Clinical trial NCT05031442: Study of Pant Type Absorbing Urinary Incontinence Products
Official title: A Randomized Study of Pant Type Absorbing Urinary Incontinence Products With Cross-over Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: Essity Hygiene and Health AB
Sponsor class: INDUSTRY
First posted: 2021-09-01
Enrollment: 100
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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 purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diary reported number of urinary leakages
timeFrame: Through study completion until Day 12 +/-2
Secondary outcomes:
measure: Incidence of safety events
timeFrame: Through study completion until Day 12 +/-2
measure: Product satisfaction questionnaire
timeFrame: Day 6 +/-1
measure: Product satisfaction questionnaire
timeFrame: Day 12 +/-2
measure: Product preference questionnaire
timeFrame: Measured on day 12 +/-2
Other outcomes:
Locations:
city: Gières
country: France
facility: Eurofins Optimed
city: Paris
country: France
facility: Intertek
city: Pierre-Bénite
country: France
facility: LyREC
Study officials:
name: Nathalie Paquet Labertrande, MD
role: PRINCIPAL_INVESTIGATOR
References: