Vacuum Erection Device in Improving Recovery of Erectile Function in Patients With Prostate Cancer Undergoing Surgery
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
2 other identifiers
interventional
2
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 6, 2012
CompletedFirst Posted
Study publicly available on registry
August 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 17, 2013
CompletedApril 13, 2017
April 1, 2017
1.9 years
August 6, 2012
April 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
Compliance and overall patient satisfaction (1 to 25 point scale) based on the self reported compliance diary and SHIM questionnaires
Up to 12 months post-surgery
Study Arms (2)
Group A (vacuum therapy, holding erection for 2 minutes)
EXPERIMENTALPatients 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.
Group B (vacuum therapy, holding erection for 5 minutes)
EXPERIMENTALPatients 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.
Interventions
Questionnaire will be completed prior to surgery and at 3, 6, 12 months and the compliance questionnaire at 3, 6, 12 months.
Receive VED
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronney Abaza, MD
Ohio State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2012
First Posted
August 8, 2012
Study Start
September 1, 2011
Primary Completion
July 17, 2013
Study Completion
July 17, 2013
Last Updated
April 13, 2017
Record last verified: 2017-04