Protocol for a randomized clinical trial investigating early sacral nerve stimulation as an adjunct to standard neurogenic bladder management following acute spinal cord injury.

BACKGROUND: Neurogenic bladder (NGB) dysfunction after spinal cord injury (SCI) is generally irreversible. Preliminary animal and human studies have suggested that initiation of sacral neuromodulation (SNM) immediately following SCI can prevent neurogenic detrusor overactivity and preserve bladder capacity and compliance. We designed a multicenter randomized clinical trial to evaluate the effectiveness of early SNM after acute SCI. METHODS/DESIGN: The scientific protocol comprises a multi-site, randomized, non-blinded clinical trial. Sixty acute, acquired SCI patients (30 per arm) will be randomized within 12 weeks of injury. All participants will receive standard care for NGB including anticholinergic medications and usual bladder management strategies. Those randomized to intervention will undergo surgical implantation of the Medtronic PrimeAdvanced Surescan 97,702 Neurostimulator with bilateral tined leads along the S3 nerve root in a single-stage procedure. All patients will undergo fluoroscopic urodynamic testing at study enrollment, 3 months, and 1-year post randomization. The primary outcome will be changes in urodynamic maximum cystometric capacity at 1-year. After accounting for a 15% loss to follow-up, we expect 25 evaluable patients per arm (50 total), which will allow detection of a 38% treatment effect. This corresponds to an 84 mL difference in bladder capacity (80% power at a 5% significance level). Additional parameters will be assessed every 3 months with validated SCI-Quality of Life questionnaires and 3-day voiding diaries with pad-weight testing. Quantified secondary outcomes include: patient reported QoL, number of daily catheterizations, incontinence episodes, average catheterization volume, detrusor compliance, presence of urodynamic detrusor overactivity and important clinical outcomes including: hospitalizations, number of symptomatic urinary tract infections, need for further interventions, and bowel and erectile function. DISCUSSION: This research protocol is multi-centered, drawing participants from large referral centers for SCI and has the potential to increase options for bladder management after SCI and add to our knowledge about neuroplasticity in the acute SCI patient. TRIAL REGISTRATION: ClinicalTrials.gov # NCT03083366 1/27/2017.

Systematic review and practice policy statements on urinary tract infection prevention in adults with spina bifida.

Urinary tract infection (UTI) is a source of morbidity and healthcare costs in adults with spina bifida (ASB). UTI prevention strategies are often recommended, but the evidence of various approaches remains unclear. We performed a systematic review to inform a best practice policy statement for UTI prevention in ASB. On behalf of the Neurogenic Bladder Research Group (NBRG.org), we developed an a priori protocol and searched the published English literature for 30 outcomes questions addressing UTI prevention in ASB. The questions spanned the categories of antibiotics, oral supplements, bladder management factors and social support. Where there was little literature in ASB, we included literature from similar populations with neurogenic bladder (NB). Data was abstracted and then reviewed with recommendations made by consensus of all authors. Level of Evidence (LoE) and Grade of Recommendation (GoR) were according to the Oxford grading system. Of 6,433 articles identified by our search, we included 99 publications. There was sufficient evidence to support use of the following: saline bladder irrigation (LoE 1, GoR B), gentamicin bladder instillation (LoE 3, GoR C), single-use intermittent catheterization (IC) (LoE 2, GoR B), hydrophilic catheters for IC (LoE 2, GoR C), intradetrusor onabotulinumtoxinA injection (LoE 3, GoR C), hyaluronic acid (HA) instillation (LoE 1, GoR B), and care coordination (LoE 3, GoR C). There was sufficient evidence to recommend against use of the following: sterile IC (LoE 1, GoR B), oral antibiotic prophylaxis (LoE 2, GoR B), treatment of asymptomatic bacteriuria (LoE 2, GoR B), cranberry (LoE 2, GoR B), methenamine salts (LoE 1, GoR B), and ascorbic acid (LoE1, GoR B). There was insufficient evidence to make a recommendation for other outcomes. Overall, there are few studies in UTI prevention in the specific population of ASB. Research in populations similar to ASB helps to guide recommendations for UTI prevention in the challenging patient group of ASB. Future studies in UTI prevention specific to ASB are needed and should focus on areas shown to be of benefit in similar populations.

