Trials / Completed
CompletedNCT01295281
Evaluation of a New Catheter Material for Intermittent Catheterization
A Prospective, Randomized, Cross-over Study - Evaluation of a New Catheter Material for Intermittent Catheterization
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 107 (actual)
- Sponsor
- Wellspect HealthCare · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | LoFric POBE 2.0 | To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively. |
| DEVICE | LoFric PVC | To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively. |
Timeline
- Start date
- 2011-03-01
- Primary completion
- 2011-05-01
- Completion
- 2011-05-01
- First posted
- 2011-02-14
- Last updated
- 2021-11-11
- Results posted
- 2014-03-03
Locations
6 sites across 1 country: Sweden
Source: ClinicalTrials.gov record NCT01295281. Inclusion in this directory is not an endorsement.