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Assessment of the Functional Significance of Accessory Pudendal Arteries

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trimix Injection with Doppler Ultrasound
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Day of Surgery:Patient is admitted through the Preoperative Surgical Center (PSC). If a large APA is identified, then subject will continue on study Dissect APA (without any changes from what is routinely done) with a penile injection of Trimix. Once the initial Doppler Ultrasound is completed, the accessory pudendal artery will be temporarily clamped to stop blood flow. After the artery is clamped, the Doppler Ultrasound will be repeated. We estimate an extension of the surgery no longer than 5 or 10 minutes in comparison to the usual operating time. Once the Doppler Ultrasound is completed, the clamp will be removed and the surgery continued in its usual fashion.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To describe peak systolic, diastolic and resistive index velocities of the dorsal artery of the penis before and after clamping of the APA.

Full Information

First Posted
December 18, 2007
Last Updated
October 25, 2011
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00577876
Brief Title
Assessment of the Functional Significance of Accessory Pudendal Arteries
Official Title
Assessment of the Functional Significance of Accessory Pudendal Arteries
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

Brief Summary
For patients with Prostate Cancer advances in medical technology have enabled us to identify "accessory" (additional) pudendal arteries (called APA) while performing a laparoscopic radical prostatectomy (a scope with a video camera is used during the surgery). APAs running near the prostate gland are identified in approximately 1 in 3 to 4 patients. However, large APAs, like the ones looked for in this study, are identified in 15-18% of all patients. These arteries are preserved more than 80% of the time, depending on their size and location.With this study, we plan to evaluate whether APAs supply blood to the penis and male erections, as well as the amount supplied.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Day of Surgery:Patient is admitted through the Preoperative Surgical Center (PSC). If a large APA is identified, then subject will continue on study Dissect APA (without any changes from what is routinely done) with a penile injection of Trimix. Once the initial Doppler Ultrasound is completed, the accessory pudendal artery will be temporarily clamped to stop blood flow. After the artery is clamped, the Doppler Ultrasound will be repeated. We estimate an extension of the surgery no longer than 5 or 10 minutes in comparison to the usual operating time. Once the Doppler Ultrasound is completed, the clamp will be removed and the surgery continued in its usual fashion.
Intervention Type
Procedure
Intervention Name(s)
Trimix Injection with Doppler Ultrasound
Intervention Description
In case a large APA was identified, it will be dissected following the usual technique. Upon completion of the dissection, patients will have intracavernosal injection of 10 units (0.1 ml) of a Trimix administered (PGE1 10 mcg/ml, papaverine hydrochloride 30 mg/mL and phentolamine mesylate 1mg/mL. Once the patient achieves a pharmacologic erection, the initial Doppler Ultrasound is completed, the accessory pudendal artery will be temporarily clamped to stop blood flow. After the artery is clamped, the Doppler Ultrasound will be repeated. We estimate an extension of the surgery no longer than 5 or 10 minutes in comparison to the usual operating time. Once the Doppler Ultrasound is completed, the clamp will be removed and the surgery continued in its usual fashion.
Primary Outcome Measure Information:
Title
To determine the proportion of men with APAs for whom APAs contribute to penile blood flow
Time Frame
18 mo
Secondary Outcome Measure Information:
Title
To describe peak systolic, diastolic and resistive index velocities of the dorsal artery of the penis before and after clamping of the APA.
Time Frame
18 mo

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Mulhall, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan-Kettering Cancer Center

Learn more about this trial

Assessment of the Functional Significance of Accessory Pudendal Arteries

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