NCT07183683

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

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 (B) manual stimulation of acupuncture points (using acupressure) in addition to routine care, compared to (C) routine care alone (control group), in female patients with multiple sclerosis (MS) and neurogenic bladder dysfunction. Key outcome parameters include symptoms of neurogenic bladder dysfunction assessed using standardized patient-reported outcome measures. Moreover, a qualitative substudy will be conducted to explore the subjectively perceived effects of the study interventions and the overall feasibility of the study. This will be carried out through semi-structured interviews and analyzed using qualitative research methodology.

Conditions

• Neurogenic Bladder Dysfunction

Interventions

Type	Name	Description
DEVICE	group 1: electrical stimulation of acupuncture points plus routine care	The acupuncture points Spleen 6 and Kidney 3 will be stimulated twice daily with a up to 30min electrical stimulation per foot with 10Hz and an intensity up to individual tolerance level.
OTHER	group 2: acupressure plus routine care	The acupuncture points Spleen 6 and Kidney 3 will be stimulated twice daily with a up to 30min massage per foot

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-12-30
• Completion: 2027-04-30
• First posted: 2025-09-19
• Last updated: 2025-09-19

Locations

1 site across 1 country: Germany