Skip to main content
OpenTrials
Completed

NCT Number: NCT05031442

Study of Pant Type Absorbing Urinary Incontinence Products

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

45 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Eurofins Optimed, Gières, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RH1 (low waist)

Device

Investigational product variant 1 low waist

Reference variant 1 (low waist)

Device

Reference product variant 1

Other names: TENA Silhouette Normal Low waist

RC2 (high waist)

Device

Investigational product variant 2 high waist

Reference variant 2 (high waist)

Device

Reference product variant 2

Other names: TENA Silhouette Normal High waist

Primary outcomes

  1. Diary reported number of urinary leakages

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

    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.

Secondary outcomes

  1. Incidence of safety events

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

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

  2. Product satisfaction questionnaire

    Time frame: Day 6 +/-1

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

  3. Product satisfaction questionnaire

    Time frame: Day 12 +/-2

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

  4. Product preference questionnaire

    Time frame: Measured on day 12 +/-2

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

Sponsors and collaborators

Lead sponsor

Essity Hygiene and Health AB

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 1, 2021
Registry last updated
Nov 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.