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| Sponsor: | University of British Columbia |
|---|---|
| Information provided by: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT00175682 |
Purpose
Sexuality is a high rehabilitative priority for persons following a spinal cord injury (SCI). Sexual acts can lead to autonomic dysreflexia (AD), dangerous consequences such as a sudden increase in blood pressure, severe headache, sweating above the level of the lesion and low heart rate to name a few. Ejaculation in men can provoke these significant symptoms and therefore men and women may refrain from a sexual life and biological parenthood. Adalat is the most common antihypertensive used in fertility clinics to reduce the incidence of AD. It dramatically reduces blood pressure and, therefore, results in side effects such as dizziness, fatigue and weakness. The investigators hypothesize that Minipress® (prazosin HCL), a blood pressure medication, which has a slower and less abrupt suppressive effect on blood pressure, would be a safe, effective and more appropriate medication for use in the outpatient sperm retrieval clinic and potentially for private use.
| Condition | Intervention |
|---|---|
|
Autonomic Dysreflexia |
Drug: Prazosin HCL |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | Prophylactic Value of Prazosin in Reducing the Objective and Subjective Measures of Autonomic Dysreflexia Provoked by Ejaculation in Men With Spinal Cord Injury |
| Estimated Enrollment: | 8 |
| Study Start Date: | December 2004 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
The consequences of sexual activity in the spinal cord injured (SCI) population include responses beyond the voluntary control of the person with SCI such as bladder and bowel issues, spasms and autonomic dysreflexia (AD). Currently we are looking at predictive measurements for AD during ejaculation in a controlled setting. Immediate-release Nifedipine (Adalat), a well-known medication used for the treatment of AD is the most commonly prescribed prophylactic antihypertensive used in sperm retrieval and urological procedures. Nifedipine has rapid onset (minutes) and dramatically lowers blood pressure for periods of up to five hours and results in dizziness, fatigue and weakness. As a sperm retrieval center not equipped for hypotensive resuscitation measures, we have refrained from using Nifedipine prior to procedures in hypotensive SCI men at risk for AD.
Our objective is to study the prophylactic capacity of a lesser prescribed antihypertensive medication Prazosin on its ability to reduce the objective and subjective measures of autonomic dysreflexia in order to assess its immediate potential for home use. Prazosin is an alpha-adrenergic blocker and has a slower and less abrupt suppressive effect on blood pressure. We hypothesize that it will reduce AD signs and symptoms, reduce the severity of cardiovascular changes, and improve client comfort without reduction in safety. Having 8 male subjects as their own controls, we plan to examine the objective (beat to beat blood pressure, EKG and visible body signs) and subjective (patient's symptomatic report) parameters of AD provoked by vibrostimulation and ejaculation on and off Minipress (Prazosin HCL). Statistical analysis will be done on three independent observations:
We will correlate objective parameters with the subjective findings to see if these observations can be predictive in determining the predictability and severity of AD and the effectiveness of Prazosin as prophylactic AD medication in an outpatient clinic or a private home setting during sexual activities.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Contacts and Locations| Contact: Maureen McGrath, RN | 604-875-4111 ext 68962 | Maureen.mcgrath@vch.ca |
| Canada, British Columbia | |
| Vancouver General Hospital, BC Centre for Sexual Medicine | Recruiting |
| Vancouver, British Columbia, Canada | |
| Contact: Maureen McGrath, RN 604-875-4111 ext 68962 | |
| Principal Investigator: Stacy Elliott, MD | |
| Principal Investigator: | Stacy Elliott, MD | University of British Columbia |
More Information
| Responsible Party: | University of British Columbia ( Dr. Stacy Elliott ) |
| Study ID Numbers: | CO4-0343 |
| Study First Received: | September 13, 2005 |
| Last Updated: | September 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00175682 History of Changes |
| Health Authority: | Canada: Health Canada |
|
Autonomic Dysreflexia SCI Vibrostimulation Ejaculation |
|
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Spinal Cord Diseases Adrenergic Agents Physiological Effects of Drugs Nervous System Diseases Wounds and Injuries Central Nervous System Diseases Disorders of Environmental Origin Cardiovascular Agents |
Trauma, Nervous System Adrenergic alpha-Antagonists Antihypertensive Agents Pharmacologic Actions Spinal Cord Injuries Autonomic Nervous System Diseases Prazosin Therapeutic Uses Autonomic Dysreflexia Adrenergic Antagonists |