Pilot Study of Intraoperative Somatic-Autonomic Nerve Grafting Technique to Preserve Erectile Function in Patients With Bladder Cancer Undergoing Radical Cystectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 主要终点
- Adverse events measured by the Clavian-Dindo classification
研究概览
简要总结
This pilot study will evaluate the safety and 1-year erectile function recovery in 10 patients undergoing a novel Nerve Restoring Radical Cystectomy (NR-RC), which includes a genitofemoral nerve graft. Erectile function will be assessed using IIEF-5, SF-MPQ, and CEEF questionnaires at baseline and at multiple post-operative intervals (4 weeks, 3, 6, 12, and 18 months). Safety will be monitored through peri- and post-operative complications, and additional demographic and clinical data will be collected for analysis.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing standard of care radical cystectomy for bladder cancer
- •Patients must have preoperative erectile function with a baseline IIEF score of ≥17
排除标准
- •Patients with previous pelvic surgery
- •Patients with previous pelvic radiotherapy
- •Patients aged < 18 years at diagnosis
- •Legally incapable patients
- •Patients who are unable to complete questionnaires and have no companion to help complete them
- •Patients undergoing a concomitant cancer surgery
- •Patients with pre-existing neurologic disease
结局指标
主要结局
Adverse events measured by the Clavian-Dindo classification
时间窗: Through study completion, an average of 18 months (5 different time points)
The primary outcome is specifically the safety of the operation measured by adverse events as defined by the Clavian-Dindo classification. The measurement varies from Grade I (Best possible outcome) to Grade V (Worst possible outcome). Grade I Deviation from normal p/o course. No pharmacological or surgical treatment, endoscopic or radiological interventions were required. Acceptable therapeutic drugs such as anti-emetics, antipyretics, analgesics, diuretics,electrolytes, physiotherapy. Wound infections, small abscess requiring incision at bedside. Grade II Normal course altered. Pharmacological management other than in Grade I. Blood transfusions and total parenteral nutrition are also included. Grade III Complications that require intervention of various degrees. Grade IV Complications threatening life of patients (including Central Nervous System complications), requiring Intensive Treatment Unit support. Grade V Death of a patient
次要结局
- Clinical Evolution of Erectile Function (CEEF)(18 months post- NR-RC)
- International Index of Erectile Function-5 (IIEF-5)(18 months post- NR-RC)
- Short Form McGill Pain Questionnaire (SF-MPQ)(18 months post- NR-RC)
研究者
Victor McPherson
Assistant Professor Division of Urology, Department of Surgery McGill University
Sir Mortimer B. Davis - Jewish General Hospital