Stimulation of Acupuncture Points in Female Patients With Multiple Sclerosis and Neurogenic Bladder Dysfunction
NCT ID: NCT07183683
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2025-09-30
2027-04-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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.
group 2: acupressure plus routine care
manual stimulation of the same two acupressure points over the inner ankle, stimulation twice daily over 5 weeks
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
group 3: routine care alone
waiting list control
No interventions assigned to this group
Interventions
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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.
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
FEMALE
No
Sponsors
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Charite University, Berlin, Germany
OTHER
Responsible Party
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Benno Brinkhaus
Professor Dr. Benno Brinkhaus
Locations
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Department for integrative medicine and prevention, Institute for social medicine, epidemiology and health economics, Charité university medicine Berlin
Berlin, State of Berlin, Germany
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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KVC 01/143/2024
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
ACULUTS-MS KVC
Identifier Type: -
Identifier Source: org_study_id
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