Evidence map›Paper›PMID 27003163›Full record

Trial reportPloS one2016

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

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

Kaori IimuraGraduate School of Health Science, Teikyo Heisei University, Tokyo, Japan.
Nobuhiro WatanabeDepartment of Autonomic Neuroscience, Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan.
Koichi MasunagaDepartment of Urology, Tokyo Metropolitan Geriatric Hospital, Tokyo, Japan.
Shogo MiyazakiGraduate School of Health Science, Teikyo Heisei University, Tokyo, Japan.
Harumi HottaDepartment of Autonomic Neuroscience, Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan.
Hunkyung KimDepartment of Promotion of Prevention of Musculoskeletal Aging, Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan.
Tatsuya HisajimaGraduate School of Health Science, Teikyo Heisei University, Tokyo, Japan.
Hidenori TakahashiGraduate School of Health Science, Teikyo Heisei University, Tokyo, Japan.
Yutaka KasuyaDepartment of Urology, Tokyo Metropolitan Geriatric Hospital, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

AgedAged, 80 and overCross-Over StudiesDouble-Blind MethodElastomersFemaleHumansMassageNocturiaPerineumPlacebosPudendal NerveSelf AdministrationSkinSleep Wake DisordersUrinary BladderElastomersPlacebos

Identifiers

PMID27003163
PMCPMC4803221

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.