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Stimulation of Acupuncture Points in Female Patients With Multiple Sclerosis and Neurogenic Bladder Dysfunction

RecruitingNA

Sponsor: Charite University, Berlin, Germany

Conditions: Neurogenic Bladder Dysfunction

Interventions: group 1: electrical stimulation of acupuncture points plus routine care, group 2: acupressure plus routine care

Countries: Germany

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 overview

Sex: FEMALE

Age: 18 Years to 60 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (1)

Berlin, State of Berlin, Germany