Overview

This trial has been completed.

Conditions male erectile disorder, prostate cancer, sexual dysfunction
Treatments sexual health inventory for men (shim) questionnaire administration, management of therapy complications, daily vacuum therapy
Sponsor Ohio State University Comprehensive Cancer Center
Start date September 2011
End date July 2013
Trial size 2 participants
Trial identifier NCT01660152, NCI-2012-00997, OSU-11019

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
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.
sexual health inventory for men (shim) questionnaire administration assessment
Questionnaire will be completed prior to surgery and at 3, 6, 12 months and the compliance questionnaire at 3, 6, 12 months.
management of therapy complications complications of therapy, management of
Receive VED
daily vacuum therapy
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.
(Experimental)
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.
sexual health inventory for men (shim) questionnaire administration assessment
Questionnaire will be completed prior to surgery and at 3, 6, 12 months and the compliance questionnaire at 3, 6, 12 months.
management of therapy complications complications of therapy, management of
Receive VED
daily vacuum therapy
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.

Primary Outcomes

Measure
Changes in sexual function based on the self reported SHIM assessment and penile morphometric outcomes based on penile dimension measurements at rest
time frame: 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
time frame: 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
time frame: 12 months post-surgery

Secondary Outcomes

Measure
Compliance and overall patient satisfaction (1 to 25 point scale) based on the self reported compliance diary and SHIM questionnaires
time frame: Up to 12 months post-surgery

Eligibility Criteria

Male participants up to 70 years old.

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

Additional Information

Official title 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
Principal investigator Ronney Abaza, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center.