Assessment of the Functional Significance of Accessory Pudendal Arteries - Full Text View

Sponsored by:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00577876

Purpose

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.

Condition	Intervention
Prostate Cancer	Procedure: Trimix Injection with Doppler Ultrasound

MedlinePlus related topics: Cancer Prostate Cancer Ultrasound

Drug Information available for: Phentolamine Alprostadil Papaverine Phentolamine mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	Assessment of the Functional Significance of Accessory Pudendal Arteries

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

To determine the proportion of men with APAs for whom APAs contribute to penile blood flow [ Time Frame: 18 mo ] [ Designated as safety issue: No ]

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. [ Time Frame: 18 mo ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	September 2006
Study Completion Date:	February 2008
Estimated Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.	Procedure: Trimix Injection with Doppler Ultrasound 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.

Arms

Assigned Interventions

1: Active Comparator

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.

Procedure: Trimix Injection with Doppler Ultrasound

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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

They have selected a LRP, with or without robotic assistance, by Dr. Bertrand Guillonneau or Karim Touijer for definitive treatment of their prostate cancer after a full discussion of treatment options.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00577876

Locations

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

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

More Information

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Bertrand Guillonneau, MD )
Study ID Numbers:	06-073
Study First Received:	December 18, 2007
Last Updated:	March 6, 2008
ClinicalTrials.gov Identifier:	NCT00577876
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Alprostadil
Phentolamine
Papaverine
Prostatic Diseases

Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009