Clinical trial NCT01284244: A Randomized Controlled Trial of the Uresta Continence Pessary
Official title: A Randomized Controlled Trial of the Uresta Continence Pessary; Short-term Uresta Efficacy Study (SURE Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Urinary Incontinence, Stress
pessary
conservative management
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
First posted: 2011-01-26
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Urodynamic diagnosis of stress urinary incontinence

Exclusion Criteria:

* Urodynamic diagnosis of mixed incontinence
* Bladder capacity less than 300mls
* Post-void residual over 100mls
* Pelvic organ prolapse greater than POP-Q stage 2
* Hematuria
* Undiagnosed vaginal bleeding
* Current pregnancy
* Previous incontinence or prolapse surgery
* Failed use of an incontinence pessary
* Physically unable to perform the activities included in the pad test

Primary outcomes:
measure: A 50% Reduction in Pad Test Weight
timeFrame: Immediately after device placement (short term).
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Department of Obstetrics and Gynecology, Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: Mount Sinai Hospital, Canada
name: Danny Lovatsis, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Farrell SA, Baydock S, Amir B, Fanning C. Effectiveness of a new self-positioning pessary for the management of urinary incontinence in women. Am J Obstet Gynecol. 2007 May;196(5):474.e1-8. doi: 10.1016/j.ajog.2006.11.038.