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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00511498
Recruitment Status : Completed
First Posted : August 6, 2007
Last Update Posted : December 1, 2008
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Prostate Cancer Drug: Sildenafil

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Official Title: Effect of Nightly Versus Prn Sildenafil on Early Return of Erectile Function Following Nerve-Sparing Laparoscopic Radical Prostatectomy
Study Start Date : March 2006
Primary Completion Date : September 2007
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Placebo Arm
Placebo nightly
Drug: Sildenafil
50 mg daily at bedtime
Other Name: Viagra
Active Comparator: Drug
Sildenafil 50mg nightly
Drug: Sildenafil
50 mg daily at bedtime
Other Name: Viagra

Outcome Measures

Primary Outcome Measures :
  1. IIEF score [ Time Frame: 13 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00511498

United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Principal Investigator: Christian P Pavlovich, MD Johns Hopkins University
More Information

Responsible Party: Christian Pavlovich, M.D., Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00511498     History of Changes
Other Study ID Numbers: NA_00001428
First Posted: August 6, 2007    Key Record Dates
Last Update Posted: December 1, 2008
Last Verified: November 2008

Keywords provided by Johns Hopkins University:
Laparoscopic Radical Prostatectomy
Nightly sildenafil

Additional relevant MeSH terms:
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents