Clinical Trial: Pharmacological Penile Rehabilitation in the Preservation of Erectile Function Following Bilateral Nerve-Sparing Radical Prostatectomy

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Randomized Trial of Pharmacological Penile Rehabilitation in the Preservation of Erectile Function Following Bilateral Nerve-Sparing Radical Prostatectomy

Brief Summary:

When a bilateral nerve-sparing radical prostatectomy (RP) is performed, recovery of erectile function (rigid erections) is reported for up to 80% of patients, who are less than 60 years old. Erectile function recovery is also impacted by patient age, erectile function before surgery, and the length of time after surgery.

Current evidence from studies suggests that developing erections is important, however, these studies have been small, and the evidence is not definite. Animal studies suggest that erection medication (Viagra, Levitra, Cialis) may protect erection tissue, even in the absence of erections. However, the correct treatment plan is unknown. For example, how often does a man need to take sildenafil (Viagra®) to protect his erectile function or to maximize his erectile function recovery? Is only using erection medication enough for erectile function recovery? Would penile injections, which almost ensure production of an erection, be better than using sildenafil (Viagra®), or might a combination be even better at helping recovery of erections? These are types of questions this study might answer.


Detailed Summary:
Sponsor: Memorial Sloan Kettering Cancer Center

Current Primary Outcome: Difference in the erectile function (EF) domain score of the International Index of Erectile Function (IIEF) between the 3 groups at 24 months. [ Time Frame: 2 years ]

Original Primary Outcome: Difference in the erectile function (EF) domain score of the International Index of Erectile Function (IIEF) between the 3 groups at 24 months post-RP. [ Time Frame: 2 years ]

Current Secondary Outcome:

  • The time to return of spontaneous functional erections. [ Time Frame: 2 years ]
  • The time for patients to respond to oral erectogenic therapy. [ Time Frame: 2 years ]
  • The proportion of patients who have normalization of their erectile function (normalization of the EF domain of the IIEF). [ Time Frame: 2 years ]


Original Secondary Outcome: Same as current

Information By: Memorial Sloan Kettering Cancer Center

Dates:
Date Received: August 7, 2009
Date Started: August 2009
Date Completion: August 2017
Last Updated: September 26, 2016
Last Verified: September 2016