Top

Trials

Published in:

Open Access 01-12-2022 | Overactive Bladder | Study protocol

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

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

Published in: Trials | Issue 1/2022

Abstract

Background

Bladder 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.

Methods

STRIPE 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 registration

ISRCTN11484954. Registered on 22 June 2021.

Parkinson’s UK. Incidence and prevalence of Parkinson’s in the UK: results from the clinical practice datalink summary report. Published online 2018.

Barone P, Antonini A, Colosimo C, et al. The PRIAMO study: a multicenter assessment of nonmotor symptoms and their impact on quality of life in Parkinson’s disease. Mov Disord. 2009;24(11):1641–9. https://doi.org/10.1002/mds.22643.CrossRefPubMed

Sakakibara R, Shinotoh H, Uchiyama T, et al. Questionnaire-based assessment of pelvic organ dysfunction in Parkinson’s disease. Auton Neurosci Basic Clin. 2001;92(1–2):76–85. https://doi.org/10.1016/S1566-0702(01)00295-8.CrossRef

Deane KHO, Flaherty H, Daley DJ, et al. Priority setting partnership to identify the top 10 research priorities for the management of parkinson’s disease. BMJ Open. 2015;4(12):e006434. https://doi.org/10.1136/bmjopen-2014-006434.CrossRef

Low V, Ben-Shlomo Y, Coward E, Fletcher S, Walker R, Clarke CE. Measuring the burden and mortality of hospitalisation in Parkinson’s disease: a cross-sectional analysis of the English Hospital Episodes Statistics database 2009–2013. Park Relat Disord. 2015;21(5):449–54. https://doi.org/10.1016/j.parkreldis.2015.01.017.CrossRef

Appell A. Clinical efficacy and safety of tolterodine in the treatment of overactive bladder: a pooled analysis. Urology. Dec;50(6A Suppl):90-6; discussion 97-9.

Khullar V, Amarenco G, Angulo JC, et al. Efficacy and tolerability of mirabegron, a β3-adrenoceptor agonist, in patients with overactive bladder: results from a randomised European-Australian phase 3 trial. Eur Urol. 2013;63(2):283–95. https://doi.org/10.1016/j.eururo.2012.10.016.CrossRefPubMed

Peters KM, Carrico DJ, Perez-Marrero RA, et al. Randomized trial of percutaneous tibial nerve stimulation versus sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial. J Urol. 2010;183(4):1438–43. https://doi.org/10.1016/j.juro.2009.12.036.CrossRefPubMed

Tai C, Chen M, Shen B, Wang J, Roppolo JR, de Groat WC. Irritation induced bladder overactivity is suppressed by tibial nerve stimulation in cats. J Urol. 2011;186(1):326–30. https://doi.org/10.1016/j.juro.2011.04.023.Irritation.CrossRefPubMedPubMedCentral

10.

Krivoborodov G, Gekht A, Korshunova E. Tibial neuromodulation in the treatment of neurogenic detrusor hyperactivity in patients with Parkinson’s disease. Urologiia. 2006;2006(4):3–6.

11.

Canbaz Kabay S, Kabay S, Yucel M, Ozden H. Acute urodynamic effects of percutaneous posterior tibial nerve stimulation on neurogenic detrusor overactivity in patients with Parkinson’s disease. Neurourol Urodyn. 2009;28(1):62–7.CrossRef

12.

Kabay S, Canbaz Kabay S, Cetiner M, et al. The clinical and urodynamic results of percutaneous posterior tibial nerve stimulation on neurogenic detrusor overactivity in patients with Parkinson’s disease. Urology. 2016;87:76–81. https://doi.org/10.1016/j.urology.2015.09.026.CrossRefPubMed

13.

