Neurogenic Bladder DysfunctionACULUTSNCT07183683
Stimulation of Acupuncture Points in Female Patients With Multiple Sclerosis and Neurogenic Bladder Dysfunction
A study testing group 1: electrical stimulation of acupuncture points plus routine care and group 2: acupressure plus routine care in people with Neurogenic Bladder Dysfunction, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Neurogenic Bladder Dysfunction
- What is being tested?
- group 1: electrical stimulation of acupuncture points plus routine care and group 2: acupressure plus routine care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2025to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department for integrative medicine and prevention, Institute for social medicine, epidemiology and health economics, Charité university medicine Berlin
Berlin, State of Berlin, 10117
Schönberg Mechthild, study nurse, +49 30 450 529 027, mechthild.schoenberg@charite.de
About this study
Official title: Electrical Versus Manual Stimulation of Acupuncture Points in Female Patients With Multiple Sclerosis and Neurogenic Bladder Dysfunction - A Pragmatic, Exploratory, Three-Arm, Randomized Controlled Trial Using a Mixed Methods Approach
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.
Read the 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.
- Conditions
- Neurogenic Bladder Dysfunction
- Being tested
- group 1: electrical stimulation of acupuncture points plus routine care, group 2: acupressure plus routine care
- Keywords
- multiple sclerosis, urinary bladder dysfunction, electrical stimulation, acupressure, acupuncture, posterior tibial nerve
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group 1: electrical stimulation of acupuncture points plus routine careDevice
Also called posterior tibial nerve stimulation
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 careOther
The acupuncture points Spleen 6 and Kidney 3 will be stimulated twice daily with a up to 30min massage per foot
| Study group | Role | What they receive |
|---|---|---|
| group 1: electrical stimulation of acupuncture points plus routine care | Experimental | 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 Receives: Device: group 1: electrical stimulation of acupuncture points plus routine care |
| group 2: acupressure plus routine care | Experimental | manual stimulation of the same two acupressure points over the inner ankle, stimulation twice daily over 5 weeks Receives: Other: group 2: acupressure plus routine care |
| group 3: routine care alone | No intervention | waiting list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incontinence Questionnaire Overactive Bladder (ICIQ-OAB)
Bladder function scoring 0-16, higher values mean worse outcome
Measured: weeks 5 and 10 after the start of the intervention
Secondary outcomes (4)
Incontinence Quality of Life Measure (I-QoL)
Disease-specific quality of life, scoring 1-110 , the higher the values the better
Measured: 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'
Measured: 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
Measured: 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
Measured: at weeks 5 and 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study startSep 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neurogenic Bladder DysfunctionStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benno Brinkhaus, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07183683
- Sponsor's protocol ID
- ACULUTS-MS KVC
- Other IDs
- KVC 01/143/2024
- Acronym
- ACULUTS
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: under reasonable request
Publications
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.
PubMed 32410904Chang 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.
PubMed 22083987Marzouk 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.
PubMed 36274285Guitynavard 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.
PubMed 35216773
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Versus Manual Stimulation of Acupuncture Points in Female Patients With Multiple Sclerosis and Neurogenic Bladder Dysfunction - A Pragmatic, Exploratory, Three-Arm, Randomized Controlled Trial Using a Mixed Methods Approach
- ClinicalTrials.gov ID
- NCT07183683
- Acronym / sponsor ID
- ACULUTS / ACULUTS-MS KVC
- Conditions
- Neurogenic Bladder Dysfunction
- Keywords
- multiple sclerosis, urinary bladder dysfunction, electrical stimulation, acupressure, acupuncture, posterior tibial nerve
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 1: electrical stimulation of acupuncture points plus routine care | Experimental | Device: group 1: electrical stimulation of acupuncture points plus routine careIntervention 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 2: acupressure plus routine care | Experimental | Other: group 2: acupressure plus routine caremanual stimulation of the same two acupressure points over the inner ankle, stimulation twice daily over 5 weeks |
| group 3: routine care alone | No intervention | –waiting list control |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| group 1: electrical stimulation of acupuncture points plus routine careAlso: posterior tibial nerve stimulationThe 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. | Device | group 1: electrical stimulation of acupuncture points plus routine care |
| group 2: acupressure plus routine careThe acupuncture points Spleen 6 and Kidney 3 will be stimulated twice daily with a up to 30min massage per foot | Other | group 2: acupressure plus routine care |
Primary outcome
Incontinence Questionnaire Overactive Bladder (ICIQ-OAB)
Time frame: weeks 5 and 10 after the start of the intervention
Bladder function scoring 0-16, higher values mean worse outcome
4 secondary outcomes
Incontinence Quality of Life Measure (I-QoL)
Time frame: weeks 5 and 10 after the start of the intervention
Patient's Global Impression of Change (PGIC)
Time frame: weeks 5 and 10 after the start of the intervention
3-day voiding diary
Time frame: weeks 5 and 10 after the start of the intervention
100mm Visual Analogue pain Scale (VAS) for last menstruation
Time frame: at weeks 5 and 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Background: PubMed 32410904Al 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.
- Background: PubMed 22083987Chang 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.
- Background: PubMed 36274285Marzouk 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.
- Background: PubMed 35216773Guitynavard 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.
- Individual participant dataSharing planned: Yes. under reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing group 1: electrical stimulation of acupuncture points plus routine care and group 2: acupressure plus routine care in people with Neurogenic Bladder Dysfunction, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benno Brinkhaus, PhD, MD (+49 30 450 529 002, benno.brinkhaus@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incontinence Questionnaire Overactive Bladder (ICIQ-OAB) (time frame: weeks 5 and 10 after the start of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07183683, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.