Stimulation of Acupuncture Points in Female Patients With Multiple Sclerosis and Neurogenic Bladder Dysfunction
Recruiting · NCT07183683 · Interventional (participants receive a specific treatment) · Lead sponsor: Charite University, Berlin, Germany
View the official record on ClinicalTrials.gov →Interventions studied
group 1: electrical stimulation of acupuncture points plus routine caregroup 2: acupressure plus routine care
What this trial is about
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.
Who can take part
Age range
18 Years to 60 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Department for integrative medicine and prevention, Institute for social medicine, epidemiology and health economics, Charité university medicine Berlin - Berlin, State of Berlin, Germany