NCT05031442

Study of Pant Type Absorbing Urinary Incontinence Products

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Essity Hygiene and Health AB · Industry
• Sex: Female
• Age: 45 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	RH1 (low waist)	Investigational product variant 1 low waist
DEVICE	Reference variant 1 (low waist)	Reference product variant 1
DEVICE	RC2 (high waist)	Investigational product variant 2 high waist
DEVICE	Reference variant 2 (high waist)	Reference product variant 2

Timeline

• Start date: 2021-08-23
• Primary completion: 2021-10-19
• Completion: 2021-11-12
• First posted: 2021-09-01
• Last updated: 2021-11-24

Locations

3 sites across 1 country: France