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  • Stimulation of the tibial nerve: a protocol for a multicentred randomised controlled trial for urinary problems associated with Parkinson’s disease—STARTUP

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Urology
Protocol
Stimulation of the tibial nerve: a protocol for a multicentred randomised controlled trial for urinary problems associated with Parkinson’s disease—STARTUP
  1. Doreen McClurg1,
  2. Jalesh Panicker2,
  3. Richard W Walker3,
  4. AnneLouise Cunnington4,
  5. Katherine H O Deane5,
  6. Danielle Harari6,
  7. Andrew Elders1,
  8. Jo Booth7,
  9. Suzanne Hagen1,
  10. Helen Mason8,
  11. Susan Stratton1
  1. 1 Nursing Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK
  2. 2 Department of Neurology, University College London, London, UK
  3. 3 Department of Medicine, North Tyneside General Hospital, North Shields, UK
  4. 4 Neurology Department, Glasgow Royal Infirmary, NHS Greater Glasgow and Clyde Clyde Division, Glasgow, UK
  5. 5 School of Health Sciences, University of East Anglia, Norwich, UK
  6. 6 Department of Ageing and Health, Kings College London, London, UK
  7. 7 School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK
  8. 8 Yunus Centre, Glasgow Caledonian University, Glasgow, UK
  1. Correspondence to Dr Doreen McClurg; doreen.mcclurg{at}gcu.ac.uk

Abstract

Introduction Parkinson’s disease is the second most common chronic neurodegenerative condition with bladder dysfunction affecting up to 71%. Symptoms affect quality of life and include urgency, frequency, hesitancy, nocturia and incontinence. Addressing urinary dysfunction is one of the top 10 priority research areas identified by the James Lind Alliance and Parkinson’s UK.

Objectives Conduct a randomised controlled trial (RCT) targeting people with Parkinson’s disease (PwP) who have self-reported problematic lower urinary tract symptoms, investigating the effectiveness of transcutaneous tibial nerve stimulation (TTNS) compared with sham TTNS. Implement a standardised training approach and package for the correct application of TTNS. Conduct a cost-effectiveness analysis of TTNS compared with sham TTNS.

Methods and analysis An RCT of 6 weeks with twice weekly TTNS or sham TTNS. Participants will be recruited in 12 National Health Service neurology/movement disorder services, using a web-based randomisation system, and will be shown how to apply TTNS or sham TTNS. Participants will receive a weekly telephone call from the researchers during the intervention period. The trial has two coprimary outcome measures: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form and the International Prostate Symptom Score. Secondary outcomes include a 3-day bladder diary, quality of life, acceptability and fidelity and health economic evaluation. Outcomes will be measured at 0, 6 and 12 weeks.

A sample size of 208 randomised in equal numbers to the two arms will provide 90% power to detect a clinically important difference of 2.52 points on the Internatioanl Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) and of 3 points in the International Prostate Symptom Score total score at 12 weeks at 5% significance level, based on an SD of 4.7 in each arm and 20% attrition at 6 weeks. Analysis will be by intention to treat and pre defined in a statistical analysis plan

Ethics and dissemination East of Scotland Research Ethics Service (EoSRES), 18/ES00042, obtained on 10 May 2018. The trial will allow us to determine effectiveness, safety, cost and acceptability of TTNS for bladder dysfunction in PWP. Results will be published in open access journals; lay reports will be posted to all participants and presented at conferences.

Trial registration number ISRCTN12437878; Pre-results.

  • parkinson-s disease
  • urology
  • neuro-urology
https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

https://doi.org/10.1136/bmjopen-2019-034887

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    Footnotes

    • Twitter @Elders

    • Contributors DM was the CI and wrote the protocol; JP, RWW and AC was a coapplicant and provided feedback on the protocol and assisted with recruitment; KHOD was an applicant assisted with recruitment and protocol development; DH was a coapplicant and provided feedback on the protocol and assisted with recruitment; AE was the trial statistician and provided input in to the protocol; JB provided expertise in TTNS and provided feedback in to the protocol. SH is a health services researcher with extensive experience in running clinical trials and provided input in to the protocol development. HM is a health economise and provided support in the development of the Health Economics section. SS is the trial manager and will be responsible for the day-to-day running of the trial including site initiation visits and sign off, telephone follow-up calls, data collection validation and entry.

    • Funding This study is supported by a grant from The Dunhill Medical Trust (RPGF 1711/16) and Parkinson’s UK PDK 1801 have provided additional support to cover NHS Support Costs.

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Author note All named authors adhere to the authorship guidelines. All authors have agreed to publication.