protocolSection identificationModule nctId: NCT06341673, orgStudyIdInfo id: IRB-2023-O3-442, briefTitle: Impact of TTNS on Bladder Symptoms Among People With MS, A RCT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2024-04-28, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Hawra Al-Dandan, class: OTHER, descriptionModule briefSummary: Background: Neurogenic lower urinary tract dysfunction is common among people with multiple sclerosis (MS). Recent studies showed that bladder storage symptoms are predominant among MS with a pooled prevalence of frequency at 73.45% followed by urgency at 63.87%. Transcutaneous tibial nerve stimulation (TTNS) is a non-invasive treatment to manage bladder storage symptoms; however, the effectiveness of TTNS is based on a small number of studies with the absence of high-quality evidence. This study aims to investigate the effectiveness of TTNS on bladder storage symptoms compared with sham TTNS among people with MS.Methods: The investigators will use a randomised sham controlled double blind study to explore the effectiveness of TTNS in the treatment of bladder storage symptoms in MS. the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) was followed to standardize the conduct and reporting of the current protocol. The recruitment plan is twofold: 1) Open recruitment for people with MS through King Fahd Hospital of the University communication channels; 2) people with any type of MS attending their routine appointments in MS clinic at King Fahd Hospital of the University, Al Khobar. The investigators will investigate the effectiveness of TTNS compared to sham TTNS on bladder storage symptoms and the effect on quality of life using ICIQ-OAB, ICIQ 3-day bladder diary, ICIQ-LUTS qol, and PSQI. Participant's perception of change post intervention will be evaluated using GPE. Outcomes will be measured at 0, 6 weeks and at 6 months post intervention. A sample size of 72 patients (36 in each group) is required to achieve 90% power with two-tailed tests at an alpha level of 0.05.Conclusion: Multiple sclerosis is a long-term condition, and self-management is important. TTNS provide a safe, non-invasive intervention that can be administered at home. Should the trial determine that TTNS is effective compared to sham TTNS, the investigators will plan to integrate TTNS into standard clinical care pathways in MS., conditionsModule conditions: Overactive Bladder Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, sham-controlled, double blind study with 1:1 allocation ratio., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Participants and those who undertake data input and data analysis will be blind to group allocation to reduce the risk of performance bias. A principal investigator and co-investigator will insert data into SPSS so that the researchers can analyse data without having access to the allocation., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 72, type: ESTIMATED, armsInterventionsModule interventions name: Active Transcutaneous Electrical Nerve Stimulation (TENS), interventions name: Sham Transcutaneous Electrical Nerve Stimulation (TENS), outcomesModule primaryOutcomes measure: The International Consultation of Incontinence Questionnaire- Overactive Bladder (ICIQ- OAB), primaryOutcomes measure: 3- day Bladder diary, primaryOutcomes measure: Urinary sensation scale., secondaryOutcomes measure: The International Consultation of incontinence Questionnaire, Lower Urinary Tract Symptoms, Quality of life (ICIQ - LUTS,Qol), secondaryOutcomes measure: Pittsburgh Sleep Quality Index (PSQI)-item 6, secondaryOutcomes measure: Global Perceived Effect (GPE) Scale, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: King Fahd Hospital of the University, status: RECRUITING, city: Khobar, state: Eastern Providence, country: Saudi Arabia, contacts name: Dr Hawra Al Dandan, PhD, role: CONTACT, phone: +966555901977, email: hdandan@iau.edu.sa, contacts name: Dr Saad Al Saadi, PhD, role: CONTACT, phone: +966552519515, email: ssaadi@iau.edu.sa, geoPoint lat: 26.27944, lon: 50.20833, hasResults: False