Wireless, Implantable Tibial Nerve Stimulator System (eCoin™) for the Treatment of Refractory Lower Urinary Tract Symptoms in Patients With MS

February 2, 2021 updated by: Chiara Zecca

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

  1. wash-out period from PTNS treatment of at least 2 months;
  2. baseline assessments;
  3. implantation of eCoin;
  4. system activation; and
  5. treatment and follow-up visits for a 6-month period post implant activation. Seven Visits are foreseen during the trial.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Ticino
      • Lugano, Ticino, Switzerland, 6903
        • Ospedale Regionale di Lugano, Neurocenter of Southern Switzerland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: eCoin
Neuromodulation of posterior tibial nerve
Device: eCoin

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and Week 24
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.
Baseline and Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline of cystometric capacity (mL)
Time Frame: Baseline and Week 24
The patients will have their cystometric capacity measured during an urodynamic exam.
Baseline and Week 24
Change from baseline of bladder compliance (mL/cmH2O)
Time Frame: Baseline and Week 24
The patients will have their bladder compliance assessed during an urodynamic exam.
Baseline and Week 24
Change from baseline of maximum detrusor pressure (cmH20) during storage phase
Time Frame: Baseline and Week 24
The patients will have their maximum detrusor pressure during storage phase measured during an urodynamic exam.
Baseline and Week 24
Change from baseline of maximum detrusor pressure (cmH20) during voiding phase
Time Frame: Baseline and Week 24
The patients will have their maximum detrusor pressure during voiding phase measured during an urodynamic exam.
Baseline and Week 24
Change from baseline of voided urine volume (mL)
Time Frame: Baseline and Week 24
The patients will have their voided urine volume measured during an urodynamic exam.
Baseline and Week 24
Change from baseline of maximum urine flow rate (mL/s)
Time Frame: Baseline and Week 24
The patients will have the maximum urine flow rate measured during an urodynamic exam.
Baseline and Week 24
Change from baseline of post void residual urine (mL)
Time Frame: Baseline and Week 24
The patients will have the post void residual urine measured during an urodynamic exam.
Baseline and Week 24
Change from baseline of pelvic floor electromyographic activity
Time Frame: Baseline and Week 24
The patients will have presence or absence of pelvic floor activity recorded during an urodynamic exam.
Baseline and Week 24
Change from baseline of vesico-uretero-renal reflux
Time Frame: Baseline and Week 24
The patients will have presence or absence of vesico-uretero-renal reflux assessed during an urodynamic exam.
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
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.
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
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).
Baseline, Week 4, 12, 24
Change from baseline to 4, 12, and 24 weeks of MSQOL54 scores.
Time Frame: Week -8, 4, 12, 24
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).
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
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).
Week 24
Incidence of adverse events
Time Frame: Week 0, 5, 12, 24
Number and proportion of patients experiencing device related adverse events during the study period will be recorded.
Week 0, 5, 12, 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chiara Zecca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Chiara Zecca, PD, MD, Ospedale Regionale di Lugano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EOC.NEUUR.1801

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Sclerosis

Clinical Trials on eCoin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings