Pilot study

The result of the first study with ProctoClean are now available. Summary:

Abstract english

Objective

Today’s standard of anal hygiene is limited to cleaning with soft tissue paper and water. So far, the cutaneus irritation of the anal region, because of fecal particles, which leak from the anal part of the rectus, was not investigated. The cleaning tool Proctoclean was developed to reduce the fecal spotting which leaks outside for the purpose to minimize the irritation of the skin around the anus. The aim of the pilot study with the cleaning tool Proctoclean was to collect data of effectivity and compatibility for patients under conditions of a proctologic medical practice.

Subjects und Methods

In this study 69 Patients were included, who used the cleaning tool Proctoclean for an average period of 4, 8 month, but at least for 2 month. Data was collected from patients in the study group, who filled out a standardized questionnaire after using the cleaning tool. Main criterion was the change in medical condition and second criteria was the improvement of living conditions, which include patient’s compliance, tolerance and occurrence of side-effects. Collected data was statistically evaluated by medical doctors responsible for study design and with professional statistical help.

Results

Data showed that most patients experienced significant reduction in their symptoms after a few days. The decrease of the symptoms was accompanied by an increase in health-related quality of life. After three month there was a documented strong relief of itching, wetting and burning sensation of the skin in the anal region. At the same time, only few adverse events related to the use of Proctoclean were reported.

Conclusion

The results showed that cleaning the anal part of the rectum with Proctoclean cleaning tool reduced irritation and inflammation of skin in the anal region. The efficacy and tolerability of Proctoclean for anal complaints were confirimed in a broad spectrum of patients in everyday practice.