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

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Department for integrative medicine and prevention, Institute for social medicine, epidemiology and health economics, Charité university medicine Berlin
RECRUITING
Berlin
Contact Information
Primary
Benno Brinkhaus, PhD, MD
benno.brinkhaus@charite.de
+49 30 450 529 002
Backup
Joanna Dietzel, MD
joanna.dietzel@charite.de
+49 30 450 529 002
Time Frame
Start Date: 2025-09
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 150
Treatments
Experimental: group 1: electrical stimulation of acupuncture points plus routine care
Intervention is electrical stimulation of two acupuncture points at the inner ankle of the foot over the posterior tibialis nerve, stimulation twice daily over 5 weeks
Experimental: group 2: acupressure plus routine care
manual stimulation of the same two acupressure points over the inner ankle, stimulation twice daily over 5 weeks
No_intervention: group 3: routine care alone
waiting list control
Sponsors
Leads: Charite University, Berlin, Germany

This content was sourced from clinicaltrials.gov