Stress Urinary Incontinence Clinical Trial
Official title:
A Randomized Controlled Trial of the Uresta Continence Pessary; Short-term Uresta Efficacy Study (SURE Study)
Stress urinary incontinence (SUI) is defined as the involuntary loss of urine with an
increase in abdominal pressure, caused either by a loss of support under the bladder neck,
or intrinsic urethral sphincter deficiency. It is a common problem in women that can
significantly impact quality of life, with up to 30% developing SUI at some point in their
lifetime.
The most commonly utilized treatments for SUI include either pelvic floor (Kegel) exercises,
or surgery. Many women find Kegel exercises unsatisfactory, but are reluctant to undergo a
surgical procedure. Also, women who are poor candidates for surgery have limited options if
Kegel exercises are unsuccessful. Over the years, there have been numerous attempts to
develop effective non-surgical alternatives for treating SUI, but the results have been
variable and the available data on efficacy limited.
A new intravaginal incontinence pessary (Uresta) has been developed for treating stress
incontinence, and is currently available in Canada via a medical distributor. The
self-positioning device is initially fitted by a healthcare provider, but then can
subsequently placed by the patient as needed. Uresta is designed to be easily inserted into
the vagina and spontaneously fall into position, providing support beneath the urethra. A
single, uncontrolled study of 21 women showed that Uresta significantly reduces urinary
incontinence measures, with no reported complications. Using questionnaires, a 47% reduction
in self-reported SUI symptoms was demonstrated. Pad weight following a pad test, an
objective assessment of urine loss, showed a 50% reduction in leakage.
This trial is intended to be a short-term assessment of the efficacy of the Uresta device,
using a placebo arm in order to remove any of the possible sources of patient biases. The
placebo ("sham") group will be obtained by placing a flexible silastic ring (inactivated
Estring) high in the vagina where it will not alter urethral forces. The aim is to
unequivocally determine whether the Uresta device provides the necessary urethral support to
stop urine leakage from stress incontinence.
The hypothesis is that the Uresta device will significantly reduce urinary losses from
baseline, shown as a significant reduction pad weight following a pad test with the device
in place.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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