Phase II Clinical Trial to Evaluate the Early Return of Urinary Continence Utilizing a Novel Hybrid Transvesical Adapted Retzius Sparing Robotic Assisted Radical Prostatectomy Technique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- EQ-5D-5L #1.2
研究概览
简要总结
The goal of this a single arm prospective study is to evaluating the 3-month return of urinary continence outcomes of patients undergoing the transvesical retzius sparing robotic radical prostatectomy (TRS-RALP) for standard of care surgical prostate removal for treatment of prostate cancer.
The main question it aims: To have patients respond to questionnaires to collect exploratory data on patient's quality of life (QoL; EuroQol-5 Dimension 5-Level [EQ-5D-5L] and prostate cancer related urinary, bowel, and sexual function questionnaires (Expanded Prostate cancer Index Composite for Clinical Practice (EPIC-CP), at their standard of care perioperative visits at baseline and at 4 weeks, 3- and 6-months post operatively.
详细描述
Patients undergoing robotic prostatectomy will have their surgery performed utilizing TRS-RALP technique, which is a novel combination of two previously described techniques. This technique is a recent alteration to our standard of care method of prostate removal, and comprises two halves of two previously validated techniques performed in succession. No new safety signals are anticipated, and the technique has been in use since May 2023. The purpose of this technique change is to improve the rate of return urinary continence, which early institutional experience supports. This trial protocol has been generated to formally evaluate this continence return improvement inside a statistical framework for prospective verification in our entire patient cohort.
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
- •Patients undergoing standard of care robotic radical prostatectomy for localized prostate cancer
排除标准
- •Patients with previous pelvic surgery
- •Patients with previous pelvic radiotherapy
- •Patient with previous focal therapy for prostate cancer
- •Patients aged < 18 years at diagnosis
- •Legally incapable patients
- •Patients who are unable to receive information about the study in a language they understand
- •Patients who are unable to complete questionnaires and have no companion to help complete them
- •Patients undergoing a concomitant cancer surgery
结局指标
主要结局
EQ-5D-5L #1.2
时间窗: 4 weeks postoperatively
The EuroQol - 5 Dimension - 5 Level is a questionnaire that provides a descriptive profile for health status. The questionnaire is comprised of 5 dimension questions; mobility, self care, usual activities, pain/discomfort, anxiety/depression. For each dimension, the patient is asked to check off a level associated; no problems, slight problems, moderate problems, severe problems, extreme problems. Each result is a 1-digit number expressing the level of that dimension. The final result is a 5 digit number describing the patient's health state. The digits range from 1 (best health - best possible outcome) to 5 (worst health - worst possible outcome). The final question asks the patient to check their current health status. This ranges from 100 (best health you can imagine - best outcome) to 0 (worst health you can imagine - worst outcome).
EQ-5D-5L #1.1
时间窗: Pperioperative baseline
The EuroQol - 5 Dimension - 5 Level is a questionnaire that provides a descriptive profile for health status. The questionnaire is comprised of 5 dimension questions; mobility, self care, usual activities, pain/discomfort, anxiety/depression. For each dimension, the patient is asked to check off a level associated; no problems, slight problems, moderate problems, severe problems, extreme problems. Each result is a 1-digit number expressing the level of that dimension. The final result is a 5 digit number describing the patient's health state. The digits range from 1 (best health - best possible outcome) to 5 (worst health - worst possible outcome). The final question asks the patient to check their current health status. This ranges from 100 (best health you can imagine - best outcome) to 0 (worst health you can imagine - worst outcome).
EQ-5D-5L #1.3
时间窗: 3 months postoperatively
The EuroQol - 5 Dimension - 5 Level is a questionnaire that provides a descriptive profile for health status. The questionnaire is comprised of 5 dimension questions; mobility, self care, usual activities, pain/discomfort, anxiety/depression. For each dimension, the patient is asked to check off a level associated; no problems, slight problems, moderate problems, severe problems, extreme problems. Each result is a 1-digit number expressing the level of that dimension. The final result is a 5 digit number describing the patient's health state. The digits range from 1 (best health - best possible outcome) to 5 (worst health - worst possible outcome). The final question asks the patient to check their current health status. This ranges from 100 (best health you can imagine - best outcome) to 0 (worst health you can imagine - worst outcome).
Expanded Prostate cancer Index Composite for Clinical Practice (EPIC-CP) #2.2
时间窗: 4 weeks postoperatively
The Expanded Prostate cancer Index Composite for Clinical Practice is a questionnaire to measure urinary, bowel,sexual and hormonal function of the patient's prostate cancer quality of life. The questionnaire is scored by the sum of the following scores: Urinary Incontinence symptom score, Urinary Irritation/Obstructive symptom score, Bowel Symptom score, Vitality/Hormonal symptom score and the overall prostate cancer quality of life score. The range of the score varies from 0 (best possible outcome) to 60 (worst possible outcome).
Expanded Prostate cancer Index Composite for Clinical Practice (EPIC-CP) #2.4
时间窗: 6 months postoperatively
The Expanded Prostate cancer Index Composite for Clinical Practice is a questionnaire to measure urinary, bowel,sexual and hormonal function of the patient's prostate cancer quality of life. The questionnaire is scored by the sum of the following scores: Urinary Incontinence symptom score, Urinary Irritation/Obstructive symptom score, Bowel Symptom score, Vitality/Hormonal symptom score and the overall prostate cancer quality of life score. The range of the score varies from 0 (best possible outcome) to 60 (worst possible outcome).
EQ-5D-5L #1.4
时间窗: 6 months postoperatively
The EuroQol - 5 Dimension - 5 Level is a questionnaire that provides a descriptive profile for health status. The questionnaire is comprised of 5 dimension questions; mobility, self care, usual activities, pain/discomfort, anxiety/depression. For each dimension, the patient is asked to check off a level associated; no problems, slight problems, moderate problems, severe problems, extreme problems. Each result is a 1-digit number expressing the level of that dimension. The final result is a 5 digit number describing the patient's health state. The digits range from 1 (best health - best possible outcome) to 5 (worst health - worst possible outcome). The final question asks the patient to check their current health status. This ranges from 100 (best health you can imagine - best outcome) to 0 (worst health you can imagine - worst outcome).
EPIC-CP #2.1
时间窗: perioperative baseline
The Expanded Prostate cancer Index Composite for Clinical Practice is a questionnaire to measure urinary, bowel,sexual and hormonal function of the patient's prostate cancer quality of life. The questionnaire is scored by the sum of the following scores: Urinary Incontinence symptom score, Urinary Irritation/Obstructive symptom score, Bowel Symptom score, Vitality/Hormonal symptom score and the overall prostate cancer quality of life score. The range of the score varies from 0 (best possible outcome) to 60 (worst possible outcome).
Expanded Prostate cancer Index Composite for Clinical Practice (EPIC-CP) #2.3
时间窗: 3 months postoperatively
The Expanded Prostate cancer Index Composite for Clinical Practice is a questionnaire to measure urinary, bowel,sexual and hormonal function of the patient's prostate cancer quality of life. The questionnaire is scored by the sum of the following scores: Urinary Incontinence symptom score, Urinary Irritation/Obstructive symptom score, Bowel Symptom score, Vitality/Hormonal symptom score and the overall prostate cancer quality of life score. The range of the score varies from 0 (best possible outcome) to 60 (worst possible outcome).
次要结局
未报告次要终点
研究者
Victor McPherson
MD, MSc, FRCSC, Assistant Professor Division of Urology
Sir Mortimer B. Davis - Jewish General Hospital