Spinal-injured neuropathic bladder antisepsis (SINBA) trial. A short-term study of nitrofurantoin prophylaxis in children managed with clean intermittent catheterization. Urinary tract infection after vaginal surgery. Effect of prophylactic treatment with methenamine hippurate. Randomized comparison of low-dose versus standard-dose praziquantel therapy in treatment of urinary tract morbidity due to Schistosoma haema tobium infection. Value of urinary prophylaxis with methenamine in gynecologic surgery. Efficacy of cranberry in prevention of urinary tract infection in a susceptible pediatric population. Are prophylactic antibiotics necessary during extracorporeal shockwave lithotripsy? Evaluation of cranberry supplement for reduction of urinary tract infections in individuals with neurogenic bladders secondary to spinal cord injury. A prospective, double-blinded, placebo-controlled, crossover study. Secondary prevention of recurrent urinary tract infections. Comparison of the effect of placebo, methenamine hippurate, nitrofurantoin and trimethoprim alone. Evaluation of cranberry tablets for the prevention of urinary tract infections in spinal cord injured patients with neurogenic bladder. A comparative trial of low dose cefaclor and macrocrystalline nitrofurantoin in the prevention of recurrent urinary tract infection. Long-term prophylaxis of urinary infections in women: comparative trial of trimethoprim, methenamine hippurate and topical povidone-iodine. Nitrofurantoin versus trimethoprim prophylaxis in recurrent urinary tract infection in children. A randomized, double-blind study.
To determine whether Methenamine Hippurate (MH) or cranberry tablets prevent urinary tract infections (UTI) in people with neuropathic bladder following spinal cord injury (SCI).
                Double-blind factorial-design randomized controlled trial (RCT) with 2 year recruitment period from November 2000 and 6 month follow-up.
                In total, 543 eligible predominantly community dwelling patients were invited to participate in the study, of whom 305 (56%) agreed.
                Eligible participants were people with SCI with neurogenic bladder and stable bladder management. All regimens were indistinguishable in appearance and taste. The dose of MH used was 1 g twice-daily. The dose of cranberry used was 800 mg twice-daily. The main outcome measure was the time to occurrence of a symptomatic UTI.
                Multivariate analysis revealed that patients randomized to MH did not have a significantly longer UTI-free period compared to placebo (HR 0.96, 95% CI: 0.68-1.35, P=0.75). Patients randomized to cranberry likewise did not have significantly longer UTI-free period compared to placebo (HR 0.93, 95% CI: 0.67-1.31, P=0.70).
                There is no benefit in the prevention of UTI from the addition of MH or cranberry tablets to the usual regimen of patients with neuropathic bladder following SCI. Because there is no evidence for the effectiveness of antibiotic prophylaxis in children with neurogenic bladder, the value of once-daily nitrofurantoin macrocrystals was assessed in a selected population with neurogenic bladder due to meningomyelocele. METHODS AND TRIAL POPULATION: Children with significant urinary tract abnormalities other than neurogenic bladder were excluded. A urinary tract "infection" was defined as > or = 10(8) colony forming units of bacteria/L of urine together with pyuria of > or = 50 x 10(6) leukocytes/L, and/or symptoms consistent with an urinary tract infection. Fifty-six children participated in a 24-week double-blinded, placebo-controlled cross-over study. The infection status was assessed at two weekly intervals or if relevant clinical manifestations occurred.
                For the whole trial the average percentage of "infections" per urine sample for each patient was reduced from 39% on placebo to 19% on single daily dose prophylaxis (P < .0003). For the first 12 weeks of the trial corresponding figures were 45% on placebo and 22% on prophylaxis (P < .0018). There was evidence for a marked carryover protective effect of nitrofurantoin into the placebo arm of the trial.
