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

NCT03753698 | Withdrawn

• 1 other identifier: EOC.NEUUR.1801
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Lower Urinary Tract Symptoms; Posterior tibial nerve stimulation; Neuromodulation

Outcome Measures

Primary Outcomes (2)

• Change from baseline in bladder volume (mL)

  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)

  The patients will have their detrusor pressure measured during an urodynamic exam.

  Baseline and Week 24

Secondary Outcomes (14)

• Change from baseline of cystometric capacity (mL)

  Baseline and Week 24

• Change from baseline of bladder compliance (mL/cmH2O)

  Baseline and Week 24

• Change from baseline of maximum detrusor pressure (cmH20) during storage phase

  Baseline and Week 24

• Change from baseline of maximum detrusor pressure (cmH20) during voiding phase

  Baseline and Week 24

• Change from baseline of voided urine volume (mL)

  Baseline and Week 24

Study Arms (1)

eCoin

EXPERIMENTAL

Neuromodulation of posterior tibial nerve

Device: eCoin

Interventions

eCoin DEVICE

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.

eCoin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiara Zecca: lead

Study Sites (1)

Ospedale Regionale di Lugano, Neurocenter of Southern Switzerland

Lugano, Canton Ticino, 6903, Switzerland

Location

MeSH Terms

Conditions

Multiple Sclerosis; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Signs and Symptoms

Study Officials

• Chiara Zecca, PD, MD

  Ospedale Regionale di Lugano

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 27, 2018
• Study Start: July 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)