Status:
WITHDRAWN
Wireless, Implantable Tibial Nerve Stimulator System (eCoin™) for the Treatment of Refractory Lower Urinary Tract Symptoms in Patients With MS
Lead Sponsor:
Chiara Zecca
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-80 years
Phase:
NA
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 outco...
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 stimulatio...
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03753698
Start Date
July 1 2020
End Date
December 31 2022
Last Update
February 4 2021
Active Locations (1)
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1
Ospedale Regionale di Lugano, Neurocenter of Southern Switzerland
Lugano, Canton Ticino, Switzerland, 6903