Stress Urinary Incontinence (SUI)
Conditions
Keywords
stress urinary incontinence, uresta pessary, handle design
Brief 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.
Detailed description
1. Introduction This research is a usability comparison study involving the Uresta bladder support, a Class II medical device indicated for adult women experiencing stress urinary incontinence. The device is Food and Drug Administration (FDA)-cleared and licensed for over-the-counter use. The study will compare user experience using the current Uresta handle design and a modified handle design intended to improve the removal process. 2. Study Objective The purpose of this study is to obtain feedback from intended users regarding the efficacy and ease of use and removal characteristics of two versions of the Uresta bladder support handle. The study will also collect feedback on an optional removal string which will be made available to further facilitate removal for certain users. 3. Background Uresta® is a reusable bladder support device designed to reduce urine leakage caused by stress urinary incontinence. When inserted into the vaginal canal, the device supports the urethra and reduces involuntary urine loss during physical activity such as coughing, laughing, or exercising. The efficacy, safety and usability of the use of the uresta pessary for the treatment of bladder leaking has been extensively investigated and the results published1-5 Post-market surveillance has identified potential improvements related to the device. User feedback suggested possible modifications including adding a finger hole to the handle, increasing handle stiffness, and providing an optional removal string to help locate the device during removal.
Interventions
DEVICEpessary handle
the participants will use two pessary handle designs as well as an optional pessary puller string and complete questionnaires to rate their experience
Sponsors
Resilia Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
single cohort, sequential use study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| questionnaire | From enrolment to completion at 4 weeks | A 15 item questionnaire in which each question is anwered on a 5-point likert scale ranging from "strongly disagree"=1 to strongly agree = 5. The higher the score the better the usability and efficacy |
| Paired samples t-test | from enrollment to completion at 4 weeks | The scores of each questionnaire will be summed and the mean scores on the pessary handle questionnaires will be compared using a paired samples t-test with a p\<0.05 considered significant |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORScott Farrell, MD
Dalhousie University
Outcome results
None listed