Vacuum Erection Device in Improving Recovery of Erectile Function in Patients With Prostate Cancer Undergoing Surgery
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ClinicalTrials.gov Identifier: NCT01660152 |
Recruitment Status :
Completed
First Posted : August 8, 2012
Last Update Posted : April 13, 2017
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Condition or disease | Intervention/treatment | Phase |
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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 |
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 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 |

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.
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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. |
- 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.
- 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.
- 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.
- 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.

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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 |
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

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
United States, Ohio | |
Ohio State University Medical Center | |
Columbus, Ohio, United States, 43210 |
Principal Investigator: | Ronney Abaza, MD | Ohio State University |
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 |
male erectile disorder prostate cancer Laparoscopic prostatectomy |
Prostatic Neoplasms Erectile Dysfunction Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Prostatic Diseases Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Mental Disorders |