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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05470751
Other study ID # CC-21-425
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2, 2023
Est. completion date April 6, 2024

Study information

Verified date April 2024
Source ConvaTec Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Male self catherterisng observational study.


Description:

This is a multicentre, prospective international observational study. Male patients in the UK, USA and France performing self-catheterisation will be asked to participate in this study. The subjects will be asked to use the GentleCath™ Intermittent Catheter with FeelClean™ Technology as per their normal routine. They will be asked to record when and where they catheterise. At the baseline, during and on completion of the study, the subjects will be asked to complete Difficulty in Catheterisation plus Intermittent Catheter related Quality of Life Questionnaires. Difficulty during catheterisation and quality of life will be assessed using the ICDQ and ISC-Q validated questionnaires during catheterisation at the start of the study before use of GentleCath™ Air has commenced (D0) and on day 1 (D1), day 15 (D15), day 30 (D30), day 45 (D45) and day 60 (D60) transcribed in a collecting record provided for this purpose. Compliance and catheter use will also be assessed. Patient confidence regarding reduced stickiness plus related risk of urethral injury and resultant bleeding or infection will also be recorded.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date April 6, 2024
Est. primary completion date April 6, 2024
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - • Adult male (aged 18 years and over) - Diagnosed with a neurological lower urinary tract dysfunction due to either spinal cord injury, Multiple Sclerosis, Parkinson's Syndrome, Cauda equina syndrome Or Diagnosed with bladder outflow obstruction secondary to benign prostate enlargement Or Diagnosed with detrusor underactivity - Performing single use clean intermittent self-catheterisation (ISC) at least twice a day - Willing to undergo training with GC Trainer video prior to use of catheter - Provided fully informed consent and has sufficient understanding of English or French - Sufficient dexterity to use GentleCath™ Air for Men intermittent including ability to open packaging - Intact urethral sensation of catheterisation - Willing to use only the GentleCath™ Air intermittent catheter for the full duration of the study (60-days) - Subject has a valid email address so the Investigator can send links to study questionnaires and the subject has access to a web enabled device Exclusion Criteria: - • Participation in another related urological study - Unable to perform ISC unaided - Already prescribed the GentleCath™ Air Intermittent Catheter - Absent urethral or perineal sensation - Unwilling to undergo training with GC Trainer prior to use of catheter - Insufficient dexterity to use GentleCath™ Air Intermittent Catheter and or packaging - Suffering from a symptomatic UTI (Urinary Tract Infections) at the time of inclusion or in the preceding 6-weeks - Undergoing surgical treatment during the period of the study - Performing catheterisation for urethral stricture

Study Design


Intervention

Device:
Intermittent self-catheterisation
Self-catheterising with GC Male and Glide Male with Feelclean technology

Locations

Country Name City State
France Centre Hospitalier Universitaire de Bordeaux | Pellegrin Hospital - Urology Department Bordeaux
France Assistance Publique Hopitaux de Paris | Pitie Salpetriere University Hospital - Urology Department Paris
United Kingdom North Bristol NHS Trust | Southmead Hospital - Research and Development - Urology Department Bristol Westbury-on-Trym
United Kingdom Kent and Canterbury Hospital | Renal Research Delivery Team Canterbury Kent
United Kingdom Broomfield Hospital Chelmsford Essex
United Kingdom Guy's and St Thomas' Foundation Trust | Guy's Hospital - Transplant, Renal and Urology Research London
United Kingdom King's College Hospital NHS Foundation Trust | King's College Hospital - Renal Research Department London
United Kingdom Newcastle upon Tyne Hospitals NHS Foundation Trust | Freeman Hospital - Urology Department Newcastle Newcastle Upon Tyne
United Kingdom Aneurin Bevan University Health Board | Royal Gwent Hospital - Clinical Research Centre Newport Gwent
United Kingdom Southampton General Hospital Southampton Hampshire
United Kingdom Mid and South Essex NHS Foundation Trust | Southend University Hospital - Research & Development Southend-on-Sea Essex
United Kingdom Stockport NHS Foundation Trust | Stepping Hill Hospital - Research and Innovation Department Stockport Cheshire
United Kingdom Sunderland Royal Hospital Sunderland Tyne & Wear
United Kingdom Mid Yorkshire Teaching NHS Trust | Pinderfields Hospital - Yorkshire Regional Spinal Injuries Centre Wakefield Yorkshire
United States Trustees of The University of Pennsylvania | Penn Urology Washington Square Philadelphia Pennsylvania
United States Kessler Institute for Rehabilitation West Orange New Jersey

Sponsors (1)

Lead Sponsor Collaborator
ConvaTec Inc.

Countries where clinical trial is conducted

United States,  France,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary To assess difficulty during catheterisation and quality of life using the ICDQ and ISC-Q validated questionnaires during catheterisation To assess difficulty during catheterisation and quality of life using the ICDQ and ISC-Q 60 days
Secondary To assess patient confidence regarding reduced stickiness plus related risk of urethral injury and resultant bleeding or infection To assess patient confidence regarding reduced stickiness plus related risk of urethral 60 days
Secondary To assess compliance with the self-catheterization for the study duration To assess compliance with the self-catheterization for the study duration 60 days
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