NCT07183683Recruiting
Stimulation of Acupuncture Points in Female Patients With Multiple Sclerosis and Neurogenic Bladder Dysfunction
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
Source: ClinicalTrials.gov · Last updated 19 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 11 Sept 2025
- Start date
- Sept 2025
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Charite University, Berlin, Germany
- Diseases
- Multiple sclerosis
- NCT number
- NCT07183683
What you commit to
- Study type: Interventional
- Planned participants: 150
- From Sept 2025 to the primary completion date, 30 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Acute MS relapse within the last 3 months prior to individual study entry
- Planned change in immunomodulatory therapy during the study period
- 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
- Previous electrical posterior tibial nerve stimulation (TNS), acupuncture, or acupressure in the same anatomical region within 3 months prior to study entry
Other illness
- Current or past history of bladder cancer
- Other serious pre-existing conditions (e.g., active cancer, heart failure, epilepsy, etc.) that contraindicate participation in the study
Other
- 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)
- Implanted defibrillator or other pacemaker
- Urogenital causes of bladder dysfunction, such as stress urinary incontinence or bladder prolapse
- Urolithiasis or urogenital tumors within the past 6 months
- 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
- Obesity, defined as BMI \> 30
- Pregnancy or breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to 60 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department for integrative medicine and prevention, Institute for social medicine, epidemiology and health economics, Charité university medicine Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.