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SINGLE CENTRE RANDOMISED PILOT STUDY OF TWO REGIMENS (30 MINS DAILY OR 30 MINS WEEKLY FOR 12 WEEKS) OF TRANSCUTANEOUS TIBIAL NERVE STIMULATION USING A NOVEL DEVICE FOR TREATING MULTIPLE SCLEROSIS-RELATED OVERACTIVE BLADDER SYMPTOMS
  1. Jai Seth1,2,
  2. Collette Haslam1,
  3. Gwen Gonzales1,
  4. Mahreen Pakzad1,
  5. Arvind Vashisht3,
  6. Sohier Elneil1,
  7. Arun Sahai4,
  8. Charles Knowles5,
  9. Art Tucker5,
  10. Jalesh Panicker1,2
  1. 1Department of Uro-Neurology, The National Hospital for Neurology and Neurosurgery
  2. 2UCL Institute of Neurology
  3. 3UCLH
  4. 4Guy's Hospital, Kings College London
  5. 5Queen Mary's University, Barts Health NHS Trust, University of London

Abstract

Introduction Percutaneous tibial nerve stimulation (PTNS) is effective for managing multiple sclerosis (MS)-related overactive bladder (OAB) symptoms. However the need for weekly clinic visits restricts its use. The purpose of this study was to evaluate safety and efficacy of a novel, self-applying device for managing OAB symptoms.

Study design, materials and methods 48 patients reporting OAB (MS n=24, idiopathic n=24), were randomized (1:1) to either daily or weekly treatments for 12 weeks with geko™, a novel device stimulating the tibial nerve transcutaneously. Efficacy was assessed using validated questionnaires (ICIQ-OAB, ICIQLUTS-QoL) and bladder diaries filled at weeks 4, 8, and 12. Urinary neurotrophins (Nerve growth factor (NGF) and Brain derived neurotrophic factor) were measured.

Results 34 patients (MS n=19) completed the study. 18 patients responded to treatment (53%); 72% of responders belonged to the MS cohort. Multilevel regression analysis suggested significant improvements in questionnaire scores (ICIQ-OAB –10.2 (–13.5 to –6.9; p=0.001), ICIQLUTS-QOL –40.8 (–57.4 to –24.3; p=0.000)), without differences between weekly and daily-treated arms. No significant adverse effects were reported and patients rated the treatment as easy to use and comfortable. NGF levels at baseline were significantly greater in non-responders (p=0.05).

Concluding message In this pilot study, a patch device suitable for self-application at home appears to be an effective, safe and convenient alternative for managing MS-related OAB symptoms.

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