Change in Penile Length Following Bilateral Nerve-Sparing Radical Prostatectomy
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Purpose
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 | Intervention |
|---|---|
|
Prostate Cancer |
Behavioral: Penile Exam, Peyronie's Plaque and Erectile function assessment |
| Study Type: | Observational |
| 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 ] [ 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 ]
- Assess the association between penile length change and erectile function. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
| Enrollment: | 121 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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. |
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients undergoing open, laparoscopic, or robotic-assisted laparoscopic radical prostatectomy at MSKCC.
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
Contacts and Locations| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00800813 History of Changes |
| Other Study ID Numbers: | 08-135 |
| Study First Received: | December 1, 2008 |
| Last Updated: | January 31, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
Prostate Erectile function Peyronie's Plaque 08-135 |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013