Reduced recurrence of late hemorrhagic radiation cystitis by WF10 therapy in cervical cancer patients: a multicenter, randomized, two-arm, open-label trial.

BACKGROUND AND PURPOSE: To evaluate the efficacy and the safety of WF10 as adjunct to standard treatment in the management of late hemorrhagic radiation cystitis compared to standard treatment alone. PATIENTS AND METHODS: Cervical cancer patients with Grade 2 or 3 late hemorrhagic radiation cystitis, were randomized and treated with WF10 0.5 ml/kg body weight, diluted in physiological saline or 5% dextrose water 250 ml, intravenous infusions over 2 h on 5 consecutive days, every 3 weeks for 2 cycles plus standard treatment (WF10 group) or standard treatment alone (control group). Fifty patients in each group were evaluated by questioning; urinalysis and cystoscopy during a 1 year follow up. RESULTS: At week 7, 37 patients (74%) in the WF10 group and 32 patients (64%) in the control group showed complete resolution in objective hematuria (P = 0.28). Significantly lower use of antibiotics (P = 0.002) and antispasmodics (P < 0.001) was found in the WF10 group. Among the responders, 24 patients (77%) in the control group experienced recurrent objective hematuria, whereas in the WF10 group only 17 patients (47%) experienced a recurrence (P = 0.01). Recurrence of objective hematuria occurred significantly faster in the control group as evidenced by Kaplan-Meier and log-rank statistics (P = 0.004), suggesting a long-term effect of WF10. Cystoscopy, at the end of the treatment period and after the one year follow up showed overall improvement without significant difference between two groups. No severe toxicity was monitored. CONCLUSIONS: WF10 therapy is a safe, non-invasive and convenient method in the management of late hemorrhagic radiation cystitis. WF10 therapy, as adjunct to standard treatment, has significantly reduced recurrence of objective hematuria, compared to standard treatment alone, during a one year follow up.

The efficacy and safety of oral sildenafil in Thai men with erectile dysfunction: a randomized, double-blind, placebo controlled, flexible-dose study.

OBJECTIVE: To evaluate the efficacy and safety of sildenafil citrate (Viagra) in a randomized, double-blind, placebo-controlled, flexible-dose study in Thai men with erectile dysfunction of broad-spectrum etiology and more than 6 months' duration. MATERIAL AND METHOD: 125 patients aged 26 to 77 years were randomized at 4 centers in Thailand to receive either sildenafil citrate (50 mg initially, increased if necessary up to 100 mg or decreased to 25 mg depending on efficacy and/or tolerability) (n = 63) or a matching placebo (n = 62) taken on an 'as needed' basis approximately 1 hour prior to anticipated sexual activity for a period of 12 weeks. Efficacy was assessed by the patients' responses to the 15-question International Index of Erectile Function (IIEF), to questions on the event log of sexual activity, and to the global efficacy assessment question concerning improvement in erections. RESULTS: At the conclusion of the study, both the primary efficacy variables relating to the achievement and maintenance of erections sufficient for sexual intercourse and the secondary efficacy variables, which included the 5 separate domains of sexual functioning of the IIEF, the percentage of successful attempts at sexual intercourse, and the global efficacy assessment question concerning improvement in erections, were all significantly improved statistically by sildenafil in comparison with placebo except in the sexual desire domain which showed no difference. The percentage of successful attempts at sexual intercourse in the sildenafil group was 66.16 per cent while in the placebo group it was 33.05 per cent. The percentage of global efficacy assessment was improved in the sildenafil group by 82.5 per cent compared to 36.1 per cent in the placebo group. Adverse events considered treatment-related occurred in 19 patients (30.2%) receiving sildenafil and 7 (11.3%) receiving placebo. The most common adverse events with sildenafil were vasodilatation (flushing), headache, and dizziness, which occurred in 14.3 per cent, 6.3 per cent, and 6.3 per cent of patients respectively. All events were mild in nature. CONCLUSIONS: Sildenafil is a safe and effective treatment for erectile dysfunction of broad-spectrum etiology in Thai men. Its efficacy appears similar to that reported in other studies in Western populations.