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Assessment of the Functional Significance of Accessory Pudendal Arteries


N/A
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

Assessment of the Functional Significance of Accessory Pudendal Arteries


Overall, approximately 50% of patients become impotent (inability to achieve or maintain an
erect penis; also called erectile dysfunction) after radical prostatectomy (removal of the
prostate). It is already known that postoperative (after surgery) erectile dysfunction does
not depend solely on the preservation of the nerves going to the penis, but also to the
preservation of the arteries bringing blood to the penis.

Although, the presence and frequency of APAs have been studied, and the ability to preserve
them has also been noted, we still do not know how much these arteries contribute to a
male's erection. With this study, we plan to evaluate whether APAs supply blood to the penis
and male erections, as well as the amount supplied. While there is no immediate benefit to
you for participating in the study, these findings will further help our understanding of
APA's and the importance in preserving them during surgery.

The primary aim of this study is to determine the proportion of men with APAs for whom APAs
contribute to penile blood flow. The secondary aim is to describe peak systolic, diastolic
and resistive index velocities of the dorsal artery of the penis before and after clamping
of the APA.


Inclusion Criteria:



- They have selected a LRP, with or without robotic assistance, by Jonathan Colelman,
MD, Bertrand Guillonneau, MD, Vincent Laudone, MD, Raul Parra, MD, or Karim Touijer
MD for definitive treatment of their prostate cancer after a full discussion of
treatment options.

Exclusion Criteria:

- Patients undergoing Open Radical Prostatectomy

- Patients with prior history of insulin dependent diabetes mellitus

- Patient who have received prior radiation therapy to the pelvis or prostate

- Patients requiring anticoagulation postoperatively

- Known allergy to Phenylephrine, Alprostadil, Papaverine or Phentolamine

- Patients whose systolic blood pressure is below 90 mmHg at the time of evaluation
despite routine measures taken by the anesthesiologist at his best criteria.

- Patients with labile hypertension or history of prior priapism

- Patients with penile scarring or penile prosthesis

- Patients with an International Index of Erectile Function score < 24

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the proportion of men with APAs for whom APAs contribute to penile blood flow

Outcome Time Frame:

18 mo

Safety Issue:

No

Principal Investigator

John Mulhall, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

06-073

NCT ID:

NCT00577876

Start Date:

September 2006

Completion Date:

October 2011

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer Center New York, New York  10021