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

ClinicalTrials.gov · TERMINATED, 2020

76 participants

Abstract

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.

Conditions: Penile Cancer, Erectile Dysfunction, Radical Prostatectomy.

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..

Enrollment: 76 participants.

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 76 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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