                Nitrofurantoin is an effective prophylactic agent during a 3-month period. Long-term studies are needed to confirm the reasonable expectation of a beneficial effect on urinary tract damage. One hundred and nine consecutive patients undergoing surgery for uterovaginal prolapse followed by indwelling urinary catheter for 3 days were randomized for prophylactic treatment with methenamine hippurate (MH) or no MH prophylaxis. Significantly less bacteriuria occurred in the MH-treated patient group. In particular, the opportunistic hospital flora appeared to be suppressed by MH treatment. It is suggested that MH prophylaxis, 1 g three times daily, be used in gynecological surgery followed by short-term urinary catheterization. At present, anthelmintic therapy with praziquantel at a dose of 40 mg/kg of body weight is the recommended treatment for control of urinary tract morbidity caused by Schistosoma haematobium. Although this standard regimen is effective, drug cost may represent a significant barrier to implementation of large-scale schistosomiasis control programs in developing areas. Previous comparison trials have established that low-dose (20-30 mg/kg) praziquantel regimens can effectively suppress the intensity of S. haematobium infection in endemic settings. However, the efficacy of these low-dose regimens in controlling infection-related morbidity has not been determined in a randomized field trial. The present random allocation study examined the relative efficacy of a 20 mg/kg dose versus a 40 mg/kg dose of praziquantel in control of hematuria and bladder and renal abnormalities associated with S. haematobium infection in an endemic area of Coast Province, Kenya. After a nine-month observation period, the results indicated an advantage to the standard 40 mg/kg praziquantel dose in terms of reduction of infection prevalence and hematuria after therapy (P < 0.01 and P < 0.005, respectively). However, the two treatment groups were equally effective in reducing structural urinary tract morbidity detected on ultrasound examination. We conclude that in certain settings, a 20 mg/kg dose of praziquantel may be sufficient in providing control of morbidity due to urinary schistosomiasis in population-based treatment programs. There is a high risk of postoperative bacteriuria and urinary tract infection after gynecologic surgery. Postoperative asymptomatic bacteriuria often disappears without treatment, but 15-20% of patients still require treatment for postoperative urinary tract infection. This study was carried out to assess the value of prophylactic treatment with methenamine hippurate after routine gynecologic surgery.
                This was a prospective, randomized, double-blind, placebo-controlled clinical trial comprising 145 patients undergoing routine gynecologic laparotomy or vaginal plastic surgery using a Foley catheter for 24 h. Antibiotics were not used. Subjects received 1 g Hiprex or placebo twice daily for 5 days. Urine was cultured preoperatively, at catheter removal, and 2 days later. Patients with positive cultures were not given antibiotics unless they were symptomatic. The follow-up period was 1 month.
                The chi-square test, Fisher exact test, and t-test were used with level of significance at 0.05, and odds ratios with 95% confidence intervals were calculated.
                Asymptomatic bacteriuria was diagnosed in 36 cases (50.0%) in the placebo group and 22 cases (30.1%) in the methenamine group (p = 0.02). Urinary tract infection was diagnosed in 10 cases (13.9%) in the placebo group and two cases (2.7%) in the methenamine group (p = 0.03). There were few adverse events.
                Prophylactic treatment with methenamine hippurate significantly reduces the incidence of postoperative bacteriuria and urinary tract infection. The objective of the study was to evaluate liquid cranberry products as prophylaxis against bacterial urinary tract infection in a pediatric neuropathic bladder population. Forty cases managed by clean intermittent catheterization with or without pharmacotherapy were enrolled in a randomized single-blind cross-over study. Subjects ingested 15 mL/kg/day of cranberry cocktail or water for six months followed by the reverse for another six months. Initial catheter urine samples and subsequent monthly and interim cultures were obtained. Associated symptoms were recorded along with follow-up attendance/compliance registry. The number of negative culture months to the number of months contributed was tabulated and compared between interventions. Individual, cumulative and antimicrobial subset analysis was performed. Twenty one patients completed the study;12 dropped out for reasons related to the cranberry (taste, caloric load and cost); seven patients dropped out for other reasons (parents too busy, death, no stated reason). Wilcoxon matched-pairs Signed-ranks analysis revealed no difference between intervention periods (2-tailed P=.5566 [whole group]; p=.2845 [antimicrobial subset]) with respect to infection. Fewer infections were observed in nine patients taking cranberry juice and in nine patients given water; no difference was noted in three. Liquid cranberry products, on a daily basis, at the dosage employed, did not have any effect greater than that of water in preventing urinary tract infections in this pediatric neuropathic bladder population. A randomised clinical study was carried out on patients admitted for ESWL treatment in order to establish the requirement for prophylactic treatment with antibiotics during this procedure. Patients with clinical signs of urinary tract infection, evidence of infectious stones or a positive urine culture were excluded. All other patients were consecutively randomised into 3 groups which were given either trimethoprim + sulphamethoxazole or mecillinam (Group A), methenamine hippurate (Group B), or no treatment at all (Group C). Evaluation with respect to clinical signs of infection was done immediately after the treatment and 4 weeks later. In addition, a urine culture was performed 2 weeks after ESWL, i.e. 1 week after completing treatment with antibiotics and methenamine hippurate. With respect to infectious complications there were no differences between Groups A and C, between Groups B and C or between Group A and B+C, whereas an unexplained slightly higher infectious rate was recorded for Group B compared with Group A. In all patients the occurrence of bacteriuria was low (6.7%) despite the fact that almost 30% of patients had a ureteric catheter during the ESWL procedure. Patients with ureteric catheters did not present with more infectious complications than those without. All patients had a bladder catheter during ESWL. It was concluded that prophylactic treatment with antibiotics during ESWL treatment is unnecessary in all situations where an infectious aetiology is unlikely. To determine the effectiveness of cranberry supplement at preventing urinary tract infections (UTIs) in persons with spinal cord injury (SCI).
