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New treatment option for Neurogenic Bladder Dysfunction
Official title Stimulation of Acupuncture Points in Female Patients With Multiple Sclerosis and Neurogenic Bladder Dysfunction
ClinicalTrials.gov ID: NCT07183683
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60, women only
You may be able to join 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...
- Participants must be willing and cognitively and linguistically capable of adhering to the study protocol, performing the study interventions, and...
- Capacity to provide informed consent, and provision of written consent for both written and electronic data collection and participation in the study
You likely can't join 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
See the full eligibility 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...
- 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
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Berlin, State of Berlin, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Berlin, State of Berlin, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.