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
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Behavioral: Penile Exam, Peyronie's Plaque and Erectile function assessment|
|Study Type :||Observational|
|Actual Enrollment :||121 participants|
|Official Title:||Assessing the Change in Penile Length Following Bilateral Nerve-Sparing Radical Prostatectomy|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
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.
- Assess the impact of radical retropubic prostatectomy on penile dimensions. [ Time Frame: conclusion of the study ]
- Assess the impact of radical retropubic prostatectomy on the development of Peyronie's Disease. [ Time Frame: conclusion of the study ]
- Assess the association between penile length change and erectile function. [ Time Frame: conclusion of the study ]
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
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||John Mulhall, MD||Memorial Sloan Kettering Cancer Center|