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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
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.
The acupuncture points Spleen 6 and Kidney 3 will be stimulated twice daily with a up to 30min massage per foot
Department for integrative medicine and prevention, Institute for social medicine, epidemiology and health economics, Charité university medicine Berlin
Berlin, State of Berlin, Germany
RECRUITINGIncontinence Questionnaire Overactive Bladder (ICIQ-OAB)
Bladder function scoring 0-16, higher values mean worse outcome
Time frame: weeks 5 and 10 after the start of the intervention
Incontinence Quality of Life Measure (I-QoL)
Disease-specific quality of life, scoring 1-110 , the higher the values the better
Time frame: weeks 5 and 10 after the start of the intervention
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'
Time frame: weeks 5 and 10 after the start of the intervention
3-day voiding diary
Objective voiding parameters, including mean voiding frequency and average fluid intake to urine output ratio, assessing daytime urination frequency
Time frame: weeks 5 and 10 after the start of the intervention
100mm Visual Analogue pain Scale (VAS) for last menstruation
Pain during the most recent menstruation ranging from 0: no pain to 100: maximum pain
Time frame: at weeks 5 and 10
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