Acupuncture-point stimulation for bladder dysfunction in women with MS.
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
This study will try whether mild electrical stimulation of acupuncture points or non-needle acupressure, added to routine care, can reduce bladder symptoms in women with MS.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 1 site (Berlin, State of Berlin) |
| Trial ID | NCT07183683 on ClinicalTrials.gov |
What this trial studies
The trial randomizes female patients with relapsing-remitting MS and neurogenic bladder dysfunction to one of three groups: electrical stimulation of acupuncture points using a TENS device plus routine care, manual acupressure plus routine care, or routine care alone. Eligible participants are women aged 18–60 with EDSS ≤6 and stable immunomodulatory therapy. Primary outcomes are patient-reported measures of neurogenic bladder symptoms, with safety monitoring and a qualitative substudy using semi-structured interviews to capture participant experiences. The investigators aim to determine feasibility, therapeutic signal, and tolerability of the two acupuncture-based interventions compared with routine care.
Who should consider this trial
Good fit: Women aged 18–60 with relapsing-remitting MS, EDSS ≤6, stable MS therapy, and signs of overactive/neurogenic bladder (at least three specified symptoms) are the intended participants.
Not a fit: Patients with a recent MS relapse, planned changes in immunomodulatory therapy, more advanced disability beyond EDSS 6, or bladder dysfunction from non-neurogenic causes may not benefit from or be eligible for this intervention.
Why it matters
Potential benefit: If successful, these low-risk therapies could offer a non-drug option to reduce urinary urgency, frequency, and incontinence in women with MS.
How similar studies have performed: Small studies of TENS or acupuncture for overactive bladder and some neurogenic bladder populations have reported symptom improvements, but high-quality randomized evidence specifically in MS is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Berlin, State of Berlin
- Department for integrative medicine and prevention, Institute for social medicine, epidemiology and health economics, Charité university medicine Berlin — Berlin, State of Berlin, Germany (Recruiting)
Study contacts
- Study coordinator: Benno Brinkhaus, PhD, MD
- Email: benno.brinkhaus@charite.de
- Phone: +49 30 450 529 002
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.