Ramírez-García I, Blanco-Ratto L, Kauffmann S, Carralero-Martínez A, Sánchez E. Efficacy of transcutaneous stimulation of the posterior tibial nerve compared to percutaneous stimulation in idiopathic overactive bladder syndrome: randomized control trial. Neurourol Urodyn. 2019;38(1):261–8. https://doi.org/10.1002/nau.23843.CrossRefPubMed

14.

de Seze M, Raibaut P, Gallien P, et al. Transcutaneous posterior tibial nerve stimulation for treatment of the overactive bladder syndrome in multiple sclerosis: results of a multicenter prospective study. Neurourol Urodyn. 2011;30(3):306–11. https://doi.org/10.1002/nau.CrossRefPubMed

15.

Ohannessian A, Kaboré FA, Agostini A, et al. Transcutaneous tibial nerve stimulation in the overactive bladder syndrome in patients with Parkinson’s syndromes. Prog en Urol. 2013;23(11):936–9. https://doi.org/10.1016/j.purol.2013.07.004.CrossRef

16.

Charvolin L, Guinet-Lacoste A, Waz D, Godmer M, Rode G. Results and compliance of transcutaneous tibial nerve stimulation on overactive bladder syndrome in patients with Parkinson’s disease. Retrospective Study. Prog en Urol. 2019;29(7):378–84. https://doi.org/10.1016/j.purol.2019.02.006.CrossRef

17.

Perissinotto MC, D’ancona CAL, Lucio A, Campos RM, Abreu A. Transcutaneous tibial nerve stimulation in the treatment of lower urinary tract symptoms and its impact on health-related quality of life in patients with parkinson disease: a randomized controlled trial. J Wound Ostomy Cont Nurs. 2015;42(1):94–9. https://doi.org/10.1097/WON.0000000000000078.CrossRef

18.

Seth JH, Gonzales G, Haslam C, et al. Feasibility of using a novel non-invasive ambulatory tibial nerve stimulation device for the home-based treatment of overactive bladder symptoms. Transl Androl Urol. 2018;7(6):912–9. https://doi.org/10.21037/tau.2018.09.12.CrossRefPubMedPubMedCentral

19.

National Institute for Clinical Excellence. The geko device for reducing the risk of venous thromboembolism. Medical Technologies Guidance [IMTG19].

20.

Araujo TG, Schmidt AP, Sanches PRS, Silva Junior DP, Rieder CRM, Ramos JGL. Transcutaneous tibial nerve home stimulation for overactive bladder in women with Parkinson’s disease: a randomized clinical trial. Neurourol Urodyn. 2021;40(1):538–48. https://doi.org/10.1002/nau.24595.CrossRefPubMed

21.

Goetz CG, Tilley BC, Shaftman SR, et al. Movement Disorder Society-Sponsored Revision of the Unified Parkinson ’ s Disease Rating Scale ( MDS-UPDRS ): scale presentation and clinimetric testing results. Mov Disord. 2008;23(15):2129–70. https://doi.org/10.1002/mds.22340.CrossRefPubMed

22.

Verghese T, Tryposkiadis K, Arifeen K, Middelton L, Latthe P. Minimal clinically important difference (MCID) for the International Consultation on Incontinence Questionnaire-Overactive Bladder (ICIQ- OAB). International Continence Society meeting. 2017.

23.

Pavy-Le Traon A, Cotterill N, Amarenco G, et al. Clinical rating scales for urinary symptoms in Parkinson disease: critique and recommendations. Mov Disord Clin Pract. 2018;5(5):479–91.CrossRefPubMedPubMedCentral

24.

Brookes ST, Donovan JL, Wright M, Jackson S, Abrams P. A scored form of the Bristol Female Lower Urinary Tract Symptoms questionnaire: data from a randomized controlled trial of surgery for women with stress incontinence. Published online 2004https://doi.org/10.1016/j.ajog.2003.12.027

25.

Coyne K, Revicki D, Hunt T, et al. Psychometric validation of an overactive bladder symptom and health-related quality of life questionnaire : The OAB-q. Qual Life Res. 2002;11:563–74 (Published online).CrossRefPubMed

26.

