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Study of Pant Type Absorbing Urinary Incontinence Products

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
RH1 (low waist)
Reference variant 1 (low waist)
RC2 (high waist)
Reference variant 2 (high waist)
Sponsored by
Essity Hygiene and Health AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Eurofins Optimed
  • Intertek
  • LyREC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

low waist arm (investigational product RH1 first)

high waist arm (Investigational product RC2 first)

low waist arm (Control product first)

high waist (Control product first)

Arm Description

Investigational product RH1 (low waist) will be used for 5 consecutive days at the start before switching to the control product (low waist) for 5 days after cross-over.

Investigational product RC2 (high waist) to be used for 5 consecutive days at the start before switching to the control product (high waist) for 5 days after cross-over.

Control product (low waist) to be used for 5 consecutive days at the start before switching to the investigational product RH1 for 5 days after cross-over.

Control product (high waist) to be used for 5 consecutive days at the start before switching to the investigational product RC2 for 5 days after cross-over.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Incidence of safety events
The number and severity of reported safety events are collected and compared for the intervention and reference products.
Product satisfaction questionnaire
Overall satisfaction score with investigational product as compared to the reference product using a 5-point likert scale.
Product satisfaction questionnaire
Overall satisfaction score with investigational product as compared to the reference product using a 5-point likert scale.
Product preference questionnaire
Subject preference score for the investigational product as compared to the reference product using a 5-point likert scale.

Full Information

First Posted
August 11, 2021
Last Updated
November 23, 2021
Sponsor
Essity Hygiene and Health AB
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1. Study Identification

Unique Protocol Identification Number
NCT05031442
Brief Title
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
August 23, 2021 (Actual)
Primary Completion Date
October 19, 2021 (Actual)
Study Completion Date
November 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Essity Hygiene and Health AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
None (Open Label)
Masking Description
Participants are randomized to start with either reference or investigational product. The type of product is masked for the participant but since there are slight differences between the products the masking cannot be ensured.
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
low waist arm (investigational product RH1 first)
Arm Type
Other
Arm Description
Investigational product RH1 (low waist) will be used for 5 consecutive days at the start before switching to the control product (low waist) for 5 days after cross-over.
Arm Title
high waist arm (Investigational product RC2 first)
Arm Type
Other
Arm Description
Investigational product RC2 (high waist) to be used for 5 consecutive days at the start before switching to the control product (high waist) for 5 days after cross-over.
Arm Title
low waist arm (Control product first)
Arm Type
Other
Arm Description
Control product (low waist) to be used for 5 consecutive days at the start before switching to the investigational product RH1 for 5 days after cross-over.
Arm Title
high waist (Control product first)
Arm Type
Other
Arm Description
Control product (high waist) to be used for 5 consecutive days at the start before switching to the investigational product RC2 for 5 days after cross-over.
Intervention Type
Device
Intervention Name(s)
RH1 (low waist)
Intervention Description
Investigational product variant 1 low waist
Intervention Type
Device
Intervention Name(s)
Reference variant 1 (low waist)
Other Intervention Name(s)
TENA Silhouette Normal Low waist
Intervention Description
Reference product variant 1
Intervention Type
Device
Intervention Name(s)
RC2 (high waist)
Intervention Description
Investigational product variant 2 high waist
Intervention Type
Device
Intervention Name(s)
Reference variant 2 (high waist)
Other Intervention Name(s)
TENA Silhouette Normal High waist
Intervention Description
Reference product variant 2
Primary Outcome Measure Information:
Title
Diary reported number of urinary leakages
Description
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 Outcome Measure Information:
Title
Incidence of safety events
Description
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
Title
Product satisfaction questionnaire
Description
Overall satisfaction score with investigational product as compared to the reference product using a 5-point likert scale.
Time Frame
Day 6 +/-1
Title
Product satisfaction questionnaire
Description
Overall satisfaction score with investigational product as compared to the reference product using a 5-point likert scale.
Time Frame
Day 12 +/-2
Title
Product preference questionnaire
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie Paquet Labertrande, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eurofins Optimed
City
Gières
ZIP/Postal Code
38610
Country
France
Facility Name
Intertek
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
LyREC
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France

12. IPD Sharing Statement

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Study of Pant Type Absorbing Urinary Incontinence Products

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