Stress Urinary Incontinence (SUI)NCT07706491
A Study of Two Versions of the Uresta Pessary Handle for Women With Stress Urinary Incontinence
A study testing pessary handle in people with Stress Urinary Incontinence (SUI), run by Resilia Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence (SUI)
- What is being tested?
- pessary handle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2026to 18 Jun 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Uresta Bladder Support Handle Comparison Study
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.
Read the detailed description
- 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.
- 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.
- 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.
- Conditions
- Stress Urinary Incontinence (SUI)
- Being tested
- pessary handle
- Keywords
- stress urinary incontinence, uresta pessary, handle design
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pessary handleDevice
the participants will use two pessary handle designs as well as an optional pessary puller string and complete questionnaires to rate their experience
| Study group | Role | What they receive |
|---|---|---|
| pessary handle comparison arm | Other | single arm, sequential use of two pessary handle designs Receives: Device: pessary handle |
What is being measured
The primary outcome is the main question the study is designed to answer.
questionnaire
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
Measured: From enrolment to completion at 4 weeks
Paired samples t-test
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
Measured: from enrollment to completion at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start20 Apr 2026
- Primary completion18 Jun 2026
- Study completion18 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary Incontinence (SUI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- single cohort, sequential use study
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Resilia Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Scott Farrell, Resilia Inc.
- Investigators
- Scott Farrell, MD, Principal investigator, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706491
- Sponsor's protocol ID
- 16000-SAFarrell
- Other IDs
- 16000-SAFarrell
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Yes
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. doi: 10.1016/j.ajog.2006.11.038.
PubMed 17466709Lovatsis D, Best C, Diamond P. Short-term Uresta efficacy (SURE) study: a randomized controlled trial of the Uresta continence device. Int Urogynecol J. 2017 Jan;28(1):147-150. doi: 10.1007/s00192-016-3090-9. Epub 2016 Jul 20.
PubMed 27438055Campbell P, Moran K, Boyle S, Gallagher C. Compliance with Uresta (CURE) study; a 12 month follow-up of 40 women. Int Urogynecol J. 2023 Mar;34(3):737-744. doi: 10.1007/s00192-022-05234-1. Epub 2022 May 27.
PubMed 35624166Farrell SA, Gillespie K, Foulem S, Lagace S. A Self-Selection Validation Study of the Uresta Bladder Support. J Obstet Gynaecol Can. 2025 Nov;47(11):103085. doi: 10.1016/j.jogc.2025.103085. Epub 2025 Sep 1.
PubMed 40902949