Study of Pant Type Absorbing Urinary Incontinence Products
- Conditions
- Urinary Incontinence
- Interventions
- Device: RH1 (low waist)Device: RC2 (high waist)Device: Reference variant 1 (low waist)Device: Reference variant 2 (high waist)
- Registration Number
- NCT05031442
- Lead Sponsor
- Essity Hygiene and Health AB
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description low waist arm (Control product first) RH1 (low waist) 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. low waist arm (investigational product RH1 first) Reference variant 1 (low waist) 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. low waist arm (investigational product RH1 first) RH1 (low waist) 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. high waist arm (Investigational product RC2 first) RC2 (high waist) 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. high waist (Control product first) RC2 (high waist) 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. high waist arm (Investigational product RC2 first) Reference variant 2 (high waist) 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. low waist arm (Control product first) Reference variant 1 (low waist) 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. high waist (Control product first) Reference variant 2 (high waist) 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.
- Primary Outcome Measures
Name Time Method Diary reported number of urinary leakages 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 Outcome Measures
Name Time Method Product satisfaction questionnaire Day 12 +/-2 Overall satisfaction score with investigational product as compared to the reference product using a 5-point likert scale.
Product preference questionnaire Measured on day 12 +/-2 Subject preference score for the investigational product as compared to the reference product using a 5-point likert scale.
Incidence of safety events 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.
Trial Locations
- Locations (3)
Eurofins Optimed
🇫🇷Gières, France
Intertek
🇫🇷Paris, France
LyREC
🇫🇷Pierre-Bénite, France