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.

The study tested single catheterizations on single test days, so it does not show how the catheters perform over longer routine use. Only 59 participants were randomized, and one participant stopped after visit 2 but was still included in the analysis. The trials were single-blinded and were run at one urology department. Healthy volunteers were included, and their bladder function and discomfort may differ from people who need long-term intermittent catheterization. The male micro-hole catheter also had a different flexible tip and sleeve from the conventional male catheter, so differences may not be due only to the micro-holes. Ultrasound residual volume measurements varied widely and could be inaccurate when very small volumes were present. Hematuria was used as a proxy for microtrauma, and the hematuria differences were not statistically significant. The study did not test urinary tract infection as a treatment outcome; the authors say further research is needed. The authors combined results across healthy volunteers, catheter users, two prototype designs and nurse-performed or self-performed catheterization for several outcomes, so it is not clear whether the effect is the same for every patient.

The supplied text does not state who funded the studies or give an author conflict-of-interest declaration. The comparator was a Coloplast product, the study devices were described as compositionally identical to Coloplast catheters, and the pressure sensor used to detect flow-stops was developed by Coloplast A/S.

Do not conclude that the micro-hole catheter prevents urinary tract infections. The study measured residual urine, flow-stops, hematuria and discomfort, not infection rates, and the hematuria differences were not statistically significant.