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.
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
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)
Parallel
group 1: electrical stimulation of acupuncture points plus routine care
DeviceThe 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
Other interventionThe acupuncture points Spleen 6 and Kidney 3 will be stimulated twice daily with a up to 30min massage per foot
Incontinence Questionnaire Overactive Bladder (ICIQ-OAB)
Bladder function scoring 0-16, higher values mean worse outcome
Incontinence Quality of Life Measure (I-QoL)
Disease-specific quality of life, scoring 1-110 , the higher the values the better
Patient's Global Impression of Change (PGIC)
Subjective improvement of bladder dysfunction since start of the study, onedimenional scale with seven grades ranging from 'very much worse' to 'very much improved'
3-day voiding diary
Objective voiding parameters, including mean voiding frequency and average fluid intake to urine output ratio, assessing daytime urination frequency
100mm Visual Analogue pain Scale (VAS) for last menstruation
Pain during the most recent menstruation ranging from 0: no pain to 100: maximum pain
rate of rescue medication
rate of use of rescue medication (e.g., anticholinergics) and self-catheterization during trial participation
rate of adverse events
the Safety of intervention will be assessed by recording the rate of adverse events and identification of adverse reactions
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