Clinical Trials Logo

Clinical Trial Summary

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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05031442
Study type Interventional
Source Essity Hygiene and Health AB
Contact Fredrik Agholme, PhD
Phone +46730323634
Email [email protected]
Status Recruiting
Phase N/A
Start date August 23, 2021
Completion date November 2021

See also
  Status Clinical Trial Phase
Completed NCT04071301 - Collection of Real-life Measurement Data for TENA SmartCare Change Indicator in Subjects With Urinary Incontinence N/A
Active, not recruiting NCT03623880 - Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders N/A
Not yet recruiting NCT03027986 - Evaluation of a Postural Rehabilitation Program Based on Sensory-motor Control in Men With Urinary Incontinence After Prostatectomy N/A
Recruiting NCT02490917 - ACT™ Balloons Versus Artificial Urinary Sphincter (AMS800™) for the Treatment of Female Stress Urinary Incontinence N/A
Enrolling by invitation NCT02529371 - Pre-Marketing Feasibility Evaluation of the UriCap-RM - Urine Collection in Hospitalized Male Patients N/A
Enrolling by invitation NCT02530372 - Feasibility of the UriCap-F for Urine Collection in Hospitalized Women N/A
Completed NCT02549729 - Effect of the Pelvic Floor Training in Postmenopausal Women With or Without Hormonal Therapy N/A
Completed NCT02338726 - Pelvic Floor Symptoms and Quality of Life in Elderly Women - a Population-based Pilot Study N/A
Completed NCT02600676 - Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis N/A
Completed NCT02368262 - Prevalence of Incontinence and Risk Factors in Children With Cerebral Palsy N/A
Completed NCT02239796 - Feasibility Controlled Trial of Tibial Nerve Stimulation for Stroke Related Urinary Incontinence N/A
Completed NCT01942681 - Female Patients With Signs of uRgE and Stress Urinary Incontinence Study of Propiverine Hydrochloride N/A
Recruiting NCT01804153 - Stem Cells Tratment for the Local Feminine Stress Urinary Incontinence Treatment (HULPURO) Phase 1/Phase 2
Completed NCT01520948 - Behavioral Therapy to Treat Urinary Symptoms in Parkinson Disease Phase 3
Completed NCT01479816 - Urinary Continence Index for Prediction of Urinary Incontinence in Older Women N/A
Active, not recruiting NCT01599715 - Translating Unique Learning for Incontinence Prevention Phase 2
Completed NCT01276340 - Prospective Evaluation of Keat Electrostimulator in the Auto-reeducation of Female Urinary Incontinence N/A
Completed NCT01239836 - Effectiveness of Continence Promotion Interventions Among Community-dwelling Older Women N/A
Completed NCT02226237 - Effectiveness of Physiotherapy to Treat the Urinary Incontinence and Erectile Dysfunction Post Retropubic Prostatectomy N/A
Completed NCT01578369 - Effect of Pelvic Floor Muscle Training Included in General Fitness Classes During Pregnacy N/A