Urinary RetentionNCT05485935
A Confirmatory Study Confirming Performance of a New Intermittent Catheter
A study testing Investigational device - intermittent catheter with micro-hole zone and Comparator - standard intermittent catheter in people with Urinary Retention, run by Coloplast A/S at 6 sites in 4 countries.
Trial summary
A multi-centre, randomized, controlled crossover design. The total study duration for the individual subject was approximately 9 weeks. The study consisted of four study visits (V0-V3) and two 4-week test periods at home (T1 and T2). Visit 0 and 1 was performed on the same day if subjects allowed. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Urinary Retention
- What is being tested?
- Investigational device - intermittent catheter with micro-hole zone and Comparator - standard intermittent catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 20 Aug 2022to 3 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Male
- Was at least 18 years of age and had full legal capacity
- Had given written informed consent
- Had signed letter of authority (only DK)
- Had used clean intermittent self-catheterization (CISC) for at least the last 3 months
- Had used intermittent catheterization as the only bladder emptying method for at least the last 3 months
- Self-catheterized using Coloplast SpeediCath Flex or Hollister VaPro catheters, CH12 or CH14, for at least 3 months prior to inclusion
- Had the ability (assessed by investigator) and willingness to adhere to a 2-month study period
Who cannot join
- Participation in any other clinical study during this investigation
- Previous participation in the study
- Symptoms of urinary tract infection as judged by the investigator (rescheduling allowed within recruitment period for LPI)
- Individuals with history, suspected or showing signs of producing urine with excessive amount of mucus or large/clustered sediments or debris
- Any known allergies towards ingredients in the investigational device
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Denmark2 sites
Rigshospitalet
Copenhagen
Sanos Clinic
Gandrup, North Denmark, 9362
United Kingdom1 site
Illingworth Research Group
Macclesfield, Cheshire, SK10 2XR
About this study
Official title: A Confirmatory, Multi-centre, Randomized, Open Label, Controlled Study Confirming Performance of a Single-use Intermittent Micro-holes Zone Catheter in a Population of Adult Male Intermittent Catheter Users.
A multi-centre, randomized, controlled crossover design. The total study duration for the individual subject was approximately 9 weeks. The study consisted of four study visits (V0-V3) and two 4-week test periods at home (T1 and T2). Visit 0 and 1 was performed on the same day if subjects allowed.
One population included all enrolled subjects who took part in the two test periods in a home setting only (T1 and T2). This constituted the Full Analysis Set (FAS) 1 (N=73)where only endpoints related to dipstick hematuria, catheter perception and quality of life were assessed.
A subset of subjects from the FAS1 also took part in two clinic visits (V2 and V3) where endpoints related to bladder emptying and discomfort were assessed. One visit took place in between the two test periods at home (V2) and the other visit took place after the last test period at home (V3) which was also the termination visit. This subset is termed the FAS 2 (N=49).
Read the detailed description
This investigation was a multi-centre, randomized, controlled crossover study including 73 male clean intermittent catheterization (CIC) users.
The study consisted of four study visits (V0-V3) and two 4-week test periods at home (T1 and T2). Visit 0 and 1 were performed on the same day if participants allowed. Visit 0 included the screening-, inclusion-, and randomization phase of participants and at visit 1, participants performed a self-catheterization with the device according to their respective randomization scheme. This was followed by a dipstick test for hematuria. This constituted the Full Analysis Set (FAS) 1, consisting of 73 participants.
In the two 4-week test periods (T1 and T2, respectively) the participants catheterized at home with the specified catheter according to their randomization scheme. Both 4-week periods started with a 2-week run-in period followed by a 2-week period during which a dipstick test for hematuria was performed daily.