                A prospective, double-blinded, placebo-controlled, crossover study.
                21 individuals with neurogenic bladders secondary to SCI.
                Favorable or unfavorable response of cranberry supplement vs placebo on urinary bacterial counts and white blood cell (WBC) counts and the combination of bacterial and WBC counts.
                Individuals with neurogenic bladders due to SCI were recruited and randomly assigned to standardized 400-mg cranberry tablets or placebo 3 times a day for 4 weeks. After 4 weeks and an additional 1-week "washout period," participants were crossed over to the other group. Participants were seen weekly, during which a urine analysis was obtained. UTI was defined as significant bacterial or yeast colony counts in the urine and elevated WBC counts (WBC count > or = 10 per high power field) in centrifuged urine. Participants with symptomatic infections were treated with appropriate antibiotics for 7 days and restarted on the cranberry tablet/ placebo after a 7-day washout period. Urinary pH between the cranberry and placebo groups was compared weekly. Data were analyzed using the Ezzet and Whitehead's random effect approach.
                There was no statistically significant treatment (favorable) effect for cranberry supplement beyond placebo when evaluating the 2 treatment groups for bacterial count, WBC count, or WBC and bacterial counts in combination. Urinary pH did not differ between the placebo and cranberry groups.
                Cranberry tablets were not found to be effective at changing urinary pH or reducing bacterial counts, urinary WBC counts, or UTIs in individuals with neurogenic bladders. Further long-term studies evaluating specific types of bladder management and UTIs will help to determine whether there is any role for the use of cranberries in individuals with neurogenic bladders. 290 patients with recurrent urinary tract infection were treated with either placebo, methenamine hippurate, nitrofurantoin or trimethoprim. 38.9% of the patients had chronic pyelonephritis and 23.8% azotemia. During the follow-up period of 1 year 63.2% recurred in the placebo group, 34.2% in the methenamine hippurate group, 25.0% in the nitrofurantoin group and 10.4% in the trimethoprim group. 62.5% of the recurrences in the trimethoprim group were associated with trimethoprim-resistant strains. However, such strains appeared only in 6.5% of the patients treated with trimethoprim, compared with 16.2% in the placebo, 8.3% in the nitrofurantoin and 11.0% in the methenamine hippurate groups. Side-effects were mild and occurred most frequently in the nitrofurantoin group (13.9%). Randomized, double blind, placebo-controlled trial with a crossover design.
                To evaluate cranberry tablets for the prevention of urinary tract infection (UTI) in spinal cord injured (SCI) patients.
                Spinal Cord Injury Unit of a Veterans Administration Hospital, MA, USA.
                Subjects with spinal cord injury and documentation of neurogenic bladder were randomized to receive 6 months of cranberry extract tablet or placebo, followed by the alternate preparation for an additional 6 months. The primary outcome was the incidence of UTI.
                Forty-seven subjects completed the trial. We found a reduction in the likelihood of UTI and symptoms for any month while receiving the cranberry tablet (P<0.05 for all). During the cranberry period, 6 subjects had 7 UTI, compared with 16 subjects and 21 UTI in the placebo period (P<0.05 for both number of subjects and incidence). The frequency of UTI was reduced to 0.3 UTI per year vs 1.0 UTI per year while receiving placebo. Subjects with a glomerular filtration rate (GFR) greater than 75 ml min(-1) received the most benefit.
                Cranberry extract tablets should be considered for the prevention of UTI in SCI patients with neurogenic bladder. Patients with a high GFR may receive the most benefit.
