Spinal Cord Research Centre
Report on Clinical Research Studies
by Orpha Schryvers, January 10, 2001
Two clinical research projects presently underway at the Rehabilitation
Hospital involve medications that have recently come onto the market in
Canada but whose effects or side effects have not been tested on people
with SCI - tolterodine and sildenafil.
Tolterodine Study
Principal Investigator: Dr. Pat Nance
Co-Investigator: Dr. Karen Ethans
Funded by: The Christopher Reeve Paralysis Foundation
Tolterodine (Detrol) is a drug that works similarly to oxybutynin
(Ditropan). Oxybutynin is prescribed often to people with SCI
to decrease incontinence or increase the length of time between
catheterizations. Initial studies have shown that tolterodine works
as well as oxybutynin in relaxing the bladder muscle but that it has
less of a side-effect of mouth dryness. Some people who take oxybutynin
regularly complain of extreme dryness of the mouth. Previous clinical
research has involved women with urge incontinence but not people with
paralyzed bladders.
In this drug study, we are comparing the effects of tolterodine to
oxybutynin and to placebo (a pill with no active drug in it). How well
these drugs work is measured by urodynamic tests which show how much
the bladder can hold and how much pressure there is in the bladder
when it is full. Other measurements include the amount and number of
catheterizations per day, the number of episodes of bladder incontinence
per day, and the degree of mouth dryness.
The importance of this drug study is that if we can demonstrate
evidence that a better treatment for the paralyzed bladder exists and is
readily available, it would be of immediate benefit to individuals who
have incontinence between catheterizations or who have to catheterize
too frequently.
Sildenafil Study
Principal Investigator: Dr. Karen Ethans
Funded through the Manitoba Neurotrauma Initiative
by the Worker's Compensation Board of Manitoba and Manitoba Public Insurance
Sildenafil (Viagra) is a drug prescribed to men with erectile
dysfunction, including men with SCI. Previous research studies have
shown that this drug can work well for men with SCI who are able to
have reflex erections, that is, it makes the erection stronger and last
longer. However, there is some concern that Viagra may cause a temporary
decrease in blood pressure in men with high levels of SCI who already
have a low blood pressure. This has not been studied previously.
In this study trial we measure the blood pressure before and at one,
two, three and four hours after taking the drug. The effect on blood
pressure after taking Viagra 50 mg will be compared to Viagra 100 mg
and to placebo (a pill with no active drug in it).
The importance of this drug study is to determine if it is safe for
men with high level SCI to take this drug to improve their erectile
ability.
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