Effect of Nightly Versus Prn Sildenafil on Early Return of Erectile Function Following Nerve-Sparing Laparoscopic Radical Prostatectomy
N/A
18 Years
64 Years
18 Years
64 Years
Not Enrolling
Male
Prostate Cancer
Male
Prostate Cancer
Trial Information
Effect of Nightly Versus Prn Sildenafil on Early Return of Erectile Function Following Nerve-Sparing Laparoscopic Radical Prostatectomy
Inclusion Criteria:
1. Male sex
2. Age < 65
3. IIEF erectile function domain score > 26 (out of 30 points possible for this
subscale)
4. Steady sexual partner
5. Untreated prostate cancer TNM stage < cT2bNxMx (cT1a, cT1b, cT1c, cT2a) and Gleason
grade < 8.
6. Willingness to participate in a clinical trial as manifested by informed consent
7. Actually undergo nerve-sparing LRP surgery
Exclusion Criteria:
1. Not fulfilling all of the criteria for entry above
2. Any prior prostate cancer treatment (radiation, hormonal deprivation, chemotherapy)
3. Contraindication to sildenafil (e.g. nitrates, hypersensitivity)
4. Existing PDE5 inhibitor requirement for functional erection (e.g. for intercourse)
preoperatively
5. Obstructive sleep apnea
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator)
Outcome Measure:
IIEF score
Outcome Time Frame:
13 months
Safety Issue:
No
Principal Investigator
Christian P Pavlovich, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Johns Hopkins University
Authority:
United States: Institutional Review Board
Study ID:
NA_00001428
NCT ID:
NCT00511498
Start Date:
March 2006
Completion Date:
October 2008
Related Keywords:
- Prostate Cancer
- Laparoscopic Radical Prostatectomy
- Nightly sildenafil
- Prostatic Neoplasms
Name | Location |
|---|---|
| Johns Hopkins Bayview Medical Center | Baltimore, Maryland 21224 |
