CompletedNot Applicable

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

United States2 participantsStarted 2011-09

Plain-language 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

Who can participate

Age range70 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Changes in sexual function based on the self reported SHIM assessment and penile morphometric outcomes based on penile dimension measurements at rest

Timeframe: 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

Timeframe: 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

Timeframe: 12 months post-surgery

Trial details

NCT IDNCT01660152

SponsorOhio State University Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-07-17

View on ClinicalTrials.gov More Male Erectile Disorder trials

Plain-language summary

Who can participate

Age range70 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Changes in sexual function based on the self reported SHIM assessment and penile morphometric outcomes based on penile dimension measurements at rest

Timeframe: 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

Timeframe: 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

Timeframe: 12 months post-surgery