Change in Penile Length Following Bilateral Nerve-Sparing Radical Prostatectomy

Prostate Cancer Clinical Trial

Official title:

Assessing the Change in Penile Length Following Bilateral Nerve-Sparing Radical Prostatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00800813
• Other study ID #: 08-135
• Status: Completed
• Phase: N/A
• First received: December 1, 2008
• Last updated: July 10, 2014
• Start date: November 2008
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the impact of radical retropubic prostatectomy on penile dimensions.		conclusion of the study	No
Primary	Assess the impact of radical retropubic prostatectomy on the development of Peyronie's Disease.		conclusion of the study	No
Secondary	Assess the association between penile length change and erectile function.		conclusion of the study	No

External Links

•   Memorial Sloan-Kettering Cancer Center