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

Completed · Not applicable

Conditions studied: Male Erectile Disorder, Prostate Cancer, Sexual Dysfunction

In brief

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

Key facts

Study ID

NCT01660152

Run by

Ohio State University Comprehensive Cancer Center

People needed

2

Starts

2011-09-01

Expected to finish

2013-07-17

Last updated by the study team

2017-04-13

Who can join

Age: any, up to 70. Sex: male. Healthy volunteers: not accepted.

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

Where it is running

• Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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