NCT05685433ClinicalTrials.gov

A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)

מגייסמקבל משתתפים כעת, לפי רשומת המרשם.

יצירת קשר עם המחקר

בקצרה

A prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the eCoin® implanted tibial nerve stimulator in subjects with urgency urinary incontinence (UUI).

התערבותידרושים 200 משתתפים22 אתריםמדינה אחת

קטגוריות

נפרולוגיה ואורולוגיה97%מיילדות וגינקולוגיה3%

רשום במרשם אחד

ClinicalTrials.govNCT05685433פתיחת רשומה זו ב־ClinicalTrials.govסונכרן לפני חודשיים

מחקר יחיד יכול להיות רשום בכמה מרשמים. אנו מציגים אותו פעם אחת ומקשרים לכל רשומה שברשותנו.

מידע הניסוי מוצג כפי שפורסם על ידי המרשם, בשפת המקור שלו.

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התחברות או צרו חשבון כדי לרשום את התעניינותכם ולעקוב אחר המחקר הזה.

How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2023-01-17; recorded start 2023-01-26
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Not stated: Participants are not randomly assignedAllocation is recorded as non-randomised
Not stated: A comparison group is not stated in the registry recordThe record describes a single study arm
Not stated: Open label (no blinding)Masking is recorded as none (open label)
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Not stated: No other studies from this sponsor are in this databaseCounted from the lead sponsor named in the record (Valencia Technologies Corporation)
Not stated: No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database

The record lists 4 conditions.
Lead sponsor type recorded as: industry.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourEXPLORATORY

An exploratory-stage design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation0/20
Allocation not stated in the record
Blinding0/20
Open-label
Control arm0/15
No comparator arm stated in the record
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 22 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study: 200 participants (target), run at 22 sites.

How this score is built

Enrolment22/40
200 participants (target)
Site count16/25
22 sites
Country count0/15
Single country
Planned duration10/10
Planned over about 108 months
Sponsor scale0/10
Valencia Technologies Corporation has led 1 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

תקציר

A prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the eCoin® implanted tibial nerve stimulator in subjects with urgency urinary incontinence (UUI).

The goal of this prospective, multicenter, single-arm study is to assess the long-term safety and effectiveness of the FDA approved eCoin® implanted tibial nerve stimulator in a real world setting. Eligible subjects having overactive bladder (OAB) with urgency urinary incontinence (UUI) will be implanted with the eCoin® implanted tibial stimulator and complete voiding diaries and questionnaires at follow-up visits through 5 years.

מצבים רפואיים

Overactive Bladder
Urge Incontinence
Incontinence, Urinary
Urinary Urge Incontinence

זכאות

זכאות
מין	הכול
גילאים	18 Years – ללא מקסימום
מתנדבים בריאים	לא

זכאות כפי שנכתבה במרשם

Inclusion Criteria: * Women and men above 18 years old with gender percentages reflective of disease prevalence in the U.S. population * Individual with diagnosis of overactive bladder with urgency urinary incontinence. * Individual has at least one urgency urinary incontinence episode on each of three days as determined on a 3-day voiding diary. * Individual gives written informed consent. * 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 (anticholinergic and β3-adrenoceptor agonists) for 2 weeks prior to baseline or longer if the physician judges that the therapeutic effect is still present. * Individual is intolerant of or has an inadequate response to any of anticholinergics, β3-adrenoceptor agonists, onabotulinumtoxinA, or who have undergone percutaneous tibial nerve stimulation (PTNS). * Individual is determined to be a suitable surgical candidate by physician. * Individual is appropriate for eCoin treatment based on the US FDA-approved IFU requirements. Exclusion Criteria: * Individual is not appropriate for eCoin therapy based upon the US FDA-approved IFU requirements. * Individual has clinically significant bladder outlet obstruction. (Suspected bladder outlet obstruction will be initially assessed by uroflow study with those having a maximum flow rate \< 15mL/s requiring additional evaluation.) * Individual has predominantly stress urinary incontinence (greater than 1/3 of leaks on baseline diary are stress). * Individual has an active urinary tract infection at time of enrollment. * Individual has known polyuria. * Individual has significant lower urinary tract pain or has been diagnosed with interstitial cystitis or bladder pain syndrome. * Individual has abnormal post void residual (i.e. greater than 200 cc initially and on repeat testing after double voiding) * Individual has clinically significant urethral stricture disease or bladder neck contracture. (Suspected disease or contracture will be initially assessed by uroflow study with those having a maximum flow rate \< 15mL/s requiring additional evaluation.) * Individual has chronic venous insufficiency with a history of skin change (hyperpigmentation, lipodermatosclerosis, ulceration) in the ankle region. * Individual has morbid obesity and in the opinion of the investigator is not a good candidate for the study. * Individual has had diagnosis of bladder, urethral, or prostate cancer. * Individual has had a prior anti-stress incontinence sling surgery within the last year. * Individual is pregnant or intends to become pregnant during the study. * Individual has the presence of urinary fistula, bladder stone, or interstitial cystitis. * Individual has uncontrolled diabetes mellitus (Hemoglobin A1C\>7) or diabetes with significant peripheral complications. (Uncontrolled diabetes will be ruled out by blood test excluding those with Hemoglobin A1C\>7). * Individual has an implantable neurostimulator, pacemaker, or implantable cardiac defibrillator (ICD). * Individual has been treated with onabotulinumtoxinA in the previous 9 months prior to enrollment, or more time if the principal investigator judges that the therapeutic effect is present. * Individual has been treated with percutaneous tibial nerve stimulation (PTNS) within the previous 4 weeks prior to enrollment or more time if the principal investigator judges that the therapeutic effect is present. * Individual is currently using transcutaneous electrical nerve stimulation (TENS) in the pelvic region, back, or legs. * Individual is aware that he or she will need an MRI scan other than a head/neck/shoulder MRI during the study period. * Individual has a clotting or bleeding disorder or is using anticoagulant therapies and in the opinion of the investigator is not a good candidate for the study (antiplatelet and anticoagulant therapy may be continued or held at the discretion of the investigator). * Individual is neutropenic or immune-compromised. * Individual has had previous surgery and/or significant scarring at the implant location. * Individual has ongoing dermatologic condition at the implant site, including but not limited to dermatitis and autoimmune disorders. * Individual has a clinically significant peripheral neuropathy in the lower extremities. * Individual has neurogenic bladder dysfunction. * Individual has pitting edema at implant location (≥ 2+ is excluded). * Individual has inadequate skin integrity or any evidence of an infection or inflammation in either lower leg. * Individual has varicose veins and is symptomatic. * Individual has open wounds, trauma, or prior surgery in the lower extremities. * Individual has arterial disease in the lower extremities. * Individual has vasculitis in the lower extremities. * Individual has bladder stones or neoplasia. (Suspected bladder stones or neoplasia will be ruled out with a urine dipstick showing no more than trace blood, and microscopic analysis (which should be done in that case) shows ≥3 PBC's /HPF unless that subject has been worked up and found negative for clinically significant disease such as malignant neoplasm or stones.) * In the opinion of the investigator, Individual is not a good candidate for participation in the study.

