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

• ClinicalTrials.gov Identifier: NCT01660152
• Recruitment Status: Completed
• First Posted: August 8, 2012
• Last Update Posted: April 13, 2017
• Sponsor: Ohio State University Comprehensive Cancer Center
• Information provided by (Responsible Party): Ohio State University Comprehensive Cancer Center

Study Description

Brief 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

Condition or disease	Intervention/treatment	Phase
Male Erectile Disorder; Prostate Cancer; Sexual Dysfunction	Other: Sexual Health Inventory for Men (SHIM) questionnaire administration; Procedure: management of therapy complications; Procedure: Daily vacuum therapy	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• 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
• Study Start Date: September 2011
• Actual Primary Completion Date: July 17, 2013
• Actual Study Completion Date: July 17, 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Other: Sexual Health Inventory for Men (SHIM) questionnaire administration; Questionnaire will be completed prior to surgery and at 3, 6, 12 months and the compliance questionnaire at 3, 6, 12 months.; Other Name: assessment; Procedure: management of therapy complications; Receive VED; Other Name: complications of therapy, management of; Procedure: 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: 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.	Other: Sexual Health Inventory for Men (SHIM) questionnaire administration; Questionnaire will be completed prior to surgery and at 3, 6, 12 months and the compliance questionnaire at 3, 6, 12 months.; Other Name: assessment; Procedure: management of therapy complications; Receive VED; Other Name: complications of therapy, management of; Procedure: 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.

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   Summarized according to assigned treatment group. Linear mixed models will be used to model the changes over time.
2. 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 ]
   Summarized according to assigned treatment group. Linear mixed models will be used to model the changes over time.
3. 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 ]
   Summarized according to assigned treatment group. Linear mixed models will be used to model the changes over time.

Secondary Outcome Measures :

1. 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 ]
   Summarized according to assigned treatment group.

Eligibility Criteria

• Ages Eligible for Study: up to 70 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Ohio

Ohio State University Medical Center

Columbus, Ohio, United States, 43210

Sponsors and Collaborators

Ohio State University Comprehensive Cancer Center

Investigators

• Principal Investigator: Ronney Abaza, MD; Ohio State University

More Information

Additional Information:

Jamesline 

• Responsible Party: Ohio State University Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT01660152
• Other Study ID Numbers: OSU-11019; NCI-2012-00997 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
• First Posted: August 8, 2012
• Last Update Posted: April 13, 2017
• Last Verified: April 2017

Keywords provided by Ohio State University Comprehensive Cancer Center:

male erectile disorder; prostate cancer; Laparoscopic prostatectomy

Additional relevant MeSH terms:

Prostatic Neoplasms; Erectile Dysfunction; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders