Prazosin Vibrostimulation Autonomic Dysreflexia and Spinal Cord Injury Study
Prophylactic Value of Prazosin in Reducing the Objective and Subjective Measures of Autonomic Dysreflexia Provoked by Ejaculation in Men With Spinal Cord Injury
1 other identifier
interventional
7
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2004
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 28, 2011
CompletedMarch 3, 2017
March 1, 2017
6.7 years
September 13, 2005
March 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 (1)
Secondary outcomes will include the subject's knowledge of AD.
Interventions
See Detailed Description
Eligibility Criteria
You may qualify if:
- Male with spinal cord injured above level T6 of greater than one year's duration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vancouver General Hospital, BC Centre for Sexual Medicine
Vancouver, British Columbia, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stacy Elliott, MD
University of British Columbia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 15, 2005
Study Start
December 1, 2004
Primary Completion
July 28, 2011
Study Completion
July 28, 2011
Last Updated
March 3, 2017
Record last verified: 2017-03