Change in Penile Length Following Bilateral Nerve-Sparing Radical Prostatectomy
|Prostate Cancer||Behavioral: Penile Exam, Peyronie's Plaque and Erectile function assessment|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Assessing the Change in Penile Length Following Bilateral Nerve-Sparing Radical Prostatectomy|
- 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 ]
|Study Start Date:||November 2008|
|Study Completion Date:||July 2014|
|Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|