A Randomized Controlled Trial of the Uresta Continence Pessary (SURE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Mount Sinai Hospital, Canada.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:
NCT01284244
First received: January 25, 2011
Last updated: August 2, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Stress Urinary Incontinence
Device: Uresta pessary
Device: Silastic ring
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of the Uresta Continence Pessary; Short-term Uresta Efficacy Study (SURE Study)

Resource links provided by NLM:


Further study details as provided by Mount Sinai Hospital, Canada:

Primary Outcome Measures:
  • A 50% reduction in pad test weight [ Time Frame: Immediately after device placement (short term). ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 36
Study Start Date: January 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Uresta Device: Uresta pessary
Participants randomized to the Uresta group will be fitted with device before immediately before performing the pad test. The Uresta pessary is made of medical grade rubber that has been extensively tested for safety. It is bell-shaped, with a narrow tip that allows for easy insertion into the vagina in a similar fashion to a tampon. The device can be easily inserted, and removed by a patient for use when needed. The Uresta comes in 3 sizes. Fitting starts with insertion of the smallest size. If urine leakage continues with valsalva or a cough stress test, it can be replaced by one size larger, until leakage is stopped. If the device prevents the patient from being able to void or is uncomfortable due to its size, the smaller size is replaced. Following the pad test, the participant will be given the opportunity to keep the device for continued use, or remove it if desired.
Sham Comparator: Silastic vaginal ring Device: Silastic ring
The silastic ring is a plastic flexible ring similar to that used to administer vaginal estrogen (Estring). It is well tolerated and would not contain any medications. Immediately before performing the pad test, it would be placed high in the vagina, away from the urethra. It would be removed immediately after the pad test. Draping will conceal from the patient which device was inserted.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01284244

Contacts
Contact: Danny Lovatsis, MD MSc 4155864566 dlovatsis@mtsinai.on.ca
Contact: Carolyn Best, BSc MD 6479859439 carolyn.best@utoronto.ca

Locations
Canada, Ontario
Department of Obstetrics and Gynecology, Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G1Z5
Contact: Danny Lovatsis, MD MSc    4165864566    dlovatsis@mtsinai.on.ca   
Contact: Carolyn Best, MD    6479859439    carolyn.best@utoronto.ca   
Principal Investigator: Danny Lovatsis, MD MSc         
Sub-Investigator: Carolyn Best, BSc MD         
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Investigators
Principal Investigator: Danny Lovatsis, MD MSc Mount Sinai Hospital, Canada
  More Information

Publications:
Responsible Party: Danny Lovatsis, Dr., Department of Obstetrics and Gynecology, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT01284244     History of Changes
Other Study ID Numbers: 100131A
Study First Received: January 25, 2011
Last Updated: August 2, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Mount Sinai Hospital, Canada:
Urinary Incontinence, Stress
pessary
conservative management

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014