Status:
RECRUITING
Stimulation of Acupuncture Points in Female Patients With Multiple Sclerosis and Neurogenic Bladder Dysfunction
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Neurogenic Bladder Dysfunction
Eligibility:
FEMALE
18-60 years
Phase:
NA
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 d...
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 (...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT07183683
Start Date
September 1 2025
End Date
April 30 2027
Last Update
September 19 2025
Active Locations (1)
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1
Department for integrative medicine and prevention, Institute for social medicine, epidemiology and health economics, Charité university medicine Berlin
Berlin, State of Berlin, Germany, 10117