Effect of Nightly Versus Prn Sildenafil on Early Return of Erectile Function Following Laparoscopic Radical Prostatectomy
Completed · Not applicable · Has a placebo group
Conditions studied: Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT00511498
- Run by
- Johns Hopkins University
- People needed
- 100
- Starts
- 2006-03-01
- Expected to finish
- 2008-10-01
- Last updated by the study team
- 2008-12-01
Who can join
Age: 18 and older, up to 64. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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