For Visit 2 and 3, a sub-group of participants was invited for a clinical test visit during which participants were catheterized with the same device applied during the preceding home-test period. First a healthcare professional (HCP)-led catheterization was performed followed by a self-catheterization, and endpoints related to bladder emptying (residual urine and number of urinary flow-stop episodes) were measured. After each catheterization, any residual urine left in the bladder was measured with a bladder scanner and hematuria was assessed with a dip-stick test. After the self-catheterization process, subjects at clinic visit V2 and V3 completed a questionnaire related to discomfort.This constituted the Full Analysis Set (FAS) 2, consisting of 49 participants.
All participants completed a perception questionnaire and a HRQoL questionnaire associated with the catheter during the last two weeks of the home test period. For participants not part of clinic visits V2 and V3, a nurse assisted with the questionnaires after each home-test period during a remote home visit. Thereafter, all participants were introduced to the second device to be tested for the next home-test period.
After the second home-test period, the study was terminated with a test visit 3 (V3), either in the clinic (for the subset group, FAS2) or a home visit by the nurse (the FAS1 group).
- Conditions
- Urinary Retention
- Being tested
- Investigational device - intermittent catheter with micro-hole zone, Comparator - standard intermittent catheter
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational device - intermittent catheter with micro-hole zoneDevice
Intermittent male catheter with micro-hole zone for urinary drainage
Comparator - standard intermittent catheterDevice
SpeediCath Flex, VaPro Pocket, VaPro Plus and VaPro Plus Pocket.
| Study group | Role | What they receive |
|---|---|---|
| Investigational device - intermittent catheter with micro-hole zone | Experimental | Single-use, sterile, hydrophilic coated intermittent male catheter. The external diameter is measured in millimeters (Charrière scale: Ch, CH) and the sizes available were CH12 and CH14 with a flexible tip and a micro-hole zone for urinary drainage. Receives: Device: Investigational device - intermittent catheter with micro-hole zone |
| Comparator device - standard intermittent catheter | Active comparator | Single-use, sterile, hydrophilic coated intermittent male catheters (sizes CH12 and CH14) with sleeves: SpeediCath Flex, VaPro, VaPro Pocket, VaPro Plus and VaPro Plus Pocket. Receives: Device: Comparator - standard intermittent catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual Urine at 1st Flow Stop (HCP-led Catheterization) i.e., Total Catheterisation Volume Minus Volume at 1st Flow-stop, Both Derived From a Catheterisation Profile
The residual urine at 1st flow-stop during catheterization (performed by a HCP) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying.
Hence, the residual volume at 1st flow-stop was calculated as the total volume post catheterisation minus the volume at 1st flow-stop, derived from a catheterisation profile which was connected to a time-logged weighing [g].
Measured: Immediately after the procedure/catheterization, at second and third clinic visit following 4 weeks of home catheterization
Number of Flow-stop Episodes (HCP-led Catheterization)
Number of flow-stop episodes were determined as instances where the flow rate decreased to less than 0.8 mL/s for a period of at least two seconds. All episodes were detected by automatic thresholding, followed by manual inspection, where the intra-catheter pressure readings were used to support the assessment of a flow stop.
Measured: Immediately after catheterisation, at second and third clinic visit following 4 weeks of home catheterization
Secondary outcomes (4)
Number of Flow-stop Episodes (Self-led Catheterization)
Number of flow-stops were measured with a pressure sensor, which is an electronic device used for monitoring the hydrostatic pressure at the outlet of an intermittent urinary catheter during emptying. From a sensor curve, flow-stops were identified by two individually trained evaluators as a hydrostatic pressure peak coinciding with a urine flow-stop/ urine dripping (flowrate lower than 0,8 ml/sec). Results from both evaluators were compared and in case of discrepancy a discussion was performed to extenuate discrepancies and agree on a final interpretation of the curves.
Measured: Immediately after the procedure/catheterization, at second and third clinic visit following 4 weeks of home catheterization
Residual Urine at 1st Flow Stop (Self-led Catheterization)
The residual urine at 1st flow-stop during catheterization (performed by the participant self) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying.
