Acupuncture-point stimulation for bladder dysfunction in women with MS.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.