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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
History of Changes
  Purpose

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 Intervention
Prostate Cancer
 Drug: Sildenafil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Effect of Nightly Versus Prn Sildenafil on Early Return of Erectile Function Following Nerve-Sparing Laparoscopic Radical Prostatectomy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • IIEF score [ Time Frame: 13 months ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: March 2006
Study Completion Date: October 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00511498

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

No publications provided

Responsible Party: Christian Pavlovich, M.D., Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00511498     History of Changes
Other Study ID Numbers: NA_00001428
Study First Received: August 3, 2007
Last Updated: November 28, 2008
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Sildenafil
 Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013