Study of Pant Type Absorbing Urinary Incontinence Products

Essity

Status: Completed

Conditions: Urinary Incontinence

Treatments: Device: RH1 (low waist); Device: Reference variant 2 (high waist); Device: Reference variant 1 (low waist); Device: RC2 (high waist)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05031442

R-ONE

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 45 to 75 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

low waist arm (investigational product RH1 first)

Other group

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.

Treatment:

Device: RH1 (low waist)

Device: Reference variant 1 (low waist)

high waist arm (Investigational product RC2 first)

Other group

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.

Treatment:

Device: Reference variant 2 (high waist)

Device: RC2 (high waist)

low waist arm (Control product first)

Other group

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.

Treatment:

Device: RH1 (low waist)

Device: Reference variant 1 (low waist)

high waist (Control product first)

Other group

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.

Treatment:

Device: Reference variant 2 (high waist)

Device: RC2 (high waist)