Change in Penile Length Following Bilateral Nerve-Sparing Radical Prostatectomy

Study Overview
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: Penile Exam, Peyronie's Plaque and Erectile function assessment


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| open, laparoscopic, or robotic-assisted lap<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the association between penile length change and erectile function. |  | conclusion of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate, Erectile function, Peyronie's Plaque, 08-135