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

NCT00511498 | Completed DMC

• 1 other identifier: NA_00001428
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Laparoscopic Radical Prostatectomy; Nightly sildenafil

Outcome Measures

Primary Outcomes (1)

• IIEF score

  13 months

Study Arms (2)

Placebo Arm

PLACEBO COMPARATOR

Placebo nightly

Drug: Sildenafil

Drug

ACTIVE COMPARATOR

Sildenafil 50mg nightly

Drug: Sildenafil

Interventions

Sildenafil DRUG

50 mg daily at bedtime

Also known as: Viagra

Drug; Placebo Arm

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male sex
• Age \< 65
• IIEF erectile function domain score \> 26 (out of 30 points possible for this subscale)
• Steady sexual partner
• Untreated prostate cancer TNM stage \< cT2bNxMx (cT1a, cT1b, cT1c, cT2a) and Gleason grade \< 8.
• Willingness to participate in a clinical trial as manifested by informed consent
• Actually undergo nerve-sparing LRP surgery

You may not qualify if:

• Not fulfilling all of the criteria for entry above
• Any prior prostate cancer treatment (radiation, hormonal deprivation, chemotherapy)
• Contraindication to sildenafil (e.g. nitrates, hypersensitivity)
• Existing PDE5 inhibitor requirement for functional erection (e.g. for intercourse) preoperatively
• Obstructive sleep apnea

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Christian P Pavlovich, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 3, 2007
• First Posted: August 6, 2007
• Study Start: March 1, 2006
• Primary Completion: September 1, 2007
• Study Completion: October 1, 2008
• Last Updated: December 1, 2008

Record last verified: 2008-11

Locations

US (1)