Introduction and objectives

To compare the new Conveen® Optima urinary sheath with the established Clear Advantage® urinary sheath with regard to patient satisfaction and preference. The primary endpoint was urinary sheath product preference, and secondary endpoints were handling, application, comfort, leakage, and skin reactions.  

Study design

This randomised, prospective, open, crossover study at seven centres in the UK included males at least 18 years of age and using at least one one-piece urinary sheath a day. Exclusion criteria were mental health problems and participation in other clinical studies. Each participant tested 10 urinary sheaths of each product Conveen Optima and Clear Advantage. Participants were randomised according to a block randomisation list.

In order to calculate a 95% confidence interval for the expected preference for each product of 50% and an estimated error of 15%, the number of subjects needed was 43. Thus, it was planned to include 50 patients to compensate for dropouts.

Data regarding demographics and nurse/helper evaluation was reported descriptively. 95% confidence intervals were calculated for the product preference results. Secondary parameters were analysed using the Wilcoxon test and the Sign test where appropriate.  

Results

Of the 53 men included in the study, 44 fulfilled the evaluability criteria and were included in the analyses. Eighty-one percent of the participants reported having a preference.

With Conveen Optima compared to Clear Advantage, more participants found that:

• It was easier to open and remove the sheath from the individual packaging
• They did not experience wrinkles or bubbles when applying the sheath
• They felt safe immediately after the application of the sheath
• The sheath was comfortable to wear
• The drainage from the sheath into the urine bag was satisfactory
• The individual packaging of the urinary sheath enabled them to easily carry it around with them
• It was easier to connect and subsequently disconnect the sheath from the urine bag
• Participants felt more secure when using the Conveen Optima (scale ranged from 0=very insecure to 10=very secure; P=0.029, Wilcoxon test).
• Where nurses applied the urinary sheaths wearing gloves, more nurses found Conveen Optima easy to apply
• For all other questions asked, there was no statistically significant difference between the Conveen Optima and the Clear Advantage urinary sheaths

Interpretation of results

This study shows that the Conveen Optima urinary sheath provides a higher feeling of security. Furthermore, the Conveen Optima sheath was found to be easier to handle and apply in some of the aspects studied, and importantly, it was found to be at least as user-friendly as the Clear Advantage sheath in all the other aspects studied.

The study showed that 67% preferred the Conveen Optima urinary sheath over Clear Advantage, which was previously shown to perform significantly better than other self-adhesive urinary sheaths on the UK market at that time. 60% of the participants were using Clear Advantage before entering the study and must therefore be expected to favor Clear Advantage.It is thus interesting to note that such a large proportion preferred Conveen Optima. This large preference may be due to the improved feeling of security, the improved comfort, and improved packaging of the product.  

Conclusion

This is one of the first randomised clinical trials aimed at providing evidence for healthcare professionals in order to assist them and their patients in making informed choices concerning a urinary sheath product. The study shows that the Conveen Optima urinary sheath provides a higher feeling of security than the well-established product, Clear Advantage. Furthermore, Conveen Optima was found to be easier to handle and apply as well as more comfortable to wear. Finally, the overall product preference for Conveen Optima was 67%, indicating that it is more acceptable than the well-established product.