Xyloglucan + Gelose Combination versus Placebo as Adjuvant Therapy to First-Line Antimicrobials for Uncomplicated Urinary Tract Infection in Adults.

BACKGROUND: A medical device containing xyloglucan-gelose-hibiscus-propolis (referred to hereafter as xyloglucan + gelose) acts as a mucosal barrier protector and urinary acidifier. The safety and efficacy of this device were investigated as adjuvant therapy to first-line antimicrobials for treatment of uncomplicated urinary tract infection (UTI) in adults. PATIENTS AND METHODS: In this multicentre, randomised, parallel group, double-blind, phase IV study, xyloglucan + gelose (n = 20) or placebo (n = 20) were administered orally in combination with an antimicrobial agent (e.g., ciprofloxacin) for 5 days, then alone for 5 days, then beginning on Day 30 of the study for 15 days per month for 2 months. RESULTS: Frequency of adverse events (AEs) was 5 and 45% in the xyloglucan + gelose and placebo groups respectively. All AEs were unrelated to study products. Xyloglucan + gelose reduced uroculture positivity (defined as a bacterial count ≥103 CFU/mL) from 100% of patients at baseline to 0% at Day 11, with recurrence in 3 patients (15%) by Day 76. Corresponding results with placebo were 100% uroculture positive patients at baseline reduced to 45% at Day 11, with recurrence in 14 patients (70%) by Day 76. Xyloglucan + gelose significantly reduced the frequency of urinary incontinence and urgency of micturition compared with placebo (both p < 0.05), with symptom resolution in all patients by Day 90. CONCLUSIONS: The xyloglucan + gelose medical device was safe, well tolerated, and it reduced bacteriological and symptomatic parameters in adults with uncomplicated UTI.

Total Colpectomy Increases the Risk of Postoperative Hydronephrosis in Vaginal Cancer Patients.

Purpose: Due to the rarity of vaginal cancer, surgical treatment results, and postoperative complications have been poorly described in the literature. The aim of this study was to improve current knowledge about the incidence of hydronephrosis following the surgical treatment of vaginal cancer. Materials and methods: 32 patients with vaginal cancer of the middle and upper third were matched with 32 cervical cancer patients (stages I and II) for comparison of long-term urological postoperative complications. All patients underwent radical surgical treatment and all stage II patients underwent neoadjuvant radiotherapy. Results: Hydronephrosis had a significantly higher incidence in the vaginal cancer group (p = 0.04), with 14 patients (43.8%) being diagnosed with this complication compared to only 5 patients (15.6%) in the cervical cancer group. Among patients that received radiotherapy, 40.1% (n = 9) and 22.7% ( = 5) of vaginal, respectively cervical cancer patients were found with postoperative hydronephrosis. Conclusions: In vaginal cancer patients total colpectomy increases the risk of developing postoperative hydronephrosis, especially if neoadjuvant radiotherapy has been applied.