Performance of a Single-use Intermittent Micro-hole Zone Catheter

Status Completed

Clinical Trial Summary

The goal of this randomized, controlled crossover study was to assess the performance of a new micro-hole zone catheter compared to a conventional 2-eyelet catheter in 42 male intermittent catheter users. The main objective of this study was to demonstrate superiority of the micro-hole zone catheter in terms of number of flow-stop episodes and residual volume at first flow-stop, with the catheterization performed by a health care professional in a hospital setting compared to a conventional two-eyelet catheter.

Clinical Trial Description

The investigation was a single-centre, randomized, controlled crossover study including 42 male IC users comparing the performance of two intermittent catheters. The study included an information visit (visit 0) and two test visits (visit 1 and 2) in which one catheterization with either the investigational device or the comparator device, according to a randomization scheme, was performed by a health care professional in a hospital setting assessing flow stop episodes, bladder emptying and hematuria. There were 4-14 days between each test visit (visit 1 and 2) and visit 0 and 1 could be held on the same day. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05485922
Study type	Interventional
Source	Coloplast A/S
Contact
Status	Completed
Phase	N/A
Start date	September 23, 2022
Completion date	November 4, 2022

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05534412` - A Practice-Based Intervention To Improve Care for a Diverse Population Of Women With Urinary Incontinence	N/A
Recruiting	`NCT05515198` - Improving Care for Women With Urinary Incontinence (EMPOWER)	N/A
Completed	`NCT04071301` - Collection of Real-life Measurement Data for TENA SmartCare Change Indicator in Subjects With Urinary Incontinence	N/A
Completed	`NCT03623880` - Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders	N/A
Recruiting	`NCT05880862` - Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls	Early Phase 1
Recruiting	`NCT04159467` - Effect of Pelvic Floor Muscle Training on Urinary Incontinence Reports in Obese Women Undergoing a Low Calorie Diet	N/A
Completed	`NCT06268782` - The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women	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	`NCT02600676` - Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis	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	`NCT02239796` - Feasibility Controlled Trial of Tibial Nerve Stimulation for Stroke Related Urinary Incontinence	N/A
Completed	`NCT02368262` - Prevalence of Incontinence and Risk Factors in Children With Cerebral Palsy	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