A Randomized Controlled Trial of the Uresta Continence Pessary

Not Applicable

Completed

Conditions: Stress Urinary Incontinence

Interventions: Device: Silastic ring
Device: Uresta pessary

Registration Number: NCT01284244

Lead Sponsor: Mount Sinai Hospital, Canada

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 36

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silastic vaginal ring	Silastic ring	-
Uresta	Uresta pessary	-

Primary Outcome Measures

Name	Time	Method
A 50% Reduction in Pad Test Weight	Immediately after device placement (short term).	A pad test is an objective measure of urine loss. With a full bladder, while wearing a pad, the participant completes five repetitions of the following physical activities: coughing, step climbing, heel bounce, standing from a sitting position and walking 50 yards. The weight of the pad is then determined. The primary outcome variable will be the achievement of a 50% reduction in the pad weight before and after device placement. This figure is obtained from the study by Farrell et al, where pad weight decreased from 20 grams to 9 grams with the use of the Uresta device.

Secondary Outcome Measures