Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00175682
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2005-09-13
Brief Title:
Prazosin Vibrostimulation Autonomic Dysreflexia and Spinal Cord Injury Study
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
1 absolute blood pressure values and reduction in abnormal heart rhythms
2 signs and symptoms of AD
3 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
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 patients 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
1 absolute blood pressure values and reduction in abnormal heart rhythms
2 signs and symptoms of AD
3 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None