyo Heisei University, Tokyo, Japan.
authors.forename: Shogo
authors.initials: S
authors.lastname: Miyazaki
authors.affiliation: Department of Autonomic Neuroscience, Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan.
authors.forename: Harumi
authors.initials: H
authors.lastname: Hotta
authors.affiliation: Department of Promotion of Prevention of Musculoskeletal Aging, Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan.
authors.forename: Hunkyung
authors.initials: H
authors.lastname: Kim
authors.affiliation: Graduate School of Health Science, Teikyo Heisei University, Tokyo, Japan.|Department of Acupuncture and Moxibustion, Faculty of Health Care, Teikyo Heisei University, Tokyo, Japan.
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Hisajima
authors.affiliation: Graduate School of Health Science, Teikyo Heisei University, Tokyo, Japan.|Department of Acupuncture and Moxibustion, Faculty of Health Care, Teikyo Heisei University, Tokyo, Japan.
authors.forename: Hidenori
authors.initials: H
authors.lastname: Takahashi
authors.affiliation: Department of Urology, Tokyo Metropolitan Geriatric Hospital, Tokyo, Japan.
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Kasuya
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D018592:Cross-Over Studies; D004311:Double-Blind Method; D020724:Elastomers; D005260:Female; D006801:Humans; D008405:Massage / Q000379:methods*; D053158:Nocturia / Q000628:therapy*; D010502:Perineum / Q000502:physiology*; D010919:Placebos; D060525:Pudendal Nerve / Q000502:physiology; D012646:Self Administration; D012867:Skin; D012893:Sleep Wake Disorders / Q000628:therapy*; D001743:Urinary Bladder / Q000502:physiology; D053201:Urinary Bladder, Overactive / Q000628:therapy*; D014554:Urination / Q000502:physiology
chemical_list: D020724:Elastomers; D010919:Placebos