Medical and surgical management of neurogenic bowel.

PURPOSE OF REVIEW: Neurogenic bowel dysfunction (NBoD) commonly affects patients with spina bifida, cerebral palsy, and spinal cord injury among other neurologic insults. NBoD is a significant source of physical and psychosocial morbidity. Treating NBoD requires a diligent relationship between patient, caretaker, and provider in establishing and maintaining a successful bowel program. A well designed bowel program allows for regular, predictable bowel movements and prevents episodes of fecal incontinence. RECENT FINDINGS: Treatment options for NBoD span conservative lifestyle changes to fecal diversion depending on the nature of the dysfunction. Lifestyle changes and oral laxatives are effective for many patients. Patients requiring more advanced therapy progress to transanal irrigation devices and retrograde enemas. Those receiving enemas may opt for antegrade enema administration via a Malone antegrade continence enema or Chait cecostomy button, which are increasingly performed in a minimally invasive fashion. Select patients benefit from fecal diversion, which simplifies care in more severe cases. SUMMARY: Many medical and surgical options are available for patients with NBoD. Selecting the appropriate medical or surgical treatment involves a careful evaluation of each patient's physical, psychosocial, financial, and geographic variables in an effort to optimize bowel function.

Use of Medical Therapy and Success of Laser Surgery and Transurethral Resection of the Prostate for Benign Prostatic Hyperplasia.

OBJECTIVE: To assess the impact of surgery for benign prostatic hyperplasia (BPH) on use of medication (5-alpha reductase inhibitors, alpha blockers, antispasmodics), we assessed preoperative and postoperative medication utilization among surgically treated men. PATIENTS AND METHODS: Using the Truven Health Analytics MarketScan Commercial Claims Database, we defined a cohort of men aged <65 years who had surgical therapy for BPH with either transurethral resection of the prostate (TURP) or laser procedures from 2007 through 2009. Primary outcomes included freedom from medical or surgical intervention by 4 months after surgery (chi-square and multivariable logistic regression) and subsequent use of medical or surgical intervention in initial responders (Kaplan-Meier and multivariable Cox regression). RESULTS: We identified 6430 patients treated with either TURP (3096) or laser procedure (3334) for BPH. Presurgical antispasmodic use was associated with the highest risk of medication use at 4 months after surgery (odds ratio, 5.19; 95% confidence interval (CI), 3.16-8.53 vs no medication use before surgery). At 3 years after surgery, 6% (95% CI, 4%-8%) of laser-treated and 4% (95% CI, 2%-5%) of TURP-treated patients had repeat surgical intervention, and both laser- and TURP-treated patients had an estimated new use of medication rate of 22% (95% CI, 18%-25% laser and 20%-25% TURP). The strongest predictor of intervention after surgery was preoperative antispasmodic use (hazard ratio, 2.49; 95% CI, 1.41-4.43). CONCLUSION: Our results show a need for effective patient counseling about continued or new use of medical therapy after laser and TURP procedures. However, most patients experience durable improvement after surgical intervention for BPH.

Short-term outcomes of Chait Trapdoor for antegrade continence enema in adults.

OBJECTIVE: To examine our short-term experience of antegrade continence enema (ACE) delivered via a Chait Trapdoor (Cook Medical, Bloomington, IN) in adults with intractable neurogenic bowel. METHODS: We performed a retrospective review at the Universities of Utah and Minnesota of 15 patients with Chait Trapdoor placed for the purpose of ACE from 2011 to 2013. Our primary outcome was continued utilization of the Chait Trapdoor. Secondary outcomes included volume of ACE used and time to produce a bowel movement. RESULTS: All patients had neurogenic bowel refractory to conventional bowel regimen. Mean follow-up was 6 months (range, 1-17 months). Thirteen patients had the Chait Trapdoor placed in the splenic flexure and 2 had it placed in the cecum. Of the 15 patients, 12 (80%) were still using the Chait Trapdoor at last follow-up. A median of 425 mL (range, 120-1000 mL) of fluid was used to produce a bowel movement in 5-120 minutes. Two patients developed postoperative wound infections, requiring return to the operating room (Clavien IIIb). Long-term complications included 5 patients with a dislodged tube requiring replacement by interventional radiology and 2 patients with local cellulitis. Two patients had the Chait Trapdoor moved to a new location to improve efficacy. CONCLUSION: Although the revision, removal, and complication rates were high, 80% of the patients were satisfied with the function and continued to use the Chait Trapdoor. The volume of irrigation required for ACE and the time it takes to produce a bowel movement vary significantly between patients.

