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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sildenafil

Drug

50 mg daily at bedtime

Other names: Viagra

Primary outcomes

IIEF score

Time frame: 13 months

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2007
Study completion: 2008
First posted: Aug 6, 2007
Registry last updated: Dec 1, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed