Analysis of Technique Comparison With a Vacuum Erection Device as Part of an Erectile Rehabilitation Program Following Robotic Radical Prostatectomy: A Randomized Comparison of Methodology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Changes in sexual function based on the self reported SHIM assessment and penile morphometric outcomes based on penile dimension measurements at rest
研究概览
简要总结
The purpose of this study is to determine which technique in using a vacuum erection device (VED) is best. Erectile dysfunction (ED) after robotic prostate cancer surgery is a concern for both the surgeon and the patient. Recent studies have shown that beginning to use the vacuum pump on a daily basis starting with in 2-8 weeks may help prevent the start of penile shrinkage. This is a potential issue that can occur because of decreased blood flow after prostate cancer surgery. This study will allow researchers to determine and compare vacuum therapy techniques and erectile function outcomes of patients who have prostate cancer surgery
详细描述
PRIMARY OBJECTIVES:
I. Determine sexual function and penile morphometric outcomes for the post-robotic-assisted laparoscopic prostatectomy (RALP) patients undergoing daily vacuum therapy using one of two randomized methods and whether these outcomes differ.
SECONDARY OBJECTIVES:
I. Compare compliance rates between the two randomized groups using the compliance questionnaire and a diary collected from patients at each follow up visit.
II. Compare overall patient satisfaction with the recovery procedure between the two randomized groups utilizing the SHIM (Sexual Health Inventory for Men) questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Sexually active men without the consistent use of erectile aids pre-operatively (i.e. oral pharmacotherapy, intraurethral prostoglandin E1 [PGE1], intracavernosal injection therapy and penile implants)
- •Undergoing a bilateral nerve sparing robotic prostatectomy
- •Pre-operative baseline SHIM total score of greater than or equal to 17
- •Presence of a female sexual partner
- •Dexterity necessary to operate vacuum pump
排除标准
- •Has a history of cardiac failure, angina, or life-threatening arrhythmia within the past 6 months
- •Has taken or has been prescribed nitrate medication in any form in the last 6 months
- •Has a known sensitivity to Phosphodiesterase type 5 inhibitors such as Sildenafil, Tadalafil or Vardenafil
- •Men with sickle cell anemia
- •Men with insufficient manual dexterity to operate vacuum device
- •Men with a history of known penile deformity or Peyronie's disease
- •Pre or postoperative androgen therapy
- •Pre or postoperative radiation therapy to pelvic area
- •Men actively smoking at time of enrollment, 1 pack per day or more
研究组 & 干预措施
Group A (vacuum therapy, holding erection for 2 minutes)
Patients receive daily vacuum therapy over 10 minutes while holding erection for 2 minutes after undergoing RALP. Patients complete erection process 5 times. SHIM questionnaire administration will be completed prior to surgery and at 3, 6, 12 months and the compliance questionnaire at 3, 6, 12 months.
干预措施: Sexual Health Inventory for Men (SHIM) questionnaire administration (Other)
Group A (vacuum therapy, holding erection for 2 minutes)
Patients receive daily vacuum therapy over 10 minutes while holding erection for 2 minutes after undergoing RALP. Patients complete erection process 5 times. SHIM questionnaire administration will be completed prior to surgery and at 3, 6, 12 months and the compliance questionnaire at 3, 6, 12 months.
干预措施: management of therapy complications (Procedure)
Group A (vacuum therapy, holding erection for 2 minutes)
Patients receive daily vacuum therapy over 10 minutes while holding erection for 2 minutes after undergoing RALP. Patients complete erection process 5 times. SHIM questionnaire administration will be completed prior to surgery and at 3, 6, 12 months and the compliance questionnaire at 3, 6, 12 months.
干预措施: Daily vacuum therapy (Procedure)
Group B (vacuum therapy, holding erection for 5 minutes)
Patients receive daily vacuum therapy over 10 minutes while holding erection for 5 minutes after undergoing RALP. Patients complete erection process 2 times.Patients complete erection process 5 times. SHIM questionnaire administration will be completed prior to surgery and at 3, 6, 12 months and the compliance questionnaire at 3, 6, 12 months.
干预措施: Sexual Health Inventory for Men (SHIM) questionnaire administration (Other)
Group B (vacuum therapy, holding erection for 5 minutes)
Patients receive daily vacuum therapy over 10 minutes while holding erection for 5 minutes after undergoing RALP. Patients complete erection process 2 times.Patients complete erection process 5 times. SHIM questionnaire administration will be completed prior to surgery and at 3, 6, 12 months and the compliance questionnaire at 3, 6, 12 months.
干预措施: management of therapy complications (Procedure)
Group B (vacuum therapy, holding erection for 5 minutes)
Patients receive daily vacuum therapy over 10 minutes while holding erection for 5 minutes after undergoing RALP. Patients complete erection process 2 times.Patients complete erection process 5 times. SHIM questionnaire administration will be completed prior to surgery and at 3, 6, 12 months and the compliance questionnaire at 3, 6, 12 months.
干预措施: Daily vacuum therapy (Procedure)
结局指标
主要结局
Changes in sexual function based on the self reported SHIM assessment and penile morphometric outcomes based on penile dimension measurements at rest
时间窗: 12 months post-surgery
Summarized according to assigned treatment group. Linear mixed models will be used to model the changes over time.
Changes in sexual function based on the self reported SHIM assessment and penile morphometric outcomes based on penile dimension measurements at rest
时间窗: 3 months post-surgery
Summarized according to assigned treatment group. Linear mixed models will be used to model the changes over time.
Changes in sexual function based on the self reported SHIM assessment and penile morphometric outcomes based on penile dimension measurements at rest
时间窗: 6 months post-surgery
Summarized according to assigned treatment group. Linear mixed models will be used to model the changes over time.
次要结局
- Compliance and overall patient satisfaction (1 to 25 point scale) based on the self reported compliance diary and SHIM questionnaires(Up to 12 months post-surgery)