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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01660152
Recruitment Status : Completed
First Posted : August 8, 2012
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
Ohio State University Comprehensive Cancer Center

Study Description
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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
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01660152


Locations
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United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
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Principal Investigator: Ronney Abaza, MD Ohio State University
More Information
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Additional Information:

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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    Key Record Dates
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:
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Prostatic Neoplasms
Erectile Dysfunction
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Prostatic Diseases
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders