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

NCT07706491 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2026-07-15

No results posted yet for this study

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)

Interventions

DEVICE

pessary 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 & Collaborators

  • Resilia Inc.

    lead INDUSTRY

Principal Investigators

  • Scott Farrell, MD · Dalhousie University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-20
Primary Completion
2026-06-18
Completion
2026-06-18
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07706491 on ClinicalTrials.gov