ObjectivesTo compare the clinical effectiveness of the intravesical administration of combined hyaluronic acid and chondroitin sulfate (HA+CS) versus current standard management in adult women with recurrent urinary tract infections (RUTIs).SettingA European Union-based multicentre, retrospective nested case–control study.Participants276 adult women treated for RUTIs starting from 2009 to 2013.InterventionsPatients treated with either intravesical administration of HA+CS or standard of care (antimicrobial/immunoactive prophylaxis/probiotics/cranberry).Primary and secondary outcome measuresThe primary outcome was occurrence of bacteriologically confirmed recurrence within 12 months. Secondary outcomes were time to recurrence, total number of recurrences, health-related quality of life and healthcare resource consumption. Crude and adjusted results for unbalanced characteristics are presented.Results181 patients treated with HA+CS and 95 patients treated with standard of care from 7 centres were included. The crude and adjusted ORs (95% CI) for the primary end point were 0.77 (0.46 to 1.28) and 0.51 (0.27 to 0.96), respectively. However, no evidence of improvement in terms of total number of recurrences (incidence rate ratio (95% CI), 0.99 (0.69 to 1.43)) or time to first recurrence was seen (HR (95% CI), 0.99 (0.61 to 1.61)). The benefit of intravesical HA+CS therapy improves when the number of instillations is ≥5.ConclusionsOur results show that bladder instillations of combined HA+CS reduce the risk of bacteriologically confirmed recurrences compared with the current standard management of RUTIs. Total incidence rates and hazard rates were instead non-significantly different between the 2 groups after adjusting for unbalanced factors. In contrast to what happens with antibiotic prophylaxis, the effectiveness of the HA+CS reinstatement therapy improves over time.Trial registration numberNCT02016118.
Introduction: We assess the effectiveness of intravesical instillation of hyaluronic acid (HA) and chondroitin sulphate (CS) as a non-antibiotic treatment option for prophylaxis of recurrent urinary tract infections (UTIs) in female patients. Methods: This was a retrospective cohort study involving 7 European institutions. We included patients with recurrent UTIs who received intravesical instillations of Ialuril (IBSA International) (50 mL HA 1.6% and CS 2% solution) between January 2010 and March 2012. Medication schedule, length of follow-up, recurrence infection time, number of UTIs/patients/year, patient quality of life, subjective symptoms score, and treatment-emergent side effects were recorded and analyzed. Results: In total, 157 women (mean age: 54.2 ± 4.1 years) were included in the analysis. All patients had at least 12 months followup. After 4 weekly and 5 monthly HA-CS bladder instillations, UTI episodes decreased from 4.13 ± 1.14 to 0.44 ± 0.50 (p = 0.01) at 12 months, while recurrent UTI time prolonged from 94.8 ± 25.1 days to 178.4 ± 37.3 days (p = 0.01) at 12 months. An improvement in symptoms and quality of life was achieved. A medium-depth pain after medication instillation was the most reported side effect. Regression model analysis showed significant risk factors in developing new UTI episodes: being more than 50 years old and having more than 4 UTI episodes per year (OR 3.41; CI 95%; p = 0.003 and OR 3.31;; p = 0.003, respectively). Retrospective design and lack of a control group represent two main limitations of the study. Conclusions: Restoring glycosaminoglycans bladder layer therapy is a promising non-antibiotic therapy to prevent recurrent UTIs.
Background Radiation-induced cystitis is a common side effect of radiotherapy (RT) to the pelvic area. Hyaluronic acid (HA) and chondroitin sulfate (CS) are components of the urothelial mucosa and positive results have been obtained for intravesical HA/CS instillations for the treatment of urinary tract infections and bladder pain syndrome. HA/CS may also have a protective effect against RT bladder toxicity. Objective To investigate whether HA and CS protect the urothelium during RT, alleviate lower urinary tract symptoms, and improve quality of life. Design, setting, and participants This multicentre randomised controlled trial was conducted across seven centres in four countries. Male patients aged ≥18 yr scheduled to undergo primary intensity-modulated radiotherapy for localised prostate cancer were enrolled. Intervention Patients were randomised to intravesical HA/CS plus an oral formulation of curcumin, quercetin, HA, and CS (group A) or no treatment (group B). Outcome measurements and statistical analysis The primary endpoint was absolute changes from baseline to follow-up in urinary domain scores for the Expanded Prostate Cancer Index Composite (EPIC), the International Consultation on Incontinence Questionnaire-Male Lower Urinary Tract Symptoms (ICIQ-MLUTS), and the EuroQol Group EQ-5D-5L questionnaire. Data analysis for efficacy and safety outcomes was performed using an intention-to-treat (ITT) approach; the ITT population was defined as all randomised patients. Results and limitations Of 57 patients screened, 49 were enrolled and randomly assigned to either active treatment (group A, n = 25) or the control (group B, n = 24). Three patients in the control group withdrew after randomisation. Changes from baseline to 12 mo were worse in the control group for subtotal scores for urinary symptoms and impact of symptoms on quality of life and for the total score ( p = 0.05, p = 0.003, and p = 0.008, respectively). There was a significant time × group interaction in favour of active treatment for the incontinence symptom score ( p = 0.011) and bother score ( p = 0.017). The absence of a sham procedure and/or placebo is the main limitation. Conclusions Our results suggest that intravesical HA/CS in combination with an oral formulation may reduce urinary symptoms and improve QoL at short-term (1 yr) follow-up. Patient summary We investigated whether hyaluronic acid (HA) and chondroitin sulfate (CS) have a protective effect against the bladder toxicity of radiotherapy for prostate cancer. HA/CS used for weekly bladder irrigation for 6 wk and given orally with curcumin and quercetin for 12 wk reduced urinary i...
Men reporting mixed storage and voiding lower urinary tract symptoms (LUTS) often experience persisting storage LUTS after initial treatment. Combination therapy of an alpha-adrenergic antagonist and an antimuscarinic is increasingly recognized as a therapy option. Clinical trials have combined tamsulosin (0.4 mg) with different doses of solifenacin. In the SATURN study, greater efficacy benefits were observed for moderate to severe storage symptoms. Single tablet administration may offer improved compliance. Accordingly, the NEPTUNE study researched fixed-dose combination (FDC) therapy for mixed LUTS, using tamsulosin (oral controlled administration system formulation), with solifenacin (6 or 9 mg). The FDC containing tamsulosin and solifenacin 6 mg improved storage and voiding LUTS, with no additional benefit from the higher solifenacin dose. During the open-label extension study, symptom improvement was maintained. Adverse events reflected the known effects of the component therapies. Acute urinary retention, an adverse event of special interest, was seen in only a small number of treated men.
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