Change in Penile Length Following Bilateral Nerve-Sparing Radical Prostatectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

121 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2014-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Penile Exam, Peyronie's Plaque and Erectile function assessment

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No