Patient comfort assessment of the Femflow. A follow-up study of the validation of a new catheter for intermittent Self-Catheterization in female patients

Completed

Conditions: Acontractile or underactive bladder dysfunction: inability to empty the bladder
10004994

Registration Number: NL-OMON45287

Lead Sponsor: ovuqare BV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

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

- 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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Comfort during insertion - quantitative assessment by participant<br /><br>Comfort of FemFlow the bladder - quantitative assessment by participant<br /><br>Comfort during urinating - quantitative assessment by participant<br /><br>Comfort during removal of FemFlow - quantitative assessment by participant<br /><br>Comfort of FemFlow for several body postures - quantitative assessment by<br /><br>participant<br /><br><br /><br><br /><br>The primary objectives will be rated with a questionnaire, using a 1-10 scale.<br /><br>The questions are set up to rate comfort; 1 represents extremely<br /><br>uncomfortable and 10 represents extremely comfortable. The question must<br /><br>score 6 or higher to be assessed as acceptable. The average outcome of the main<br /><br>study parameters shall score 7 or higher.</p><br>

Secondary Outcome Measures