Study of Pant Type Absorbing Urinary Incontinence Products

NCT05031442 | Completed

• 1 other identifier: R-ONE
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Incidence of safety events

  Through study completion until Day 12 +/-2

• Product satisfaction questionnaire

  Day 6 +/-1

• Product satisfaction questionnaire

  Day 12 +/-2

• Product preference questionnaire

  Measured on day 12 +/-2

Study Arms (4)

low waist arm (investigational product RH1 first)

OTHER

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); Device: Reference variant 1 (low waist)

high waist arm (Investigational product RC2 first)

OTHER

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); Device: Reference variant 2 (high waist)

low waist arm (Control product first)

OTHER

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); Device: Reference variant 1 (low waist)

high waist (Control product first)

OTHER

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); Device: Reference variant 2 (high waist)

Interventions

RH1 (low waist) DEVICE

Investigational product variant 1 low waist

low waist arm (Control product first); low waist arm (investigational product RH1 first)

Reference variant 1 (low waist) DEVICE

Reference product variant 1

Also known as: TENA Silhouette Normal Low waist

low waist arm (Control product first); low waist arm (investigational product RH1 first)

RC2 (high waist) DEVICE

Investigational product variant 2 high waist

high waist (Control product first); high waist arm (Investigational product RC2 first)

Reference variant 2 (high waist) DEVICE

Reference product variant 2

Also known as: TENA Silhouette Normal High waist

high waist (Control product first); high waist arm (Investigational product RC2 first)

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Essity Hygiene and Health AB: lead

Study Sites (3)

Eurofins Optimed

Gières, 38610, France

Location

Intertek

Paris, 75013, France

Location

LyREC

Pierre-Bénite, 69310, France

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nathalie Paquet Labertrande, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: September 1, 2021
• Study Start: August 23, 2021
• Primary Completion: October 19, 2021
• Study Completion: November 12, 2021
• Last Updated: November 24, 2021

Record last verified: 2021-11

Locations

FR (3)