Urgency Urinary IncontinenceNCT03029624
eCoin Tibial Nerve Stimulation for OAB
A study testing eCoin in people with Urgency Urinary Incontinence, run by Valencia Technologies Corporation at 7 sites in 2 countries.
Trial summary
The study is a single arm, prospective study of the safety and effectiveness of the Valencia Technologies eCoin System to stimulate the tibial nerve for the treatment of patients with refractory urgency urinary incontinence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urgency Urinary Incontinence
- What is being tested?
- eCoin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 3 Apr 2017to 1 Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women and men 18 years and older.
- Diagnosis of overactive bladder with urgency urinary incontinence or mixed urge and stress incontinence with a predominant urgency component, for at least 6 months (self-reported).
- Individual has at least four urgency incontinence episodes on a three-day voiding diary with at least one episode per 24 hour time period
- Individual with urinary frequency, defined as an average of greater than or equal to 8 times/24 hours (ie. a total of greater than or equal to 24 micturitions on a 3 day diary)
- Individual is unresponsive to, inadequately responsive to, or intolerant of behavioral, rehabilitation, and pharmacologic therapy.
- Individual is able to give his or her written, informed consent.
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- Individual is mentally competent and able to understand all study requirements.
- Individual is willing and able to complete a 3-day voiding diary and quality of life questionnaire.
- Individual is without pharmacological treatment of overactive bladder (antimuscarinics and beta-3 agonists) for 2 weeks prior to screening.
- The individual demonstrates a positive nerve integrity test.
Who cannot join
- Individual has predominantly stress urinary incontinence
- Individual has clinically significant bladder outlet obstruction.
- Individual has clinically significant pelvic organ prolapse.
- Individual has abnormal post void residual (i.e., greater than 150 cc).
- Individual has clinically significant urethral stricture disease or bladder neck contracture
- Individual has an active urinary tract infection at time of enrollment.
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- Individual has recurrent urinary tract infections defined as 4 or more UTI's per year.
- Individual has morbid obesity.
- Individual has had positive urine cytology or diagnosis of bladder or prostate cancer.
- Individual has neurogenic bladder dysfunction.
- Individual is taking an alpha-blocker for benign prostatic hyperplasia.
- Individual is pregnant or intends to become pregnant during the study.
- Patient is breast feeding or is less than 9-month post-partum.
- Individual has the presence of urinary fistula, bladder stone, or interstitial cystitis.
- Individual has uncontrolled diabetes mellitus.
- Individual has a cardiac pacemaker or implanted defibrillator.
- Individual has been previously treated with sacral nerve stimulation.
- Individual has been treated with onabotulinumtoxinA in the previous 9 months prior to enrollment.
- Individual has been treated with percutaneous tibial nerve stimulation within the previous 12 weeks prior to enrollment.
- Individual requires regular Magnetic Resonance Imaging for other health care conditions. (ASK)
- Individual has a clotting or bleeding disorder; antiplatelet and anticoagulant therapy may be continued or held at the discretion of the investigator
- Individual has a clinically significant peripheral neuropathy.
- Individual is neutropenic or immunocompromised.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States4 sites
The Institute for Female Pelvic Medicine & Reconstructive Surgery (FPM Institute)
Allentown, Pennsylvania, 18103
Alliance Urology Specialists
Greensboro, North Carolina, 27403
The Clark Center for Urogynecology
Newport Beach, California, 92663
UnityPoint Clinic
Waterloo, Iowa, 50703
New Zealand3 sites
Urology Associates
Christchurch, 8013
Roundhay Medical Centre
Nelson
Tauranga Urology Research Ltd
Tauranga
About this study
Official title: Subcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence
The study is a single arm, prospective study of the safety and effectiveness of the Valencia Technologies eCoin System to stimulate the tibial nerve for the treatment of patients with refractory urgency urinary incontinence.
Read the detailed description
This trial is a single arm, prospective study of the safety and effectiveness of eCoin tibial nerve stimulation in 25 subjects with refractory overactive bladder as defined by the American Urological Association.. The eCoin neuromodulation device will be implanted subcutaneously in the right or left leg of patients with urgency urinary incontinence. After a 4 week implant healing period, subjects will have their devices activated (turned ON). After 3 months of device therapy (occurring 4 months post-implant), the primary endpoint will be assessed. It is anticipated that subjects will reach the full therapeutic effect at approximately 3 months of therapy. Subjects will be followed for an additional 9 months to assess the safety of maintenance stimulation therapy with fewer sessions occurring during this time interval.
- Conditions
- Urgency Urinary Incontinence
- Being tested
- eCoin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eCoinDevice
Patients are implanted with active implantable device called eCoin. eCoin is turned ON in order to deliver neuromodulation therapy.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Treatment Arm receives implanted eCoin device and therapy is turned ON. Receives: Device: eCoin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incontinent Episodes
The change in number of incontinence episodes from baseline to three months post-activation.
