Stimulation of Acupuncture Points in Female Patients With Multiple Sclerosis and Neurogenic Bladder Dysfunction

Официальное название

Electrical Versus Manual Stimulation of Acupuncture Points in Female Patients With Multiple Sclerosis and Neurogenic Bladder Dysfunction - A Pragmatic, Exploratory, Three-Arm, Randomized Controlled Trial Using a Mixed Methods Approach

Обзор

Electrical vs. manual stimulation: The study compares two types of acupuncture - one using mild electrical currents and one using just manual no-needle techniques in the treatment of urinary bladder disfunction. The study focuses on women diagnosed with multiple sclerosis (MS) who also have neurogenic bladder dysfunction - a condition where the bladder doesn't work properly due to nerve damage.

Подробное описание

The objective of this study is to evaluate the feasibility, therapeutic effects, and safety of (A) electrical stimulation of acupuncture points (using a TENS device) in addition to routine care, and (B) manual stimulation of acupuncture points (using acupressure) in addition to routine care, compared to (C) routine care alone (control group), in female patients with multiple sclerosis (MS) and neurogenic bladder dysfunction.

Key outcome parameters include symptoms of neurogenic bladder dysfunction assessed using standardized patient-reported outcome measures.

Moreover, a qualitative substudy will be conducted to explore the subjectively perceived effects of the study interventions and the overall feasibility of the study. This will be carried out through semi-structured interviews and analyzed using qualitative research methodology.

Вмешательства

• Устройство group 1: electrical stimulation of acupuncture points plus routine care
  The acupuncture points Spleen 6 and Kidney 3 will be stimulated twice daily with a up to 30min electrical stimulation per foot with 10Hz and an intensity up to individual tolerance level.
• Другое group 2: acupressure plus routine care
  The acupuncture points Spleen 6 and Kidney 3 will be stimulated twice daily with a up to 30min massage per foot

Первичные конечные точки

• Incontinence Questionnaire Overactive Bladder (ICIQ-OAB) [Срок оценки: weeks 5 and 10 after the start of the intervention]

Вторичные конечные точки (4)

• Incontinence Quality of Life Measure (I-QoL) [Срок оценки: weeks 5 and 10 after the start of the intervention]
• Patient's Global Impression of Change (PGIC) [Срок оценки: weeks 5 and 10 after the start of the intervention]
• 3-day voiding diary [Срок оценки: weeks 5 and 10 after the start of the intervention]
• 100mm Visual Analogue pain Scale (VAS) for last menstruation [Срок оценки: at weeks 5 and 10]

Критерии участия

Критерии включения

• Female patients, aged 18-60 years, with relapsing-remitting multiple sclerosis (RRMS) and an Expanded Disability Status Scale (EDSS) score ≤ 6
• Stable immunomodulatory MS therapy for at least 3 months prior to enrollment
• Presence of at least 3 out of the following 6 criteria indicative of overactive bladder dysfunction: urgency, daytime urinary frequency >10 times, nocturia >1 time per night, post-void dribbling, incontinence, or delayed initiation of micturition
• Participants must be willing and cognitively and linguistically capable of adhering to the study protocol, performing the study interventions, and completing the required study documentation
• Capacity to provide informed consent, and provision of written consent for both written and electronic data collection and participation in the study

Критерии исключения

• Acute MS relapse within the last 3 months prior to individual study entry
• Planned change in immunomodulatory therapy during the study period
• Current need for regular self-catheterization (more than twice per week)
• Clinically relevant post-void residual volume, confirmed by ultrasound (>100 mL or >40% of pre-void volume)
• Current or past history of bladder cancer
• Implanted defibrillator or other pacemaker
• Urogenital causes of bladder dysfunction, such as stress urinary incontinence or bladder prolapse
• Spinal trauma within 5 years prior to study entry or any other pre-existing central nervous system disorders (e.g., stroke, Parkinson's disease), or history of pelvic, spinal, or bladder surgery
• Acute urinary tract infection at the time of screening or within the previous 4 weeks
• Urolithiasis or urogenital tumors within the past 6 months
• Previous electrical posterior tibial nerve stimulation (TNS), acupuncture, or acupressure in the same anatomical region within 3 months prior to study entry
• Regular pelvic floor training (more than twice per week) in the past 6 weeks or planned during the study period
• Planned participation in another interventional clinical trial during the study period
• Open wounds, edema, or lymphedema in the lower leg that may interfere with local intervention
• Other serious pre-existing conditions (e.g., active cancer, heart failure, epilepsy, etc.) that contraindicate participation in the study
• Obesity, defined as BMI > 30
• Pregnancy or breastfeeding

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 1 центр

• Department for integrative medicine and prevention, Institute for social medicine, epidemi — Berlin

Публикации

• Al Dandan HB, Coote S, McClurg D. Prevalence of Lower Urinary Tract Symptoms in People with Multiple Sclerosis: A Systematic Review and Meta-analysis. Int J MS Care. 2020 Mar-Apr;22(2):91-99. doi: 10.7224/1537-2073.2019-030. PMID 32410904
• Chang KK, Wong TK, Wong TH, Leung AW, Chung JW. Effect of acupressure in treating urodynamic stress incontinence: a randomized controlled trial. Am J Chin Med. 2011;39(6):1139-59. doi: 10.1142/S0192415X11009469. PMID 22083987
• Marzouk MH, Darwish MH, El-Tamawy MS, Morsy S, Abbas RL, Ali AS. Posterior tibial nerve stimulation as a neuromodulation therapy in treatment of neurogenic overactive bladder in multiple sclerosis: A prospective randomized controlled study. Mult Scler Relat Disord. 2022 Dec;68:104252. doi: 10.1016/j.msard.2022.104252. Epub 2022 Oct 17. PMID 36274285
• Guitynavard F, Mirmosayyeb O, Razavi ERV, Hosseini M, Hosseinabadi AM, Ghajarzadeh M, Azadvari M. Percutaneous posterior tibial nerve stimulation (PTNS) for lower urinary tract symptoms (LUTSs) treatment in patients with multiple sclerosis (MS): A systematic review and meta-analysis. Mult Scler Relat Disord. 2022 Feb;58:103392. doi: 10.1016/j.msard.2021.103392. Epub 2021 Nov 10. PMID 35216773

Идентификаторы

NCT: NCT07183683 · ACULUTS-MS KVC · KVC 01/143/2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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