Change in Penile Length Following Bilateral Nerve-Sparing Radical Prostatectomy

Completed

• Conditions: Prostate Cancer
• Interventions: Behavioral: Penile Exam, Peyronie's Plaque and Erectile function assessment

• Registration Number: NCT00800813
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

Some men complain of changes in the shape or dimensions of their penis after undergoing radical prostatectomy (removal of the prostate) for prostate cancer. Changes in penile dimensions include shortening or decreased girth. Changes in shape include a curvature or bending of the penis, and/or the appearance of indentation. These changes may be associated with formation of scar tissue involving the covering of the erection chambers, known as "plaque". The appearance of indurated plaque and a resultant curvature or indentation is a well described medical condition known as "Peyronie's Disease" and may occur in men who did or did not undergo radical prostatectomy. The purpose of this study is to evaluate these changes in penile shape and dimensions.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-12-01
• Study First Submitted QC: 2008-12-01
• Study First Posted: 2008-12-02
• Status Verified: 2014-07
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2014-07-10
• Last Update Posted: 2014-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 121

Inclusion Criteria

• Males, age 21 years or older (no maximum age limit)
• Ability and willingness to give informed consent
• Clinically localized prostate cancer
• Open, laparoscopic or robotic-assisted radical prostatectomy
• Must be sexually active (penetrative or non-penetrative sexual encounters, either with a partner or self-stimulation)

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Exclusion Criteria

• Preoperative / Postoperative pelvic radiation therapy
• Preoperative / Postoperative hormonal treatment
• Preoperative Peyronie's disease
• Preoperative presence of a penile implant

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
open, laparoscopic, or robotic-assisted lap	Penile Exam, Peyronie's Plaque and Erectile function assessment	Patients will also be assessed for penile length and the presence of Peyronie's Disease at these specified times.

Primary Outcome Measures

Name	Time	Method
Assess the impact of radical retropubic prostatectomy on penile dimensions.	conclusion of the study
Assess the impact of radical retropubic prostatectomy on the development of Peyronie's Disease.	conclusion of the study

Secondary Outcome Measures

Name	Time	Method
Assess the association between penile length change and erectile function.	conclusion of the study

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States