Measured: Baseline to three months post-activation.
Secondary outcomes (3)
System and Procedure Related AEs
Number of System and Procedure Related Adverse Events from implantation to one month post-implantation.
Measured: Implantation to one month post-implantation.
MAEs
Number of all Major Adverse Events from baseline to 3 months post-activation.
Measured: Baseline to 3 months post-activation.
Percentage of Responders
Percentage of Responders, defined as participants who experienced a 50% or greater reduction in UUI after 3 months of treatment
Measured: 3 months after activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study start3 Apr 2017
- Primary completion30 Dec 2017
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urgency Urinary 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valencia Technologies Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sharon English, MD, Principal investigator, Urology AssociatesScott MacDiarmid, MD, Principal investigator, Alliance Urology Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03029624
- Sponsor's protocol ID
- 111-3175
- Status last verified
- Nov 2020
- First submitted
- 20 Jan 2017
- Last updated
- 22 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kaaki B, English S, Gilling P, Meffan P, Lucente V, MacDiarmid S, Clark M, Sen SK. Six-Month Outcomes of Reimplantation of a Coin-Sized Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome With Urgency Urinary Incontinence. Female Pelvic Med Reconstr Surg. 2022 May 1;28(5):287-292. doi: 10.1097/SPV.0000000000001105. Epub 2022 Sep 22.
PubMed 35536667
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence
- ClinicalTrials.gov ID
- NCT03029624
- Acronym / sponsor ID
- 111-3175
- Conditions
- Urgency Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Valencia Technologies CorporationIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 24 Jan 2017 (estimated)
- Results
- Posted 27 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a single arm, prospective study of the safety and effectiveness of the Valencia Technologies eCoin System to stimulate the tibial nerve for the treatment of patients with refractory urgency urinary incontinence.
Detailed description
This trial is a single arm, prospective study of the safety and effectiveness of eCoin tibial nerve stimulation in 25 subjects with refractory overactive bladder as defined by the American Urological Association.. The eCoin neuromodulation device will be implanted subcutaneously in the right or left leg of patients with urgency urinary incontinence. After a 4 week implant healing period, subjects will have their devices activated (turned ON). After 3 months of device therapy (occurring 4 months post-implant), the primary endpoint will be assessed. It is anticipated that subjects will reach the full therapeutic effect at approximately 3 months of therapy. Subjects will be followed for an additional 9 months to assess the safety of maintenance stimulation therapy with fewer sessions occurring during this time interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: eCoinTreatment Arm receives implanted eCoin device and therapy is turned ON. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Women and men 18 years and older.
- Diagnosis of overactive bladder with urgency urinary incontinence or mixed urge and stress incontinence with a predominant urgency component, for at least 6 months (self-reported).
- Individual has at least four urgency incontinence episodes on a three-day voiding diary with at least one episode per 24 hour time period
- Individual with urinary frequency, defined as an average of greater than or equal to 8 times/24 hours (ie. a total of greater than or equal to 24 micturitions on a 3 day diary)
- Individual is unresponsive to, inadequately responsive to, or intolerant of behavioral, rehabilitation, and pharmacologic therapy.
Key exclusion criteria (23 listed)
- Individual has predominantly stress urinary incontinence
- Individual has clinically significant bladder outlet obstruction.
- Individual has clinically significant pelvic organ prolapse.
- Individual has abnormal post void residual (i.e., greater than 150 cc).
- Individual has clinically significant urethral stricture disease or bladder neck contracture
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 |
|---|---|---|
| eCoinPatients are implanted with active implantable device called eCoin. eCoin is turned ON in order to deliver neuromodulation therapy. | Device | Treatment Arm |
Primary outcome
Incontinent Episodes
Time frame: Baseline to three months post-activation.
The change in number of incontinence episodes from baseline to three months post-activation.
3 secondary outcomes
System and Procedure Related AEs
Time frame: Implantation to one month post-implantation.
MAEs
Time frame: Baseline to 3 months post-activation.
Percentage of Responders
Time frame: 3 months after activation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35536667Kaaki B, English S, Gilling P, Meffan P, Lucente V, MacDiarmid S, Clark M, Sen SK. Six-Month Outcomes of Reimplantation of a Coin-Sized Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome With Urgency Urinary Incontinence. Female Pelvic Med Reconstr Surg. 2022 May 1;28(5):287-292. doi: 10.1097/SPV.0000000000001105. Epub 2022 Sep 22.
- 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.
Sharon English, MD principal investigator
Urology Associates
Scott MacDiarmid, MD principal investigator
Alliance Urology Specialists
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eCoin in people with Urgency Urinary Incontinence, run by Valencia Technologies Corporation at 7 sites in 2 countries.
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 10 inclusion and 23 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 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, New Zealand. 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?
Yes. Results are posted in the registry (first posted 27 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incontinent Episodes (time frame: Baseline to three months post-activation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03029624, which also lists 1 linked publication.
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 22 Dec 2020.