We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Change in Penile Length Following Bilateral Nerve-Sparing Radical Prostatectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00800813
Recruitment Status : Completed
First Posted : December 2, 2008
Last Update Posted : July 14, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Prostate Cancer Behavioral: Penile Exam, Peyronie's Plaque and Erectile function assessment

Study Type : Observational
Actual Enrollment : 121 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessing the Change in Penile Length Following Bilateral Nerve-Sparing Radical Prostatectomy
Study Start Date : November 2008
Primary Completion Date : July 2014
Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
open, laparoscopic, or robotic-assisted lap
Patients will also be assessed for penile length and the presence of Peyronie's Disease at these specified times.
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.




Primary Outcome Measures :
  1. Assess the impact of radical retropubic prostatectomy on penile dimensions. [ Time Frame: conclusion of the study ]
  2. Assess the impact of radical retropubic prostatectomy on the development of Peyronie's Disease. [ Time Frame: conclusion of the study ]

Secondary Outcome Measures :
  1. Assess the association between penile length change and erectile function. [ Time Frame: conclusion of the study ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing open, laparoscopic, or robotic-assisted laparoscopic radical prostatectomy at MSKCC.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00800813


Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: John Mulhall, MD Memorial Sloan Kettering Cancer Center

Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00800813     History of Changes
Other Study ID Numbers: 08-135
First Posted: December 2, 2008    Key Record Dates
Last Update Posted: July 14, 2014
Last Verified: July 2014

Keywords provided by Memorial Sloan Kettering Cancer Center:
Prostate
Erectile function
Peyronie's Plaque
08-135