Urinary CatheterizationNCT00748033

A Study Evaluating a Urinary Catheter With Different Activation Times for the Wetting Solution, in Healthy Male Volunteers.

A study testing Reference catheter: LoFric PVC, Nelaton 40 cm, CH 12, LoFric POBE Hydro-Kit II, 5 seconds and LoFric POBE Hydro-Kit II, 24 hours in people with Urinary Catheterization, run by Wellspect HealthCare at 1 site in Sweden.

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

Who is it for?: Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for: Urinary Catheterization
What is being tested?: Reference catheter: LoFric PVC, Nelaton 40 cm, CH 12, LoFric POBE Hydro-Kit II, 5 seconds and LoFric POBE Hydro-Kit II, 24 hours
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteSweden
Study dates: Aug 2008to Aug 2008
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
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Provision of written informed consent
Healthy volunteer
Male aged 18 years or over

Who cannot join

Known or suspected, current impairment of and/or decreased urethral sensibility
History of urethral morbidity
History of urinary tract infection within three months, or ongoing symptomatic urinary tract infection
Use of medications that may affect the urethra´s dryness (anti-cholinergic drugs or cortisone)
Current drug, alcohol or other substance abuse
Other significant disease or condition (e.g. benign prostate hypertrophy, other prostatic lesions), which may interfere with treatment and/or evaluation
Allergy to antibiotics suspected poor compliance with the protocol during the complete study period

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Karolinska Trial Alliance A2:01, Karolinska University Hospital
Stockholm, SE-171 76

Other trials in Sweden

About this study

Official title: A Randomized, Single-blind, Cross-over, Single-centre Study in Healthy Volunteers Evaluating Subject Perception and Friction at Withdrawal of Catheters With Different Activation Times Compared to a Reference Catheter

The primary purpose of this study is to compare the subject's perception (separately for each randomized catheter) of practicing catheterization when using catheters with sodium chloride in wetting solution (using two different activation times) with a standard reference catheter. The hypothesis is that the subjects' perception of catheterization is the same or more positive when using the test catheters compared to the reference catheter.

Read the detailed description

The study is designed as a randomized, single-blind, cross-over, single-centre, study in healthy male volunteers.

All subjects will first be catheterized with a reference catheter, which is proven to be well tolerated by most subjects. This catheter will be used as a reference catheter to be compared with the randomized catheters. One more reason for this first test is to withdraw subjects who cannot tolerate catheterizations. Subjects will qualify for the randomized part of the study only if the first catheterization could be performed without significant discomfort.

When the subject is randomized he will be catheterized with two urinary catheters in a randomized order during one day. The activation times for the wetting solution will be 5 seconds and 24 (± 2h) hours.

During each catheterization, the friction at withdrawal will be measured for the catheter using a Tension Test System.

The subjects will be blinded. 25 healthy volunteers will be recruited from a single centre in Sweden.

Conditions: Urinary Catheterization
Being tested: Reference catheter: LoFric PVC, Nelaton 40 cm, CH 12, LoFric POBE Hydro-Kit II, 5 seconds, LoFric POBE Hydro-Kit II, 24 hours

What participants receive

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

Reference catheter: LoFric PVC, Nelaton 40 cm, CH 12Device
The subjects were first catheterized with this reference catheter.
LoFric POBE Hydro-Kit II, 5 secondsDevice
An unsalted LoFric POBE Hydro-Kit II, Nelaton 40 cm, CH 12 with sodium chloride in wetting solution, activation time 5 seconds
LoFric POBE Hydro-Kit II, 24 hoursDevice
An unsalted LoFric POBE Hydro-Kit II, Nelaton 40 cm, CH 12 with sodium chloride in wetting solution, activation time 24 hours

Study groups in NCT00748033
Study group	Role	What they receive
LoFric POBE Hydro-Kit II, 5 seconds and then LoFric POBE Hydro-Kit II, 24 hours	Experimental	All subjects were first catheterizised with the reference catheter. After randomisation this group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 5 seconds. Then the next test catheter was used LoFric POBE Hydro-Kit II, activation time 24 hours. Receives: Device: Reference catheter: LoFric PVC, Nelaton 40 cm, CH 12; Device: LoFric POBE Hydro-Kit II, 5 seconds; Device: LoFric POBE Hydro-Kit II, 24 hours
LoFric POBE Hydro-Kit II, 24 hours and then LoFric POBE Hydro-Kit II, 5 seconds	Experimental	All subjects were first catheterizised with the reference catheter. After randomisation this group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 24 hours. Then the next test catheter was used LoFric POBE Hydro-Kit II, activation time 5 seconds. Receives: Device: Reference catheter: LoFric PVC, Nelaton 40 cm, CH 12; Device: LoFric POBE Hydro-Kit II, 5 seconds; Device: LoFric POBE Hydro-Kit II, 24 hours

