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Completed

NCT Number: NCT05470751

GentleCath™ for Men Intermittent Catheter With FeelClean™ Technology

Male self catherterisng observational study.

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Key information

Conditions

Bladder Outlet Obstruction Autoimmune Diseases Autoimmune Diseases of the Nervous System Basal Ganglia Diseases Brain Diseases Cauda Equina Syndrome Central Nervous System Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Detrusor Underactivity Enlarged Prostate With Lower Urinary Tract Symptoms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Immune System Diseases Lower Urinary Tract Symptoms Male Urogenital Diseases Movement Disorders Multiple Sclerosis Nerve Compression Syndromes Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Neuromuscular Diseases Pain Parkinson Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Polyradiculoneuropathy Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Synucleinopathies Trauma, Nervous System Urethral Diseases Urethral Obstruction Urinary Bladder Diseases Urinary Bladder Neck Obstruction Urinary Bladder, Neurogenic Urinary Bladder, Underactive Urogenital Diseases Urologic Diseases Urological Manifestations Wounds and Injuries

Age range

18 year–100 year

Sex eligibility

Male

Study type

Observational

Primary location

Centre Hospitalier Universitaire de Bordeaux | Pellegrin Hospital - Urology Department, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intermittent self-catheterisation

Device

Self-catheterising with GC Male and Glide Male with Feelclean technology

Primary outcomes

  1. To assess difficulty during catheterisation and quality of life using the ICDQ and ISC-Q validated questionnaires during catheterisation

    Time frame: 60 days

    To assess difficulty during catheterisation and quality of life using the ICDQ and ISC-Q

Secondary outcomes

  1. To assess patient confidence regarding reduced stickiness plus related risk of urethral injury and resultant bleeding or infection

    Time frame: 60 days

    To assess patient confidence regarding reduced stickiness plus related risk of urethral

  2. To assess compliance with the self-catheterization for the study duration

    Time frame: 60 days

    To assess compliance with the self-catheterization for the study duration

Sponsors and collaborators

Lead sponsor

ConvaTec Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 22, 2022
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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