Short summary

This study aims to investigate whether bacterial interference through bladder flushing with an asymptomatic strain of E.coli can prevent the recurrence of urinary tract infections (UTI). The effectiveness of this intervention will be assessed by the frequency of UTI events that occur over a twelve-month period and compared against standard treatment and Saline bladder flushing. Additionally, the study will assess the impact of this intervention on voiding function and quality of life.

Rationale

Urinary tract infection (UTI) is one of the most common bacterial infections worldwide. It affects 150 million people annually. Treatment of patients with UTI entails a high consumption of antibiotics and large social and health costs. With this protocol, we want to elucidate alternative treatment methods for recurrent urinary tract infection (rUTI). Bacteria have internal competitiveness (bacterial interference) and it is known that the non-pathogenic E.coli can outcompete the pathogenic E.coli in laboratory studies. In a newly developed UTI pig model, we investigate concentrations and the optimal conditions for the treatment of UTI with a non-pathogenic E.coli. This protocol intends to address unanswered questions regarding the bacterial interference treatment of rUTI by strengthening the clinical evidence of bacterial interference prophylactic treatment through a randomized, placebo-controlled, triple-blinded trial (RCT) at Odense University Hospital.

Description of the cohort

Participants are included in the department of Urology at Odense University Hospital and at Aarhus University Hospital. Individuals diagnosed with recurrent UTIs, including at least two episodes of rUTI within the last 6 months or three episodes in the last 12 months can participate. The inclusion criteria includes screening for lower urinary tract dysfunction (LUTD) using methods such as voiding diary, voiding diagram, test for residual urine, flexible cystoscopy, and CT urography. Furthermore the following is needed. -Functional bladder volume over 200 mL. -Failed previously treatments. -Individuals aged 18 years or older -Patients with spontaneous voiding, the need for CIC, indwelling catheter (IDC) or stoma can be included. -Previous treated malignancy in the urinary tract including active surveillance and watchful waiting regime for prostate cancer can be included.

Data and biological material

The data collected for the study includes demographic information, responses to questionnaires, medical reports, details on previous antibiotic treatments, and results from clinical tests such as blood pressure, temperature, urine culture, and blood tests.

Collaborating researchers and departments

Department of Urology at Aarhus University Hospital

• Charlotte Graugaard-Jensen

Deparment of Urology, Lillebaelt Hospital Vejle

• Bettina Nørby

Publications associated with the project

Karin Andersen, Louise Thomsen Schmidt Arenholt, Kristian Stærk, Thomas Emil Andersen & Lars Lund. Simple, recidiverende og komplicerede urinvejsinfektioner. Ugeskr Læger 2022;184:V03220200