                Spinal Cord Research Foundation, sponsored by the Paralyzed Veterans of America. One hundred and twenty women, aged between 18 and 90 years, with a history of at least four episodes of symptomatic urinary tract infection in the preceding 12 months, were randomized in an open, prospective study to prophylactic treatment with cefaclor 250 mg at bedtime or macrocrystalline nitrofurantoin 50 mg at bedtime for 12 months. Ninety-seven (49 taking cefaclor, 48 taking macrocrystalline nitrofurantoin) were assessed for efficacy; 80% of these were symptomatically improved and remained abacteriuric during the period of prophylaxis. Symptomatic attacks while patients were taking prophylaxis occurred at least five times less often than before prophylaxis had started. Seventy percent of the patients continued in an improved condition after having stopped prophylaxis. All 120 patients were assessed for adverse events; these were twice as frequent in patients taking macrocrystalline nitrofurantoin (20% vs. 10%), but only 11 patients (three taking cefaclor, eight taking macrocrystalline nitrofurantoin) withdrew from the study. Due to the small numbers of patients experiencing adverse events, these differences are not statistically significant. No significant changes in haematological or biochemical parameters were found during or after the end of the 12-month course. The 22 patients assessable for efficacy who had a non-obstructive radiological abnormality responded as well to prophylaxis as those with no detectable abnormality. Long-term, low-dose prophylaxis with a suitable antimicrobial agent is highly effective management for patients with recurrent urinary tract infections, and can appropriately be provided by the family doctor. Prophylaxis given for 1 year gives better results than when given for 6 months. We randomized 64 patients with a history of recurrent urinary tract infections among 3 regimens of long-term (1 year) prophylactic treatment: 20 were given 100 mg. trimethoprim at night, 25 received 1,000 mg. methenamine hippurate every 12 hours and 19 were asked to cleanse the perineum (especially the periurethral area) twice daily with povidone-iodine solution. The progress of patients in terms of urinary symptoms and/or bacteriuria, changes in periurethral flora, side effects, and hematological and biochemical profiles was followed at regular intervals. All treatments were effective in reducing the incidence of symptomatic attacks when compared to the 12 months immediately before therapy and there was little to choose between the individual regimens on this account. However, trimethoprim was tolerated better than were the other 2 treatment regimens. In the group given trimethoprim most of the breakthrough infections (71.4 per cent) that occurred were caused by trimethoprim-resistant organisms (usually Escherichia coli), while in the other 2 groups the incidence of trimethoprim-resistant organisms causing infection was low (2.7 per cent). Treatment with trimethoprim reduced significantly the periurethral colonization of Escherichia coli. The efficiency of nitrofurantoin and trimethoprim prophylaxis in preventing recurrent urinary tract infections (UTI) was compared by means of actuarial percentage recurrence-free curves in a randomized, double blind study in 130 children (126 girls, 4 boys) aged 1 to 14 years (mean 7.5). The children received the antibiotics for 6 months. Nitrofurantoin proved to be the most efficient prophylactic drug in patients with abnormal urography and/or reflux (n = 60) as evaluated by actuarial percentage recurrence-free analysis (p = 0.0025). However, no differences was found in patients without urinary tract abnormalities. Nitrofurantoin prophylaxis altered neither the pattern of resistance nor the bacteriological constellation, while patients receiving trimethoprim prophylaxis had 76% trimethoprim resistant bacteria during prophylaxis, compared with 8% before (p less than 0.0001) and 17% after (p less than 0.0001) prophylaxis. The percentage of recurrences due to E. coli (70-80%) was unaffected by trimethoprim prophylaxis, but the proportion due to trimethoprim resistant E. coli was significantly higher during prophylaxis (65%) than before (6%, p less than 0.0001) and after (11%, p less than 0.001). The percentage of Staphylococcus epidermidis UTI was significantly higher during trimethoprim prophylaxis (27%) than before (2%, p less than 0.0003). Following prophylaxis there was no difference in the actuarial percentage recurrence-free curves of the two regimens. Side effects occurred more frequently in the nitrofurantoin group (37%) than in the trimethoprim group (21%) (p = 0.05). The majority of side effects in the nitrofurantoin group derived from gastrointestinal symptoms. In conclusion, nitrofurantoin is recommended as the first choice prophylactic treatment of children with recurrent UTI and urinary tract abnormalities.
Methenamine hippurate may be effective for preventing UTI in patients without renal tract abnormalities, particularly when used for short-term prophylaxis. It does not appear to work in patients with neuropathic bladder or in patients who have renal tract abnormalities. The rate of adverse events was low, but poorly described.
There is a need for further large well-conducted RCTs to clarify this question, particularly for longer term use for people without neuropathic bladder.