Wireless, Implantable Tibial Nerve Stimulator System (eCoin™) for the

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

WithdrawnNot a drug-phase studyMS (type not specified)NCT03753698

What it found

Stopped

The trial ended early for another reason (see below).

Reason given: Substantial amendment to be implemented using another device

What was tested

Treatment tested

  • eCoin

What it measured

Main measures

  • Change from baseline in bladder volume (mL)

    Baseline and Week 24

    Bladder, bowel and sexual function

  • Change from baseline of detrusor pressure amplitude (cmH2O)

    Baseline and Week 24

Other measures (14)

  • Change from baseline of cystometric capacity (mL)

    Baseline and Week 24

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

    Baseline and Week 24

    Bladder, bowel and sexual function

  • 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

    Bladder, bowel and sexual function

  • Change from baseline of voided urine volume (mL)

    Baseline and Week 24

    Bladder, bowel and sexual function

  • Change from baseline of maximum urine flow rate (mL/s)

    Baseline and Week 24

  • Change from baseline of post void residual urine (mL)

    Baseline and Week 24

    Bladder, bowel and sexual function

  • Change from baseline of pelvic floor electromyographic activity

    Baseline and Week 24

  • Change from baseline of vesico-uretero-renal reflux

    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

    Baseline and Week 4, 12, 24

    Bladder, bowel and sexual function

Who could take part

MS (type not specified) · 18 to 80

Show the full criteria

Inclusion 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

Exclusion criteria

Not separately supplied in the registry.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      Jul 2020

    2. Main results due

      Dec 2022

    3. Finished

      Dec 2022

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