Study of Pant Type Absorbing Urinary Incontinence Products

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

Detailed Description
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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.

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

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Device: RH1 (low waist)
* Device: Reference variant 1 (low waist)
* Device: RC2 (high waist)
* Device: Reference variant 2 (high waist)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: low waist arm (investigational product RH1 first)<br>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. | Device: RH1 (low waist)<br>* Investigational product variant 1 low waist<br>Device: Reference variant 1 (low waist)<br>* Reference product variant 1<br>* Other names: TENA Silhouette Normal Low waist;|
| Other: high waist arm (Investigational product RC2 first)<br>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. | Device: RC2 (high waist)<br>* Investigational product variant 2 high waist<br>Device: Reference variant 2 (high waist)<br>* Reference product variant 2<br>* Other names: TENA Silhouette Normal High waist;|
| Other: low waist arm (Control product first)<br>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. | Device: RH1 (low waist)<br>* Investigational product variant 1 low waist<br>Device: Reference variant 1 (low waist)<br>* Reference product variant 1<br>* Other names: TENA Silhouette Normal Low waist;|
| Other: high waist (Control product first)<br>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. | Device: RC2 (high waist)<br>* Investigational product variant 2 high waist<br>Device: Reference variant 2 (high waist)<br>* Reference product variant 2<br>* Other names: TENA Silhouette Normal High waist;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Through study completion until Day 12 +/-2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of safety events | The number and severity of reported safety events are collected and compared for the intervention and reference products. | Through study completion until Day 12 +/-2 | 
| Product satisfaction questionnaire | Overall satisfaction score with investigational product as compared to the reference product using a 5-point likert scale. | Day 6 +/-1 | 
| Product satisfaction questionnaire | Overall satisfaction score with investigational product as compared to the reference product using a 5-point likert scale. | Day 12 +/-2 | 
| Product preference questionnaire | Subject preference score for the investigational product as compared to the reference product using a 5-point likert scale. | Measured on day 12 +/-2 |