Improved Performance With the Micro-Hole Zone Intermittent Catheter: A Combined Analysis of 3 Randomized Controlled Studies Comparing the New Catheter Technology With a Conventional Eyelet Catheter

Malene Hornbak Landauro; Fabio Tentor; Troels Pedersen; Lotte Jacobsen; Per Bagi

doi:10.1097/WON.0000000000001029

Improved Performance With the Micro-Hole Zone Intermittent Catheter: A Combined Analysis of 3 Randomized Controlled Studies Comparing the New Catheter Technology With a Conventional Eyelet Catheter

J Wound Ostomy Continence Nurs. 2023 Nov-Dec;50(6):504-511. doi: 10.1097/WON.0000000000001029.

Authors

Malene Hornbak Landauro^{1

2

3

4

5}, Fabio Tentor^{1

2

3

4

5}, Troels Pedersen^{1

2

3

4

5}, Lotte Jacobsen^{1

2

3

4

5}, Per Bagi^{1

2

3

4

5}

Affiliations

¹ Malene Hornbak Landauro, PhD , Coloplast A/S, Humlebæk, Denmark.
² Fabio Tentor, PhD , Coloplast A/S, Humlebæk, Denmark.
³ Troels Pedersen, MS , Coloplast A/S, Humlebæk, Denmark.
⁴ Lotte Jacobsen, MS , Coloplast A/S, Humlebæk, Denmark.
⁵ Per Bagi, MD , Department of Urology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.

Abstract

Purpose: To assess the performance of a new urinary intermittent catheter (IC) prototype designed with a micro-hole drainage zone compared to a conventional eyelet catheter (CEC) in terms of flow-stop, bladder emptying, and hematuria.

Design: Randomized controlled crossover studies.

Subject and setting: The sample comprised 15 male healthy volunteers (HV) and 15 IC users, along with 15 female HV and 15 IC users. The age range was lower for HV participants than for IC users (range: 20-57 years for HV vs 21-82 years for IC users). The study setting was the Department of Urology, located in Rigshospitalet, Copenhagen.

Methods: Number of flow-stop incidents, residual urine volume at first flow-stop (RV1), and dipstick hematuria were measured during and after catheterization by a health care professional (HV) and by self-catheterisation (IC-users). Results from the 3 studies were combined for HV and IC users on RV1 and number of flow-stop incidents but separated on sex. For incidents of hematuria, an effect of underlying condition was assumed, and a combined analysis on sex was performed, separating HV and IC users.

Results: When compared to the micro-hole drainage zone design, catheterizations with CEC resulted in a significantly higher mean RV1 (mean difference: 49 mL in males and 32 mL in females, both P < .001) and average number of flow-stop incidents (8 and 21 times more frequent for males and females, respectively, both P < .001). The likelihood for hematuria was 5.84 higher with CEC than with micro-hole drainage hole design, P = .053, during normal micturition in HV postcatheterization. No serious adverse events were reported.

Conclusion: The micro-hole drainage zone catheter provides IC users fewer premature flow-stops. This design feature reduces modifiable urinary tract infection risk factors, such as residual urine and micro-trauma; additional research is needed to determine its effects on bladder health.

Trial registration: ClinicalTrials.gov NCT04445051.

Publication types

Randomized Controlled Trial

MeSH terms

Adult
Cross-Over Studies
Female
Hematuria / complications
Humans
Male
Middle Aged
Technology
Urinary Bladder
Urinary Catheterization* / methods
Urinary Catheters / adverse effects
Urinary Tract Infections* / etiology
Young Adult

Associated data

ClinicalTrials.gov/NCT04445051