Challenges in the management of infections due to carbapenem-resistant Enterobacteriaceae.

Carbapenem-resistant Enterobacteriaceae (CRE) infections are increasing and are associated with considerable morbidity and mortality. Members of the Emerging Infections Network treating CRE encountered difficulties in obtaining laboratory results and struggled with limited treatment options. In addition, many treated patients experienced an alarming degree of drug toxicity from CRE therapies.

Microwave thermotherapy for benign prostatic hyperplasia.

BACKGROUND: Transurethral resection of the prostate (TURP) has been the gold-standard treatment for alleviating urinary symptoms and improving urinary flow in men with symptomatic benign prostatic hyperplasia (BPH). However, the morbidity of TURP approaches 20%, and less invasive techniques have been developed for treating BPH. Preliminary data suggest that microwave thermotherapy, which delivers microwave energy to produce coagulation necrosis in prostatic tissue, is a safe, effective treatment for BPH. OBJECTIVES: To assess the therapeutic efficacy and safety of microwave thermotherapy techniques for treating men with symptomatic benign prostatic obstruction. SEARCH METHODS: Randomized controlled trials were identified from The Cochrane Library, MEDLINE, EMBASE, bibliographies of retrieved articles, reviews, technical reports, and by contacting relevant expert trialists and microwave manufacturers. SELECTION CRITERIA: All randomized controlled trials evaluating transurethral microwave thermotherapy (TUMT) for men with symptomatic BPH were eligible for this review. Comparison groups could include transurethral resection of the prostate, minimally invasive prostatectomy techniques, sham thermotherapy procedures, and medications. Outcome measures included urinary symptoms, urinary function, prostate volume, mortality, morbidity, and retreatment. Two review authors independently identified potentially relevant abstracts and then assessed the full papers for inclusion. DATA COLLECTION AND ANALYSIS: Two review authors independently abstracted study design, baseline characteristics, and outcomes data and assessed methodological quality using a standard form. We attempted to obtain missing data from authors or sponsors, or both. MAIN RESULTS: In this update, we identified no new randomized comparisons of TUMT that provided evaluable effectiveness data. Fifteen studies involving 1585 patients met the inclusion criteria, including six comparisons of microwave thermotherapy with TURP, eight comparisons with sham thermotherapy procedures, and one comparison with an alpha-blocker. Study durations ranged from 3 to 60 months. The mean age of participants was 66.8 years and the baseline symptom scores and urinary flow rates, which did not differ across treatment groups, demonstrated moderately severe lower urinary tract symptoms. The pooled mean urinary symptom scores decreased by 65% with TUMT and by 77% with TURP. The weighted mean difference (WMD) with 95% confidence interval (CI) for the International Prostate Symptom Score (IPSS) was -1.00 (95% CI -2.03 to -0.03), favoring TURP. The pooled mean peak urinary flow increased by 70% with TUMT and by 119% with TURP. The WMD for peak urinary flow was 5.08 mL/s (95% CI 3.88 to 6.28 mL/s), favoring TURP. Compared to TURP, TUMT was associated with decreased risks for retrograde ejaculation, treatment for strictures, hematuria, blood transfusions, and the transurethral resection syndrome, but increased risks for dysuria, urinary retention, and retreatment for BPH symptoms. Microwave thermotherapy improved IPSS symptom scores (WMD -5.15, 95% CI -4.26 to -6.04) and peak urinary flow (WMD 2.01 mL/s, 95% CI 0.85 to 3.16) compared with sham procedures. Microwave thermotherapy also improved IPSS symptom scores (WMD -4.20, 95% CI -3.15 to -5.25) and peak urinary flow (WMD 2.30 mL/s, 95% CI 1.47 to 3.13) in the one comparison with alpha-blockers. No studies evaluated the effects of symptom duration, patient characteristics, prostate-specific antigen levels, or prostate volume on treatment response. AUTHORS' CONCLUSIONS: Microwave thermotherapy techniques are effective alternatives to TURP and alpha-blockers for treating symptomatic BPH in men with no history of urinary retention or previous prostate procedures and prostate volumes between 30 to 100 mL. However, TURP provided greater symptom score and urinary flow improvements and reduced the need for subsequent BPH treatments compared to TUMT. Small sample sizes and differences in study design limit comparisons between devices with different designs and energy levels. The effects of symptom duration, patient characteristics, or prostate volume on treatment response are unknown.

