Feasibility and acceptability of transcutaneous tibial nerve stimulation for the treatment of bladder storage symptoms among people with multiple sclerosis

Abstract Background Neurogenic lower urinary tract dysfunction is an abnormality in the presence of underlying neurologic disease. A recent systematic review and meta-analysis demonstrated that storage phase symptoms are the predominant symptoms among people with multiple sclerosis (PwMS). Transcuta...

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Main Authors: Hawra B. Al Dandan, Rose Galvin, Katie Robinson, Doreen McClurg, Susan Coote
Format: Article
Language:English
Published: BMC 2022-07-01
Series:Pilot and Feasibility Studies
Subjects:
Online Access:https://doi.org/10.1186/s40814-022-01120-1
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author Hawra B. Al Dandan
Rose Galvin
Katie Robinson
Doreen McClurg
Susan Coote
author_facet Hawra B. Al Dandan
Rose Galvin
Katie Robinson
Doreen McClurg
Susan Coote
author_sort Hawra B. Al Dandan
collection DOAJ
description Abstract Background Neurogenic lower urinary tract dysfunction is an abnormality in the presence of underlying neurologic disease. A recent systematic review and meta-analysis demonstrated that storage phase symptoms are the predominant symptoms among people with multiple sclerosis (PwMS). Transcutaneous tibial nerve stimulation (TTNS) is a non-invasive treatment for bladder storage symptoms; however, the potential efficacy of stimulation among PwMS is based on a small number of studies with the absence of high-quality evidence. The aim of this study was to evaluate the feasibility, acceptability, and safety of TTNS in PwMS using an affordable transcutaneous electrical nerve stimulation (TENS) unit. Methods A total of 23 participants with MS enrolled in the study. The primary outcomes included recruitment/retention rate, completion of the outcomes and the intervention, adherence to the protocol, adverse events, and acceptability of the intervention. The primary outcomes were assessed using diaries and a satisfaction questionnaire. The secondary outcomes included changes in urinary symptoms and quality of life assessed using a set of validated outcome measures including a 3-day bladder diary, PPIUS, ICIQ-OAB, and KHQ at baseline and post-intervention. Results Twenty participants completed the study. Three participants (13.04%) withdrew. All 20 participants completed the 6-week intervention and all the outcome measures (100%), with no reported adverse events. Participants were satisfied and found the unit acceptable. Three-day bladder diary showed changes in urinary frequency from a daily median of 10 times to 8 times and daily median urgency changed from 6 times at baseline to 2 times post-intervention. PPIUS showed changes in daily median sever urgency from 3 points (IQR=4) to 1 point (IQR=1) post-intervention. ICIQ-OAB total scores changed from 8 points (IQR=2.25) to 4 points (IQR=2.5) post-intervention. Median and mean scores of KHQ showed a clinical meaningful change of QoL in part-two and part-three of the questionnaire. Conclusions TTNS is feasible, safe, and acceptable for PwMS. Changes of urinary symptoms scores and QoL post-intervention suggested improvements. Future implications need to consider the treatment protocol including frequency of treatment sessions, duration of treatment, and the electrical stimulation parameters as well as the outcome measures followed in the current study for the implementation of the future pilot RCT. Trial registration ClinicalTrials.gov NCT04528784 . Registered on 27 August 2020. https://register.clinicaltrials.gov/prs/app/action/LoginUser?ts=1&cx=-jg9qo4 .
