Change in Penile Length Following Bilateral Nerve-Sparing Radical Prostatectomy - Full Text View

Sponsor:	Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00800813

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 2013
Estimated Primary Completion Date:	December 2013 (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.

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

Study Population

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00800813

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

John Mulhall, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

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 24, 2012
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 24, 2012