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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00511498
• Other study ID #: NA_00001428
• Status: Completed
• Phase: N/A
• First received: August 3, 2007
• Last updated: November 28, 2008
• Start date: March 2006
• Est. completion date: October 2008

Study information

• Verified date: November 2008
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2008
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

Drug:
• Sildenafil
50 mg daily at bedtime

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IIEF score		13 months	No