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Stimulation of Acupuncture Points in Female Patients With Multiple Sclerosis and Neurogenic Bladder Dysfunction
RECRUITINGN/ASponsored by Charite University, Berlin, Germany
Actively Recruiting
PhaseN/A
SponsorCharite University, Berlin, Germany
Started2025-09
Est. completion2026-12-30
Eligibility
Age18 Years – 60 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07183683
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.
Eligibility
Age: 18 Years – 60 YearsSex: FEMALEHealthy volunteers accepted
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
Conditions2
Multiple SclerosisNeurogenic Bladder Dysfunction
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Actively Recruiting
PhaseN/A
SponsorCharite University, Berlin, Germany
Started2025-09
Est. completion2026-12-30
Eligibility
Age18 Years – 60 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07183683