What is being measured

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

Subjects' Perception at Insertion of Test Catheter Activated for 5 Seconds, Compared to Reference.
The assessment was made in relation to the reference catheter, and the question to the subject was 'How do you experience this procedure/catheterization in comparison with the baseline procedure/catheterization regarding insertion?'.
Measured: A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.
Subjects' Perception at Insertion of Test Catheter Activated for 24 Hours, Compared to Reference.
The assessment was made in relation to the reference catheter, and the question to the subject was 'How do you experience this procedure/catheterization in comparison with the baseline procedure/catheterization regarding insertion?'.
Measured: A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.
Subjects' Perception at Withdrawal of Test Catheter Activated for 5 Seconds, Compared to Reference.
The assessment was made in relation to the reference catheter, and the question to the subject was 'How do you experience this procedure/catheterization in comparison with the baseline procedure/catheterization regarding withdrawal?'.
Measured: A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.
Subjects' Perception at Withdrawal of Test Catheter Activated for 24 Hours, Compared to Reference.
The assessment was made in relation to the reference catheter, and the question to the subject was 'How do you experience this procedure/catheterization in comparison with the baseline procedure/catheterization regarding withdrawal?'.
Measured: A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.

Secondary outcomes (9)

Comparison of the Perception at Insertion Between 5s and 24h Activation Times. Times
Comparison of the perception at insertion between the catheters with 5s and 24h activation times.
Measured: A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.
Comparison of the Perception at Withdrawal Between 5s and 24h Activation Times.
Comparison of the perception at withdrawal between the catheters with 5s and 24h activation times.
Measured: A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.
Test of Carry-over Effect at Insertion, Mean Rating of Perception on a Scale of 0 to 5
The subjects perception of the catheterization will be classified as very negative, slightly negative, same, slightly positive or very positive.
The mean perception of the 5s and the 24h catheter is calculated for each subject.
The perception was measured on a scale from 1 (=very negative compared to the reference catheter) to 5 (=very positive compared to the reference catheter) and a 3 indicating that the perception was the same for the test catheter as for the reference catheter. Before doing any statistics all answers were reduced by 3 resulting in values from -2 (=very negative compared to the reference catheter) to +2 (=very positive compared to the reference catheter) and a 0 indicating that the perception was the same for the test catheter as for the reference catheter.
Measured: A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.
Test of Carry-over Effect at Withdrawal, Mean Rating of Perception on a Scale of 0 to 5
They had five alternative answers.The subjects perception of the catheterization will be classified as very negative, slightly negative, same, slightly positive or very positive.
The mean perception of the 5s and the 24h catheter is calculated for each subject.
The perception was measured on a scale from 1 (=very negative compared to the reference catheter) to 5 (=very positive compared to the reference catheter) and a 3 indicating that the perception was the same for the test catheter as for the reference catheter. Before doing any statistics all answers were reduced by 3 resulting in values from -2 (=very negative compared to the reference catheter) to +2 (=very positive compared to the reference catheter) and a 0 indicating that the perception was the same for the test catheter as for the reference catheter.
Measured: A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.
Tension Test System: Ref-24h Mean
Tension test system (friction) at withdrawal. Comparison between the reference catheter and the 24 hours activation time. The MEAN for the withdrawal friction was measured in Newton (N).
Measured: The Tension test system was performed while withdrawing the catheters up to 5 seconds.
Tension Test System: Ref-24h Work
Tension test system (friction) at withdrawal. Comparison between the reference catheter and the 24 hours activation time. The WORK for the withdrawal friction was measured in Joule (J).
Measured: The Tension test system was performed while withdrawing the catheters up to 5 seconds.
Tension Test System: Ref-5s MEAN
Tension test system (friction) at withdrawal. Comparison between the reference catheter and the 5 seconds activation time. The MEAN for the withdrawal friction was measured in Newton (N).
Measured: The Tension test system was performed while withdrawing the catheters, up to 5 seconds.
Tension Test System: Ref-5s WORK
Tension test system (friction) at withdrawal. Comparison between the reference catheter and the 5 seconds activation time. The WORK for the withdrawal friction was measured in Joule (J).
Measured: The Tension test system was performed while withdrawing the catheters, up to 5 seconds.
Tension Test System: 24h-5s
Tension test system (friction) at withdrawal. Comparison between the catheters with 24h activation time and the 5 seconds activation time.
The MEAN for the withdrawal friction was measured in Newton (N).
Measured: The Tension test system was performed while withdrawing the catheters, up to 5 seconds.

