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

This study has been completed.
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00511498
First received: August 3, 2007
Last updated: November 28, 2008
Last verified: November 2008

August 3, 2007
November 28, 2008
March 2006
September 2007   (final data collection date for primary outcome measure)
IIEF score [ Time Frame: 13 months ] [ Designated as safety issue: No ]
IIEF score [ Time Frame: 13 months ]
Complete list of historical versions of study NCT00511498 on ClinicalTrials.gov Archive Site
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Effect of Nightly Versus Prn Sildenafil on Early Return of Erectile Function Following Laparoscopic Radical Prostatectomy
Effect of Nightly Versus Prn Sildenafil on Early Return of Erectile Function Following Nerve-Sparing 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Prostate Cancer
Drug: Sildenafil
50 mg daily at bedtime
Other Name: Viagra
  • Placebo Comparator: Placebo Arm
    Placebo nightly
    Intervention: Drug: Sildenafil
  • Active Comparator: Drug
    Sildenafil 50mg nightly
    Intervention: Drug: Sildenafil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
October 2008
September 2007   (final data collection date for primary outcome measure)

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
Male
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00511498
NA_00001428
Yes
Christian Pavlovich, M.D., Johns Hopkins University
Johns Hopkins University
Not Provided
Principal Investigator: Christian P Pavlovich, MD Johns Hopkins University
Johns Hopkins University
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP