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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00577876 |
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Date of registration:
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18/12/2007 |
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Primary sponsor: |
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Public title:
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Assessment of the Functional Significance of Accessory Pudendal Arteries
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Scientific title:
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Assessment of the Functional Significance of Accessory Pudendal Arteries |
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Date of first enrolment:
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September 2006 |
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Target sample size:
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38 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00577876 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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John Mulhall, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Memorial Sloan-Kettering Cancer Center |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Prostate Cancer
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Intervention(s)
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Procedure: Trimix Injection with Doppler Ultrasound
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Primary Outcome(s)
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To determine the proportion of men with APAs for whom APAs contribute to penile blood flow
[Time Frame: 18 mo]
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Secondary Outcome(s)
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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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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