The validation of a new catheter for intermittent Self-Catheterization in female patients; proof of principles

Completed

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

• Registration Number: NL-OMON42152
• Lead Sponsor: ovoqare B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

Female patients with normal anatomy of urethra en bladder.

Exclusion Criteria

Multiple operations in bladder and/or urethra. Deformities of the urethra

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Ease of insertion (Qualitative)<br /><br>Indication of pull force required to drain the bladder (Newtons)<br /><br>Time needed to empty the bladder (Seconds)<br /><br>Rebound of the catheter back into the bladder and the assessment of any urine<br /><br>leakage (Qualitative)<br /><br>Indication of pull force required for retraction of FemFlow from the bladder<br /><br>(Newtons)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Mucosa damage (Qualitative)</p><br>