Retention, UrinaryNCT04445051

Investigation of New Intermittent Catheters in Healthy Volunteers

A study testing SpeediCath® Standard male or female, New intermittent Variant 1 catheter for male or female and New intermittent Variant 2 catheter for male or female in people with Retention, Urinary, run by Coloplast A/S at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Investigation of non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters with a comparator catheter in 30 adult healthy volunteers. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Retention, Urinary
What is being tested?: SpeediCath® Standard male or female, New intermittent Variant 1 catheter for male or female and New intermittent Variant 2 catheter for male or female
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteDenmark
Study dates: 1 Mar 2020to 1 Sep 2020
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Minimum 18 years of age and with full legal capacity
Written informed consent and signed letter of authority and secrecy agreement given
Willing to comply with not using analgesics 1 up to 24 hours prior to catheterization visits
Urine Multistix negative for erythrocytes (hematuria)

Who cannot join

Participation in any other clinical investigations during this investigation
Known hypersensitivity towards any of the test products
Symptoms of urinary tract infection (UTI) (Investigators judgement)
Pregnancy or breastfeeding

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Urologisk klinik, Afsnit 2112, Rigshospitalet
Copenhagen, Copenhagen Ø, 2100

Other trials in Denmark

About this study

Official title: Exploratory Investigation on Performance and Safety of New Intermittent Catheters in Healthy Volunteers

Read the detailed description

The CP322 study investigated a novel non-CE marked intermittent catheter for males and females, designed in two different variants, Variant 1 and Variant 2, respectively. The study was conducted in Denmark and was a randomized, single blinded, cross-over investigation comparing the two new variant catheters with a comparator catheter in 30 adult healthy volunteers.

For each participant, the study thus contained three test visits/treatment arms (Comparator, Variant 1 and Variant 2, respectively), to which the 30 participants were randomized using a randomization sequence of six (i.e., there were six different random options for the order in which the participants tested the three catheters). There were 4-14 days between the test visits.

Conditions: Retention, Urinary
Being tested: SpeediCath® Standard male or female, New intermittent Variant 1 catheter for male or female, New intermittent Variant 2 catheter for male or female
Medical subject headings: Urinary Retention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SpeediCath® Standard male or femaleDevice
Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male or female.
New intermittent Variant 1 catheter for male or femaleDevice
Intermittent catheterization through the urethra draining the bladder, using the new Variant 1 for male or female.
New intermittent Variant 2 catheter for male or femaleDevice
Intermittent catheterization through the urethra draining the bladder, using the new Variant 2 for male or female.

Study groups in NCT04445051
Study group	Role	What they receive
Intermittent catheter; SpeediCath® Standard male or female	Active comparator	Participants underwent catheterization with standard of care intermittent catheter. The catheterization was performed by a trained nurse. Receives: Device: SpeediCath® Standard male or female
New intermittent catheter Variant 1 for male or female	Experimental	Participants underwent catheterization with the new intermittent catheter Variant 1 for males or females. The catheterization was performed by a trained nurse. Receives: Device: New intermittent Variant 1 catheter for male or female
New intermittent catheter Variant 2 for male or female	Experimental	Participants underwent catheterization with the new intermittent catheter Variant 2 for males or females. The catheterization was performed by a trained nurse. Receives: Device: New intermittent Variant 2 catheter for male or female

What is being measured

The primary outcome is the main question the study is designed to answer.

Residual Urine at 1st Flow-stop
The residual urine at 1st flow-stop during catheterization (performed by a nurse) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying/urination. This was assessed using a pressure sensor with time-logged weighing, meaning that a flow-stop was registered measuring the hydrostatic pressure at the outlet of an intermittent urinary catheter. Simultaneously, the collected urine was weighed and converted to volume, and the residual volume at first flow stop was calculated as the difference between the total urine volume collected and the volume collected at the first flow-stop.
Measured: Immediately after the procedure/catheterization, up to 5 min.

