Factors associated with symptomatic urinary tract infection in persons with spinal cord lesions who perform clean intermittent catheterization with single-use catheters.

OBJECTIVES: To investigate factors associated with symptomatic urinary tract infection (sUTI) in persons with chronic spinal cord lesion (SCL) who were using single-use catheters for intermittent self-catheterization (ISC). METHODS: Among respondents to an internet survey on the burden of illness on persons with SCL who were considered to be able to perform ISC, 111 persons using single-use catheters were included to examine factors associated with self-reported sUTI by univariate as well as multivariable analysis. RESULTS: The incidence of sUTI was significantly higher in males than in females (56.9% vs. 31.6%, p = .011), persons with stocks of antibiotics than those without it (82.9% vs. 28.6%, p < .011), and persons with more frequent bleeding during catheterization than those with less frequent bleeding (100% vs. 46.5%, p = .036). The incidence did not significantly differ between respective groups when various variables were evaluated by other characteristics of the participants, adherence to ISC procedures, and complications. On multivariable analysis, male gender and stocks of antibiotics were significant independent factors for sUTI. CONCLUSIONS: Male gender and stocks of antibiotics were associated with sUTI in persons with SCL who were performing ISC with single-use catheters.

Hygiene management of intermittent self-catheterization using reusable silicone catheters in people with spinal cord lesions: A cross-sectional Internet survey in Japan.

OBJECTIVES: To investigate hygiene management and catheter maintenance of reusable silicone catheters for intermittent self-catheterization (ISC) in Japan and examine their relationship with symptomatic urinary tract infection (sUTI). METHODS: We conducted a cross-sectional Internet survey of people performing ISC using reusable silicone catheters owing to spinal cord lesions in Japan. Hygiene management and catheter maintenance of reusable silicone catheters and the incidence and frequency of sUTI were evaluated. We also examined the significant risk factors for sUTI. RESULTS: Of 136 respondents, 62 (46%), 41 (30%), and 58 (43%) washed hands with water, washed hands with soap, and cleaned or disinfected the urethral meatus every time or most of the time before ISC, respectively. No significant difference was observed in the incidence and frequency of sUTI between respondents who adhered to these procedures and those who did not. There were no significant differences in the incidence and frequency of sUTI in respondents who changed their catheters every month and in those who changed their preservation solution within 2 days compared with those who did not. In multivariate analysis, pain during ISC, inconvenience of indoor mobility, bowel management problems, and participants' feeling of never having received instruction on catheter replacement were significant risk factors for sUTI. CONCLUSIONS: There are individual differences in hygiene management and catheter maintenance of reusable silicone catheters, but the influence of these differences on the incidence and frequency of sUTI is not clear. Pain during ISC, bowel management problems, and inadequate instruction on catheter maintenance procedures are factors associated with sUTI.

Cross-sectional internet survey exploring symptomatic urinary tract infection by type of urinary catheter in persons with spinal cord lesion in Japan.

STUDY DESIGN: Cross-sectional study by members of patient advocacy groups. OBJECTIVES: To evaluate the incidence and frequency of symptomatic urinary tract infection (sUTI) in persons with spinal cord lesion (SCL) using different types of catheters based on an internet survey in Japan. SETTING: An internet survey. METHODS: We conducted an Internet survey of persons with SCL who were considered to be able to perform intermittent self-catheterization (ISC). We evaluated the incidence and frequency of sUTI over the last year in persons performing ISC and those managed by indwelling catheterization (IDC). We also compared the same parameters between persons in the ISC group using reusable silicone catheters and single-use catheters and those with and without a concomitant use of intermittent balloon catheters (i-IDC). RESULTS: Two-hundred and eighty-two persons were analyzed. In the ISC and IDC groups, sUTI occurred in 52.2% and 31.4% of persons (p = 0.021), respectively, in the last year, and the frequencies were 2.8 and 3.5 times a year (p = 0.127), respectively. There were no significant differences in the incidence or frequency of sUTI between persons using reusable catheters and single-use catheters or those with and without the concomitant use of i-IDC. CONCLUSIONS: sUTI occurred in about 1 in 2 persons with SCL performing ISC, which was significantly higher than in the IDC group, and the frequency of sUTI in persons performing ISC was about 3 times a year. The different types of catheters used for ISC were not associated with the incidence or frequency of sUTI. Sponsorship Coloplast Japan Inc.

