A Confirmatory Study Confirming Performance of a New Intermittent Catheter

Urinary Retention Clinical Trial

Official title: A Confirmatory, Multi-centre, Randomised, Open Label, Controlled Study Confirming Performance of a Single-use Intermittent Micro-holes Zone Catheter in a Population of Adult Male Intermittent Catheter Users.

Status Completed

Clinical Trial Summary

A multi-centre, randomised, controlled crossover design. The total study duration for the individual subject was approximately 9 weeks, consisting of four site visits and two 4-week test periods at home. Visits 0 and 1 could be performed on the same day. For visit 2 and 3, catheterisations were performed in a hospital setting for bladder emptying assessment and collection of urine samples (the latter only in Denmark). Visit 1 and 2 were followed by a home-use test period, followed by visit 3 which terminated the study.

Clinical Trial Description

This investigation was a multi-centre, randomised, controlled crossover study including 73 male CIC users.

The study consisted of four study visits (V0-V3) and two 4-week test periods at home (T1 and T2). Visit 0 and 1 were performed on the same day if subjects allowed. Visit 0 included the screening-, inclusion-, and randomization phase of subjects and at visit 1 subjects performed a self-catheterisation with the device according to their respective randomization scheme. This was followed by a dipstick test for haematuria.

In the two 4-week test periods (T1 and T2, respectively) the subjects catheterised at home with the specified catheter according to their randomization scheme. Both 4-week periods started with a 2-week run-in period followed by a 2-week period during which a dipstick test for haematuria was performed daily. For Visit 2 and 3, a sub-group of subjects was invited for a clinical test visit during which subjects were catheterised with the same device applied during the preceding home-test period. First a healthcare professional (HCP)-led catheterisation was performed followed by a self-catheterisation, and endpoints related to bladder emptying (residual urine and number of urinary flow-stop episodes) were measured. After each catheterisation, any residual urine left in the bladder was measured with a bladder scanner and haematuria was assessed with a dip-stick test. After the self-catheterisation process, subjects at clinic visit V2 and V3 completed a questionnaire related to discomfort.

Finally, all subjects completed a perception questionnaire and a HRQoL questionnaire associated with the catheter during the last two weeks of the home test period. For subjects not part of visits V2 and V3, a nurse assisted with the questionnaires after each home-test period during a remote home visit. Thereafter, all subjects were introduced to the second device to be tested for the next home-test period.

After the second home-test period, the study was terminated with a test visit 3 (V3), either in the clinic (for the subset group) or a home visit by the nurse (the remaining subjects). ;

Related Conditions & MeSH terms

• Urinary Retention

• NCT number: NCT05485935
• Study type: Interventional
• Source: Coloplast A/S
• Status: Completed
• Phase: N/A
• Start date: August 20, 2022
• Completion date: January 3, 2023