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GentleCath™ Air for Men Intermittent Catheter With FeelClean™ Technology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05470751
Recruitment Status : Not yet recruiting
First Posted : July 22, 2022
Last Update Posted : January 23, 2023
Sponsor:
Information provided by (Responsible Party):
ConvaTec Inc.

Brief Summary:

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.


Condition or disease Intervention/treatment
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 Device: Intermittent self-catheterisation

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Study Type : Observational
Estimated Enrollment : 165 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-centre Prospective Observational Study of the User Experience of Catheterisation and Quality of Life in Patients Prescribed GentleCath™ Air for Men Intermittent Catheter With FeelClean™ Technology
Estimated Study Start Date : January 2023
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : May 2023



Intervention Details:
  • Device: Intermittent self-catheterisation
    Self-catheterising with GC Air Male with Feelclean technology


Primary Outcome Measures :
  1. To assess difficulty during catheterisation and quality of life using the ICDQ and ISC-Q validated questionnaires during catheterisation [ Time Frame: 60 days ]

Secondary Outcome Measures :
  1. To assess patient confidence regarding reduced stickiness plus related risk of urethral injury and resultant bleeding or infection [ Time Frame: 60 days ]
  2. To assess compliance with the self-catheterization for the study duration [ Time Frame: 60 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult males who self-catheterise
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05470751


Contacts
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Contact: Chris Harding 0191 2137321 c.harding@nhs.net

Sponsors and Collaborators
ConvaTec Inc.
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Responsible Party: ConvaTec Inc.
ClinicalTrials.gov Identifier: NCT05470751    
Other Study ID Numbers: CC-21-425
First Posted: July 22, 2022    Key Record Dates
Last Update Posted: January 23, 2023
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by ConvaTec Inc.:
neurogenic bladder
intermittent self-catherterisation
pain
bladder outflow obstruction
Additional relevant MeSH terms:
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Parkinson Disease
Multiple Sclerosis
Spinal Cord Injuries
Hypokinesia
Cauda Equina Syndrome
Urinary Bladder Neck Obstruction
Urinary Bladder, Underactive
Lower Urinary Tract Symptoms
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries
Urological Manifestations
Urethral Obstruction
Urethral Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications