Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
FEMALE
NCT07183683

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

Led by Charite University, Berlin, Germany · Updated on 2025-09-19

150

Participants Needed

1

Research Sites

86 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 60Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged 18 to 60 years with relapsing-remitting multiple sclerosis (RRMS) and an Expanded Disability Status Scale (EDSS) score of 6 or less
  • Stable immunomodulatory MS therapy for at least 3 months before enrollment
  • Presence of at least 3 of these symptoms: urgency, daytime urinary frequency over 10 times, nocturia more than once per night, post-void dribbling, incontinence, or delayed start of urination
  • Willingness and ability to follow the study protocol, perform interventions, and complete study documents
  • Capacity to provide informed consent and written consent for data collection and participation
Not Eligible

You will not qualify if you...

  • Acute MS relapse within 3 months before study entry
  • Planned changes in immunomodulatory therapy during the study
  • Regular self-catheterization more than twice per week
  • Significant residual urine volume confirmed by ultrasound (>100 mL or >40% of pre-void volume)
  • Current or past bladder cancer
  • Implanted defibrillator or pacemaker
  • Bladder dysfunction due to other causes like stress urinary incontinence or bladder prolapse
  • Spinal trauma within 5 years or other central nervous system disorders or prior pelvic, spinal, or bladder surgery
  • Acute urinary tract infection at screening or within 4 weeks prior
  • Urolithiasis or urogenital tumors within past 6 months
  • Previous electrical nerve stimulation, acupuncture, or acupressure in the target area within 3 months
  • Regular pelvic floor training more than twice per week in past 6 weeks or planned during study
  • Participation in another interventional clinical trial during study
  • Open wounds, edema, or lymphedema in lower leg affecting intervention
  • Serious pre-existing conditions like active cancer, heart failure, epilepsy
  • Obesity with BMI over 30
  • Pregnancy or breastfeeding

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department for integrative medicine and prevention, Institute for social medicine, epidemiology and health economics, Charité university medicine Berlin

Berlin, State of Berlin, Germany, 10117

Actively Recruiting

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Research Team

B

Benno Brinkhaus, PhD, MD

CONTACT

J

Joanna Dietzel, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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