Miami Membrane for Potency (MMeP) Trial to Assess the Impact of Dehydrated Human Amnion Membrane Allograft Placement During Robotic Radical Prostatectomy on Early Return of Erectile Function
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- The Difference in Average Change in SHIM Score, Between Baseline and 12-Months Post-RARP, of Study Participants in Each Group
研究概览
简要总结
The use of dehydrated human amnionic membrane allograft improves erectile function recovery (as measured by (Sexual History Inventory for Men (SHIM) score) at 12 months after robotic assisted radical prostatectomy (RARP) compared to a control group with no allograft.
详细描述
This is a phase 2 prospective randomized trial investigating the impact of amniotic membrane placement over the neurovascular bundles after bilateral nerve sparing robot assisted radical prostatectomy on potency. The study will have a control arm that will follow standard of care surgery, without placement of any membranes. 70 men will be allocated to each arm.
The research study will involve follow up every 3 months for the first 12 months. After this the investigators will follow patients annually with prostate-specific antigen (PSA) measurements and an assessment of any secondary therapies for 5 years post-surgery.
Randomization of study patients will be done in equal proportion to Arm I (membrane placement) and Arm II (no membrane placement, standard of care surgery) using a permuted block design stratified by baseline SHIM score (<17 vs. >=17), and use of ANY erectile aids (Yes vs. No) in the last 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants will not know their treatment arm assignment until after robotic assisted radical prostatectomy (RARP) surgery.
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men age 40-80 with localized prostate cancer who are undergoing bilateral nerve sparing RARP at the University of Miami
排除标准
- •Men with poor urinary control at baseline requiring the use of pads for leakage
- •Previous treatment for prostate cancer
- •Previous history of pelvic radiation
- •Men who are using non-oral erectile aids such as vacuum pump, intra-cavernous injections, MUSE, penile prosthesis.
研究组 & 干预措施
Arm 1 - Amniotic Membrane Placement
Participants who receive the human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals.
干预措施: EPIC 26 (Behavioral)
Arm 1 - Amniotic Membrane Placement
Participants who receive the human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals.
干预措施: Amniotic Membrane Placement (Biological)
Arm 1 - Amniotic Membrane Placement
Participants who receive the human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals.
干预措施: PSA Measurement (Other)
Arm 1 - Amniotic Membrane Placement
Participants who receive the human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals.
干预措施: Sexual History Inventory for Men (Behavioral)
Arm 2 - No Amniotic Membrane Placement
Participants who do not receive human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals.
干预措施: EPIC 26 (Behavioral)
Arm 2 - No Amniotic Membrane Placement
Participants who do not receive human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals.
干预措施: PSA Measurement (Other)
Arm 2 - No Amniotic Membrane Placement
Participants who do not receive human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals.
干预措施: Sexual History Inventory for Men (Behavioral)
结局指标
主要结局
The Difference in Average Change in SHIM Score, Between Baseline and 12-Months Post-RARP, of Study Participants in Each Group
时间窗: Baseline, 12 Months Post-RARP
The difference in average change in Sexual History Inventory for Men (SHIM) score, between baseline and 12 months post RARP between the membrane and control arms will be assessed as the primary endpoint. The SHIM score is measured in points on a scale: The minimum score is 5 to 7 indicating severe erectile dysfunction (ED), the maximum score is 22 to 25, indicating no ED.
次要结局
- 5-year Rate of Prostate Cancer Recurrence Between Both Study Arms(5 years post-RARP)
- Proportion of Men in Each Group Who Are Able to Achieve An Erection Sufficient for Intercourse More the 50% of the Time Post-RARP.(Baseline, 3, 6, 9 and 12 months Post-RARP)
- Proportion of Men in Each Group With Mild Erectile Dysfunction (ED) or Better Post-RARP(Baseline, 3, 6, 9 12 Months Post-RARP)
- Proportion of Men Who Require the Use of More Invasive Erectile Aids Post-RARP(3, 6, 9 and 12 Months Post-RARP)
- Rates of Urinary Control Experienced by Study Participants(Baseline, 3, 6, 9, and 12 months Post-RARP)
研究者
Sanoj Punnen
Associate Professor of Clinical
University of Miami