Multicenter randomized controlled trial of bacterial interference for prevention of urinary tract infection in patients with neurogenic bladder.

OBJECTIVES: To compare the effectiveness of bacterial interference versus placebo in preventing urinary tract infection (UTI). METHODS: The main outcome measure was the numbers of episodes of UTI/patient-year. Randomization was computer generated, with allocation concealment by visibly indistinguishable products distributed from a core facility. The healthcare providers and those assessing the outcomes were unaware of the group allocation. Adult patients (n = 65) with neurogenic bladder after spinal cord injury and a history of recurrent UTI were randomized in a 3:1 ratio to receive either Escherichia coli HU2117 or sterile saline. Urine cultures were obtained weekly during the first month and then monthly for 1 year. The patients were evaluable if they remained colonized with E. coli HU2117 for >4 weeks (experimental group). The trial is closed to follow-up. RESULTS: Of the 59 patients who received bladder inoculations, 27 were evaluable (17 in the experimental group and 10 in the placebo group). The 2 study groups had comparable clinical characteristics. Of 17 patients colonized with E. coli HU2117 and the 10 control patients, 5 (29%, 95% confidence interval 0.11-0.56) and 7 (70%, 95% confidence interval 0.35-0.92) developed >1 episode of UTI (P = .049; 1-sided Fisher's exact test), respectively. The average number of episodes of UTI/patient-year was also lower (P = .02, Wilcoxon rank sum test) in the experimental (0.50) than in the control group (1.68). E. coli HU2117 did not cause symptomatic UTI. CONCLUSIONS: Bladder colonization with E. coli HU2117 safely reduces the risk of symptomatic UTI in patients with spinal cord injury. Effective, but less complex, methods for achieving bladder colonization with E. coli HU2117 are under investigation.

Puboprostatic sling repair for treatment of urethral incompetence in adult neurogenic incontinence.

PURPOSE: An incompetent urethral sphincter can be a significant factor contributing to urinary incontinence in patients with neurogenic bladders. We review our experience with 12 men who underwent a puboprostatic sling. MATERIALS AND METHODS: The study included 12 men (mean age 37.1 years) with neurogenic bladder due to spinal cord injury in 9 and spina bifida in 3. All patients were diagnosed with urethral incompetence based on fluorourodynamic evaluation. Medical therapy failed in all 12 patients and all complained of urine leakage with activity. All patients underwent placement of an autologous fascial sling distal to the prostatic urethra via an abdominal approach. Ten patients also underwent simultaneous bladder augmentation to correct high intravesical pressures. RESULTS: Followup ranged from 1 to 39 months (average 14.25). All patients manage the bladder with intermittent catheterization. Of the patients 8 are completely dry between catheterizations and 2 had significant improvement with only minimal leakage (1 pad per day), with an overall success rate of 83%. One patient improved initially but subsequently underwent placement of an artificial urinary sphincter for residual stress incontinence. In 1 patient several external sphincterotomies failed despite adequate sling placement. There were no complications related to the placement of the sling and all patients are able to perform intermittent catheterization without difficulty. CONCLUSIONS: In select male patients the puboprostatic sling can be an effective and safe method to treat urethral incompetence secondary to neurogenic voiding dysfunction.

Clinical assessment of sildenafil in the treatment of neurogenic male sexual dysfunction: After the hype.

Objective: To evaluate the efficacy and safety of sildenafil over a two-year period in patients with erectile dysfunction caused by spinal cord injury and multiple sclerosis in a clinical practice following FDA approval and release of the medication to the general healthcare community. Study design: 40 patients including 33 SCI (13 quadriplegics, 20 paraplegics; 14 complete, 19 incomplete) and 7 MS patients were prescribed sildenafil in varying dosages. The patients were asked to return to the clinic for additional prescriptions so that we could assess their clinical response and their incidence of side effects. They were then followed for a period of up to two years either by follow up clinic visits or telephone interviews to determine whether they continued to use sildenafil as an ongoing solution to their erectile dysfunction. Results: Mean erectile response went from 4.9 to 7.8 (scale 1--10). Non-responders went from 9 to 4. 36 of the 40 were able to achieve erections sufficient for sexual intercourse. At the 2-year interval 13 of the 40 were no longer using sildenafil but only six discontinued due to lack of response. Adverse effects were minimal and mimicked those seen in the able-bodied studies. Conclusion: Sildenafil is a safe and effective first line treatment for the treatment of male neurogenic erectile dysfunction. However close clinical surveillance is necessary so that patients can avail themselves of other options should sildenafil not be effective.