Evaluation of a New Catheter Material for Intermittent Catheterization
NCT ID: NCT01295281
Last Updated: 2021-11-11
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
107 participants
INTERVENTIONAL
2011-03-31
2011-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
LoFric POBE 2.0 - PVC
First period (7 days) use of LoFric POBE 2.0 followed by second period (7 days) use of LoFric PVC
LoFric POBE 2.0
To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.
LoFric PVC
To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.
LoFric PVC - POBE 2.0
First period (7 days) use of LoFric PVC followed by second period (7 days) use of LoFric POBE 2.0.
LoFric POBE 2.0
To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.
LoFric PVC
To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
LoFric POBE 2.0
To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.
LoFric PVC
To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Wellspect HealthCare
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Birgit Johansson, Urotherapist
Role: PRINCIPAL_INVESTIGATOR
Kärnsjukhuset Skövde
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kirurg och Urologmottagningen, Alingsås lasarett
Alingsås, , Sweden
Urologcentrum
Borås, , Sweden
Kirurg- och urologmottagningen, Gävle Sjukhus
Gävle, , Sweden
Urologmottagningen, Lundby Sjukhus
Gothenburg, , Sweden
Uroterapimottagningen Kärnsjukhuset Skövde
Skövde, , Sweden
Urologmottagningen Uddevalla sjukhus
Uddevalla, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LOF-0018
Identifier Type: -
Identifier Source: org_study_id