Clinical Trials Logo
  1. Home
  2. Urinary Incontinence
  3. NCT04619992
  4. Details
NCT04619992 Clinical Trial

Consumer Evaluation of Intermittent Catheter Product Modifications

Urinary Incontinence Clinical Trial

Official title:
Consumer Evaluation of Intermittent Catheter Product Modifications

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04619992
Other study ID # 6009-CONT
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 14, 2020
Est. completion date August 17, 2021

Study information
Verified date August 2022
Source Hollister Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to collect feedback from hydrophilic intermittent catheter end-users to assess user acceptance of the test hydrophilic intermittent catheter and generate evidence to support commercial marketing objectives.

Recruitment information / eligibility
Status Completed
Enrollment 62
Est. completion date August 17, 2021
Est. primary completion date August 17, 2021
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility A. Inclusion Criteria for Arm 1 Subject who: 1. is male and at least 18 years of age 2. has been performing unassisted, self-catheterizations, with a Hollister standard with tip Hydrophilic intermittent catheter, 3 or more times a day for at least 1 month B. Exclusion Criteria for Arm 1 Subject who: 1. is currently undergoing chemotherapy, radiation or steroid therapy 2. has a symptomatic urinary tract infection (UTI) 3. is currently using a coude intermittent catheter product to perform catheterization 4. performs non-urethral catheterization C. Inclusion Criteria for Arm 2 Subject who: 1. is male and at least 18 years of age 2. has been performing unassisted, self-catheterizations, with a non-standard with tip Hydrophilic intermittent catheter, 3 or more times a day for at least 1 month D. Exclusion Criteria for Arm 2 Subject who: 1. is currently undergoing chemotherapy, radiation or steroid therapy 2. has a symptomatic urinary tract infection (UTI) 3. is currently using a coude intermittent catheter product to perform catheterization 4. performs non-urethral catheterization 5. is unable to use a Hollister standard with tip hydrophilic intermittent catheter

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Currently marketed Hydrophillic Intermittent Catheter
Currently marketed Hollister standard with tip hydrophilic intermittent catheter
• Test Hydrophilic Intermittent Catheter
Hollister standard with tip hydrophilic intermittent catheter with design enhancements

Locations
Country Name City State
United States Hollister Incorporated Libertyville Illinois

Sponsors (1)
Lead Sponsor Collaborator
Hollister Incorporated

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Acceptability of Test Hydrophilic Intermittent Catheter Users will rate if Test device is an acceptable alternative to currently marketed device. Acceptability will be rated via a standard 5-point Likert agreement scale. Agreement signifies Test catheter is an acceptable alternative to currently marketed catheter. 10 days
Primary Preference of Test Hydrophilic Intermittent Catheter Users will rate if Test device is preferred to currently marketed device. Preference will be rated via a standard 5-point Likert agreement scale. Agreement signifies Test catheter is preferred to currently marketed catheter. 10 days
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 NCT05485922 - Performance of a Single-use Intermittent Micro-hole Zone Catheter 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 NCT02338726 - Pelvic Floor Symptoms and Quality of Life in Elderly Women - a Population-based Pilot Study N/A
Completed NCT02549729 - Effect of the Pelvic Floor Training in Postmenopausal Women With or Without Hormonal Therapy 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