Study of Pant Type Absorbing Urinary Incontinence Products

Essity Hygiene and Health AB100 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Urinary Incontinence

Interventions

RH1 (low waist)DEVICE

Investigational product variant 1 low waist

Reference variant 1 (low waist)DEVICE

Reference product variant 1

RC2 (high waist)DEVICE

Investigational product variant 2 high waist

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

Eurofins Optimed

Gières, France

Intertek

Paris, France

LyREC

Pierre-Bénite, France

Outcomes

Primary Outcomes

Diary reported number of urinary leakages

The proportion of products experiencing urine leakage over the 5 day test period is compared between the investigational and reference product. A diary is used to collect this information for each used product.

Time frame: Through study completion until Day 12 +/-2

Secondary Outcomes

Incidence of safety events

The number and severity of reported safety events are collected and compared for the intervention and reference products.

Time frame: Through study completion until Day 12 +/-2

Product satisfaction questionnaire

Overall satisfaction score with investigational product as compared to the reference product using a 5-point likert scale.

Time frame: Day 6 +/-1

Product satisfaction questionnaire

Overall satisfaction score with investigational product as compared to the reference product using a 5-point likert scale.

Time frame: Day 12 +/-2

Product preference questionnaire

Subject preference score for the investigational product as compared to the reference product using a 5-point likert scale.

Time frame: Measured on day 12 +/-2

Data from ClinicalTrials.gov

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