Kroenke K, Spitzer RL, Williams JBW. The PHQ-9. 46202:606–613score. Published online 2006:625–631. https://doi.org/10.1038/sj.sc.3101887

27.

Donovan J, Peters T, Abrams P, Brooks S, de la Rosette J, Schafer W. Scoring the short form ICSmale SF questionnaire. J Urol. 2000;164(6):1948–55.CrossRefPubMed

28.

Visser M, Marinus J, Stiggelbout AM. Assessment of autonomic dysfunction in Parkinson’s disease: the SCOPA-AUT. Mov Disord. 2004;19(11):1306–12. https://doi.org/10.1002/mds.20153.CrossRefPubMed

29.

Krogh K, Christensen P, Sabroe S, Laurberg S. Neurogenic bowel dysfunction score. Spinal Cord. 2006;44(10):625-31.

30.

Davis NJ, Gold E, Pascual-Leone A, Bracewell RM. Challenges of proper placebo control for non-invasive brain stimulation in clinical and experimental applications. Eur J Neurosci. 2013;38(7):2973–7. https://doi.org/10.1111/ejn.12307.CrossRefPubMed

31.

Li S, Li X, Theisen K, et al. Saphenous nerve stimulation normalizes bladder underactivity induced by tibial nerve stimulation in cats. Published online 2021:3–4. https://doi.org/10.1152/ajprenal.00422.2017

32.

Li L, Leung GK, Lui W. Sacral nerve stimulation for neurogenic bladder. World Neurosurg. 2016;90:236–43. https://doi.org/10.1016/j.wneu.2016.02.108.CrossRefPubMed

33.

Kabay S, Kabay S. The sustained therapeutic effects of percutaneous posterior tibial nerve stimulation in the treatment of neurogenic lower urinary tract symptoms in patients with Parkinson’s disease: 24-months clinical and urodynamic results. Urology. 2021. https://doi.org/10.1016/j.urology.2021.01.044 (Published online).CrossRefPubMed

34.

Amarenco G, Sheikh Ismael S, Even-Schneider A, et al. Urodynamic effect of acute transcutaneous posterior tibial nerve stimulation in overactive bladder. J Urol. 2003;169(6):2210–5. https://doi.org/10.1097/01.ju.0000067446.17576.bd.CrossRefPubMed

35.

Li S, Browning J, Theisen K, et al. Prolonged nonobstructive urinary retention induced by tibial nerve stimulation in cats. Am J Physiol Regul Integr Comp Physiol. 2020;318(2):R428–34. https://doi.org/10.1152/AJPREGU.00277.2019.CrossRefPubMedPubMedCentral

Title: 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
Authors: Matthew D. Smith
Emma Tenison
Marcus J. Drake
Yoav Ben-Shlomo
Emily J. Henderson
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Overactive Bladder
Nerve Stimulation
Parkinson's Disease
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06827-3

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2022

A cluster-randomized trial of a complex intervention to encourage deprescribing antidepressants in nursing home residents with dementia: a study protocol

The NICU Antibiotics and Outcomes (NANO) trial: a randomized multicenter clinical trial assessing empiric antibiotics and clinical outcomes in newborn preterm infants

Evaluation of the safety and immunogenicity of different COVID-19 vaccine combinations in healthy individuals: study protocol for a randomized, subject-blinded, controlled phase 3 trial [PRIBIVAC]

Statistical analysis plan for the OPTIMUM study: optimising immunisation using mixed schedules, an adaptive randomised controlled trial of a mixed whole-cell/acellular pertussis vaccine schedule

The SCRIPT trial: study protocol for a randomised controlled trial of a polygenic risk score to tailor colorectal cancer screening in primary care

Effectiveness of the online Acceptance and Commitment Therapy intervention “Embrace Pain” for cancer survivors with chronic painful chemotherapy-induced peripheral neuropathy: study protocol for a randomized controlled trial