Acontractile or underactive bladder dysfunction: inability to empty the bladder
Conditions
Interventions
Sponsors
Novuqare BV
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Age 18-80 years - Woman on CIC who cannot empty the bladder themselves (so no incomplete voiders) - Patient has signed a written Informed Consent form - Patient is free of uncontrolled psychiatric illness - Patient is free of urinary tract infection - is the patient free of urethral strictures, trauma of necrosis?
Exclusion criteria
Exclusion criteria: - Patients with large deviations in urethra or bladder caused by anatomical defects, earlier surgery or caused by other damage of the pelvic floor. - Patients with a urinary tract infection, or a history of urinary tract infections. - Patients who can urinate themselves, or on partial Clean Intermittent Catheterization - Morbid obesity (BMI > 40 kg/m2) - Patients with hematuria and/or blood clots in the urine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comfort during insertion - quantitative assessment by participant Comfort of FemFlow the bladder - quantitative assessment by participant Comfort during urinating - quantitative assessment by participant Comfort during removal of FemFlow - quantitative assessment by participant Comfort of FemFlow for several body postures - quantitative assessment by participant The primary objectives will be rated with a questionnaire, using a 1-10 scale. The questions are set up to rate comfort; 1 represents *extremely uncomfortable* and 10 represents *extremely comfortable*. The question must score 6 or higher to be assessed as acceptable. The average outcome of the main study parameters shall score 7 or higher. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters/endpoints. No mucosa damage. Cystoscopic investigation. | — |
Countries
The Netherlands
Outcome results
None listed