Bladder Outlet ObstructionNCT05470751
GentleCath™ for Men Intermittent Catheter With FeelClean™ Technology
An observational study of Bladder Outlet Obstruction and Multiple Sclerosis, run by ConvaTec Inc. at 16 sites in 3 countries.
Trial summary
Male self catherterisng observational study. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Bladder Outlet Obstruction, Multiple Sclerosis, Cauda Equina Syndrome
- What is being tested?
- Intermittent self-catheterisation
- Type of treatment
- Medical device
- How many people
- 72 participants
- Where
- 16 sitesin 3 countries
- Study dates
- 2 Feb 2023to 6 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Adult males who self-catheterise
Who may be able to join
- • 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
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- 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
Who cannot join
- • 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
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- 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
Trial locations and contacts
16 sites in 3 countries.
16 sites in 3 countries
United Kingdom12 sites
North Bristol NHS Trust | Southmead Hospital - Research and Development - Urology Department
Bristol, Westbury-on-Trym, BS10 5NB
Kent and Canterbury Hospital | Renal Research Delivery Team
Canterbury, Kent, CT2 7FG
Broomfield Hospital
Chelmsford, Essex, CM1 7ET
Guy's and St Thomas' Foundation Trust | Guy's Hospital - Transplant, Renal and Urology Research
London, SE1 9RT
King's College Hospital NHS Foundation Trust | King's College Hospital - Renal Research Department
London, SE5 9RS
Newcastle upon Tyne Hospitals NHS Foundation Trust | Freeman Hospital - Urology Department
Newcastle, Newcastle Upon Tyne, NE7 7DN
Aneurin Bevan University Health Board | Royal Gwent Hospital - Clinical Research Centre
Newport, Gwent, NP20 2UB
Southampton General Hospital
Southampton, Hampshire, SO16 6YD
Mid and South Essex NHS Foundation Trust | Southend University Hospital - Research & Development
Southend-on-Sea, Essex, SS0 0RY
Stockport NHS Foundation Trust | Stepping Hill Hospital - Research and Innovation Department
Stockport, Cheshire, SK2 7JE
Sunderland Royal Hospital
Sunderland, Tyne & Wear, SR4 7TP
Mid Yorkshire Teaching NHS Trust | Pinderfields Hospital - Yorkshire Regional Spinal Injuries Centre
Wakefield, Yorkshire, WF1 4DG
United States2 sites
Trustees of The University of Pennsylvania | Penn Urology Washington Square
Philadelphia, Pennsylvania, 19106
Kessler Institute for Rehabilitation
West Orange, New Jersey, 07052
France2 sites
Centre Hospitalier Universitaire de Bordeaux | Pellegrin Hospital - Urology Department
Bordeaux, 33076
Assistance Publique Hopitaux de Paris | Pitie Salpetriere University Hospital - Urology Department
Paris, 75013
About this study
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
Male self catherterisng observational study.
Read the 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.
- Conditions
- Bladder Outlet Obstruction, Multiple Sclerosis, Cauda Equina Syndrome, Enlarged Prostate With Lower Urinary Tract Symptoms, Parkinson Disease, Lower Urinary Tract Symptoms
- Being tested
- Intermittent self-catheterisation
- Keywords
- neurogenic bladder, intermittent self-catherterisation, pain, bladder outflow obstruction
- Medical subject headings
- Urinary Bladder Neck Obstruction, Multiple Sclerosis, Cauda Equina Syndrome, Parkinson Disease, Lower Urinary Tract Symptoms, Urinary Bladder, Underactive, Spinal Cord Injuries, Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent self-catheterisationDevice
Self-catheterising with GC Male and Glide Male with Feelclean technology
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 60 days
Secondary outcomes (2)
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
Measured: 60 days
To assess compliance with the self-catheterization for the study duration
To assess compliance with the self-catheterization for the study duration
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start2 Feb 2023
- Primary completion6 Apr 2024
- Study completion6 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Outlet ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- ConvaTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chris Harding, Principal investigator, Site Investigator - Newcastle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05470751
- Sponsor's protocol ID
- CC-21-425
- Status last verified
- Apr 2024
- First submitted
- 20 Jul 2022
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05470751
- Acronym / sponsor ID
- CC-21-425
- Conditions
- Bladder Outlet Obstruction, Multiple Sclerosis, Cauda Equina Syndrome, Enlarged Prostate With Lower Urinary Tract Symptoms, Parkinson Disease, Lower Urinary Tract Symptoms
- Keywords
- neurogenic bladder, intermittent self-catherterisation, pain, bladder outflow obstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- ConvaTec Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 6 Apr 2024 (actual)
- Study completion
- 6 Apr 2024 (actual)
- First posted
- 22 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult males who self-catheterise
Key inclusion criteria (9 listed)
- • Adult male (aged 18 years and over)
Key exclusion criteria (9 listed)
- • Participation in another related urological study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent self-catheterisationSelf-catheterising with GC Male and Glide Male with Feelclean technology | Device | – |
Primary outcome
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
2 secondary outcomes
To assess patient confidence regarding reduced stickiness plus related risk of urethral injury and resultant bleeding or infection
Time frame: 60 days
To assess compliance with the self-catheterization for the study duration
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Harding principal investigator
Site Investigator - Newcastle
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Outlet Obstruction and Multiple Sclerosis, run by ConvaTec Inc. at 16 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United Kingdom, United States, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess difficulty during catheterisation and quality of life using the ICDQ and ISC-Q validated questionnaires during catheterisation (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.