RESUMO
OBJECTIVES: To compare the clinical efficacy of the on-demand use of four drugs in the management of patients with premature ejaculation (PE), as the off-label use of selective serotonin-reuptake inhibitors and topical penile anaesthetics is frequently indicated for the management of patients with PE, and tramadol HCl and sildenafil citrate were also tried for managing this disorder, but with recommendations based on weak evidence. PATIENTS AND METHODS: This was a single-centre, single-blind, placebo-controlled clinical trial conducted on 150 patients who had PE for >1 year. Patients were randomised equally into five groups. On-demand tramadol, sildenafil, paroxetine, local lidocaine gel or placebo was given for patients in groups 1-5, respectively. During the month before treatment, the intravaginal ejaculation latency time (IELT) and sexual satisfaction scores (on a 0-5-point scale) were measured and compared to the mean IELT and sexual satisfaction scores recorded during 4 weeks of on-demand drug administration, with monitoring of any possible side-effects. RESULTS: Tramadol-treated patients had a significantly longer mean (SD) IELT, of 351 (119) s, than the other groups. Local anaesthetic was significantly better than paroxetine in prolonging the IELT, at 278 (111) vs. 186 (65) s, respectively. The improvement in sexual satisfaction was significantly better in the sildenafil group, with a mean (SD) improvement of 2.9 (1) points, than in the paroxetine and local anaesthetic groups, at 2.2 (0.9) and 1.9 (0.9) points, respectively. CONCLUSIONS: The four drugs significantly improved IELT values over placebo. Tramadol was associated with significantly longer IELT values, whilst sildenafil induced significantly better sexual satisfaction than the other drugs. The four drugs had tolerable side-effects.
RESUMO
PURPOSE: Vesicovaginal fistula is a socially debilitating problem with important psychological and medicolegal implications. Complicated fistulas include large fistulas or those with failed prior repair attempts. The key to successful closure of such fistulas is the use of adjuncts such as a Martius, peritoneal or omental flap. Small intestinal submucosa is an acellular collagen matrix graft that is nonimmunogenic, biodegradable and ready to use off the shelf. We evaluated small intestinal submucosa as an interposition patch during complicated vesicovaginal fistula repair. MATERIALS AND METHODS: A total of 23 women with a mean age of 33.5 years who had a complicated vesicovaginal fistula were enrolled in this clinical trial. Complicating factors were failed primary repair in 9 cases, excessive perifistulous scarring in 4 patients and a fistula 1.5 cm or greater in the remainder. Transvaginal repair was done in 7 low fistula cases and transabdominal repair was done in the remainder with a high fistula. A small intestinal submucosa patch was interposed in all cases at classic abdominal or vaginal repair. All patients were evaluated 1, 3 and 6 months postoperatively. RESULTS: All patients who underwent vaginal repair were dry during followup. Of the 16 women who underwent transabdominal repair 14 were dry. The overall success rate was 91.3%. No reported allergic or inflammatory reactions were documented. CONCLUSIONS: Using small intestinal submucosa as an interposition layer at anatomical vaginal and/or transabdominal repair of complicated vesicovaginal fistulas seems to be a simple, feasible solution.
