NCT02901392招募中不适用
Fundación Instituto Valenciano de Oncología Prospective Registry for Patients Undergoing Male Sling or Artificial Urinary Sphincter After Prostatectomy or Radiation Therapy for Prostate Cancer.
Fundación Instituto Valenciano de Oncología1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2004年4月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Success rate
研究概览
简要总结
Stress urinary incontinence is a significant potential source of morbidity after radical prostatectomy or radiation therapy for prostate cancer. At present, artificial urinary sphincter remains the preferred therapeutic option. However, this technique is not free from complications. In an attempt to avoid such complications, male sling has been suggested for use in patients with mild degrees of stress incontinence.
详细描述
This is a prospective collection of pre-defined parameters on the treatment of male stress urinary incontinence by male sling or artificial urinary sphincter.
This registry includes:
- Pre-operative urodynamic assessment, cystoscopy and other preoperative clinical parameters (i.e. age, body mass index, bladder neck contracture treated, urgency, 24h-PW, cystometry and pressure/flow, repositioning test)
- Description of surgical technique
- Continence is evaluated 3 months after surgery, avoiding the potential confounding impact of the initial tissue edema (Cure was defined as no pad use, and all other cases were defined as failures)
- Evaluation of long term functional outcome (efficacy, late complications and the loss of continence)
Surgery is performed with:
Device: Virtue® Device: Advance® and AdvanceXP® Device: Artificial urinary sphincter AMS-800® Device: Invance® Male Incontinence Sling
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The subject has agreed to be treated with the male Incontinence surgery devices
- •The subject is willing and able to give valid informed consent.
- •The subject is > 18 years of age.
- •The subject has confirmed stress urinary incontinence for at least 12 months after prostatectomy or radiotherapy.
- •It has been confirmed the stress urinary incontinence with 24-Hour Pad Weight test
- •Pre-operative urodynamic assessment and flexible cystoscopy were performed in all cases
- •The subject is willing and able to return for follow-up evaluations and questionnaire completion according to the study protocol.
- •There are no surgical contraindications.
排除标准
- •The subject has an active urinary tract infection or active skin infection in region of surgery
- •The subject has serious bleeding disorders
- •The subject has unstable bladder neck stricture disease
- •The subject has Neurogenic bladder condition that is not treatable or controllable by pharmacological or alternative methods.
- •The subject has Detrusor-external sphincter dyssynergia.
- •The subject is unable or unwilling to sign the informed consent form (ICF)and/or comply with all follow-up requirements according to the study protocol
- •The subject is likely to undergo radiation therapy within the next 6 months
- •The subject has a history of connective tissue or autoimmune conditions.
- •The subject has a compromised immune system.
- •The subject has renal insufficiency, and upper and/or lower urinary tract relative obstruction.
- •The subject's reading level is judged inadequate for reading and understanding the quality of life questionnaires and other study materials
结局指标
主要结局
Success rate
时间窗: 3 months
Cure is defined as no pad use
次要结局
- Continence improvement(15 years)
- Lower tract urinary symptoms modification after male surgery incontinence(15 years)
- Quality of Life in patients with male surgery incontinence(15 years)
研究者
研究点 (1)
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