Clinical trial NCT05470751: GentleCath™ for Men Intermittent Catheter With FeelClean™ Technology
Official title: A Multi-centre Prospective Observational Study of the User Experience of Catheterisation and Quality of Life in Patients Prescribed GentleCath™ for Men Intermittent Catheter With FeelClean™ Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Outlet Obstruction
Multiple Sclerosis
Cauda Equina Syndrome
Enlarged Prostate With Lower Urinary Tract Symptoms
Parkinson Disease
Lower Urinary Tract Symptoms
Detrusor Underactivity
Spinal Cord Injuries
Keywords: neurogenic bladder
intermittent self-catherterisation
pain
bladder outflow obstruction
Lead sponsor: ConvaTec Inc.
Sponsor class: INDUSTRY
First posted: 2022-07-22
Enrollment: 72
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult males who self-catheterise

Brief summary: Male self catherterisng observational study.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: To assess difficulty during catheterisation and quality of life using the ICDQ and ISC-Q validated questionnaires during catheterisation
timeFrame: 60 days
Secondary outcomes:
measure: To assess patient confidence regarding reduced stickiness plus related risk of urethral injury and resultant bleeding or infection
timeFrame: 60 days
measure: To assess compliance with the self-catheterization for the study duration
timeFrame: 60 days
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Institute for Rehabilitation
state: New Jersey
city: Philadelphia
country: United States
facility: Trustees of The University of Pennsylvania | Penn Urology Washington Square
state: Pennsylvania
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux | Pellegrin Hospital - Urology Department
city: Paris
country: France
facility: Assistance Publique Hopitaux de Paris | Pitie Salpetriere University Hospital - Urology Department
city: Stockport
country: United Kingdom
facility: Stockport NHS Foundation Trust | Stepping Hill Hospital - Research and Innovation Department
state: Cheshire
city: Chelmsford
country: United Kingdom
facility: Broomfield Hospital
state: Essex
city: Southend-on-Sea
country: United Kingdom
facility: Mid and South Essex NHS Foundation Trust | Southend University Hospital - Research & Development
state: Essex
city: Newport
country: United Kingdom
facility: Aneurin Bevan University Health Board | Royal Gwent Hospital - Clinical Research Centre
state: Gwent
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
state: Hampshire
city: Canterbury
country: United Kingdom
facility: Kent and Canterbury Hospital | Renal Research Delivery Team
state: Kent
city: Newcastle
country: United Kingdom
facility: Newcastle upon Tyne Hospitals NHS Foundation Trust | Freeman Hospital - Urology Department
state: Newcastle Upon Tyne
city: Sunderland
country: United Kingdom
facility: Sunderland Royal Hospital
state: Tyne & Wear
city: Bristol
country: United Kingdom
facility: North Bristol NHS Trust | Southmead Hospital - Research and Development - Urology Department
state: Westbury-on-Trym
city: Wakefield
country: United Kingdom
facility: Mid Yorkshire Teaching NHS Trust | Pinderfields Hospital - Yorkshire Regional Spinal Injuries Centre
state: Yorkshire
city: London
country: United Kingdom
facility: Guy's and St Thomas' Foundation Trust | Guy's Hospital - Transplant, Renal and Urology Research
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust | King's College Hospital - Renal Research Department
Study officials:
affiliation: Site Investigator - Newcastle
name: Chris Harding
role: PRINCIPAL_INVESTIGATOR
References: