Multiple SclerosisNCT03753698
Wireless, Implantable Tibial Nerve Stimulator System (eCoin™) for the Treatment of Refractory Lower Urinary Tract Symptoms in Patients With MS
A study testing eCoin in people with Multiple Sclerosis, run by Chiara Zecca at 1 site in Switzerland.
Trial summary
Prevalence of lower urinary tract symptoms (LUTS) in patients with MS increases with disease duration. Current management of urinary clinical symptoms in MS is mainly conservative. Its long-term outcome is often poor because of the progressive disease course and the treatment related side effects. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- eCoin
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Diagnosis of MS according to MacDonald (2011);
- Clinical stability over the past 6 months (no relapses or EDSS progression over the last 6 months);
- One or more of: urinary frequency greater than 8 times/24 hours, urinary urge incontinence at least 2 episodes in 24 hours on 3-day voiding diary
- Urodynamic diagnosis of detrusor over-activity (DOA) and / or detrusor-sphincter dyssynergia (DSD);
- Previous failure of conservative treatments (challenge over ≥6 months) i.e. lifestyle modification-fluid consumption, behavioural modification, and pharmacological therapy and stable OAB medications for at least 30 days or intolerance to pharmacological therapy (side effect);
- Positive response to ongoing PTNS treatment defined as ≥50% reduction in urinary frequency, and/or ≥50% fewer incontinence episodes, or a return to normal voiding frequency [<8 voids/day], based on retrospective diary review;
- Competent sphincter mechanism and normally functioning upper urinary tract;
- Leg circumference in the range of 20-30 cm at implantation site;
- Ability to comply with study requirements;
- Having provided written informed consent
Main Exclusion Criteria:
- Participation in another study with any investigational drug or device within the past 90 days;
- Any metal implant in the area of eCoin implantation site;
- Anatomical defects that preclude use of the device;
- Treatment with botulinum toxin injections, urinary incontinence surgery or implantation of artificial graft material, spinal or genitourinary surgery, abdominoperineal resection of the rectum or radical hysterectomy (female)/ prostatectomy (male) within the last 6 months;
- Previous treatment with sacral neuromodulation;
- Diagnosis of pelvic pain disorders, stress incontinence, current urinary tract infection, urinary stone and/or urinary tract malignancy; cystocele, enterocele or rectocele of grade 3 or 4;
- Previous or current pelvic radiotherapy and/or chemotherapy;
- Severe uncontrolled diabetes;
- Pregnant or lactating women or women planning a pregnancy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Ospedale Regionale di Lugano, Neurocenter of Southern Switzerland
Lugano, Canton Ticino, 6903
About this study
Official title: A Prospective, Single Arm, Interventional, Self-controlled Pilot Study to Assess the Performance and Safety of the New Generation, Wireless, Implantable Tibial Nerve Stimulator System (eCoin™) for the Treatment of Refractory Lower Urinary Tract Symptoms in Patients With Multiple Sclerosis
Prevalence of lower urinary tract symptoms (LUTS) in patients with MS increases with disease duration. Current management of urinary clinical symptoms in MS is mainly conservative. Its long-term outcome is often poor because of the progressive disease course and the treatment related side effects. Alternative therapeutic options are botulinum toxin injections, electrical stimulation of dorsal penile/clitoral nerve, and sacral nerve modulation. Posterior tibial nerve stimulation (PTNS) is a second minimally-invasive method of electrical stimulation. Multiple benefits may derive from the development and validation of a dedicated protocol of a new self-activated neuromodulation therapy, which may improve therapy compliance/effectiveness, quality of life and social life in MS patients with refractory LUTS. Furthermore, it may contribute to reduce outpatient visits, health costs and work absenteeism.
To investigate the performance and safety of the medical device eCoin™ for the treatment of refractory LUTS in patients with MS over a period of 6 months.
Read the detailed description
This is a prospective, interventional, single arm, self-controlled pilot study in patients with multiple sclerosis and OAB symptoms with a 6-month treatment period of posterior tibial nerve stimulation with the medical device eCoin.
It is a pilot study to explore the effectiveness and safety of using this device to treat MS patients with OAB in daily clinical practice in. Based on feasibility considerations, we plan to include approximately 20 patients.
It consists of:
- wash-out period from PTNS treatment of at least 2 months;
- baseline assessments;
- implantation of eCoin;
- system activation; and
- treatment and follow-up visits for a 6-month period post implant activation. Seven Visits are foreseen during the trial.
