Urinary Incontinence
Conditions
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.
Interventions
DEVICERH1 (low waist)
Investigational product variant 1 low waist
DEVICEReference variant 1 (low waist)
Reference product variant 1
DEVICERC2 (high waist)
Investigational product variant 2 high waist
DEVICEReference variant 2 (high waist)
Reference product variant 2
Sponsors
Essity Hygiene and Health AB
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
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.
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Product satisfaction questionnaire | Day 6 +/-1 | 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. |
Countries
France
Outcome results
None listed