Study of Pant Type Absorbing Urinary Incontinence Products

Urinary Incontinence Clinical Trial

Official title:

A Randomized Study of Pant Type Absorbing Urinary Incontinence Products With Cross-over Design

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05031442
• Other study ID #: R-ONE
• Status: Completed
• Phase: N/A
• Start date: August 23, 2021
• Est. completion date: November 12, 2021

Study information

• Verified date: November 2021
• Source: Essity Hygiene and Health AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 12, 2021
• Est. primary completion date: October 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Urinary Incontinence

Intervention

Device:
• RH1 (low waist)
Investigational product variant 1 low waist
• Reference variant 1 (low waist)
Reference product variant 1
• RC2 (high waist)
Investigational product variant 2 high waist
• Reference variant 2 (high waist)
Reference product variant 2

Locations

Country	Name	City	State
France	Eurofins Optimed	Gières
France	Intertek	Paris
France	LyREC	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Essity Hygiene and Health AB

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through study completion until Day 12 +/-2
Secondary	Incidence of safety events	The number and severity of reported safety events are collected and compared for the intervention and reference products.	Through study completion until Day 12 +/-2
Secondary	Product satisfaction questionnaire	Overall satisfaction score with investigational product as compared to the reference product using a 5-point likert scale.	Day 6 +/-1
Secondary	Product satisfaction questionnaire	Overall satisfaction score with investigational product as compared to the reference product using a 5-point likert scale.	Day 12 +/-2
Secondary	Product preference questionnaire	Subject preference score for the investigational product as compared to the reference product using a 5-point likert scale.	Measured on day 12 +/-2