Monocentric Pilot Study for the Application of an Endourethral Device for the Treatment of Stress Urinary Incontinence
概览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Relief srl
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The safety of UroRelief
概览
简要总结
Stress urinary incontinence is defined as the involuntary loss of urine during exertion or physical activity (i.e., sports) or during sneezing or coughing. Approximately 127 million women and 10 million men reported suffering from stress urinary incontinence in 2008, and current estimates are on the rise.
The prevalence of stress urinary incontinence is higher in older age groups, with 10% of women and 5% of men over the age of 65 suffering from this condition. The initial management of urinary incontinence consists of basic diagnostic investigations to rule out any reversible conditions (i.e., bacterial urinary tract infections, UTIs), while conservative and non-invasive treatment options include lifestyle changes, (PFMT) with or without biofeedback, and bladder retraining.
详细描述
Stress urinary incontinence is defined as the involuntary loss of urine during exertion or physical activity (i.e., sports) or during sneezing or coughing.
It is estimated to be the most common type of urinary incontinence worldwide due to its high prevalence in women. Approximately 127 million women and 10 million men reported suffering from stress urinary incontinence in 2008, and current estimates are on the rise. It can be primary or secondary and is caused by damage to either the sphincter innervation or the anatomical structures that make up the urethral sphincter. It is usually classified according to its severity and, consequently, according to the impairment of the patient's quality of life. It can seriously affect patients' quality of life in severalareas, leading to conditions such as sexual dysfunction, social isolation, withdrawal from physical activity, and major depression. The initial management of urinary incontinence consists of basic diagnostic investigations to rule out any reversible conditions (i.e., bacterial urinary tract infections, UTIs), while conservative and non-invasive treatment options include lifestyle changes, pelvic floor muscle training (PFMT) with or without biofeedback and bladder retraining, as well as the chronic and daily use of external aids (diapers).
The goal of treatment is to achieve complete or partial continence, with the aim of restoring normal sexual function. (PFMT) with or without biofeedback and bladder retraining, as well as the chronic and daily use of external aids (diapers, collection systems, prophylactics, etc.). However, this does not guarantee the restoration of a good quality of life. The current guidelines of the European Association of Urology (EAU) recommend surgical treatment when conservative and pharmacological therapies fail. In men, the most common surgical treatment for stress urinary incontinence that does not respond to therapy is the implantation of an artificial urethral sphincter, while in women, the indication is for complicated stress urinary incontinence (failure of other treatments such as retropubic or transobturator mid-retral slings). Currently, the most widely used device is a three-chamber device (consisting of a cuff, a balloon, and a pump) placed extraurethrally, whose application requires general and/or spinal anesthesia. The system proposed in the study, on the other hand, is an endourethral device to be applied endoscopically after anesthesia. The device is applied through a simple endoscopic maneuver without the need for other devices implanted in other anatomical sites and can be activated by slight abdominal pressure exerted by the patient.
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
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (both women and men) aged between 21 and 85 years
- •Documented stress urinary incontinence (urethral hypermobility or intrinsic sphincter deficiency) in which urgency symptoms are a minor component of the incontinence symptoms
- •Stress urinary incontinence present and physiologically stable over the last 6 months.
- •Urinary leakage \>150 ml in the 24-hour PAD test performed during the pre-implantation screening phasefor male patients.- Urinary leakage \>150 ml in the 24-hour PAD test performed during the pre-implantation screening phase
- •Cognitive/manual ability to use the device.
- •The patient is willing and able to meet the requirements of the protocol.
- •The patient has decided to be implanted with the device for the treatment of urinary incontinence
- •Willingness to sign the informed consent form.
- •Willingness to return for follow-up evaluations and complete questionnaires.
- •The patient has been informed about alternative therapies available for the treatment or management of urinary incontinence and about all possible risks associated with the implantation of the device.
排除标准
- •Primary urge incontinence or mixed stress and urge incontinence in which urge symptoms are a major component of the incontinence symptoms.
- •Detrusor overactivity.
- •History of recurrent bladder stones.
- •Atonic neurogenic bladder or detrusor sphincter dyssynergia.
- •Patients taking specific medications for bladder dysfunction or currently undergoing treatment for incontinence.
- •Post-void residual urine \>200 ml.
- •Maximum cystometric capacity \<150 ml.
- •Detrusor pressure \>20 cmH2O.
- •Flexible cystoscopy showing stenosis that prevents device implantation.
- •History of previously undiagnosed and unidentified microhematuria.
结局指标
主要结局
The safety of UroRelief
时间窗: 18 months
\- Complete characterization of all serious and unrecorded adverse events, including frequency and severity, reported throughout the study, according to the Clavien Dindo classification (I, II, 111°, IIIb, IVa, IVb, V).
次要结局
- Assess incontinence at 30 days, measured using the 24-hour pad weight test.(18 months)