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spelling doaj.art-4bc16827400848a5a822a033a1fba38a2022-12-22T03:40:58ZengBMCPilot and Feasibility Studies2055-57842022-07-018111110.1186/s40814-022-01120-1Feasibility and acceptability of transcutaneous tibial nerve stimulation for the treatment of bladder storage symptoms among people with multiple sclerosisHawra B. Al Dandan0Rose Galvin1Katie Robinson2Doreen McClurg3Susan Coote4School of Allied Health, Faculty of Education and Health Sciences, University of LimerickSchool of Allied Health, Faculty of Education and Health Sciences, University of LimerickSchool of Allied Health, Faculty of Education and Health Sciences, University of LimerickNursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian UniversitySchool of Allied Health, Faculty of Education and Health Sciences, University of LimerickAbstract Background Neurogenic lower urinary tract dysfunction is an abnormality in the presence of underlying neurologic disease. A recent systematic review and meta-analysis demonstrated that storage phase symptoms are the predominant symptoms among people with multiple sclerosis (PwMS). Transcutaneous tibial nerve stimulation (TTNS) is a non-invasive treatment for bladder storage symptoms; however, the potential efficacy of stimulation among PwMS is based on a small number of studies with the absence of high-quality evidence. The aim of this study was to evaluate the feasibility, acceptability, and safety of TTNS in PwMS using an affordable transcutaneous electrical nerve stimulation (TENS) unit. Methods A total of 23 participants with MS enrolled in the study. The primary outcomes included recruitment/retention rate, completion of the outcomes and the intervention, adherence to the protocol, adverse events, and acceptability of the intervention. The primary outcomes were assessed using diaries and a satisfaction questionnaire. The secondary outcomes included changes in urinary symptoms and quality of life assessed using a set of validated outcome measures including a 3-day bladder diary, PPIUS, ICIQ-OAB, and KHQ at baseline and post-intervention. Results Twenty participants completed the study. Three participants (13.04%) withdrew. All 20 participants completed the 6-week intervention and all the outcome measures (100%), with no reported adverse events. Participants were satisfied and found the unit acceptable. Three-day bladder diary showed changes in urinary frequency from a daily median of 10 times to 8 times and daily median urgency changed from 6 times at baseline to 2 times post-intervention. PPIUS showed changes in daily median sever urgency from 3 points (IQR=4) to 1 point (IQR=1) post-intervention. ICIQ-OAB total scores changed from 8 points (IQR=2.25) to 4 points (IQR=2.5) post-intervention. Median and mean scores of KHQ showed a clinical meaningful change of QoL in part-two and part-three of the questionnaire. Conclusions TTNS is feasible, safe, and acceptable for PwMS. Changes of urinary symptoms scores and QoL post-intervention suggested improvements. Future implications need to consider the treatment protocol including frequency of treatment sessions, duration of treatment, and the electrical stimulation parameters as well as the outcome measures followed in the current study for the implementation of the future pilot RCT. Trial registration ClinicalTrials.gov NCT04528784 . Registered on 27 August 2020. https://register.clinicaltrials.gov/prs/app/action/LoginUser?ts=1&cx=-jg9qo4 .https://doi.org/10.1186/s40814-022-01120-1Neurogenic lower urinary tract dysfunctionNeuromodulationElectrical nerve stimulationQuality of life questionnaireTibial nerve
spellingShingle Hawra B. Al Dandan
Rose Galvin
Katie Robinson
Doreen McClurg
Susan Coote
Feasibility and acceptability of transcutaneous tibial nerve stimulation for the treatment of bladder storage symptoms among people with multiple sclerosis
Pilot and Feasibility Studies
Neurogenic lower urinary tract dysfunction
Neuromodulation
Electrical nerve stimulation
Quality of life questionnaire
Tibial nerve
title Feasibility and acceptability of transcutaneous tibial nerve stimulation for the treatment of bladder storage symptoms among people with multiple sclerosis
title_full Feasibility and acceptability of transcutaneous tibial nerve stimulation for the treatment of bladder storage symptoms among people with multiple sclerosis
title_fullStr Feasibility and acceptability of transcutaneous tibial nerve stimulation for the treatment of bladder storage symptoms among people with multiple sclerosis
title_full_unstemmed Feasibility and acceptability of transcutaneous tibial nerve stimulation for the treatment of bladder storage symptoms among people with multiple sclerosis
title_short Feasibility and acceptability of transcutaneous tibial nerve stimulation for the treatment of bladder storage symptoms among people with multiple sclerosis
title_sort feasibility and acceptability of transcutaneous tibial nerve stimulation for the treatment of bladder storage symptoms among people with multiple sclerosis
topic Neurogenic lower urinary tract dysfunction
Neuromodulation
Electrical nerve stimulation
Quality of life questionnaire
Tibial nerve
url https://doi.org/10.1186/s40814-022-01120-1
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