Timeline

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

Aug 2008Aug 2008

First posted8 Sep 2008 (estimated)
Study startAug 2008
Primary completionAug 2008
Study completionAug 2008

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 CatheterizationStudies 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: Other
Allocation: Randomised
Intervention model: Crossover
Model description: Two different activation times for the wetting solution for a urinary catheter will be used in healthy volunteers, compared to the use of a registered urinary catheter.
Masking: Single blind
Who is masked: Participant
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00748033
Sponsor's protocol ID: YA-CLO-0005
Status last verified: Apr 2021
First submitted: 5 Sep 2008
Last updated: 6 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated device: No

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

Active, not recruiting
Urinary Catheterization Versus No Catheterization in Laparoscopic Total Extraperitoneal Inguinal Hernia Repair
Inguinal Hernias
Not yet recruitingObservational study
Evaluate of the Use of Uromune as a Potential Non-antibiotic Prophylactic Strategy for Catheter-associated Urinary Tract Infection in Patients With Long-term Catheterization.
Catheter-Associated Urinary Tract Infections (CAUTIs)
Not yet recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Effectiveness of the NowCath Foley in Reducing Catheter-Associated UTIs and Blockages in Long-Term Indwelling Catheter Users (REDUCE)
Urinary Catheters, Urinary Catheterization
RecruitingObservational study
Effect of Catheter Duration on Prostate Laser Enucleation Surgery Outcomes in Patients With Urinary Retention
Urinary Retention, Benign Prostate Obstruction (BPO)

All Urinary Catheterization trials

Study at a glance

From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Single-blind, Cross-over, Single-centre Study in Healthy Volunteers Evaluating Subject Perception and Friction at Withdrawal of Catheters With Different Activation Times Compared to a Reference Catheter
ClinicalTrials.gov ID: NCT00748033
Acronym / sponsor ID: YA-CLO-0005
Conditions: Urinary Catheterization
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Wellspect HealthCareIndustry (pharma, biotech, devices)
Study start: Aug 2008
Primary completion: Aug 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 8 Sep 2008 (estimated)
Results: Posted 6 May 2021

Clinical summary

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

Detailed description

The study is designed as a randomized, single-blind, cross-over, single-centre, study in healthy male volunteers.

During each catheterization, the friction at withdrawal will be measured for the catheter using a Tension Test System.

The subjects will be blinded. 25 healthy volunteers will be recruited from a single centre in Sweden.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2
Model description: Two different activation times for the wetting solution for a urinary catheter will be used in healthy volunteers, compared to the use of a registered urinary catheter.

Arm	Type	Receives
LoFric POBE Hydro-Kit II, 5 seconds and then LoFric POBE Hydro-Kit II, 24 hours	Experimental	Device: Reference catheter: LoFric PVC, Nelaton 40 cm, CH 12, Device: LoFric POBE Hydro-Kit II, 5 seconds, Device: LoFric POBE Hydro-Kit II, 24 hoursAll subjects were first catheterizised with the reference catheter. After randomisation this group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 5 seconds. Then the next test catheter was used LoFric POBE Hydro-Kit II, activation time 24 hours.
LoFric POBE Hydro-Kit II, 24 hours and then LoFric POBE Hydro-Kit II, 5 seconds	Experimental	Device: Reference catheter: LoFric PVC, Nelaton 40 cm, CH 12, Device: LoFric POBE Hydro-Kit II, 5 seconds, Device: LoFric POBE Hydro-Kit II, 24 hoursAll subjects were first catheterizised with the reference catheter. After randomisation this group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 24 hours. Then the next test catheter was used LoFric POBE Hydro-Kit II, activation time 5 seconds.

