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GentleCath™ for Men Intermittent Catheter With FeelClean™ Technology

CompletedN/A

Sponsor: ConvaTec Inc.

Conditions: Bladder Outlet Obstruction, Multiple Sclerosis, Cauda Equina Syndrome, Enlarged Prostate With Lower Urinary Tract Symptoms, Parkinson Disease

Interventions: Intermittent self-catheterisation

Countries: United States, France, United Kingdom

Male self catherterisng observational study.

Eligibility overview

Sex: MALE

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

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

Locations (16)

West Orange, New Jersey, United States
Philadelphia, Pennsylvania, United States
Bordeaux, France
Paris, France
Stockport, Cheshire, United Kingdom
Chelmsford, Essex, United Kingdom
Southend-on-Sea, Essex, United Kingdom
Newport, Gwent, United Kingdom
Southampton, Hampshire, United Kingdom
Canterbury, Kent, United Kingdom
Newcastle, Newcastle Upon Tyne, United Kingdom
Sunderland, Tyne & Wear, United Kingdom
Bristol, Westbury-on-Trym, United Kingdom
Wakefield, Yorkshire, United Kingdom
London, United Kingdom
London, United Kingdom