A Study of Two Versions of the Uresta Pessary Handle for Women With Stress Urinary Incontinence
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.
연구 개요
상세 설명
- 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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
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Georgia
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Atlanta, Georgia, 미국, 30339
- Stirling IRB
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-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: pessary handle comparison arm
single arm, sequential use of two pessary handle designs
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the participants will use two pessary handle designs as well as an optional pessary puller string and complete questionnaires to rate their experience
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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questionnaire
기간: From enrolment to completion at 4 weeks
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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
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From enrolment to completion at 4 weeks
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Paired samples t-test
기간: from enrollment to completion at 4 weeks
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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
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from enrollment to completion at 4 weeks
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Scott Farrell, MD, Dalhousie University
간행물 및 유용한 링크
일반 간행물
- 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.
- Lovatsis 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.
- Campbell 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.
- Farrell 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 16000-SAFarrell (레지스트리 식별자: Sterling IRB)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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