A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)
Study Details
Study Description
Brief Summary
The goal of this prospective, multicenter, single-arm study is to test the safety and effectiveness of eCoin ® tibial nerve stimulation in subjects having overactive bladder (OAB) with urgency urinary incontinence (UUI). The main questions it aims to answer are:
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The proportion of subjects achieving at least a 50% improvement in the number of urgency urinary incontinence episodes on a 3-day voiding diary (72 hours) after 12 months of therapy.
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The rate of device- or procedure-related AEs through 12 months post-activation of eCoin ®.
Participants will be implanted with eCoin ® and complete voiding diaries and patient reported-outcomes through 12 months of eCoin ® therapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: eCoin Tibial Nerve Stimulation Subcutaneous stimulation of the tibial nerve using the eCoin device. |
Device: eCoin Tibial Nerve Stimulation
Subcutaneous stimulation of the tibial nerve using the eCoin device.
|
Outcome Measures
Primary Outcome Measures
- Proportion of responders at 12 months post-activation. [12 months]
Proportion of subjects achieving at least a 50% improvement in the number of urgency urinary incontinence episodes on a 3-day voiding diary.
- Safety Data at 12 months post-activation. [12 months]
Rate of all device or procedure related AEs.
Secondary Outcome Measures
- Proportion of responders at 24 months post-activation. [24 months]
Proportion of subjects achieving at least a 50% improvement in the number of urgency urinary incontinence episodes on a 3-day voiding diary.
- Safety Data at 24 months post-activation. [24 months]
Rate of all device or procedure related AEs through 24 months post activation of eCoin.
- Safety data through 7 months post-reimplantation. [7 months post reimplantation]
Rate of device or procedure-related AEs through 7 months post reimplantation.
Other Outcome Measures
- Proportion of responders (50% improvement) after 12, 24, 36, 48, and 60 months of therapy. [12, 24, 36, 48, and 60 months]
Proportion of subjects achieving at least a 50% improvement in the number of urgency urinary incontinence episodes on a 3-day voiding diary.
- Proportion of responders (75% improvement) after 12, 24, 36, 48, and 60 months of therapy. [12, 24, 36, 48, and 60 months]
Proportion of subjects achieving at least a 75% improvement in the number of urgency urinary incontinence episodes on a 3-day voiding diary.
- Proportion of responders (100% improvement) after 12, 24, 36, 48, and 60 months of therapy. [12, 24, 36, 48, and 60 months]
Proportion of subjects achieving at least a 100% improvement in the number of urgency urinary incontinence episodes on a 3-day voiding diary.
- Reduction in the number of urgency urinary incontinence episodes. [12, 24, 36, 48, and 60 months]
Reduction in the number of urgency urinary incontinence episodes on a 3-day voiding diary.
- Reduction in the number of urgency urinary incontinence episodes for subjects with 8+ voids per day at baseline. [12, 24, 36, 48, and 60 months]
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.
- Reduction in urgency episodes. [12, 24, 36, 48, and 60 months]
Reduction in the number of urgency episodes on a 3-day voiding diary.
- Reduction in nocturia episodes [12, 24, 36, 48, and 60 months]
Reduction in nocturia episodes on a 3-day voiding diary.
- Patient reported qualify of life [12, 24, 36, 48, and 60 months]
Improvement in patient reported qualify of life utilizing the Overactive Bladder Symptom Quality of Life Questionnaire (OABq).
- Patient reported overactive bladder condition improvement. [12, 24, 36, 48, and 60 months]
Improvement in patient reported overactive bladder condition utilizing the Patient Global Impression of Improvement (PGI-I) questionnaire.
- Patient reported sexual health. [12 months]
Assess patient reported sexual health using the PROMIS Sexual Function and Satisfaction survey.
- Patient reported satisfaction with eCoin. [12, 24, 36, 48, and 60 months]
Assess patient-reported satisfaction with eCoin therapy using the custom patient satisfaction rating survey.
- Device-related adverse events from implantation. [12, 24, 36, 48, and 60 months]
Rate of device-related adverse events from implantation.
- Procedure-related adverse events from implantation. [12, 24, 36, 48, and 60 months]
Rate of procedure-related adverse events from implantation.
- Procedure-related adverse events due to suture technique [12, 24, 36, 48, and 60 months]
Rate of procedure-related adverse events occurring as a result of inappropriate suture technique.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Women and men above 18 years old with gender percentages reflective of disease prevalence in the U.S. population
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Individual with diagnosis of overactive bladder with urgency urinary incontinence.
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Individual has at least one urgency urinary incontinence episode on each of three days as determined on a 3-day voiding diary.
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Individual gives written informed consent.
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Individual is mentally competent and able to understand all study requirements.
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Individual is willing and able to complete a 3-day voiding diary and quality of life questionnaire.
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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.
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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).
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Individual is determined to be a suitable surgical candidate by physician.
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Individual is appropriate for eCoin treatment based on the US FDA-approved IFU requirements.
Exclusion Criteria:
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Individual is not appropriate for eCoin therapy based upon the US FDA-approved IFU requirements.
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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.)
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Individual has predominantly stress urinary incontinence (greater than 1/3 of leaks on baseline diary are stress).
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Individual has an active urinary tract infection at time of enrollment.
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Individual has known polyuria.
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Individual has significant lower urinary tract pain or has been diagnosed with interstitial cystitis or bladder pain syndrome.
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Individual has abnormal post void residual (i.e. greater than 200 cc initially and on repeat testing after double voiding)
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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.)
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Individual has chronic venous insufficiency with a history of skin change (hyperpigmentation, lipodermatosclerosis, ulceration) in the ankle region.
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Individual has morbid obesity and in the opinion of the investigator is not a good candidate for the study.
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Individual has had diagnosis of bladder, urethral, or prostate cancer.
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Individual has had a prior anti-stress incontinence sling surgery within the last year.
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Individual is pregnant or intends to become pregnant during the study.
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Individual has the presence of urinary fistula, bladder stone, or interstitial cystitis.
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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).
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Individual has an implantable neurostimulator, pacemaker, or implantable cardiac defibrillator (ICD).
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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.
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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.
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Individual is currently using transcutaneous electrical nerve stimulation (TENS) in the pelvic region, back, or legs.
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Individual is aware that he or she will need an MRI scan other than a head/neck/shoulder MRI during the study period.
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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).
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Individual is neutropenic or immune-compromised.
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Individual has had previous surgery and/or significant scarring at the implant location.
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Individual has ongoing dermatologic condition at the implant site, including but not limited to dermatitis and autoimmune disorders.
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Individual has a clinically significant peripheral neuropathy in the lower extremities.
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Individual has neurogenic bladder dysfunction.
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Individual has pitting edema at implant location (≥ 2+ is excluded).
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Individual has inadequate skin integrity or any evidence of an infection or inflammation in either lower leg.
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Individual has varicose veins and is symptomatic.
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Individual has open wounds, trauma, or prior surgery in the lower extremities.
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Individual has arterial disease in the lower extremities.
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Individual has vasculitis in the lower extremities.
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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.)
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In the opinion of the investigator, Individual is not a good candidate for participation in the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Southern Urogynecology | West Columbia | South Carolina | United States | 29169 |
Sponsors and Collaborators
- Valencia Technologies Corporation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 111-5702