An open label, non-controlled, multicentre, interventional trial to investigate the safety and efficacy of Canephron® N in the management of uncomplicated urinary tract infections (uUTIs)

Abstract

Background Despite of increasing prevalence of bacterial resistance to antibiotics and possible adverse drug reactions (ADRs), uncomplicated lower urinary tract infections (uUTIs) are usually treated with antibiotics. Canephron® N, a herbal medicinal product, was now investigated for safety and efficacy in women suffering from uUTI. Methods In an open-label, non-randomized, multicentre clinical trial 125 Caucasian female patients suffering from uUTI with a sum score of at least 6 for the symptoms dysuria, frequency and urgency (each rated 0–4) were enrolled. Patients were treated with 3x2 tablets Canephron® N for seven days. Symptom assessment was performed by the patient on a daily basis and by the investigator at Day 0, Day 7, Day 37. Primary endpoint was the incidence of ADRs during the treatment. Secondary endpoints were clinical cure (none of the main symptoms scored as worse than mild (“1”)) on Day 7, severity of uUTI symptoms on Day 7 and Day 37, patients requiring antibiotic treatment until Day 7, duration of uUTI symptoms and patients with early recurrence. Changes in safety data (dipstick analysis of urine; analysis of blood and urine in a central laboratory) were analysed descriptively. Further post hoc analyses were performed. Results None of 19 adverse events within the study period was considered as drug-related or serious. The responder rate was 71.2 % on Day 7 and 85.6 % on Day 37 (FAS, N = 125) with a significant improvement of all symptoms (all: p < 0.001). Only 2.4 % of patients required antibiotics during the treatment period and none of the patients met the definition of recurrence until Day 37. The mean changes of the main symptoms on Day 7 and Day 37 compared to Day 0 were: −1.9/-2.3 (dysuria); −1.8/-2.4 (frequency); −1.6/-1.9 (urgency). Symptomatic improvement was accompanied by decreased nitrite, leukocytes as well as erythrocyte levels from Day 0 to Day 7 and Day 37. Conclusions This trial emphasises the safe usage and efficacious opportunity of a non-antibiotic therapy approach with Canephron® N and fully justifies a large-scale controlled clinical trial. Trial registration Eudra CT nr. 2011-000838-11. ClinicalTrials.gov Identifier NCT01478620