N/A
N=105
Evaluation of a New Catheter Material for Intermittent Catheterization
Catheterization (Clean, Intermittent Urinary Catheterization)
Bottom Line
View on ClinicalTrials.gov: NCT01295281 ↗Enrolled (actual)
105
Serious AEs
1.4%
Results posted
Mar 2014
Primary outcome: Primary: Number of Participants With Discomfort — 15; 29 participants — p=0.0066
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- LoFric POBE 2.0 (Device); LoFric PVC (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Wellspect HealthCare
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Discomfort |
15; 29 | 0.0066 sig |
| SECONDARY Perception of Pain |
— | — |
| SECONDARY Perception of Burning Sensation |
— | — |
| SECONDARY Presence of Bleeding |
— | — |
| SECONDARY Perception of "Other Discomfort" |
— | — |
| SECONDARY Perception of Stiffness/ Rigidity |
— | — |
| SECONDARY Perception of Catheter Eyes |
— | — |
| SECONDARY Perception of Catheter Adherence |
— | — |
| SECONDARY Perception of Catheter Tip |
— | — |
| SECONDARY Perception of Slipperiness |
— | — |
| SECONDARY Perception of Smoothness |
— | — |
| SECONDARY Perception of Resistance |
— | — |
| SECONDARY Perception of Discomfort Due to Other Causes |
— | — |
Summary
The hypothesis to be investigated is if the tolerability of intermittent catheterization with Polyolefin Based Elastomer (POBE) 2.0 and Polyvinyl Chloride (PVC) is clinically equal - i.e. clinically non-inferior when using POBE 2.0 compared to PVC.
Secondary objectives are to evaluate the safety and the subject's perception associated with the use of the catheters, assessed by the recording of adverse events and the ease of handling by means of a subjective assessment scale.
Eligibility Criteria
Inclusion Criteria
- Provision of informed consent
- Males, aged 18 years and over
- Maintained urethra sensibility
- Practice intermittent self-catheterization at least 2 times daily
- Using catheters in the length of 40 cm and size charrière (Ch) 12 or Ch 14
- Experienced practitioners of intermittent self-catheterization defined as a minimum of three months on therapy
- Experience of using LoFric catheter within the last 12 months prior to study entry
- Adults able to read, write and understand information given to them regarding the study
Exclusion Criteria
- Ongoing, symptomatic urinary tract infection (UTI) at enrolment as judged by investigator
- Known urethral stricture at enrolment as judged by investigator
- Involvement in the planning and/or conduct of the study (applies to both Astra Tech staff or staff at the study site)
- Previous enrolment or randomisation of treatment in the present study
Data sourced from ClinicalTrials.gov (NCT01295281). 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.