Prazosin Vibrostimulation Autonomic Dysreflexia and Spinal Cord Injury Study
Condition: Autonomic Dysreflexia
MeSH terms: Spinal Cord Injuries; Autonomic Dysreflexia
Study type: Interventional

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:

        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.
    

Intervention name(s): Prazosin HCL
Intervention type(s): Drug
Intervention description(s): See Detailed Description
Intervention MeSH terms: Prazosin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Autonomic Dysreflexia; SCI; Vibrostimulation; Ejaculation