Hence, the residual volume at 1st flow-stop was calculated as the total volume post catheterisation minus the volume at 1st flow-stop, derived from a catheterisation profile which was connected to a time-logged weighing [g].
Measured: Immediately after the procedure/catheterization, at second and third clinic visit following 4 weeks of home catheterization
Mean Red Blood Cell Concentration
The average (mean) Red blood cell concentration based on a dipstick test, collected daily during the two weeks of the home test period T1 and T2 [Erythrocytes/µL].
Measured: Dipstick test for haematuria was performed daily were performed in week 3 and 4 (1st home-period) and in week 7 and 8 (2nd home-period).
Positive Hematuria Event Post-catheterisation
Number of positive hematuria events (i.e., blood in urine) based on a dipstick test, collected daily during the final two weeks of the home test period T1 and T2 [positive/negative scale]. Positive value = blood in the urine. Negative value = no blood in the urine.
Measured: week 3 and 4 (1st home-period) and in week 7 and 8 (2nd home-period).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start20 Aug 2022
- Primary completion3 Jan 2023
- Study completion3 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urinary RetentionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This was a multi-centre, randomized, controlled crossover design. The total study duration for the individual participant was approximately 9 weeks. The study consisted of four study visits (V0-V3) and two 4-week test periods at home (T1 and T2). Visit 0 and 1 was performed on the same day if subjects allowed. One population included all enrolled subjects who took part in the two test periods in a home setting only (T1 and T2). This constituted the Full Analysis Set (FAS) 1 (N=73) where only endpoints related to dipstick hematuria, catheter perception and quality of life were assessed. A subset of subjects from the FAS1 also took part in two clinic visits (V2 and V3) where endpoints related to bladder emptying and discomfort were assessed. One visit took place in between the two test periods at home (V2) and the other visit took place after the last test period at home (V3) which was also the termination visit. This subset is termed the FAS 2 (N=49).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nikesh thiruchelvam, Dr, Study chair, NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05485935
- Sponsor's protocol ID
- CP334
- Status last verified
- Feb 2025
- First submitted
- 30 Jun 2022
- Last updated
- 18 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Confirmatory, Multi-centre, Randomized, Open Label, Controlled Study Confirming Performance of a Single-use Intermittent Micro-holes Zone Catheter in a Population of Adult Male Intermittent Catheter Users.
- ClinicalTrials.gov ID
- NCT05485935
- Acronym / sponsor ID
- CP334
- Conditions
- Urinary Retention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 20 Aug 2022 (actual)
- Primary completion
- 3 Jan 2023 (actual)
- Study completion
- 3 Jan 2023 (actual)
- First posted
- 3 Aug 2022 (actual)
- Results
- Posted 18 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multi-centre, randomized, controlled crossover design. The total study duration for the individual subject was approximately 9 weeks. The study consisted of four study visits (V0-V3) and two 4-week test periods at home (T1 and T2). Visit 0 and 1 was performed on the same day if subjects allowed.
One population included all enrolled subjects who took part in the two test periods in a home setting only (T1 and T2). This constituted the Full Analysis Set (FAS) 1 (N=73)where only endpoints related to dipstick hematuria, catheter perception and quality of life were assessed.
A subset of subjects from the FAS1 also took part in two clinic visits (V2 and V3) where endpoints related to bladder emptying and discomfort were assessed. One visit took place in between the two test periods at home (V2) and the other visit took place after the last test period at home (V3) which was also the termination visit. This subset is termed the FAS 2 (N=49).
Detailed description
This investigation was a multi-centre, randomized, controlled crossover study including 73 male clean intermittent catheterization (CIC) users.
