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Change in Penile Length Following Bilateral Nerve-Sparing Radical Prostatectomy

NCT00800813 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 121

Last updated 2014-07-14

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Penile Exam, Peyronie's Plaque and Erectile function assessment

At the baseline visit, the patient's co-morbidities, height, weight with calculation of body mass index will be documented. After surgery, the patient will be instructed to keep a diary to record erectile function including how often they use a PDE-5 inhibitor or injection therapy and each time they get an erection and the level of rigidity. The diary is required to document PDE-5 inhibitor and injection therapy use and response in each sexual encounter, unlike the IIEF questionnaire, which addresses erectile function over a 4-week period. Accurate documentation is essential for erectile function assessment, as patient choice of erectile function medication may differ in each sexual encounter, and accordingly, the achieved rigidity level.

Sponsors & Collaborators

Principal Investigators

  • John Mulhall, MD · Memorial Sloan Kettering Cancer Center

Eligibility

Min Age
21 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00800813 on ClinicalTrials.gov