N/A
N=25
A Study Evaluating a Urinary Catheter With Different Activation Times for the Wetting Solution, in Healthy Male Volunteers.
Urinary Catheterization
Bottom Line
View on ClinicalTrials.gov: NCT00748033 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Subjects' Perception at Insertion of Test Catheter Activated for 5 Seconds, Compared to Reference. — 3; 10; 5; 6 participants — p=0.0650
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 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 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Wellspect HealthCare
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjects' Perception at Insertion of Test Catheter Activated for 5 Seconds, Compared to Reference. |
3; 10; 5; 6; 0 | 0.0650 |
| PRIMARY Subjects' Perception at Insertion of Test Catheter Activated for 24 Hours, Compared to Reference. |
4; 8; 5; 7; 1 | 0.2487 |
| PRIMARY Subjects' Perception at Withdrawal of Test Catheter Activated for 5 Seconds, Compared to Reference. |
4; 6; 4; 8; 2 | 0.7288 |
| PRIMARY Subjects' Perception at Withdrawal of Test Catheter Activated for 24 Hours, Compared to Reference. |
6; 6; 11; 2; 0 | 0.0045 sig |
| SECONDARY Comparison of the Perception at Insertion Between 5s and 24h Activation Times. Times |
3; 3; 10; 8; 5; 5 | 0.4561 |
| SECONDARY Comparison of the Perception at Withdrawal Between 5s and 24h Activation Times. |
4; 5; 6; 6; 4; 11 | 0.1797 |
| SECONDARY Test of Carry-over Effect at Insertion, Mean Rating of Perception on a Scale of 0 to 5 |
-0.17; -0.46 | 0.5171 |
| SECONDARY Test of Carry-over Effect at Withdrawal, Mean Rating of Perception on a Scale of 0 to 5 |
-0.33; -0.33 | 0.7105 |
| SECONDARY Tension Test System: Ref-24h Mean |
0.077 | 0.0003 sig |
| SECONDARY Tension Test System: Ref-24h Work |
0.011 | 0.0346 sig |
| SECONDARY Tension Test System: Ref-5s MEAN |
0.073 | 0.0016 sig |
| SECONDARY Tension Test System: Ref-5s WORK |
0.009 | — |
| SECONDARY Tension Test System: 24h-5s |
-0.013 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Provision of written informed consent
- Healthy volunteer
- Male aged 18 years or over
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00748033). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.