The study consisted of four study visits (V0-V3) and two 4-week test periods at home (T1 and T2). Visit 0 and 1 were performed on the same day if participants allowed. Visit 0 included the screening-, inclusion-, and randomization phase of participants and at visit 1, participants performed a self-catheterization with the device according to their respective randomization scheme. This was followed by a dipstick test for hematuria. This constituted the Full Analysis Set (FAS) 1, consisting of 73 participants.
In the two 4-week test periods (T1 and T2, respectively) the participants catheterized at home with the specified catheter according to their randomization scheme. Both 4-week periods started with a 2-week run-in period followed by a 2-week period during which a dipstick test for hematuria was performed daily.
For Visit 2 and 3, a sub-group of participants was invited for a clinical test visit during which participants were catheterized with the same device applied during the preceding home-test period. First a healthcare professional (HCP)-led catheterization was performed followed by a self-catheterization, and endpoints related to bladder emptying (residual urine and number of urinary flow-stop episodes) were measured. After each catheterization, any residual urine left in the bladder was measured with a bladder scanner and hematuria was assessed with a dip-stick test. After the self-catheterization process, subjects at clinic visit V2 and V3 completed a questionnaire related to discomfort.This constituted the Full Analysis Set (FAS) 2, consisting of 49 participants.
All participants completed a perception questionnaire and a HRQoL questionnaire associated with the catheter during the last two weeks of the home test period. For participants not part of clinic visits V2 and V3, a nurse assisted with the questionnaires after each home-test period during a remote home visit. Thereafter, all participants were introduced to the second device to be tested for the next home-test period.
After the second home-test period, the study was terminated with a test visit 3 (V3), either in the clinic (for the subset group, FAS2) or a home visit by the nurse (the FAS1 group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This was a multi-centre, randomized, controlled crossover design. The total study duration for the individual participant was approximately 9 weeks. The study consisted of four study visits (V0-V3) and two 4-week test periods at home (T1 and T2). Visit 0 and 1 was performed on the same day if subjects allowed. One population included all enrolled subjects who took part in the two test periods in a home setting only (T1 and T2). This constituted the Full Analysis Set (FAS) 1 (N=73) where only endpoints related to dipstick hematuria, catheter perception and quality of life were assessed. A subset of subjects from the FAS1 also took part in two clinic visits (V2 and V3) where endpoints related to bladder emptying and discomfort were assessed. One visit took place in between the two test periods at home (V2) and the other visit took place after the last test period at home (V3) which was also the termination visit. This subset is termed the FAS 2 (N=49).
| Arm | Type | Receives |
|---|---|---|
| Investigational device - intermittent catheter with micro-hole zone | Experimental | Device: Investigational device - intermittent catheter with micro-hole zoneSingle-use, sterile, hydrophilic coated intermittent male catheter. The external diameter is measured in millimeters (Charrière scale: Ch, CH) and the sizes available were CH12 and CH14 with a flexible tip and a micro-hole zone for urinary drainage. |
| Comparator device - standard intermittent catheter | Active comparator | Device: Comparator - standard intermittent catheterSingle-use, sterile, hydrophilic coated intermittent male catheters (sizes CH12 and CH14) with sleeves: SpeediCath Flex, VaPro, VaPro Pocket, VaPro Plus and VaPro Plus Pocket. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male
- Was at least 18 years of age and had full legal capacity
- Had given written informed consent
- Had signed letter of authority (only DK)
- Had used clean intermittent self-catheterization (CISC) for at least the last 3 months
Key exclusion criteria (5 listed)
- Participation in any other clinical study during this investigation
- Previous participation in the study
- Symptoms of urinary tract infection as judged by the investigator (rescheduling allowed within recruitment period for LPI)
- Individuals with history, suspected or showing signs of producing urine with excessive amount of mucus or large/clustered sediments or debris
- Any known allergies towards ingredients in the investigational device
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 |
|---|---|---|
| Investigational device - intermittent catheter with micro-hole zoneIntermittent male catheter with micro-hole zone for urinary drainage | Device | Investigational device - intermittent catheter with micro-hole zone |
| Comparator - standard intermittent catheterSpeediCath Flex, VaPro Pocket, VaPro Plus and VaPro Plus Pocket. | Device | Comparator device - standard intermittent catheter |
Primary outcome
Residual Urine at 1st Flow Stop (HCP-led Catheterization) i.e., Total Catheterisation Volume Minus Volume at 1st Flow-stop, Both Derived From a Catheterisation Profile
Time frame: Immediately after the procedure/catheterization, at second and third clinic visit following 4 weeks of home catheterization
The residual urine at 1st flow-stop during catheterization (performed by a HCP) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying. Hence, the residual volume at 1st flow-stop was calculated as the total volume post catheterisation minus the volume at 1st flow-stop, derived from a catheterisation profile which was connected to a time-logged weighing [g].
