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Change in Penile Length Following Bilateral Nerve-Sparing Radical Prostatectomy
This study is currently recruiting participants.
Study NCT00800813   Information provided by Memorial Sloan-Kettering Cancer Center
First Received: December 1, 2008   Last Updated: October 20, 2009   History of Changes

December 1, 2008
October 20, 2009
November 2008
December 2010   (final data collection date for primary outcome measure)
  • Assess the impact of radical retropubic prostatectomy on penile dimensions. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
  • Assess the impact of radical retropubic prostatectomy on the development of Peyronie's Disease. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00800813 on ClinicalTrials.gov Archive Site
Assess the association between penile length change and erectile function. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
Same as current
 
Change in Penile Length Following Bilateral Nerve-Sparing Radical Prostatectomy
Assessing the Change in Penile Length Following Bilateral Nerve-Sparing Radical Prostatectomy

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.

 
 
Observational
Cohort, Prospective
Prostate Cancer
Behavioral: 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.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
120
December 2010
December 2010   (final data collection date for primary outcome measure)

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)

Exclusion Criteria:

  • Preoperative / Postoperative pelvic radiation therapy
  • Preoperative / Postoperative hormonal treatment
  • Preoperative Peyronie's disease
  • Preoperative presence of a penile implant
Male
21 Years and older
No
Contact: Jamie Yingst yingstj@mskcc.edu
United States
 
NCT00800813
John Mulhall, MD, Memorial Sloan-Kettering Cancer Center
08-135
Memorial Sloan-Kettering Cancer Center
 
Principal Investigator: John Mulhall, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP