Prazosin Vibrostimulation Autonomic Dysreflexia and Spinal Cord Injury Study
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|ClinicalTrials.gov Identifier: NCT00175682|
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : March 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Autonomic Dysreflexia||Drug: Prazosin HCL||Not Applicable|
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:
- absolute blood pressure values and reduction in abnormal heart rhythms
- signs and symptoms of AD
- client confidence to undergo ejaculation
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||December 2004|
|Actual Primary Completion Date :||July 28, 2011|
|Actual Study Completion Date :||July 28, 2011|
Drug: Prazosin HCL
- The hypothesis will be tested by measuring three parameters during prazosin and non-prazosin trials in which ejaculation occurs.
- Objective parameters: absolute beat-to-beat BP, differences between systolic and diastolic BP readings, heart rate variability, heart rate and ECG readings (looking for irregular rhythms) and visible signs of AD experienced by the subject
- Subjective parameters: subject perceived efficacy and side effects of the medication and willingness to use the medication at home
- Secondary outcomes will include the subject's knowledge of AD.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00175682
|Canada, British Columbia|
|Vancouver General Hospital, BC Centre for Sexual Medicine|
|Vancouver, British Columbia, Canada|
|Principal Investigator:||Stacy Elliott, MD||University of British Columbia|