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.
調査の概要
詳細な説明
- 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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Georgia
-
Atlanta、Georgia、アメリカ、30339
- Stirling IRB
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：順次割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：pessary handle comparison arm
single arm, sequential use of two pessary handle designs
|
the participants will use two pessary handle designs as well as an optional pessary puller string and complete questionnaires to rate their experience
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
questionnaire
時間枠：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
|
From enrolment to completion at 4 weeks
|
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Paired samples t-test
時間枠：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
|
from enrollment to completion at 4 weeks
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Scott Farrell, MD、Dalhousie University
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 16000-SAFarrell (レジストリ識別子：Sterling IRB)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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