Who may qualify

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

Key inclusion criteria (3 listed)

Provision of written informed consent
Healthy volunteer
Male aged 18 years or over

Key exclusion criteria (7 listed)

Known or suspected, current impairment of and/or decreased urethral sensibility
History of urethral morbidity
History of urinary tract infection within three months, or ongoing symptomatic urinary tract infection
Use of medications that may affect the urethra´s dryness (anti-cholinergic drugs or cortisone)
Current drug, alcohol or other substance abuse

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
Reference catheter: LoFric PVC, Nelaton 40 cm, CH 12The subjects were first catheterized with this reference catheter.	Device	LoFric POBE Hydro-Kit II, 24 hours and then LoFric POBE Hydro-Kit II, 5 seconds, LoFric POBE Hydro-Kit II, 5 seconds and then LoFric POBE Hydro-Kit II, 24 hours
LoFric POBE Hydro-Kit II, 5 secondsAn unsalted LoFric POBE Hydro-Kit II, Nelaton 40 cm, CH 12 with sodium chloride in wetting solution, activation time 5 seconds	Device	LoFric POBE Hydro-Kit II, 24 hours and then LoFric POBE Hydro-Kit II, 5 seconds, LoFric POBE Hydro-Kit II, 5 seconds and then LoFric POBE Hydro-Kit II, 24 hours
LoFric POBE Hydro-Kit II, 24 hoursAn unsalted LoFric POBE Hydro-Kit II, Nelaton 40 cm, CH 12 with sodium chloride in wetting solution, activation time 24 hours	Device	LoFric POBE Hydro-Kit II, 24 hours and then LoFric POBE Hydro-Kit II, 5 seconds, LoFric POBE Hydro-Kit II, 5 seconds and then LoFric POBE Hydro-Kit II, 24 hours

Primary outcome

Subjects' Perception at Insertion of Test Catheter Activated for 5 Seconds, Compared to Reference.
Time frame: A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.
The assessment was made in relation to the reference catheter, and the question to the subject was 'How do you experience this procedure/catheterization in comparison with the baseline procedure/catheterization regarding insertion?'.
Subjects' Perception at Insertion of Test Catheter Activated for 24 Hours, Compared to Reference.
Time frame: A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.
The assessment was made in relation to the reference catheter, and the question to the subject was 'How do you experience this procedure/catheterization in comparison with the baseline procedure/catheterization regarding insertion?'.
Subjects' Perception at Withdrawal of Test Catheter Activated for 5 Seconds, Compared to Reference.
Time frame: A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.
The assessment was made in relation to the reference catheter, and the question to the subject was 'How do you experience this procedure/catheterization in comparison with the baseline procedure/catheterization regarding withdrawal?'.
Subjects' Perception at Withdrawal of Test Catheter Activated for 24 Hours, Compared to Reference.
Time frame: A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.
The assessment was made in relation to the reference catheter, and the question to the subject was 'How do you experience this procedure/catheterization in comparison with the baseline procedure/catheterization regarding withdrawal?'.

9 secondary outcomes

Comparison of the Perception at Insertion Between 5s and 24h Activation Times. Times
Time frame: A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.
Comparison of the Perception at Withdrawal Between 5s and 24h Activation Times.
Time frame: A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.
Test of Carry-over Effect at Insertion, Mean Rating of Perception on a Scale of 0 to 5
Time frame: A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.
Test of Carry-over Effect at Withdrawal, Mean Rating of Perception on a Scale of 0 to 5
Time frame: A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.
Tension Test System: Ref-24h Mean
Time frame: The Tension test system was performed while withdrawing the catheters up to 5 seconds.
Tension Test System: Ref-24h Work
Time frame: The Tension test system was performed while withdrawing the catheters up to 5 seconds.
Tension Test System: Ref-5s MEAN
Time frame: The Tension test system was performed while withdrawing the catheters, up to 5 seconds.
Tension Test System: Ref-5s WORK
Time frame: The Tension test system was performed while withdrawing the catheters, up to 5 seconds.
Tension Test System: 24h-5s
Time frame: The Tension test system was performed while withdrawing the catheters, up to 5 seconds.

