Segmental and Ear Acupuncture for Prevention of Recurrent Urinary Tract Infections(SARUTI Study): a Multicenter Randomized Controlled Trial

1. Background 1.1. Urinary tract infection

Urinary tract infections (UTI) are considered to be the most common bacterial infections, with approximately 80% of all UTIs occurring in women (1). Nearly one in three women is expected to have at least one episode of UTI by the age of 24 years and almost half of all women will experience one UTI during their lifetime (2). Recurrence affect approximately 20-30% of women with initial UTI, although recurrence rates vary widely (3).

Recurrent UTIs are a common problem seen in clinical practice with important medical, social and financial implications. Prophylaxis of recurrent UTI is an ongoing challenge with several different management strategies being used (4). Low dose antibiotic prophylaxis for several months is effective, but fosters the development of antibiotic resistance of the causative microorganisms, but also the commensal flora.(4-8). In postmenopausal women vaginal estrogen therapy reduces symptomatic UTI episodes (1, 7). Further prevention strategies include the oral immunostimulant OM-89, the vaginal vaccine Urovac, lactobacilli prophylaxis, cranberry products and acupuncture (5, 7, 9).

1.2.Cranberry products Cranberries have been used in the prevention of UTIs for many years. Cranberries contain two compounds with antiadherence properties that prevent fimbriated Escherichia coli from adhering to uroepithelial cells in the urinary tract (10). A recent review of 24 studies showed that the use of various cranberry products may have a small benefit for women with recurrent UTIs, although differences were not statistically significant (11).

1.3. Acupuncture treatment The effectiveness of acupuncture has been established for a series of different conditions (12, 13). Up to date there are only two clinical trials studying the effect of acupuncture on the prevention of recurrent UTI, both conducted from the same research group. In one controlled trial of 67 adult women acupuncture was significantly more effective in preventing recurrent UTI compared to sham acupuncture than no treatment over an observation period of 6 months (14). In the second trial of 100 women acupuncture, administered twice weekly for 4 weeks, was significantly more effective in reducing the number of UTIs, but also in reducing the volume of residual urine. Acupuncture points were chosen according to patients´ individual diagnoses following traditional Chinese medical patterns. (15) 2. Study aims The present study aims to compare acupuncture treatment with standard treatment (recommendation for cranberry intake) in the treatment of uncomplicated recurrent UTIs in women and is designed as a prospective randomized controlled trial. We will assess the number of acute lower UTIs and subsequent treatment, the type and amount of self medication (cranberry products and others), health related quality of life and treatment satisfaction within a defined period of time.