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A Clinical Trial to Evaluate Leakage Performance in a Hybrid Absorbing Incontinence Product

NCT06091111 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2024-09-19

No results posted yet for this study

Summary

The study is prospective, sequential, single group, and interventional but not invasive. The primary objective is to evaluate the leakage performance of the investigational medical devices (absorbing hygiene products, AHPs) compared to reference AHPs currently being used by the subjects. The study is cross-over and subjects will act as their own control, using their regular device during a 10-day period and comparing this to use of investigational device for 10 days with an initial 3-5 day transition period. In total the subjects participate in the study for about 30 days. The sequence of device use is randomized. The target population are subjects who are suffering from urinary incontinence and are current users of AHPs to manage the incontinence. Subjects are care dependent and being cared for in a care home. The study is conducted at multiple care homes in the United Kingdom. The investigational device is a new type of AHP developed to be more sustainable with a disposable insert placed into a reusable pant. The leakage performance will be tracked by collecting used AHPs and assess the occurrence of leakages and urine content. The number of leakages during the intervention period will be compared to that of the reference period. As secondary outcomes safety, changes in skin condition and caregiver and subject product satisfaction is assessed. In total 42 subjects are planned for the study.

Conditions

Interventions

DEVICE

THD, THN

New hybrid absorbing incontinence product for day (THD) and night (THN) use. These are variants of the same product. The intervention product is a novel design that contains reusable elements allowing for a more sustainable product.

Sponsors & Collaborators

  • Lincolnshire Community Health Services NHS Trust

    collaborator OTHER

  • Essity Hygiene and Health AB

    lead INDUSTRY

Principal Investigators

  • Janice Weisman · Lincolnshire Community Health Services NHS

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-06
Primary Completion
2024-05-30
Completion
2024-06-30

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06091111 on ClinicalTrials.gov