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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Danny Lovatsis, Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:
NCT01284244
First received: January 25, 2011
Last updated: February 12, 2017
Last verified: February 2017
Results First Received: December 17, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant;   Primary Purpose: Treatment
Condition: Stress Urinary Incontinence
Interventions: Device: Uresta pessary
Device: Silastic ring

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Uresta 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 Vaginal Ring 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.

Participant Flow:   Overall Study
    Uresta   Silastic Vaginal Ring
STARTED   18   18 
COMPLETED   18   18 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Uresta 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 Vaginal Ring 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 Total of all reporting groups

Baseline Measures
   Uresta   Silastic Vaginal Ring   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   18   36 
Age 
[Units: Years]
Mean (Standard Deviation)
 52  (11)   50  (7)   51  (9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      18 100.0%      18 100.0%      36 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
Canada   18   18   36 


  Outcome Measures

1.  Primary:   A 50% Reduction in Pad Test Weight   [ Time Frame: Immediately after device placement (short term). ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.


Results Point of Contact:  
Name/Title: Dr. Danny Lovatsis
Organization: Mount Sinai Hospital
phone: 416-586-4566
e-mail: danny.lovatsis@sinaihealthsystem.ca


Publications:

Responsible Party: Danny Lovatsis, Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT01284244     History of Changes
Other Study ID Numbers: 100131A
Study First Received: January 25, 2011
Results First Received: December 17, 2016
Last Updated: February 12, 2017