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Change in Penile Length Following Bilateral Nerve-Sparing Radical Prostatectomy

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ClinicalTrials.gov Identifier: NCT00800813
Recruitment Status : Completed
First Posted : December 2, 2008
Last Update Posted : July 14, 2014
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date December 1, 2008
First Posted Date December 2, 2008
Last Update Posted Date July 14, 2014
Study Start Date November 2008
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 1, 2008)
  • Assess the impact of radical retropubic prostatectomy on penile dimensions. [ Time Frame: conclusion of the study ]
  • Assess the impact of radical retropubic prostatectomy on the development of Peyronie's Disease. [ Time Frame: conclusion of the study ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00800813 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 1, 2008)
Assess the association between penile length change and erectile function. [ Time Frame: conclusion of the study ]
Original Secondary Outcome Measures Same as current
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Change in Penile Length Following Bilateral Nerve-Sparing Radical Prostatectomy
Official Title Assessing the Change in Penile Length Following Bilateral Nerve-Sparing Radical Prostatectomy
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients undergoing open, laparoscopic, or robotic-assisted laparoscopic radical prostatectomy at MSKCC.
Condition Prostate Cancer
Intervention 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.

Study Groups/Cohorts 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.
Intervention: Behavioral: Penile Exam, Peyronie's Plaque and Erectile function assessment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 13, 2011)
121
Original Estimated Enrollment
 (submitted: December 1, 2008)
100
Actual Study Completion Date July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Male
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00800813
Other Study ID Numbers 08-135
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor Memorial Sloan Kettering Cancer Center
Collaborators Not Provided
Investigators
Principal Investigator: John Mulhall, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date July 2014