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Change in Penile Length Following Bilateral Nerve-Sparing Radical Prostatectomy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00800813
Enrollment
121
Registered
2008-12-02
Start date
2008-11-30
Completion date
2014-07-31
Last updated
2014-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

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

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.

Interventions

BEHAVIORALPenile 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.

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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

MeasureTime frame
Assess the association between penile length change and erectile function.conclusion of the study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026