Secondary outcomes (6)

Post-void Residual Urine
The volume of residual urine (urine left in the bladder) post catheterization (performed by the nurse) measured in triplicates using an ultrasound scanner.
Measured: Immediately after the procedure/catheterization, up to 15 min.
Catheterization Insertion Discomfort
Discomfort measured at catheter insertion, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.
Measured: Immediately after the procedure/catheterization, up to 5 min.
Catheterization Urination Discomfort
Discomfort measured during catheter emptying/urination, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.
Measured: Immediately after the procedure/catheterization, up to 5 min.
Withdrawal Discomfort
Discomfort measured during catheter withdrawal, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.
Measured: Immediately after the procedure/catheterization, up to 5 min.
Overall Catheterization Discomfort
Discomfort measured for the overall/entire catheterization procedure, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.
Measured: Immediately after the procedure/catheterization, up to 5 min.
Post-catheterization Urination Discomfort
Discomfort measured for the first normal void/urination after the catheterization procedure, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.
Measured: Immediately after the first normal void following the procedure/catheterization, up to 5 min.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 20201 Sep 2020

First posted24 Jun 2020
Study start1 Mar 2020
Primary completion1 Sep 2020
Study completion1 Sep 2020

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Retention, UrinaryStudies 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: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04445051
Sponsor's protocol ID: CP322
Status last verified: Aug 2022
First submitted: 28 May 2020
Last updated: 3 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Landauro MH, Tentor F, Pedersen T, Jacobsen L, Bagi P. Improved Performance With the Micro-Hole Zone Intermittent Catheter: A Combined Analysis of 3 Randomized Controlled Studies Comparing the New Catheter Technology With a Conventional Eyelet Catheter. J Wound Ostomy Continence Nurs. 2023 Nov-Dec 01;50(6):504-511. doi: 10.1097/WON.0000000000001029.
PubMed 37966080

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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
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
Recruiting
Tamsulosin for Early Catheter Removal After Rectal Cancer Surgery
Urinary Catheters, Rectal Cancer

All Retention, Urinary trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exploratory Investigation on Performance and Safety of New Intermittent Catheters in Healthy Volunteers
ClinicalTrials.gov ID: NCT04445051
Acronym / sponsor ID: CP322
Conditions: Retention, Urinary
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Coloplast A/SIndustry (pharma, biotech, devices)
Study start: 1 Mar 2020 (actual)
Primary completion: 1 Sep 2020 (actual)
Study completion: 1 Sep 2020 (actual)
First posted: 24 Jun 2020 (actual)
Results: Posted 3 Jul 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Intermittent catheter; SpeediCath® Standard male or female	Active comparator	Device: SpeediCath® Standard male or femaleParticipants underwent catheterization with standard of care intermittent catheter. The catheterization was performed by a trained nurse.
New intermittent catheter Variant 1 for male or female	Experimental	Device: New intermittent Variant 1 catheter for male or femaleParticipants underwent catheterization with the new intermittent catheter Variant 1 for males or females. The catheterization was performed by a trained nurse.
New intermittent catheter Variant 2 for male or female	Experimental	Device: New intermittent Variant 2 catheter for male or femaleParticipants underwent catheterization with the new intermittent catheter Variant 2 for males or females. The catheterization was performed by a trained nurse.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Minimum 18 years of age and with full legal capacity
Written informed consent and signed letter of authority and secrecy agreement given
Willing to comply with not using analgesics 1 up to 24 hours prior to catheterization visits
Urine Multistix negative for erythrocytes (hematuria)

Key exclusion criteria (4 listed)

Participation in any other clinical investigations during this investigation
Known hypersensitivity towards any of the test products
Symptoms of urinary tract infection (UTI) (Investigators judgement)
Pregnancy or breastfeeding

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
SpeediCath® Standard male or femaleIntermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male or female.	Device	Intermittent catheter; SpeediCath® Standard male or female
New intermittent Variant 1 catheter for male or femaleIntermittent catheterization through the urethra draining the bladder, using the new Variant 1 for male or female.	Device	New intermittent catheter Variant 1 for male or female
New intermittent Variant 2 catheter for male or femaleIntermittent catheterization through the urethra draining the bladder, using the new Variant 2 for male or female.	Device	New intermittent catheter Variant 2 for male or female

Primary outcome

Residual Urine at 1st Flow-stop
Time frame: Immediately after the procedure/catheterization, up to 5 min.
The residual urine at 1st flow-stop during catheterization (performed by a nurse) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying/urination. This was assessed using a pressure sensor with time-logged weighing, meaning that a flow-stop was registered measuring the hydrostatic pressure at the outlet of an intermittent urinary catheter. Simultaneously, the collected urine was weighed and converted to volume, and the residual volume at first flow stop was calculated as the difference between the total urine volume collected and the volume collected at the first flow-stop.