[DEVELOPMENT OF JAPANESE TRANSLATION OF THE NEUROGENIC BLADDER SYMPTOM SCORE].

(Objectives) To develop Japanese translations of the standard and short forms of the Neurogenic Bladder Symptom Score (Subjects and methods) The questionnaires were forward translated by a Japanese healthcare professional and non-medical professional and backward translated by two native English-speaking translators. Then, the products were harmonized by the participants involved in the translational processes. Finally, 15 persons with spinal cord lesions were interviewed to improve the provisional Japanese translations based on their suggestions. (Results) Throughout the forward and backward translations and their harmonization, no major translational problems were encountered, other than those attributable to differences in syntax between English and Japanese. The persons could complete the provisional Japanese translations of the standard and short forms in median 7.0 and 3.0 minutes, respectively. Although none of them reported difficulty in answering the questions, 6, 3, and 5 persons pointed out that the tenth question (the seventh question in the short form) and the answers to the nineteenth and twenty-second questions, respectively, were not easy to understand. Taking their suggestions into consideration, we finalized the Japanese translations with the help of a developer of the questionnaire as well as the back-translators. (Conclusions) After a multi-step review process, linguistically valid Japanese translations of the standard and short forms of the Neurogenic Bladder Symptom Score (Neurogenic Bladder Symptom Score Japanese version 1.0) were completed. We hope that these Japanese translations will facilitate future research on patient-reported outcomes in persons with neurogenic lower urinary tract dysfunction.

The impact of the coronavirus disease 2019 pandemic on changes in antimicrobial prophylaxis and development of genito-urinary tract infections after urodynamic study: A retrospective comparative study of a single rehabilitation hospital in Japan.

AIMS: To investigate the changes in the proportion of antimicrobial prophylaxis (AP) during the urodynamic study (UDS) and the frequency of posttest genito-urinary tract infections (GUTI) before and after coronavirus disease 2019 (COVID-19) pandemic, and evaluate this associations. PATIENTS AND METHODS: Patients who underwent UDS between 2015 and 2021 were targeted, and they were allocated to pre-2020 as before the appearance of COVID-19 and post-2020 as after that, and propensity score matching was performed. The impact on AP was assessed by the administration rate, and that on the development of febrile GUTI after UDS was assessed for an equivalence by the GUTI-free rate at 7 days after testing. RESULTS: After matching, 384 cases of 192 cases each were included. The frequency of AP was 58.3% in pre-2020 and 77.1% in post-2020, an increase of about 19%, and the rate increased significantly in post-2020 (p < 0.001). However, the incidence of GUTI after UDS was 4.2% and 4.7%, respectively, with no significant difference. The ratio of GUTI-free rates was within the equivalence margin, confirming an equivalence before and after the appearance of COVID-19. CONCLUSIONS: Under the influence of COVID-19 pandemic, even though AP rate during UDS was increased by 19% from that brought by following the guideline-based administration methods, the frequency of GUTI after UDS was similar, so it is thought to be important to use AP during UDS appropriately for high-risk cases as recommended in the guidelines.

Retrospective Observational Study of Risk Factors for Febrile Infectious Complications after Urodynamic Studies in Patients with Suspected Neurogenic Lower Urinary Tract Disturbance.

INTRODUCTION: We retrospectively investigated the risk factors for post-urodynamic study (UDS) infectious complications in long-term hospitalized inpatients with suspected neurogenic lower urinary tract disturbance (NLUTD) in a monocenter study, to accurately assess post-UDS urinary tract infections (UTI). METHODS: We retrospectively analyzed data including background information, UDS-related data, and potential risk factors for infection from 489 NLUTD-suspected inpatients who underwent UDS from 2015 to 2019 and examined the risk factors for post-UDS infectious complications using univariate and multivariate statistical analyses. RESULTS: Symptomatic post-UDS UTI occurred in 20 out of 489 (4.1%) patients, including 3 (15%) with recurrent UTI. During follow-up prior to UDS for 1 year, 220 cases were investigated by urine culture revealing Escherichia coli (n = 77), Klebsiella pneumoniae (n = 29), Enterococcus faecalis (n = 18), extended-spectrum beta-lactamase-producing E. coli (n = 17), and Pseudomonas aeruginosa (n = 9). As risk factors for post-UDS infectious complications, American Spinal Injury Association impairment scale (AIS): AIS ≧ C (A or B or C) (hazard ratio: 4.29, p = 0.0076), management method of urination (hazard ratio: 4.30, p = 0.048), and age (hazard ratio: 1.04, p = 0.025) were significantly correlated with the occurrence of post-UDS infection. CONCLUSIONS: The significant risk factors for post-UDS UTI were AIS ≧ C, management method of urination, and age in the suspected NLUTD patient context. This study was originally started with the goal of reducing unnecessary antibiotics and may contribute to the proper use of antibiotics based on antimicrobial stewardship.

