Flavoxate hydrochloride for urinary urgency after pelvic radiotherapy: comparison of 600 mg versus 1200 mg daily dosages. A phase II study to evaluate WF10 in patients with late hemorrhagic radiation cystitis and proctitis. Post-irradiation cystitis improved by instillation of early placental extract in saline.
This preliminary communication reports on a non-randomized pilot type trial of 34 females with urgency after pelvic radiotherapy who were treated with flavoxate hydrochloride for 4 weeks. A dosage of 600 mg/day was given to 21 patients and 1200 mg/day to 13 patients. Clinically, both regimens achieved comparable results. Urodynamically (first desire volume, bladder capacity and pressure at capacity) treatment with 1200 mg/day was significantly superior to 600 mg/day. Both schedules were equally well tolerated by patients and no treatment interruption occurred. A randomized double-blind trial comparing 600 and 1200 mg/day flavoxate hydrochloride is currently underway the results of which will be reported in due course. To evaluate efficacy and safety of WF10 (TCDO iv solution) therapy in patients with late hemorrhagic radiation cystitis and proctitis in a long-term follow up.
                From February 1999 to July 2001, 30 symptomatic patients with endoscopically confirmed grade 2 and 3 late hemorrhagic cystitis (n = 16) and proctitis (n = 14) were treated with WF10. The dose was 0.5 ml/kg BW, diluted in 250 ml 5%D/W, administered by intravenous infusion over 2 h, 5 consecutive days, every 3 weeks for 2-4 cycles, combined with standard therapy. The patients were clinically followed up every 3 weeks for 3 months, then every 3 months for 1 year and then every 3-6 months. The study endpoints were immediate response with improvement to Grade 0-1 within 3 months and the incidence of recurrence to Grade > or =2 during the follow up time.
                After completion of the WF10 therapy, 14 cystitis patients (88%) had improved to grade 0-1 hematuria, and 14 proctitis patients (100%) had improved in bleeding per rectum to grade 0-1 within 3 months. The median follow up time was 51 months. During the follow up period, among the responders, 4 cystitis patients (28%) had recurrent hematuria of grade 2 and two proctitis patients (14%) had recurrent bleeding per rectum of grade 2 and 3. No treatment toxicity was observed.
                The WF10 therapy combined with conventional treatment is simple and safe with long-term efficacy in the treatment of late hemorrhagic radiation cystitis and proctitis. 21 patients with chronic cystitis due to irradiation therapy for carcinoma of the cervix had symptomatic and cystoscopic improvement from instillations of early placental extract in saline. There was a statistically significant difference between these patients and a control group.
Late radiation cystitis is a relatively uncommon treatment complication and there are obvious difficulties in identifying sufficient patients to participate in a RCT. The number of published reports is a reflection of the degree of medical interest that exists in providing therapeutic solutions for late radiation cystitis. However, in spite of the two studies of level IIA evidence and the solitary RCT it is difficult to draw any firm conclusions.