Evidence map›Paper›PMID 36307874›Full record

Trial reportTrials2022

Stimulation of the Tibial nerve Repetitively to Improve Incontinence in Parkinson's Electronically (STRIPE trial): a randomised control trial of tibial nerve stimulation for bladder symptoms in Parkinson's disease using a self-contained wearable device.

Matthew D Smith, Emma Tenison, Marcus J Drake, Yoav Ben-Shlomo, Emily J Henderson

Open access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
1.6field-weighted citation impact, top 18% of its field
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, 2 syntheses or guidelines pooled it, 7 citations in OpenAlex.

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

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 4 institutions in 1 country.

Matthew D SmithOlder People's Unit, Royal United Hospital NHS Foundation Trust, Bath, UK. matthew.smith@bristol.ac.uk.ORCID http://orcid.org/0000-0002-4685-375X
Emma TenisonOlder People's Unit, Royal United Hospital NHS Foundation Trust, Bath, UK.
Marcus J DrakeBristol Urological Institute, North Bristol NHS Trust, Bristol, UK.
Yoav Ben-ShlomoOlder People's Unit, Royal United Hospital NHS Foundation Trust, Bath, UK.
Emily J HendersonOlder People's Unit, Royal United Hospital NHS Foundation Trust, Bath, UK.
University of Bristol · GBAt Bristol · GBNorth Bristol NHS Trust · GBRoyal United Hospital Bath NHS Trust · GB

Funding

Gatsby Charitable Foundation GAT 3676
6 · The paper itself

Abstract

backgroundBladder symptoms are common in Parkinson's disease (PD), affecting half of all individuals. These have significant impact on quality of life as well as implications for morbidity, contributing to falls and hospital admission. The treatment of bladder symptoms can be complicated by the tendency to side-effects in people with PD including cognitive impairment and gait instability with anti-muscarinics. The development of new, better treatments is therefore warranted. Tibial nerve stimulation is a form of neuromodulation demonstrated to improve overactive bladder symptoms in non-neurogenic cohorts. Previously requiring hospital attendance, we aim to explore the use of this intervention using a simple device that can be used by patients at home.

methodsSTRIPE is a phase II randomised control trial of tibial nerve stimulation delivered by the Geko™ device, a small, self-adhesive neuromuscular stimulation device currently used for thromboembolism prophylaxis post-surgery. Active tibial nerve stimulation will be compared to sham stimulation, with participants blinded to treatment allocation and undertaking outcome assessment whilst still blinded. Participants will be asked to self-administer stimulation at home twice per week, for 30 min per session, over the course of 3 months. Primary outcome measure will be the International Consultation on Incontinence Overactive Bladder Questionnaire (OAB) at week 12. Secondary outcomes will include pre- and post-intervention bladder diary (frequency, urgency episodes, nocturia), patient perception of global change, bowel function and bladder-related quality of life. Participants will be recruited from the Proactive Integrated Management and Empowerment (PRIME) cross-sectional trial in which participants have been screened for bladder symptoms and invited to take part, as well as clinician referral from around the region. DISCUSSION: This trial will involve a randomised control trial of a novel and easy to use method of delivering tibial nerve stimulation for PD in the patient's own home. This may potentially have huge benefit, avoiding the problems with side effects that can be seen with anti-muscarinics and providing a new potential modality of treatment.

trial registrationISRCTN11484954. Registered on 22 June 2021.

Indexed as

Parkinson DiseaseTranscutaneous Electric Nerve StimulationUrinary Bladder, OveractiveUrinary IncontinenceWearable Electronic DevicesCross-Sectional StudiesHumansQuality of LifeTibial NerveTreatment OutcomeUrinary BladderBladder symptomsNeuromodulationParkinson’s diseaseRandomised control trialTibial nerve stimulation

Identifiers

PMID36307874
PMCPMC9617363
OpenAlexW4307712661

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.