Results and safety

Results posted to the registry on 6 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LoFric POBE Hydro-Kit II, 5 Seconds and Then LoFric POBE Hydro-Kit II, 24 Hours	12	12
LoFric POBE Hydro-Kit II, 24 Hours and Then LoFric POBE Hydro-Kit II, 5 Seconds	13	12

Primary outcome: Subjects' Perception at Insertion of Test Catheter Activated for 5 Seconds, Compared to Reference.

Time frame: A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.. Number. Unit: participants

Measure	LoFric POBE Hydro-Kit II, 5 Seconds n = 24
Very negative	3
Slightly negative	10
Same	5
Slightly positive	6
Very positive	0

LoFric POBE Hydro-Kit II, 5 Seconds: p = 0.0650, Wilcoxon (Mann-Whitney)

Population analysed: The study was analysed using a per protocol approach only. One subject (Subject ID 125) was catheterized with the reference catheter and the catheter activated 24 hours, but not with the catheter activated 5 seconds. After discussions it has, however, been decided to use all available data. In conclusion all subjects fulfilling the inclusion criteria but none of the exclusion criteria were included in the Per-Protocol (PP) analysis set.

Primary outcome: Subjects' Perception at Insertion of Test Catheter Activated for 24 Hours, Compared to Reference.

Measure	LoFric POBE Hydro-Kit II, 24 Hours n = 25
Very negative	4
Slightly negative	8
Same	5
Slightly positive	7
Very positive	1

LoFric POBE Hydro-Kit II, 24 Hours: p = 0.2487, Wilcoxon (Mann-Whitney)

Primary outcome: Subjects' Perception at Withdrawal of Test Catheter Activated for 5 Seconds, Compared to Reference.

Measure	LoFric POBE Hydro-Kit II, 5 Seconds Hours n = 24
Very negative	4
Slightly negative	6
Same	4
Slightly positive	8
Very positive	2

LoFric POBE Hydro-Kit II, 5 Seconds Hours: p = 0.7288, Wilcoxon (Mann-Whitney)

Population analysed: Subjects fulfilling the inclusion criteria but none of the exclusion criteria were included in the Per-Protocol (PP) analysis set.

Primary outcome: Subjects' Perception at Withdrawal of Test Catheter Activated for 24 Hours, Compared to Reference.

Measure	LoFric POBE Hydro-Kit II, 24 Hours n = 25
Very negative	6
Slightly negative	6
Same	11
Slightly positive	2
Very positive	0

LoFric POBE Hydro-Kit II, 24 Hours: p = 0.0045, Wilcoxon (Mann-Whitney)

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Each subjects visited the clinic during one day. The subjects were catheterized for 3 minutes with each catheter. All subjects were catheterized with 3 catheters each, except one subject, who discontinued after test catheter 1 and was therefore only catheterized twice. At least 2 hours elapsed between each catheterization.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LoFric POBE Hydro-Kit II, 5 Seconds	0 of 24 (0%)	17 of 24 (70.8%)	0 of 24
LoFric POBE Hydro-Kit II, 24 Hours	0 of 25 (0%)	18 of 25 (72%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Urinary Catheterization

Active, not recruiting
Urinary Catheterization Versus No Catheterization in Laparoscopic Total Extraperitoneal Inguinal Hernia Repair
Inguinal Hernias
Not yet recruitingObservational study
Evaluate of the Use of Uromune as a Potential Non-antibiotic Prophylactic Strategy for Catheter-associated Urinary Tract Infection in Patients With Long-term Catheterization.
Catheter-Associated Urinary Tract Infections (CAUTIs)
Not yet recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Effectiveness of the NowCath Foley in Reducing Catheter-Associated UTIs and Blockages in Long-Term Indwelling Catheter Users (REDUCE)
Urinary Catheters, Urinary Catheterization
RecruitingObservational study
Effect of Catheter Duration on Prostate Laser Enucleation Surgery Outcomes in Patients With Urinary Retention
Urinary Retention, Benign Prostate Obstruction (BPO)

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.

Magnus Jacobsson, MD, PhD, Prof. study director

Dentsply Sirona Implants and Consumables

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 3 inclusion and 7 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 6 May 2021. 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 Sweden. 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 6 May 2021). 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?

Subjects' Perception at Insertion of Test Catheter Activated for 5 Seconds, Compared to Reference. (time frame: A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.). The study lists 4 primary outcomes in all. 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 NCT00748033.

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 6 May 2021.