National trends in surgical therapy for benign prostatic hyperplasia in the United States (2000-2008).

OBJECTIVE: To report an update of the change in usage trends for different surgical treatments of benign prostatic hyperplasia (BPH) among the United States Medicare population data from 2000-2008. The rate of usage of thermotherapy and laser therapy in the surgical treatment of BPH has been changing over the past decade in conjunction with a steady decrease of transurethral resection of the prostate (TURP). METHODS: Using the 100% Medicare carrier file for the years 2000-2008, we calculated counts and population-adjusted rates of BPH surgery. Rates of TURP, thermotherapy, and laser-using modalities were calculated and compared in relation to age, race, clinical setting, and reimbursement. RESULTS: After years of a steady rise, the total rate of all BPH procedures peaked in 2005 at 1078/100,000 and then declined by 15.4% to 912/100,000 in 2008. TURP rates continued to decline from 670 in 2000 to 351/100,000 in 2008. Rates of microwave thermoablation peaked in 2006 at 266/100,000 and then declined 26% in 2008. Laser vaporization almost completely replaced laser coagulation and in 2008 was the most commonly performed procedure second to TURP, with the majority performed as outpatient procedures (70%) and an increasing percentage in the office (12%). Men between ages 70 and 75 had the highest rate of procedures. Reimbursement rates correlate using some but not all procedures. Racial disparities reported previously appear to have resolved. CONCLUSION: Surgical treatment of BPH continues to change rapidly. TURP continues to decline and laser vaporization is the fastest growing modality. There is a big shift toward outpatient/office procedures. Reimbursement rates do not appear to have a consistent effect on usage.

Practice patterns in benign prostatic hyperplasia surgical therapy: the dramatic increase in minimally invasive technologies.

PURPOSE: We describe the trends in transurethral prostatectomy and minimally invasive surgical treatments for benign prostate hyperplasia from 1999 through 2005 among elderly male Medicare beneficiaries. MATERIALS AND METHODS: Benign prostatic hyperplasia surgeries were identified using the annual 100% Medicare carrier files which contain physician claims for services reimbursed under Medicare Part B. The annual age group specific procedure rates as well as the age adjusted rates by race and percent of each procedure performed in different clinical settings were calculated. RESULTS: The total number of benign prostatic hyperplasia procedures increased 44% from 88,868 in 1999 to 127,786 in 2005. The minimally invasive surgical treatment procedure counts increased 529% from 11,582 to 72,887 and the rates increased 439% from 136 to 678 per 100,000 males during that period. The transurethral prostate resection rate decreased approximately 5% per year. By 2005 minimally invasive surgical treatment procedures accounted for 57% of total benign prostatic hyperplasia surgeries, while transurethral prostate resection accounted for only 39%. Almost all transurethral microwave thermotherapy, 86% of transurethral needle ablation and 54% of laser coagulation procedures were performed in office clinics, and 78% of laser vaporization procedures were performed in hospital outpatient clinics. Black beneficiaries were 17% less likely to receive minimally invasive surgical treatment than whites in 2005. CONCLUSIONS: The increase of total benign prostatic hyperplasia procedure rate was driven by a marked increase in minimally invasive surgical treatment and a continuing decrease of transurethral prostate resection. Differences in the use of minimally invasive surgical treatment across age and racial groups persisted. This dramatic change in the pattern of benign prostatic hyperplasia surgical treatment may have a profound impact on health care expenditures and outcomes, and requires further investigation.