INTRODUCTION AND HYPOTHESIS: The glycosaminoglycan hyaluronic acid (HA) protects the urothelium; damage may increase bacterial adherence and infection risk. This study evaluated the effect of intravesical HA in recurrent bacterial cystitis (RBC). METHODS:Women with RBC were randomized to intravesical HA 800 mg and chondroitin sulfate (CS) 1 g (IALURIL, IBSA) in 50 mL of saline solution once weekly for 4 weeks then once every 2 weeks twice more (group 1) or long term antibiotic prophylaxis using sulfamethoxazole 200 mg and trimethoprim 40 mg once weekly for 6 weeks (group 2; control). Evaluations included: cystitis recurrence at 2 and 12 months; subjective pain symptoms (visual analog scale [VAS]); 3 day voiding; sexual function; quality of life (King's Health Questionnaire [KHQ]); frequency symptoms/frequency symptoms (PUF symptom scale); and maximum cystometric capacity (MCC). Means ± standard deviations were reported, with Mann-Whitney test for between-group comparison (significance P < .05). RESULTS: Of 28 women (mean age 60 ± 13 y) randomized, 26 completed follow-up (mean follow-up 11.5 mo). Group 1 showed a significant improvement in all evaluations; cystitis recurrence (1 ± 1.2 versus 2.3 ± 1.4, P = .02); 3-day voiding (mean 17.8 ± 3.5 vs 24.2 ± 8.3, P = .04); symptom VAS (1.6 ± 0.8 vs 7.8 ± 1.6, P < .001); PUF score (11.2 ± 2.7 vs 19.6 ± 2.2, P < .001), KHQ score (18.4 ± 7.2 vs 47.3 ± 13.6, P < .001), and MCC (380 ± 78 vs 229 ± 51 mL, P < .001) vs group 2 at 12 mo. No adverse effects were recorded. CONCLUSIONS:Intravesical HA and CS in combination significantly reduced cystitis recurrence and improved urinary symptoms, quality of life, and cystometric capacity in RBC patients at 12 mo follow-up versus antibiotic prophylaxis. Study limitations include a small sample and relatively short follow-up.
RCT Entities:
INTRODUCTION AND HYPOTHESIS: The glycosaminoglycanhyaluronic acid (HA) protects the urothelium; damage may increase bacterial adherence and infection risk. This study evaluated the effect of intravesical HA in recurrent bacterial cystitis (RBC). METHODS:Women with RBC were randomized to intravesical HA 800 mg and chondroitin sulfate (CS) 1 g (IALURIL, IBSA) in 50 mL of saline solution once weekly for 4 weeks then once every 2 weeks twice more (group 1) or long term antibiotic prophylaxis using sulfamethoxazole 200 mg and trimethoprim 40 mg once weekly for 6 weeks (group 2; control). Evaluations included: cystitis recurrence at 2 and 12 months; subjective pain symptoms (visual analog scale [VAS]); 3 day voiding; sexual function; quality of life (King's Health Questionnaire [KHQ]); frequency symptoms/frequency symptoms (PUF symptom scale); and maximum cystometric capacity (MCC). Means ± standard deviations were reported, with Mann-Whitney test for between-group comparison (significance P < .05). RESULTS: Of 28 women (mean age 60 ± 13 y) randomized, 26 completed follow-up (mean follow-up 11.5 mo). Group 1 showed a significant improvement in all evaluations; cystitis recurrence (1 ± 1.2 versus 2.3 ± 1.4, P = .02); 3-day voiding (mean 17.8 ± 3.5 vs 24.2 ± 8.3, P = .04); symptom VAS (1.6 ± 0.8 vs 7.8 ± 1.6, P < .001); PUF score (11.2 ± 2.7 vs 19.6 ± 2.2, P < .001), KHQ score (18.4 ± 7.2 vs 47.3 ± 13.6, P < .001), and MCC (380 ± 78 vs 229 ± 51 mL, P < .001) vs group 2 at 12 mo. No adverse effects were recorded. CONCLUSIONS: Intravesical HA and CS in combination significantly reduced cystitis recurrence and improved urinary symptoms, quality of life, and cystometric capacity in RBC patients at 12 mo follow-up versus antibiotic prophylaxis. Study limitations include a small sample and relatively short follow-up.
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