זכאות במשפטים פשוטים

הקריטריונים של רשומה זו טרם פורקו למשפטים נפרדים. טקסט המרשם שלמעלה שלם והוא הגרסה המחייבת.

תכנון המחקר

תכנון המחקר
סוג המחקר	התערבותי
שלב	לא רלוונטי
הקצאה	לא רלוונטי
מודל ההתערבות	SINGLE_GROUP
מטרה ראשית	TREATMENT
הסתרה	NONE (0)
גיוס	דרושים 200 משתתפים

נותן חסות ושותפים

Valencia Technologies Corporation נותן חסות

זרועות והתערבויות

eCoin Tibial Nerve StimulationEXPERIMENTAL
Subcutaneous stimulation of the tibial nerve using the eCoin device.

התערבויות

התקן eCoin Tibial Nerve Stimulation
Subcutaneous stimulation of the tibial nerve using the eCoin device.

מדדי תוצאה

מדד תוצאה ראשוני
Responder Rate
Proportion of subjects achieving at least a 50% improvement in the number of urgency urinary incontinence episodes on a 3-day voiding diary.
מסגרת זמן 12 months
מדד תוצאה ראשוני
Safety: 12 months rate of all device or procedure related AEs.
Rate of all device or procedure related AEs.
מסגרת זמן 12 months
מדד תוצאה משני
Responder Rate
Proportion of subjects achieving at least a 50% improvement in the number of urgency urinary incontinence episodes on a 3-day voiding diary.
מסגרת זמן 24 months
מדד תוצאה משני
Safety Data
Rate of all device or procedure related AEs through 24 months post activation of eCoin.
מסגרת זמן 24 months
מדד תוצאה משני
Safety data through 7 months post-reimplantation.
Rate of device or procedure-related AEs through 7 months post reimplantation.
מסגרת זמן 7 months post reimplantation
מדד תוצאה אחר
Patient reported overactive bladder condition improvement.
Improvement in patient reported overactive bladder condition utilizing the Patient Global Impression of Improvement (PGI-I) questionnaire.
מסגרת זמן 12, 24, 36, 48, and 60 months
מדד תוצאה אחר
Patient reported sexual health.
Assess patient reported sexual health using the PROMIS Sexual Function and Satisfaction survey.
מסגרת זמן 12 months
מדד תוצאה אחר
Proportion of responders (50% improvement) after 12, 24, 36, 48, and 60 months of therapy.
Proportion of subjects achieving at least a 50% improvement in the number of urgency urinary incontinence episodes on a 3-day voiding diary.
מסגרת זמן 12, 24, 36, 48, and 60 months
מדד תוצאה אחר
Proportion of responders (75% improvement) after 12, 24, 36, 48, and 60 months of therapy.
Proportion of subjects achieving at least a 75% improvement in the number of urgency urinary incontinence episodes on a 3-day voiding diary.
מסגרת זמן 12, 24, 36, 48, and 60 months
מדד תוצאה אחר
Proportion of responders (100% improvement) after 12, 24, 36, 48, and 60 months of therapy.
Proportion of subjects achieving at least a 100% improvement in the number of urgency urinary incontinence episodes on a 3-day voiding diary.
מסגרת זמן 12, 24, 36, 48, and 60 months
מדד תוצאה אחר
Reduction in the number of urgency urinary incontinence episodes.
Reduction in the number of urgency urinary incontinence episodes on a 3-day voiding diary.
מסגרת זמן 12, 24, 36, 48, and 60 months
מדד תוצאה אחר
Reduction in the number of urgency urinary incontinence episodes for subjects with 8+ voids per day at baseline.
Reduction in the number of urgency urinary incontinence episodes on a 3-day voiding diary for subjects who experience more than 8 voids per day at baseline.