- Conditions
- Multiple Sclerosis
- Being tested
- eCoin
- Keywords
- Multiple Sclerosis, Lower Urinary Tract Symptoms, Posterior tibial nerve stimulation, Neuromodulation
- Medical subject headings
- Multiple Sclerosis, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eCoinDevice
Implantation of device electrodes subcutaneous in lower tibia area;
Stimulation of posterior tibial nerves:
Regimen 1 (months 0-3): Six stimulation treatments per week, one stimulation per day, for duration of 30 minutes each Regimen 2 (months 3-6): Three stimulation treatments per week, one stimulation per day, for duration of 30 minutes each. Stimulation is activated by the patient.
| Study group | Role | What they receive |
|---|---|---|
| eCoin | Experimental | Neuromodulation of posterior tibial nerve Receives: Device: eCoin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in bladder volume (mL)
The patients will have their bladder filling volume measured during a urodynamic exam.
Measured: Baseline and Week 24
Change from baseline of detrusor pressure amplitude (cmH2O)
The patients will have their detrusor pressure measured during an urodynamic exam.
Measured: Baseline and Week 24
Secondary outcomes (14)
Change from baseline of cystometric capacity (mL)
The patients will have their cystometric capacity measured during an urodynamic exam.
Measured: Baseline and Week 24
Change from baseline of bladder compliance (mL/cmH2O)
The patients will have their bladder compliance assessed during an urodynamic exam.
Measured: Baseline and Week 24
Change from baseline of maximum detrusor pressure (cmH20) during storage phase
The patients will have their maximum detrusor pressure during storage phase measured during an urodynamic exam.
Measured: Baseline and Week 24
Change from baseline of maximum detrusor pressure (cmH20) during voiding phase
The patients will have their maximum detrusor pressure during voiding phase measured during an urodynamic exam.
Measured: Baseline and Week 24
Change from baseline of voided urine volume (mL)
The patients will have their voided urine volume measured during an urodynamic exam.
Measured: Baseline and Week 24
Change from baseline of maximum urine flow rate (mL/s)
The patients will have the maximum urine flow rate measured during an urodynamic exam.
Measured: Baseline and Week 24
Change from baseline of post void residual urine (mL)
The patients will have the post void residual urine measured during an urodynamic exam.
Measured: Baseline and Week 24
Change from baseline of pelvic floor electromyographic activity
The patients will have presence or absence of pelvic floor activity recorded during an urodynamic exam.
Measured: Baseline and Week 24
Change from baseline of vesico-uretero-renal reflux
The patients will have presence or absence of vesico-uretero-renal reflux assessed during an urodynamic exam.
Measured: Baseline and Week 24
Change from baseline to 4, 12, and 24 weeks of bladder voiding assessed by means of a 3-day voiding diary
The patients will self-record their bladder voiding during three consecutive days at each time point including the number of voids/day, volume voided/void, number of leaks per day, degree of urgency prior to void (none, mild, moderate, severe, incontinence), number of self-catheterization needed through the day.
Measured: Baseline and Week 4, 12, 24
Change from baseline to 4, 12, and 24 weeks of overactive bladder symptoms scores using the short form of the overactive bladder questionnaire OAB-q
The patients will rate their overactive bladder symptoms using the OAB-qSF questionnaire. It is self-administered and asks about how much a patients is bothered by selected bladder symptoms. It contains 6 questions about symptom severity and 13 on coping, sleeping, social life each to be rated on a 6-point scale (none of the time, a little of the time, some of the time, a good bit of the time, most of the time, all of the time). Symptom severity ranges from 6 (not bothered) to 36 (extremely bothered), impact on health related quality of life ranges from 13 (not bothered) to 78 (extremely bothered).
Measured: Baseline, Week 4, 12, 24
Change from baseline to 4, 12, and 24 weeks of MSQOL54 scores.
The patients will assess their health related quality of life using the short form of the MSQOL 54 questionnaire. This is a self-administered multidimensional questionnaire on health-related quality of life with generic and multiple sclerosis specific questions on physical and mental health. The summary scores are derived from 12 subscales (physical function, physical role limitations, emotional role limitations, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, sexual function). A low score indicates bad quality of life, a higher score improved quality of life (range 0-100).
Measured: Week -8, 4, 12, 24
Treatment satisfaction, as measured on a composite visual analogue scale (VAS) score ranging from 0-100
The patients will mark a point on a 100 mm long line with a pencil to indicate their treatment satisfaction. 0 (not satisfied at all), 100 (very satisfied).
Measured: Week 24
Incidence of adverse events
Number and proportion of patients experiencing device related adverse events during the study period will be recorded.
