Multiple Sclerosis, Relapsing-RemittingStimrouterNCT04567264
Wireless, Implantable Tibial Nerve Stimulator System for the Treatment of Refractory Lower Urinary Tract Symptoms in Patients With Multiple Sclerosis
A study of Multiple Sclerosis, Relapsing-Remitting, run by Chiara Zecca at 1 site in Switzerland.
Trial summary
Prevalence of lower urinary tract symptoms (LUTS) in patients with multiple sclerosis (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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSwitzerland
- Study dates
- 26 Aug 2020to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18 - 80;
- Diagnosis of multiple sclerosis according to McDonald [20];
- Clinical stability over the past 6 months (no relapses and no disability progression, defined as worsening of ≥1 point in the EDSS score if reference EDSS is ≤5.5, and ≥0.5 points if reference EDSS is>5.5);
- 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, behavioral modification, and pharmacological therapy and stable OAB medications for at least 30 days;
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- No pharmacological treatment of overactive bladder (antimuscarinics and beta-3 agonists) for 2 weeks prior to screening;
- 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 (treatment compliant and non-compliant patients) or PTNS treatment naïve able to sense tibial nerve stimulation (to be tested with TENS exam).
- Competent sphincter mechanism and normally functioning upper urinary tract;
- Leg circumference in the range of 20-30 cm at implantation site;
- No contraindications for surgical intervention (e.g. being immunocompetent, no anticoagulant treatment, no current infection);
- For female patients: using effective contraceptive methods;
- Ability to comply with study requirements;
- Having provided written informed consent.
Who cannot join
- Previous participation in another study with any investigational drug or device within the past 90 days;
- Any metal implant in the area of StimRouter lead 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;
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- Critical limb ischemia;
- Previous or current pelvic radiotherapy and/or chemotherapy;
- Severe uncontrolled diabetes;
- Being prone to excessive bleeding;
- Having a pacemaker or implantable defibrillator or other neural stimulation systems;
- Exposure to diathermy or electrocautery;
- Clinically significant peripheral neuropathy;
- Neutropenic or immune compromised;
- Pelvic radio- and/or chemotherapy;
- Morbid obesity (BMI >40);
- Pregnant or lactating women, or women planning a pregnancy during the study, <9 months post-partum;
- Male: alpha-blocker for benign prostatic hyperplasia;
- Allergy to local anesthetic or adhesive;
- Life expectancy <1 year.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Ospedale Regionale di Lugano, Neurocenter of Southern Switzerland
Lugano, Canton Ticino, 6903
About this study
Official title: Prospective Single Centre Trial of Percutaneous Tibial Nerve Stimulation With the Implantable StimRouter Neuromodulation System for the Treatment of Refractory Lower Urinary Tract Symptoms in Patients With Multiple Sclerosis
Prevalence of lower urinary tract symptoms (LUTS) in patients with multiple sclerosis (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.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- StimRouter®, Self-activated and self-controlled neuromodulation device (Bioness Inc, CE0086).
- Keywords
- overactive bladder, posterior tibial nerve stimulation, lower urinary tract symptoms
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Urinary Bladder, Overactive, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StimRouter®, Self-activated and self-controlled neuromodulation device (Bioness Inc, CE0086).Device
Regimen 1 (weeks 0-12): one stimulation every 2 days, for a duration of 30 minutes each.
Regimen 2 (weeks 12-24): Three stimulation treatments per week, for a duration of 30 minutes each.
| Study group | Role | What they receive |
|---|---|---|
| With stimulation | Experimental | Implantation of device electrodes subcutaneous in lower tibia area; stimulation of posterior tibial nerves. Receives: Device: StimRouter®, Self-activated and self-controlled neuromodulation device (Bioness Inc, CE0086). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bladder volume
filling volume at the time of the first uninhibited detrusor contraction during cystometry
Measured: 6 months
Secondary outcomes (16)
Cystometric capacity (mL)
Video-urodynamic parameter
Measured: 6 months
Compliance (ml/cmH20)
Video-urodynamic parameter
Measured: 6 months
Maximum detrusor pressure (cmH20) during storage phase
Video-urodynamic parameter
Measured: 6 months
Maximum detrusor pressure (cmH20) during voiding phase
Video-urodynamic parameter
Measured: 6 months
Voided volume (mL)
Video-urodynamic parameter
Measured: 6 months
Maximum flow rate (mL/s)
Video-urodynamic parameter
Measured: 6 months
Post void residual
Video-urodynamic parameter
Measured: 6 months
Pelvic floor electromyographic activity (normal/detrusor sphincter dyssynergia/non-relaxing pelvic floor)
Video-urodynamic parameter
Measured: 6 months
Number of voids/day
3-day voiding diary
Measured: 3, 4.5, 6 months
Volume voided/void
3-day voiding diary
Measured: 3, 4.5, 6 months
Number of leaks per day
3-day voiding diary
Measured: 3, 4.5, 6 months
Degree of urgency prior to void
3-day voiding diary
Measured: 3, 4.5, 6 months
Number of CISC through the day
3-day voiding diary
Measured: 3, 4.5, 6 months
Residual urine volume
3-day voiding diary
Measured: 3, 4.5, 6 months
Multiple Sclerosis Quality of Life-54 (MSQOL-54)
54 items, two summary scores: physical health and mental health, range 0-100, a higher score indicates a better quality of life
Measured: 3, 4.5, 6 months
Over active bladder questionnaire (OAB)
Symptom severity of OAB range 6-36, higher score values indicate greater symptom severity or bother, lower scores indicate minimal symptom severity.
