SURE: A Randomized Controlled Trial of the Uresta Continence Pessary

• Sponsor: Mount Sinai Hospital, Canada (Other)
• Overall Status: Completed
• CT.gov ID: NCT01284244
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 2
• Duration (Months): 40
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence	Device: Uresta pessary; Device: Silastic ring	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Trial of the Uresta Continence Pessary; Short-term Uresta Efficacy Study (SURE Study)
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Department of Obstetrics and Gynecology, Mount Sinai Hospital	Toronto	Ontario	Canada	M5G1Z5

Sponsors and Collaborators

• Mount Sinai Hospital, Canada

Investigators

• Principal Investigator: Danny Lovatsis, MD MSc, Mount Sinai Hospital, Canada

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Danny Lovatsis, Dr., Mount Sinai Hospital, Canada
• ClinicalTrials.gov Identifier: NCT01284244
• Other Study ID Numbers: 100131A
• First Posted: Jan 26, 2011
• Last Update Posted: Mar 31, 2017
• Last Verified: Feb 1, 2017

• Keywords provided by Danny Lovatsis, Dr., Mount Sinai Hospital, Canada: Urinary Incontinence, Stress; pessary; conservative management
• Additional relevant MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress

Study Results

Participant Flow

Arm/Group Title	Uresta	Silastic Vaginal Ring
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	18	18
COMPLETED	18	18
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Uresta	Silastic Vaginal Ring	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	18	18	36
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52 (11)	50 (7)	51 (9)
Sex: Female, Male (Count of Participants)
Female	18 100%	18 100%	36 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Canada	18 100%	18 100%	36 100%

Outcome Measures

1. Primary Outcome

Title	A 50% Reduction in Pad Test Weight
Description	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.
Time Frame	Immediately after device placement (short term).

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Uresta	Silastic Vaginal Ring
Arm/Group Description	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.	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.
Measure Participants	18	18
Count of Participants [Participants]	12 66.7%	4 22.2%

Adverse Events

Arm/Group Title	Uresta		Silastic Vaginal Ring
Arm/Group Description	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.		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.
All Cause Mortality
	Uresta		Silastic Vaginal Ring
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Uresta		Silastic Vaginal Ring
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/18 (0%)
Other (Not Including Serious) Adverse Events
	Uresta		Silastic Vaginal Ring
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/18 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.