6 secondary outcomes

Post-void Residual Urine
Time frame: Immediately after the procedure/catheterization, up to 15 min.
Catheterization Insertion Discomfort
Time frame: Immediately after the procedure/catheterization, up to 5 min.
Catheterization Urination Discomfort
Time frame: Immediately after the procedure/catheterization, up to 5 min.
Withdrawal Discomfort
Time frame: Immediately after the procedure/catheterization, up to 5 min.
Overall Catheterization Discomfort
Time frame: Immediately after the procedure/catheterization, up to 5 min.
Post-catheterization Urination Discomfort
Time frame: Immediately after the first normal void following the procedure/catheterization, up to 5 min.

Results and safety

Results posted to the registry on 3 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Comparator, Then Variant 2, Then Variant 1	5	5
Variant 2, Then Variant 1, Then Comparator	4	4
Comparator, Then Variant 1, Then Variant 2	5	4
Variant 1, Then Comparator, Then Variant 2	6	6
Variant 1, Then Variant 2, Then Comparator	5	5
Variant 2, Then Comparator, Then Variant 1	5	5

Primary outcome: Residual Urine at 1st Flow-stop

Time frame: Immediately after the procedure/catheterization, up to 5 min.. Mean (Standard Deviation). Unit: mL

Measure	Intermittent Catheter; SpeediCath® Standard Female n = 15	New Intermittent Catheter Variant 1 for Female n = 15	New Intermittent Catheter Variant 2 for Female n = 15	Intermittent Catheter; SpeediCath® Standard Male n = 15	New Intermittent Catheter Variant 1 for Male n = 15	New Intermittent Catheter Variant 2 for Male n = 14
Value	35.0 (71.0)	1.1 (2.6)	0.2 (0.7)	37.0 (40.0)	2.2 (6.2)	1.0 (4.0)

Intermittent Catheter; SpeediCath® Standard Female vs New Intermittent Catheter Variant 1 for Female: Mean Difference (Final Values): 32.9 (95% CI 8.3 to 57.5), p = 0.010, Mixed Models Analysis
Intermittent Catheter; SpeediCath® Standard Female vs New Intermittent Catheter Variant 2 for Female: Mean Difference (Final Values): 34.3 (95% CI 9.8 to 58.8), p = 0.007, Mixed Models Analysis
New Intermittent Catheter Variant 1 for Female vs New Intermittent Catheter Variant 2 for Female: Mean Difference (Final Values): 1.4 (95% CI -23.1 to 25.9), p = 0.908, Mixed Models Analysis

Population analysed: The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Each participant was enrolled for 3 x 4-14 days for the entire investigation, thus a maximum of 42 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intermittent Catheter; SpeediCath® Standard Female	0 of 15 (0%)	0 of 15 (0%)	0 of 15
New Intermittent Catheter Variant 1 for Female	0 of 15 (0%)	0 of 15 (0%)	0 of 15
New Intermittent Catheter Variant 2 for Female	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Intermittent Catheter; SpeediCath® Standard Male	0 of 15 (0%)	0 of 15 (0%)	0 of 15
New Intermittent Catheter Variant 1 for Male	0 of 15 (0%)	1 of 15 (6.7%)	0 of 15
New Intermittent Catheter Variant 2 for Male	0 of 14 (0%)	0 of 14 (0%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37966080Landauro MH, Tentor F, Pedersen T, Jacobsen L, Bagi P. Improved Performance With the Micro-Hole Zone Intermittent Catheter: A Combined Analysis of 3 Randomized Controlled Studies Comparing the New Catheter Technology With a Conventional Eyelet Catheter. J Wound Ostomy Continence Nurs. 2023 Nov-Dec 01;50(6):504-511. doi: 10.1097/WON.0000000000001029.
Individual participant dataSharing planned: No

Related trials for Retention, Urinary

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
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
Recruiting
Tamsulosin for Early Catheter Removal After Rectal Cancer Surgery
Urinary Catheters, Rectal Cancer

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.

Per Bagi, MD principal investigator

Blegdamsvej 9, Urologisk klinik Afsnit 2112, Rigshospitalet, Denmark

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 4 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 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. 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 3 Jul 2023). 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 (time frame: Immediately after the procedure/catheterization, up to 5 min.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04445051, which also lists 1 linked publication.

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 3 Jul 2023; AzTrials last refreshed its copy on 8 Nov 2026.