Prostate Cancer Clinical Trial

Effect of Nightly Versus Prn Sildenafil on Early Return of Erectile Function Following Laparoscopic Radical Prostatectomy

Summary

The ability of sildenafil to aid in the return of erections after nerve-sparing radical prostatectomy has been established. Patients who had either one or both neurovascular bundles spared demonstrated dramatically better responses to "as needed" sildenafil than those that did not, and a positive erectile response to sildenafil was only seen in patients in whom at least one NVB was spared. This study has been designed to determine if sildenafil taken nightly works better than sildenafil on as "as needed" basis for the return of erectile function. The investigators hypothesis is that sildenafil taken nightly promotes a more rapid return of erectile function after nerve-sparing laparoscopic radical prostatectomy.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Male sex
Age < 65
IIEF erectile function domain score > 26 (out of 30 points possible for this subscale)
Steady sexual partner
Untreated prostate cancer TNM stage < cT2bNxMx (cT1a, cT1b, cT1c, cT2a) and Gleason grade < 8.
Willingness to participate in a clinical trial as manifested by informed consent
Actually undergo nerve-sparing LRP surgery

Exclusion Criteria:

Not fulfilling all of the criteria for entry above
Any prior prostate cancer treatment (radiation, hormonal deprivation, chemotherapy)
Contraindication to sildenafil (e.g. nitrates, hypersensitivity)
Existing PDE5 inhibitor requirement for functional erection (e.g. for intercourse) preoperatively
Obstructive sleep apnea

Study is for people with:

Prostate Cancer

Estimated Enrollment:

100

Study ID:

NCT00511498

Recruitment Status:

Completed

Sponsor:

Johns Hopkins University

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There is 1 Location for this study

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Johns Hopkins Bayview Medical Center
Baltimore Maryland, 21224, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

100

Study ID:

NCT00511498

Recruitment Status:

Completed

Sponsor:


Johns Hopkins University

How clear is this clinincal trial information?

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