A Study of Two Versions of the Uresta Pessary Handle for Women With Stress Urinary Incontinence

NCT07706491 | Completed DMC FDA Device

• 1 other identifier: 16000-SAFarrell
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence (SUI)

Keywords

stress urinary incontinence; uresta pessary; handle design

Outcome Measures

Primary Outcomes (2)

• 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

  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

  from enrollment to completion at 4 weeks

Study Arms (1)

pessary handle comparison arm

OTHER

single arm, sequential use of two pessary handle designs

Device: pessary handle

Interventions

pessary handle DEVICE

the participants will use two pessary handle designs as well as an optional pessary puller string and complete questionnaires to rate their experience

pessary handle comparison arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Resilia Inc.: lead

Study Sites (1)

Stirling IRB

Atlanta, Georgia, 30339, United States

Location

Related Publications (4)

• 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.

  PMID: 17466709 BACKGROUND

• 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.

  PMID: 27438055 BACKGROUND

• 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.

  PMID: 35624166 BACKGROUND

• 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.

  PMID: 40902949 BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Scott Farrell, MD

  Dalhousie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Emeritus

Model Details: single cohort, sequential use study

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 15, 2026
• Study Start: April 20, 2026
• Primary Completion: June 18, 2026
• Study Completion: June 18, 2026
• Last Updated: July 15, 2026

Record last verified: 2026-07

Locations

US (1)