Comparison between antimicrobial stewardship program and intervention by infection control team for managing antibiotic use in neurogenic bladder-related urinary tract infection patients: A retrospective chart audit.

BACKGROUND: Antimicrobial prescriptions are relatively common in urologic outpatients. Therefore, it is necessary to investigate the impact of antimicrobial stewardship program (ASP) interventions. METHODS: In urology outpatients, antimicrobial use density (AUD), antimicrobial agent costs, isolation of urinary tract infection (UTI)-causing organisms and their antimicrobial susceptibilities were compared between intervention by infection control team (ICT) era (pre-2014) and ASP era (post-2014) in 2739 patients with lower urinary tract symptoms, including neurogenic bladder patients with UTI or suspected UTI, from 2011 to 2020. RESULTS: In the ASP, overall AUD (P<.001), cefotiam (CTM) (P=.0013), 2nd-generation cephalosporins (P=.026), cefdinir (CFDN) (P<.001), levofloxacin (LVFX) (P<.001), sitafloxacin (STFX) (P=.0016), and tosufloxacin (TFLX) (P=.0044) showed a significant decrease, but cefaclor (P=.019) showed a significant increase. Regarding antimicrobial agent costs, overall (P=.016), CTM (P=.021), 2nd-generation cephalosporins (P=.033), CFDN (P=.016), LVFX (P=.016), STFX (P=.033), and TFLX (P=.033) showed a significant decrease in the ASP. UTI-causing antimicrobial susceptibilities, CTM (P=.035), LVFX (P=.026) and sulfamethoxazole/trimethoprim (P=.048) in E. coli, and minocycline (P=.026) in K. pneumoniae showed a significant improve in the ASP. CONCLUSION: ASP contributed to decrease AUD and antimicrobial agent costs, and to improve antimicrobial susceptibilities of E. coli and K. pneumoniae to several antibiotics, compared to ICT. Further prospective studies are necessary for definitive conclusions.

The 1-year continuation rate and discontinuation factors of vibegron and mirabegron: A retrospective comparative study in a rehabilitation hospital in Japan.

OBJECTIVES: To compare the 1-year continuation rate and discontinuation factors between vibegron and mirabegron in patients with neurogenic and nonneurogenic overactive bladder. METHODS: Continuation or discontinuation of the target drugs and reasons for discontinuation as well as patients' grounds and adverse effects were evaluated retrospectively from the medical records between September 2018 and December 2020. After selecting patients according to the inclusion and exclusion criteria, 180 cases taking mirabegron and 132 taking vibegron were adjusted for intergroup variability by propensity score matching. We performed Cox proportional hazards regression for the 1-year continuation rate and Fine-Gray proportional hazards regression for the 1-year cumulative incidence of discontinuation events. Subgroup analysis was also performed for the background factors related to the 1-year continuation rate. RESULTS: The 1-year continuation rate was 83.8% for vibegron and 58.2% for mirabegron, and the hazard ratio was 0.32 (95% CI: 0.18-0.57, P < .001) as for an incidence of discontinuation events of vibegron against mirabegron. The incidence of discontinuation due to an inadequate efficacy was 8.7% for vibegron and 29.1% for mirabegron, and similarly the hazard ratio was 0.26 (95% CI: 0.12-0.55, P < .001). The subgroup analysis indicated a similar tendency in each subgroup except for that of catheterization, and there was no significant interaction between the groups. CONCLUSIONS: It is suggested that vibegron is superior to mirabegron in the continuity of administration in neurogenic and nonneurogenic overactive bladder populations without catheterization with fewer discontinuations due to inadequate efficacy.

