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

NCT07183683 | Recruiting

• 2 other identifiers: ACULUTS-MS KVCKVC 01/143/2024
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neurogenic Bladder Dysfunction

Keywords

multiple sclerosis; urinary bladder dysfunction; electrical stimulation; acupressure; acupuncture; posterior tibial nerve

Outcome Measures

Primary Outcomes (1)

• Incontinence Questionnaire Overactive Bladder (ICIQ-OAB)

  Bladder function scoring 0-16, higher values mean worse outcome

  weeks 5 and 10 after the start of the intervention

Secondary Outcomes (4)

• Incontinence Quality of Life Measure (I-QoL)

  weeks 5 and 10 after the start of the intervention

• Patient's Global Impression of Change (PGIC)

  weeks 5 and 10 after the start of the intervention

• 3-day voiding diary

  weeks 5 and 10 after the start of the intervention

• 100mm Visual Analogue pain Scale (VAS) for last menstruation

  at weeks 5 and 10

Other Outcomes (2)

• rate of rescue medication

  between weeks 1 and 5 and at week 10

• rate of adverse events

  from week 1 to 10

Study Arms (3)

group 1: electrical stimulation of acupuncture points plus routine care

EXPERIMENTAL

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

Device: group 1: electrical stimulation of acupuncture points plus routine care

group 2: acupressure plus routine care

EXPERIMENTAL

manual stimulation of the same two acupressure points over the inner ankle, stimulation twice daily over 5 weeks

Other: group 2: acupressure plus routine care

group 3: routine care alone

NO INTERVENTION

waiting list control

Interventions

group 1: electrical stimulation of acupuncture points plus routine care DEVICE

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.

Also known as: posterior tibial nerve stimulation

group 1: electrical stimulation of acupuncture points plus routine care

group 2: acupressure plus routine care OTHER

The acupuncture points Spleen 6 and Kidney 3 will be stimulated twice daily with a up to 30min massage per foot

group 2: acupressure plus routine care

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

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

Berlin, State of Berlin, 10117, Germany

RECRUITING

Related Publications (4)

• Al Dandan HB, Coote S, McClurg D. Prevalence of Lower Urinary Tract Symptoms in People with Multiple Sclerosis: A Systematic Review and Meta-analysis. Int J MS Care. 2020 Mar-Apr;22(2):91-99. doi: 10.7224/1537-2073.2019-030.

  PMID: 32410904 BACKGROUND

• Chang KK, Wong TK, Wong TH, Leung AW, Chung JW. Effect of acupressure in treating urodynamic stress incontinence: a randomized controlled trial. Am J Chin Med. 2011;39(6):1139-59. doi: 10.1142/S0192415X11009469.

  PMID: 22083987 BACKGROUND

• Marzouk MH, Darwish MH, El-Tamawy MS, Morsy S, Abbas RL, Ali AS. Posterior tibial nerve stimulation as a neuromodulation therapy in treatment of neurogenic overactive bladder in multiple sclerosis: A prospective randomized controlled study. Mult Scler Relat Disord. 2022 Dec;68:104252. doi: 10.1016/j.msard.2022.104252. Epub 2022 Oct 17.

  PMID: 36274285 BACKGROUND

• Guitynavard F, Mirmosayyeb O, Razavi ERV, Hosseini M, Hosseinabadi AM, Ghajarzadeh M, Azadvari M. Percutaneous posterior tibial nerve stimulation (PTNS) for lower urinary tract symptoms (LUTSs) treatment in patients with multiple sclerosis (MS): A systematic review and meta-analysis. Mult Scler Relat Disord. 2022 Feb;58:103392. doi: 10.1016/j.msard.2021.103392. Epub 2021 Nov 10.

  PMID: 35216773 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Benno Brinkhaus, PhD, MD

CONTACT

+49 30 450 529 002; benno.brinkhaus@charite.de

Joanna Dietzel, MD

CONTACT

+49 30 450 529 002; joanna.dietzel@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr. Benno Brinkhaus

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 19, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: from 31.12.2027- 31.12.2032

Locations

DE (1)