Neurogenic Bladder Dysfunction
Conditions
Keywords
multiple sclerosis, urinary bladder dysfunction, electrical stimulation, acupressure, acupuncture, posterior tibial nerve
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.
Detailed description
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.
Interventions
DEVICEgroup 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.
OTHERgroup 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
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Obesity, defined as BMI \> 30 * Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incontinence Questionnaire Overactive Bladder (ICIQ-OAB) | weeks 5 and 10 after the start of the intervention | Bladder function scoring 0-16, higher values mean worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incontinence Quality of Life Measure (I-QoL) | weeks 5 and 10 after the start of the intervention | Disease-specific quality of life, scoring 1-110 , the higher the values the better |
| Patient's Global Impression of Change (PGIC) | weeks 5 and 10 after the start of the intervention | 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 | weeks 5 and 10 after the start of the intervention | 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 | at weeks 5 and 10 | Pain during the most recent menstruation ranging from 0: no pain to 100: maximum pain |
Other
| Measure | Time frame | Description |
|---|---|---|
| rate of rescue medication | between weeks 1 and 5 and at week 10 | rate of use of rescue medication (e.g., anticholinergics) and self-catheterization during trial participation |
| rate of adverse events | from week 1 to 10 | the Safety of intervention will be assessed by recording the rate of adverse events and identification of adverse reactions |
Countries
Germany
Contacts
Primary ContactBenno Brinkhaus, PhD, MD
Backup ContactJoanna Dietzel, MD
Outcome results
None listed