Vacuum Erection Device in Improving Recovery of Erectile Function in Patients With Prostate Cancer Undergoing Surgery

Study Overview
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Brief Summary
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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

Detailed Description
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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. OUTLINE: Patients are randomized to 1 of 2 treatment groups. GROUP A: Patients receive vacuum therapy daily over 10 minutes while holding erection for 2 minutes after undergoing RALP. Patients complete erection process 5 times. GROUP B: Patients receive vacuum therapy daily over 10 minutes while holding erection for 5 minutes after undergoing RALP. Patients complete erection process 2 times. After completion of study treatment, patients are followed up at 3, 6, and 12 months.

Official Title
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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

Conditions
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Male Erectile Disorder, Prostate Cancer, Sexual Dysfunction

Intervention / Treatment
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* Other: Sexual Health Inventory for Men (SHIM) questionnaire administration
* Procedure: management of therapy complications
* Procedure: Daily vacuum therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A (vacuum therapy, holding erection for 2 minutes)<br>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. | Other: Sexual Health Inventory for Men (SHIM) questionnaire administration<br>* Questionnaire will be completed prior to surgery and at 3, 6, 12 months and the compliance questionnaire at 3, 6, 12 months.<br>* Other names: assessment;Procedure: management of therapy complications<br>* Receive VED<br>* Other names: complications of therapy, management of;Procedure: Daily vacuum therapy<br>* Patients randomized to Group A or Group B following removal of catheter at first post op visit following surger. Daily vacuum therapy for approximately 10 minutes. Depending on which group randomized to erection held for 2 minutes or 5 mintues.<br>|
| Experimental: Group B (vacuum therapy, holding erection for 5 minutes)<br>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. | Other: Sexual Health Inventory for Men (SHIM) questionnaire administration<br>* Questionnaire will be completed prior to surgery and at 3, 6, 12 months and the compliance questionnaire at 3, 6, 12 months.<br>* Other names: assessment;Procedure: management of therapy complications<br>* Receive VED<br>* Other names: complications of therapy, management of;Procedure: Daily vacuum therapy<br>* Patients randomized to Group A or Group B following removal of catheter at first post op visit following surger. Daily vacuum therapy for approximately 10 minutes. Depending on which group randomized to erection held for 2 minutes or 5 mintues.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in sexual function based on the self reported SHIM assessment and penile morphometric outcomes based on penile dimension measurements at rest | Summarized according to assigned treatment group. Linear mixed models will be used to model the changes over time. | 3 months post-surgery | 
| Changes in sexual function based on the self reported SHIM assessment and penile morphometric outcomes based on penile dimension measurements at rest | Summarized according to assigned treatment group. Linear mixed models will be used to model the changes over time. | 6 months post-surgery | 
| Changes in sexual function based on the self reported SHIM assessment and penile morphometric outcomes based on penile dimension measurements at rest | Summarized according to assigned treatment group. Linear mixed models will be used to model the changes over time. | 12 months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance and overall patient satisfaction (1 to 25 point scale) based on the self reported compliance diary and SHIM questionnaires | Summarized according to assigned treatment group. | Up to 12 months post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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male erectile disorder, prostate cancer, Laparoscopic prostatectomy