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Study of Pant Type Absorbing Urinary Incontinence Products

NCT ID: NCT05031442

Last Updated: 2021-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-23

Study Completion Date

2021-11-12

Brief Summary

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Pre-market feasibility clinical investigation designed to evaluate the clinical performance and safety of the investigational product in its intended target population

Detailed Description

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The clinical clinical investigation is prospective, cross-over, interventional, multicentre and pre-market. The investigation aims to demonstrate the performance and safety of a new absorbing hygiene product (medical device) when used as intended in subjects affected with light to medium urinary incontinence compared to a reference (control) product representing standard of care.

The study participants will be randomly assigned to one of 4 groups. Each group will receive a predefined pair of investigational and reference products (variants: either high waist or low waist) to be used in a predefined order (crossover design: investigational or reference product to be used first). Hence, each study subject will use two products (one investigational product and a corresponding reference product of the same variant) and act as its own control. The study subjects will use one product for 5 days and then switch to use the other product for 5 days.

The primary endpoint for the investigation is the comparison in leakage performance of the investigation product with the reference product. There are also secondary endpoints regarding safety and product satisfaction and product preference.

Conditions

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Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Subjects use one product for 5 days and then switch to another product for 5 days. One of the products is the investigational product and one is the reference product.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Participants are randomized to start with either reference or investigational product. The type of product is masked for the participant but since there are slight differences between the products the masking cannot be ensured.

Study Groups

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low waist arm (investigational product RH1 first)

Investigational product RH1 (low waist) will be used for 5 consecutive days at the start before switching to the control product (low waist) for 5 days after cross-over.

Group Type OTHER

RH1 (low waist)

Intervention Type DEVICE

Investigational product variant 1 low waist

Reference variant 1 (low waist)

Intervention Type DEVICE

Reference product variant 1

high waist arm (Investigational product RC2 first)

Investigational product RC2 (high waist) to be used for 5 consecutive days at the start before switching to the control product (high waist) for 5 days after cross-over.

Group Type OTHER

RC2 (high waist)

Intervention Type DEVICE

Investigational product variant 2 high waist

Reference variant 2 (high waist)

Intervention Type DEVICE

Reference product variant 2

low waist arm (Control product first)

Control product (low waist) to be used for 5 consecutive days at the start before switching to the investigational product RH1 for 5 days after cross-over.

Group Type OTHER

RH1 (low waist)

Intervention Type DEVICE

Investigational product variant 1 low waist

Reference variant 1 (low waist)

Intervention Type DEVICE

Reference product variant 1

high waist (Control product first)

Control product (high waist) to be used for 5 consecutive days at the start before switching to the investigational product RC2 for 5 days after cross-over.

Group Type OTHER

RC2 (high waist)

Intervention Type DEVICE

Investigational product variant 2 high waist

Reference variant 2 (high waist)

Intervention Type DEVICE

Reference product variant 2

Interventions

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RH1 (low waist)

Investigational product variant 1 low waist

Intervention Type DEVICE

Reference variant 1 (low waist)

Reference product variant 1

Intervention Type DEVICE

RC2 (high waist)

Investigational product variant 2 high waist

Intervention Type DEVICE

Reference variant 2 (high waist)

Reference product variant 2

Intervention Type DEVICE

Other Intervention Names

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TENA Silhouette Normal Low waist TENA Silhouette Normal High waist

Eligibility Criteria

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Inclusion Criteria

* Adult women between age 45 and 75.
* Be willing and able to provide informed consent.
* Capability and willingness to follow the protocol.
* Experience incontinence daily or at least two times a week.
* Uses some sort of protection for the incontinence daily or at least two times a week.
* Uses five or more pieces of protection per week.
* Is currently using protective underwear; a pull-up (pant) product made for incontinence.
* Is able to wear a pant product of size M.
* Is currently using TENA Silhouette or Always Discreet Boutique product.
* Should be affiliate to the social security system.

Exclusion Criteria

* Is pregnant or nursing.
* Known allergies or intolerances to one or several components of the investigational products.
* Be dependent on either alcohol or recreational drugs.
* Participation in an investigational study of a drug, biologic, or device within 30 days prior to entering the clinical investigation or planned during the course of the clinical investigation.
* Being under safeguard and protection of justice
* Having cognitive impairments.
* Any other condition that may make participation in the clinical investigation inappropriate, as judged by investigator.
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Essity Hygiene and Health AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nathalie Paquet Labertrande, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

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Eurofins Optimed

Gières, , France

Site Status

Intertek

Paris, , France

Site Status

LyREC

Pierre-Bénite, , France

Site Status

Countries

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France

Other Identifiers

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R-ONE

Identifier Type: -

Identifier Source: org_study_id