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Completed

NCT Number: NCT00800813

Change in Penile Length Following Bilateral Nerve-Sparing Radical Prostatectomy

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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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

21 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Memorial Sloan-Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: conclusion of the study

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

    Time frame: conclusion of the study

Secondary outcomes

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

    Time frame: conclusion of the study

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Dec 2, 2008
Registry last updated
Jul 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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