NCT05685433招募中不适用
A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 38
- 主要终点
- Responder Rate
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
eCoin Tibial Nerve Stimulation
Experimental
Subcutaneous stimulation of the tibial nerve using the eCoin device.
干预措施: eCoin Tibial Nerve Stimulation (Device)
结局指标
主要结局
Responder Rate
时间窗: 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: 12 months rate of all device or procedure related AEs.
时间窗: 12 months
Rate of all device or procedure related AEs.
次要结局
- Responder Rate(24 months)
- Safety Data(24 months)
- Safety data through 7 months post-reimplantation.(7 months post reimplantation)
研究者
研究点 (38)
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