Number of Flow-stop Episodes (HCP-led Catheterization)
Time frame: Immediately after catheterisation, at second and third clinic visit following 4 weeks of home catheterization
Number of flow-stop episodes were determined as instances where the flow rate decreased to less than 0.8 mL/s for a period of at least two seconds. All episodes were detected by automatic thresholding, followed by manual inspection, where the intra-catheter pressure readings were used to support the assessment of a flow stop.
4 secondary outcomes
Number of Flow-stop Episodes (Self-led Catheterization)
Time frame: Immediately after the procedure/catheterization, at second and third clinic visit following 4 weeks of home catheterization
Residual Urine at 1st Flow Stop (Self-led Catheterization)
Time frame: Immediately after the procedure/catheterization, at second and third clinic visit following 4 weeks of home catheterization
Mean Red Blood Cell Concentration
Time frame: Dipstick test for haematuria was performed daily were performed in week 3 and 4 (1st home-period) and in week 7 and 8 (2nd home-period).
Positive Hematuria Event Post-catheterisation
Time frame: week 3 and 4 (1st home-period) and in week 7 and 8 (2nd home-period).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Urinary Retention
Not yet recruiting
Effect of Voiding Position (Standing in the Shower vs. Sitting) on Post- Void Residual Urine Volume (PVR) After Removal of Urinary Catheter in Women Following Vaginal Delivery With Epidural Analgesia: A Double- Blind Randomized Controlled Trial
Postpartum Urinary Retention
Recruiting
Pelvic Health Electrically Evoked Recording (PEER) 2 Study
Overactive Bladder, Fecal Incontinence
Not yet recruitingObservational study
Long-Term Effectiveness and Safety of Sacral Neuromodulation With InterStim for Lower Urinary Tract Dysfunction
Overactive Bladder (OAB), Urgency Urinary Incontinence
Recruiting
Evaluating the Clinical Efficacy of Thulio vs. Holmium Laser Enucleation of the Prostate
BPH With Symptomatic Lower Urinary Tract Symptoms, BPH With Urinary Obstruction
Active, not recruiting
Preoperative Pelvic Floor Physical Therapy to Minimize Stress Urinary Incontinence After Holmium Laser Enucleation of the Prostate
Benign Prostatic Hyperplasia With Outflow Obstruction, Urinary Retention
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.
Nikesh thiruchelvam, Dr study chair
NHS Foundation Trust
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational device - intermittent catheter with micro-hole zone and Comparator - standard intermittent catheter in people with Urinary Retention, run by Coloplast A/S at 6 sites in 4 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 8 inclusion and 5 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 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Denmark, France, Germany, United Kingdom. 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?
Yes. Results are posted in the registry (first posted 18 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Residual Urine at 1st Flow Stop (HCP-led Catheterization) i.e., Total Catheterisation Volume Minus Volume at 1st Flow-stop, Both Derived From a Catheterisation Profile (time frame: Immediately after the procedure/catheterization, at second and third clinic visit following 4 weeks of home catheterization). The study lists 2 primary outcomes in all. 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 18 Mar 2025.