Change in Penile Length Following Bilateral Nerve-Sparing Radical Prostatectomy

NCT00800813 | Completed

• 1 other identifier: 08-135
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate; Erectile function; Peyronie's Plaque; 08-135

Outcome Measures

Primary Outcomes (2)

• Assess the impact of radical retropubic prostatectomy on penile dimensions.

  conclusion of the study

• Assess the impact of radical retropubic prostatectomy on the development of Peyronie's Disease.

  conclusion of the study

Secondary Outcomes (1)

• Assess the association between penile length change and erectile function.

  conclusion of the study

Study Arms (1)

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

Interventions

Penile Exam, Peyronie's Plaque and Erectile function assessment BEHAVIORAL

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.

open, laparoscopic, or robotic-assisted lap

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing open, laparoscopic, or robotic-assisted laparoscopic radical prostatectomy at MSKCC.

You may qualify if:

• 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)

You may not qualify if:

• Preoperative / Postoperative pelvic radiation therapy
• Preoperative / Postoperative hormonal treatment
• Preoperative Peyronie's disease
• Preoperative presence of a penile implant

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• John Mulhall, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2008
• First Posted: December 2, 2008
• Study Start: November 1, 2008
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 14, 2014

Record last verified: 2014-07

Locations

US (1)