Health related quality of life (HRQL) subscales (coping, sleep, and social), range 13-78, Higher scores indicate better HRQL.
Measured: 3, 4.5, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start26 Aug 2020
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, interventional, single center
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiara Zecca
- Sponsor type
- University, hospital or other
- Collaborators
- ABREOC
- Responsible party
- Sponsor-investigator, Chiara Zecca, Ente Ospedaliero Cantonale, Bellinzona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04567264
- Sponsor's protocol ID
- EOC.NEUUR.2002
- Acronym
- Stimrouter
- Status last verified
- Sep 2023
- First submitted
- 23 Sep 2020
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Single Centre Trial of Percutaneous Tibial Nerve Stimulation With the Implantable StimRouter Neuromodulation System for the Treatment of Refractory Lower Urinary Tract Symptoms in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04567264
- Acronym / sponsor ID
- Stimrouter / EOC.NEUUR.2002
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- overactive bladder, posterior tibial nerve stimulation, lower urinary tract symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Chiara ZeccaUniversity, hospital or other
- Collaborators
- ABREOC
- Study start
- 26 Aug 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prevalence of lower urinary tract symptoms (LUTS) in patients with multiple sclerosis (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, interventional, single center
| Arm | Type | Receives |
|---|---|---|
| With stimulation | Experimental | Device: StimRouter®, Self-activated and self-controlled neuromodulation device (Bioness Inc, CE0086).Implantation of device electrodes subcutaneous in lower tibia area; stimulation of posterior tibial nerves. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female aged 18 - 80;
- Diagnosis of multiple sclerosis according to McDonald [20];
- Clinical stability over the past 6 months (no relapses and no disability progression, defined as worsening of ≥1 point in the EDSS score if reference EDSS is ≤5.5, and ≥0.5 points if reference EDSS is>5.5);
- 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);
Key exclusion criteria (20 listed)
- Previous participation in another study with any investigational drug or device within the past 90 days;
- Any metal implant in the area of StimRouter lead 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StimRouter®, Self-activated and self-controlled neuromodulation device (Bioness Inc, CE0086).Regimen 1 (weeks 0-12): one stimulation every 2 days, for a duration of 30 minutes each. Regimen 2 (weeks 12-24): Three stimulation treatments per week, for a duration of 30 minutes each. | Device | With stimulation |
Primary outcome
Change in bladder volume
Time frame: 6 months
filling volume at the time of the first uninhibited detrusor contraction during cystometry
16 secondary outcomes
Cystometric capacity (mL)
Time frame: 6 months
Compliance (ml/cmH20)
Time frame: 6 months
Maximum detrusor pressure (cmH20) during storage phase
Time frame: 6 months
Maximum detrusor pressure (cmH20) during voiding phase
Time frame: 6 months
Voided volume (mL)
Time frame: 6 months
Maximum flow rate (mL/s)
Time frame: 6 months
Post void residual
Time frame: 6 months
Pelvic floor electromyographic activity (normal/detrusor sphincter dyssynergia/non-relaxing pelvic floor)
Time frame: 6 months
Number of voids/day
Time frame: 3, 4.5, 6 months
Volume voided/void
Time frame: 3, 4.5, 6 months
Number of leaks per day
Time frame: 3, 4.5, 6 months
Degree of urgency prior to void
Time frame: 3, 4.5, 6 months
Number of CISC through the day
Time frame: 3, 4.5, 6 months
Residual urine volume
Time frame: 3, 4.5, 6 months
Multiple Sclerosis Quality of Life-54 (MSQOL-54)
Time frame: 3, 4.5, 6 months
Over active bladder questionnaire (OAB)
Time frame: 3, 4.5, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Multiple Sclerosis, Relapsing-Remitting, run by Chiara Zecca at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bladder volume (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.