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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Incontinence Questionnaire Overactive Bladder (ICIQ-OAB)
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
group 1: electrical stimulation of acupuncture points plus routine care
Intervention is electrical stimulation of two acupuncture points at the inner ankle of the foot over the posterior tibialis nerve, stimulation twice daily over 5 weeks
Intervention: group 1: electrical stimulation of acupuncture points plus routine care (Device)
group 2: acupressure plus routine care
manual stimulation of the same two acupressure points over the inner ankle, stimulation twice daily over 5 weeks
Intervention: group 2: acupressure plus routine care (Other)
group 3: routine care alone
waiting list control
Outcomes
Primary Outcomes
Incontinence Questionnaire Overactive Bladder (ICIQ-OAB)
Time Frame: weeks 5 and 10 after the start of the intervention
Bladder function scoring 0-16, higher values mean worse outcome
Secondary Outcomes
- Incontinence Quality of Life Measure (I-QoL)(weeks 5 and 10 after the start of the intervention)
- Patient's Global Impression of Change (PGIC)(weeks 5 and 10 after the start of the intervention)
- 3-day voiding diary(weeks 5 and 10 after the start of the intervention)
- 100mm Visual Analogue pain Scale (VAS) for last menstruation(at weeks 5 and 10)
Investigators
Benno Brinkhaus
Professor Dr. Benno Brinkhaus
Charite University, Berlin, Germany