מסגרת זמן 12, 24, 36, 48, and 60 months
מדד תוצאה אחר
Reduction in urgency episodes.
Reduction in the number of urgency episodes on a 3-day voiding diary.
מסגרת זמן 12, 24, 36, 48, and 60 months
מדד תוצאה אחר
Reduction in nocturia episodes
Reduction in nocturia episodes on a 3-day voiding diary.
מסגרת זמן 12, 24, 36, 48, and 60 months
מדד תוצאה אחר
Patient reported qualify of life
Improvement in patient reported qualify of life utilizing the Overactive Bladder Symptom Quality of Life Questionnaire (OABq).
מסגרת זמן 12, 24, 36, 48, and 60 months
מדד תוצאה אחר
Patient reported satisfaction with eCoin.
Assess patient-reported satisfaction with eCoin therapy using the custom patient satisfaction rating survey.
מסגרת זמן 12, 24, 36, 48, and 60 months
מדד תוצאה אחר
Device-related adverse events from implantation.
Rate of device-related adverse events from implantation.
מסגרת זמן 12, 24, 36, 48, and 60 months
מדד תוצאה אחר
Procedure-related adverse events from implantation.
Rate of procedure-related adverse events from implantation.
מסגרת זמן 12, 24, 36, 48, and 60 months
מדד תוצאה אחר
Procedure-related adverse events due to suture technique
Rate of procedure-related adverse events occurring as a result of inappropriate suture technique.
מסגרת זמן 12, 24, 36, 48, and 60 months

תאריכים

תאריכים
תאריך התחלה	26 בינואר 2023 (בפועל)
סיום ראשוני	1 במרץ 2027 (משוער)
סיום	1 בדצמבר 2031 (משוער)
פורסם לראשונה	17 בינואר 2023 (בפועל)
עודכן לאחרונה	28 בינואר 2026
התוצאות פורסמו	לא צוין ברשומת המרשם
המצב אומת לאחרונה	אפריל 2025

בפועל פירושו שהאירוע התרחש. משוער פירושו שנותן החסות צופה אותו. שתי המשמעויות שונות זו מזו.

מיקומים

19 אתרים מגייסים

United States

United States
מתקן	עיר	מדינה או אזור	מצב
The Iowa Clinic	Ankeny	Iowa	מגייס
UPNT Research Institute	Arlington	Texas	מגייס
The Emory Clinic	Atlanta	Georgia	מגייס
Rush University	Chicago	Illinois	מגייס
Urological Research Network Corp	Hialeah	Florida	מגייס
Urology Centers of Alabama	Homewood	Alabama	מגייס
The Methodist Hospital Research Institute	Houston	Texas	מגייס
Baylor College of Medicine	Houston	Texas	מגייס
University of Iowa	Iowa City	Iowa	מגייס
University of California, Irvine	Irvine	California	מגייס
University of Kansas Medical Center Research Institute, Inc	Kansas City	Kansas	מגייס
Arkansas Urology	Little Rock	Arkansas	מגייס
AIR Research	Los Angeles	California	מגייס
USA Health	Mobile	Alabama	בוטל
Weill Cornell Medicine: Department of Urology	New York	New York	מגייס
The Oregon Clinic	Portland	Oregon	פעיל, ללא גיוס
Louisiana State University Health Sciences Center	Shreveport	Louisiana	פעיל, ללא גיוס
Specialty Clinical Research of St. Louis	St Louis	Missouri	מגייס
Stanford Health	Stanford	California	מגייס
Southern Urogynecology	West Columbia	South Carolina	מגייס
Cypress Medical Research	Wichita	Kansas	מגייס
Minnesota Urology	Woodbury	Minnesota	מגייס

מסמכי המחקר

לא צורפו מסמכים ברשומת מרשם זו.

שינויים לאורך זמן

לא נרשמו שינויים מאז שקלטנו רשומה זו לראשונה.

שינוי נרשם בכל פעם שנותן החסות מעדכן את רשומת המרשם. מצב, תאריכים, גיוס ואתרים מופיעים כאן ככל שהם משתנים.

מרשם: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT05685433