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


N/A
18 Years
64 Years
Not Enrolling
Male
Prostate Cancer

Thank you

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 CenterBaltimore, Maryland  21224