Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
39 participants
INTERVENTIONAL
2014-06-20
2017-03-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
LoFric
LoFric catheters
LoFric catheters
LoFric single use catheters to be used 4-6 times daily for 4 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
LoFric catheters
LoFric single use catheters to be used 4-6 times daily for 4 weeks.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Female and/or male aged 18 years and over
* Intermittent self-catheterization as primary bladder management method, defined as a normal catheterization frequency of at least 4 times daily
* Reuse of the same silicon, rubber (latex) or plastic (e.g. vinyl, PVC) catheter
* Accustomed intermittent catheterization user, defined as intermittent catheterization use for at least 3 months
* Able to use catheters of size:
40 cm, CH12 or CH14; 16'', FR12 or FR14; 15 cm, CH10 or CH12; 6'', FR10 or FR12;
Exclusion Criteria
* Drug or alcohol abuse or other disease of addiction
* Immunocompromising diseases or medications
* Known urological/renal anatomical abnormalities with potential impact on subject´s compliance as judged by the investigator
* Diagnosis of severe fecal incontinence that may compromise study participation as judged by the investigator
* Involvement in the planning and conduct of the study (applies to both Wellspect HealthCare staff and staff at the study site)
* Previous enrollment in the present study
* Simultaneous participation in another clinical study that may interfere with the present study, as judged by the investigator
* Severe non-compliance to protocol as judged by the investigator and/or Wellspect HealthCare
18 Years
ALL
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.
Bonne Lee, Dr
Role: PRINCIPAL_INVESTIGATOR
Prince of Wales Hospital, Randwick, Australia
Diane Newman, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania, Philadelphia, US
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
North Idaho Urology
Coeur d'Alene, Idaho, United States
University of Pennsylvania, Penn Urology
Philadelphia, Pennsylvania, United States
Froedtert Medical College and Specialty Clinic
Milwaukee, Wisconsin, United States
Royal Rehab
Ryde, New South Wales, Australia
Prince of Wales Hospital Spinal Unit
Sydney, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Caulfield Hospital, Spinal Rehabilitation Unit
Melbourne, Victoria, Australia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Newman DK, New PW, Heriseanu R, Petronis S, Hakansson J, Hakansson MA, Lee BB. Intermittent catheterization with single- or multiple-reuse catheters: clinical study on safety and impact on quality of life. Int Urol Nephrol. 2020 Aug;52(8):1443-1451. doi: 10.1007/s11255-020-02435-9. Epub 2020 Mar 14.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LOF-0028
Identifier Type: -
Identifier Source: org_study_id