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Prazosin Vibrostimulation Autonomic Dysreflexia and Spinal Cord Injury Study

Primary Purpose

Autonomic Dysreflexia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Prazosin HCL
Sponsored by
University of British Columbia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Autonomic Dysreflexia focused on measuring Autonomic Dysreflexia, SCI, Vibrostimulation, Ejaculation

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: Male with spinal cord injured above level T6 of greater than one year's duration

Sites / Locations

  • Vancouver General Hospital, BC Centre for Sexual Medicine

Outcomes

Primary Outcome Measures

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 Outcome Measures

Secondary outcomes will include the subject's knowledge of AD.

Full Information

First Posted
September 13, 2005
Last Updated
March 1, 2017
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT00175682
Brief Title
Prazosin Vibrostimulation Autonomic Dysreflexia and Spinal Cord Injury 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
July 28, 2011 (Actual)
Study Completion Date
July 28, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autonomic Dysreflexia
Keywords
Autonomic Dysreflexia, SCI, Vibrostimulation, Ejaculation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Prazosin HCL
Intervention Description
See Detailed Description
Primary Outcome Measure Information:
Title
The hypothesis will be tested by measuring three parameters during prazosin and non-prazosin trials in which ejaculation occurs.
Title
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
Title
Subjective parameters: subject perceived efficacy and side effects of the medication and willingness to use the medication at home
Secondary Outcome Measure Information:
Title
Secondary outcomes will include the subject's knowledge of AD.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male with spinal cord injured above level T6 of greater than one year's duration
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacy Elliott, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital, BC Centre for Sexual Medicine
City
Vancouver
State/Province
British Columbia
Country
Canada

12. IPD Sharing Statement

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Prazosin Vibrostimulation Autonomic Dysreflexia and Spinal Cord Injury Study

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