Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03753698
Recruitment Status : Not yet recruiting
First Posted : November 27, 2018
Last Update Posted : July 18, 2019
Sponsor:
Collaborator:
Swiss Multiple Sclerosis Society
Information provided by (Responsible Party):
Zecca Chiara, Ente Ospedaliero Cantonale, Bellinzona

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Device: eCoin Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : December 20, 2019
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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).

  12. 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).

  13. 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).

  14. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03753698


Contacts
Layout table for location contacts
Contact: Chiara Zecca, PD, MD +41 91 811 6921 chiara.zecca@eoc.ch
Contact: Claudio Gobbi, PD, MD +41 91 811 6921 claudio.gobbi@eoc.ch

Locations
Layout table for location information
Switzerland
Ospedale Regionale di Lugano, Neurocenter of Southern Switzerland Not yet recruiting
Lugano, Ticino, Switzerland, 6903
Contact: Chiara Zecca, MD    +41 91 811 6921    chiara.zecca@eoc.ch   
Contact: Claudio Gobbi, MD    +41 91 811 6921    claudio.gobbi@eoc.ch   
Principal Investigator: Chiara Zecca, MD         
Sub-Investigator: Julien Renard, MD         
Sub-Investigator: Claudio Gobbi, MD         
Sub-Investigator: Paolo Maino, MD         
Sub-Investigator: Rosaria Sacco, MD         
Sub-Investigator: Alex Digesu, MD         
Sponsors and Collaborators
Zecca Chiara
Swiss Multiple Sclerosis Society
Investigators
Layout table for investigator information
Study Director: Chiara Zecca, PD, MD Ospedale Regionale di Lugano

Layout table for additonal information
Responsible Party: Zecca Chiara, Principal Investigator, Ente Ospedaliero Cantonale, Bellinzona
ClinicalTrials.gov Identifier: NCT03753698     History of Changes
Other Study ID Numbers: EOC.NEUUR.1801
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zecca Chiara, Ente Ospedaliero Cantonale, Bellinzona:
Multiple Sclerosis
Lower Urinary Tract Symptoms
Posterior tibial nerve stimulation
Neuromodulation

Additional relevant MeSH terms:
Layout table for MeSH terms
Lower Urinary Tract Symptoms
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Urological Manifestations
Signs and Symptoms