Status:
COMPLETED
Evaluation of a New Female Urinary Intermittent Catheter
Lead Sponsor:
Wellspect HealthCare
Conditions:
Female Intermittent Urethral Catheterization
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
A prospective, multi-centre, interventional study. All subjects will use the study device for two weeks and the angulated handle available with the device must be used by each subject at least 10 time...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent.
- Females aged 18 years and over.
- Maintained urethra sensibility as judged by the subject. (Can you feel the catheter during catheterization? Yes.).
- Practice intermittent catheterization at least 2 times daily.
- Use catheter size available in the study
- Experienced practitioners of intermittent catheterization defined as a minimum of three months on therapy, but not more than approximately 5 years on therapy.
- Adults able to read, write and understand information given to them regarding the study.
Exclusion
- Ongoing, symptomatic UTI at enrolment as judged by investigator. The definition of UTI, is a positive urine culture of ≥10\^3 CFU/ml of ≥1 bacterial species and presence of symptoms or signs compatible with UTI with no other identified source of infection.
- Known urethral stricture which, in the opinion of the investigator, could influence the subject's evaluation of the catheters.
- Involvement in the planning and conduct of the study (applies to both Wellspect staff and staff at the study site).
- Previous enrolment in the present study.
- Simultaneous participation in another clinical study that may impact the primary endpoint
- Expected or severe non-compliance to protocol as judged by the investigator and/or Wellspect.
Key Trial Info
Start Date :
March 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04304599
Start Date
March 13 2020
End Date
February 27 2023
Last Update
April 28 2023
Active Locations (4)
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1
Alicante University General Dr. Balmis Hospital
Alicante, Spain
2
Hospital Clinic Barcelona
Barcelona, Spain
3
Carlanderska Hospital
Gothenburg, Sweden, SE-405 45
4
Urologiska kliniken, mottagning Universitetssjukhuset Örebro
Örebro, Örebro County, Sweden, 701 85