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Completed
NCT07706491
A Study of Two Versions of the Uresta Pessary Handle for Women With Stress Urinary Incontinence
Conditions: Stress Urinary Incontinence (SUI)
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 113
Sponsor: Resilia Inc.
Location: Stirling IRB Atlanta Georgia
Summary
The goal of this clinical trial is to learn if a new handle design for the uresta pessary works better than the current handle design for women when they are using the pessary. The main questions it aims to answer are:
Is the new pessary equally effective for users. Do pessary users find the new handle design is more or less helpful for insertion and removal of the pessary Is the optional removal string, provided with the new handle, helpful in pessary handling.
The participants will use both the original and the new uresta pessary handle designs and complete a questionnaire to rate both handles.
The score for the two questionnaires will be compared to determine which handle is best.
Eligibility Criteria
Inclusion Criteria:
* Adult women aged 18 years or older
* Currently using a Uresta bladder support successfully
* Using size 3, 4, or 5 from the Uresta Starter Kit
* Living in the United States
* Able to participate within 10-20 days of consent
* Willing to complete study questionnaires and use the modified device
Exclusion Criteria:
* Individuals not residing in the United States
* Individuals not currently using Uresta
* Individuals using sizes other than 3, 4, or 5
* Individuals unable to complete study activities within the study timeline
* Pregnant women
Source: ClinicalTrials.gov (NCT07706491). StuddyBuddy aggregates publicly available trial information.