Measured: Week 0, 5, 12, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start1 Jul 2020 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Why it stopped: Substantial amendment to be implemented using another device
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiara Zecca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chiara Zecca, Ente Ospedaliero Cantonale, Bellinzona
- Investigators
- Chiara Zecca, PD, MD, Study director, Ospedale Regionale di Lugano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753698
- Sponsor's protocol ID
- EOC.NEUUR.1801
- Status last verified
- Feb 2021
- First submitted
- 15 Nov 2018
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Arm, Interventional, Self-controlled Pilot Study to Assess the Performance and Safety of the New Generation, Wireless, Implantable Tibial Nerve Stimulator System (eCoin™) for the Treatment of Refractory Lower Urinary Tract Symptoms in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03753698
- Acronym / sponsor ID
- EOC.NEUUR.1801
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Lower Urinary Tract Symptoms, Posterior tibial nerve stimulation, Neuromodulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Substantial amendment to be implemented using another device
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Chiara ZeccaUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 27 Nov 2018 (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.
Prevalence of lower urinary tract symptoms (LUTS) in patients with MS increases with disease duration. Current management of urinary clinical symptoms in MS is mainly conservative. Its long-term outcome is often poor because of the progressive disease course and the treatment related side effects. Alternative therapeutic options are botulinum toxin injections, electrical stimulation of dorsal penile/clitoral nerve, and sacral nerve modulation. Posterior tibial nerve stimulation (PTNS) is a second minimally-invasive method of electrical stimulation. Multiple benefits may derive from the development and validation of a dedicated protocol of a new self-activated neuromodulation therapy, which may improve therapy compliance/effectiveness, quality of life and social life in MS patients with refractory LUTS. Furthermore, it may contribute to reduce outpatient visits, health costs and work absenteeism.
To investigate the performance and safety of the medical device eCoin™ for the treatment of refractory LUTS in patients with MS over a period of 6 months.
Detailed description
This is a prospective, interventional, single arm, self-controlled pilot study in patients with multiple sclerosis and OAB symptoms with a 6-month treatment period of posterior tibial nerve stimulation with the medical device eCoin.
It is a pilot study to explore the effectiveness and safety of using this device to treat MS patients with OAB in daily clinical practice in. Based on feasibility considerations, we plan to include approximately 20 patients.
It consists of:
- wash-out period from PTNS treatment of at least 2 months;
- baseline assessments;
- implantation of eCoin;
- system activation; and
- treatment and follow-up visits for a 6-month period post implant activation. Seven Visits are foreseen during the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eCoin | Experimental | Device: eCoinNeuromodulation of posterior tibial nerve |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| eCoinImplantation of device electrodes subcutaneous in lower tibia area; Stimulation of posterior tibial nerves: Regimen 1 (months 0-3): Six stimulation treatments per week, one stimulation per day, for duration of 30 minutes each Regimen 2 (months 3-6): Three stimulation treatments per week, one stimulation per day, for duration of 30 minutes each. Stimulation is activated by the patient. | Device | eCoin |
Primary outcome
Change from baseline in bladder volume (mL)
Time frame: Baseline and Week 24
The patients will have their bladder filling volume measured during a urodynamic exam.
Change from baseline of detrusor pressure amplitude (cmH2O)
Time frame: Baseline and Week 24
The patients will have their detrusor pressure measured during an urodynamic exam.
14 secondary outcomes
Change from baseline of cystometric capacity (mL)
Time frame: Baseline and Week 24
Change from baseline of bladder compliance (mL/cmH2O)
Time frame: Baseline and Week 24
Change from baseline of maximum detrusor pressure (cmH20) during storage phase
Time frame: Baseline and Week 24
Change from baseline of maximum detrusor pressure (cmH20) during voiding phase
Time frame: Baseline and Week 24
Change from baseline of voided urine volume (mL)
Time frame: Baseline and Week 24
Change from baseline of maximum urine flow rate (mL/s)
Time frame: Baseline and Week 24
Change from baseline of post void residual urine (mL)
Time frame: Baseline and Week 24
Change from baseline of pelvic floor electromyographic activity
Time frame: Baseline and Week 24
Change from baseline of vesico-uretero-renal reflux
Time frame: Baseline and Week 24
Change from baseline to 4, 12, and 24 weeks of bladder voiding assessed by means of a 3-day voiding diary
Time frame: Baseline and Week 4, 12, 24
Change from baseline to 4, 12, and 24 weeks of overactive bladder symptoms scores using the short form of the overactive bladder questionnaire OAB-q
Time frame: Baseline, Week 4, 12, 24
Change from baseline to 4, 12, and 24 weeks of MSQOL54 scores.
Time frame: Week -8, 4, 12, 24
Treatment satisfaction, as measured on a composite visual analogue scale (VAS) score ranging from 0-100
Time frame: Week 24
Incidence of adverse events
Time frame: Week 0, 5, 12, 24
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Chiara Zecca, PD, MD study director
Ospedale Regionale di Lugano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eCoin in people with Multiple Sclerosis, run by Chiara Zecca at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 4 Feb 2021. 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 Switzerland. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in bladder volume (mL) (time frame: Baseline and Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2021; AzTrials last refreshed its copy on 6 Nov 2026.