Urge IncontinenceNCT02781636
Protect Chronic Tibial Nerve Stimulator (CTNS) System
A study testing Device: StimGuard Protect System in people with Urge Incontinence, run by Uro Medical Corporation at 1 site in Belgium.
Trial summary
30 patient Study. All patients implanted with StimGuard Protect System. Patient followed out to 90 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urge Incontinence
- What is being tested?
- Device: StimGuard Protect System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2016to Sep 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of overactive bladder with urgency urinary incontinence
Who cannot join
- Primary complaint of stress urinary incontinence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A European Trial to Assess the Efficacy of an Implantable Wireless Neuromodulation Device at the Tibial Nerve to Treat Urinary Urgency Incontinence
30 patient Study. All patients implanted with StimGuard Protect System. Patient followed out to 90 days.
Read the detailed description
The proposed therapy is called chronic tibial nerve stimulation (CTNS), which is a low-risk, minimally invasive chronic implant for the treatment of urgency urinary incontinence. CTNS works by the same mechanism as percutaneous tibial nerve stimulation (PTNS), but is provided for chronic use with an implantable device. CTNS treatment involves the placement of a minimally invasive stimulator with an embedded receiver at the tibial nerve. The Protect CTNS System has an external transmitter that activates the implanted stimulator and sends mild electrical pulses to the tibial nerve. These impulses travel to the sacral nerve plexus, the group of nerves at the base of the spine responsible for bladder function. Since stimulation with the Protect CTNS System is chronic it is expected that bladder activity can be changed more quickly and without the frequency of treatments related to PTNS.
- Conditions
- Urge Incontinence
- Being tested
- Device: StimGuard Protect System
- Keywords
- Efficacy, Implantable, Wireless, Neuromodulation, Device, Tibial
- Medical subject headings
- Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: StimGuard Protect SystemDevice
Also called Chronic Afferent Nerve Stimulation
Lead implanted adjacent to tibial nerve. Wireless rechargeable system.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Tibial Implant Arm | Experimental | StimGuard Protect System (Chronic Tibial Nerve Stimulation) Implant Procedure. Lead implanted adjacent to tibial nerve. Wireless rechargeable system. Receives: Device: Device: StimGuard Protect System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Urge Incontinence Episodes
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2016 (estimated)
- Study startApr 2016
- Primary completionSep 2017
- Study completionSep 2017
Why it stopped: Replaced by US RCT
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urge IncontinenceStudies 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
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uro Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02781636
- Sponsor's protocol ID
- 30-00136
- Status last verified
- Sep 2020
- First submitted
- 20 May 2016
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Upon Study Completion
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A European Trial to Assess the Efficacy of an Implantable Wireless Neuromodulation Device at the Tibial Nerve to Treat Urinary Urgency Incontinence
- ClinicalTrials.gov ID
- NCT02781636
- Acronym / sponsor ID
- 30-00136
- Conditions
- Urge Incontinence
- Keywords
- Efficacy, Implantable, Wireless, Neuromodulation, Device, Tibial
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Replaced by US RCT
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Uro Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 24 May 2016 (estimated)
- 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.
30 patient Study. All patients implanted with StimGuard Protect System. Patient followed out to 90 days.
Detailed description
The proposed therapy is called chronic tibial nerve stimulation (CTNS), which is a low-risk, minimally invasive chronic implant for the treatment of urgency urinary incontinence. CTNS works by the same mechanism as percutaneous tibial nerve stimulation (PTNS), but is provided for chronic use with an implantable device. CTNS treatment involves the placement of a minimally invasive stimulator with an embedded receiver at the tibial nerve. The Protect CTNS System has an external transmitter that activates the implanted stimulator and sends mild electrical pulses to the tibial nerve. These impulses travel to the sacral nerve plexus, the group of nerves at the base of the spine responsible for bladder function. Since stimulation with the Protect CTNS System is chronic it is expected that bladder activity can be changed more quickly and without the frequency of treatments related to PTNS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Tibial Implant Arm | Experimental | Device: Device: StimGuard Protect SystemStimGuard Protect System (Chronic Tibial Nerve Stimulation) Implant Procedure. Lead implanted adjacent to tibial nerve. Wireless rechargeable system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of overactive bladder with urgency urinary incontinence
Key exclusion criteria (1 listed)
- Primary complaint of stress urinary incontinence
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 |
|---|---|---|
| Device: StimGuard Protect SystemAlso: Chronic Afferent Nerve StimulationLead implanted adjacent to tibial nerve. Wireless rechargeable system. | Device | Chronic Tibial Implant Arm |
Primary outcome
Reduction in Urge Incontinence Episodes
Time frame: 90 days
Results and safety
The study was stopped early (reason given: Replaced by US RCT). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Individual participant dataSharing planned: Yes. Upon Study Completion
Related trials for Urge Incontinence
RecruitingPhase 2
Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer
Urinary Urge Incontinence, Stress Urinary Incontinence
Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
Active, not recruiting
INTIBIA Pivotal Study
Urinary Incontinence, Urge, Urinary Bladder, Overactive
Recruiting
Post Approval Effectiveness and Durability Evaluation of the Altaviva™ Tibial Device
Urge Urinary Incontinence
Recruiting
A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)
Overactive Bladder, Urge Incontinence
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 testing Device: StimGuard Protect System in people with Urge Incontinence, run by Uro Medical Corporation at 1 site in Belgium.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 9 Sep 2020. 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 Belgium. 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 was stopped early (reason given: Replaced by US RCT). Results are not available in the source record.
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?
Reduction in Urge Incontinence Episodes (time frame: 90 days). 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 9 Sep 2020.