Validation of the Monitoring Efficacy of Neurogenic Bowel Treatment on Response (MENTOR) Tool in a Japanese Rehabilitation Setting.

STUDY DESIGN: Prospective observational study. OBJECTIVE: To validate the Monitoring Efficacy of NBD Treatment On Response (MENTOR) tool in individuals with a spinal cord injury (SCI) or spina bifida, suffering from neurogenic bowel dysfunction (NBD) in a rehabilitation center in Japan. METHODS: First, the MENTOR tool was translated from English to Japanese using a validated translation process. Second, the MENTOR tool was validated in a rehabilitation clinic in Japan. Participants completed the MENTOR tool prior to a consultation with an expert physician. According to the results of the tool, each participant was allocated to one of three categories regarding change in treatment: "adequately treated," "further discussion," and "recommended change." The results of the MENTOR tool were compared with the treatment decision made by an expert physician, who was blinded to the results of the MENTOR tool. RESULTS: A total of 60 participants completed the MENTOR tool. There was an acceptable concordance between individuals allocated as respectively, being adequately treated (100%) and recommended change in treatment (61%) and the physicians' decision on treatment. The concordance was lower for individuals allocated as requiring further discussion (48%). CONCLUSIONS: In this study the MENTOR tool was successfully validated in a Japanese rehab setting. The tool will help identify individuals with SCI that need further treatment of their NBD symptoms.

Clinical guidelines for the diagnosis and treatment of lower urinary tract dysfunction in patients with spinal cord injury.

The present article is an abridged English translation of the Japanese clinical guidelines for the diagnosis and treatment of lower urinary tract dysfunction in patients with spinal cord injury updated as of July 2019. The patients are adult spinal cord injured patients with lower urinary tract dysfunction; special consideration of pediatric and elderly populations is presented separately. The target audience is healthcare providers who are engaged in the medical care of patients with spinal cord injury. The mandatory assessment includes medical history, physical examination, frequency-volume chart, urinalysis, blood chemistry, transabdominal ultrasonography, measurement of post-void residual urine, uroflowmetry and video-urodynamic study. Optional assessments include questionnaires on the quality of life, renal scintigraphy and cystourethroscopy. The presence or absence of risk factors for renal damage and symptomatic urinary tract infection affects urinary management, as well as pharmacological treatments. Further treatment is recommended if the maximum conservative treatment fails to improve or prevent renal damage and symptomatic urinary tract infection. In addition, management of urinary incontinence should be considered individually in patients with risk factors for urinary incontinence and decreased quality of life.

Risk factors for febrile genito-urinary infection in the catheterized patients by with spinal cord injury-associated chronic neurogenic lower urinary tract dysfunction evaluated by urodynamic study and cystography: a retrospective study.

INTRODUCTION: To investigate the risk factors for febrile genito-urinary tract infection (GUTI) in spinal cord injury-associated neurogenic lower urinary tract dysfunction (NLUTD) patients who perform routine clean intermittent catheterization (CIC) evaluated by urodynamic study (UDS) and cystography. PATIENTS AND METHODS: Over a 3-year period, we retrospectively assessed risk factors for febrile UTI in 141 spinal cord injury patients diagnosed as NLUTD and performing routine CIC, regarding gender, UDS findings such as bladder compliance, maximum cystometric capacity, and cystography. RESULTS: A total of 41 patients had febrile GUTI in the follow-up period as along with 32 cases of pyelonephritis, 10 cases of epididymitis, and 1 case of prostatitis, including patients with multiple infectious diseases. The causative bacteria were Escherichia coli (14 cases) followed by Pseudomonas aeruginosa (n = 5), Klebsiella pneumoniae (n = 4), and Klebsiella oxytoca (n = 4). Antibiotic-resistant E. coli were seen, with 36.4% instances of extended-spectrum beta-lactamase production in whole of E. coli. Male gender (p = 0.018), ASIA Impairment Scale (AIS) C or more severe (p = 0.031), the number of CIC (p = 0.034), use of quinolones (p < 0.001) and severe bladder deformity (DG 2 or more, p = 0.004) were significantly associated with febrile GUTI occurrence. CONCLUSIONS: Our data demonstrated that male gender, severe bladder deformity (DG 2 or more), AIS C or more, the number of CIC, and use of quinolones were significantly associated with febrile GUTI occurrence in NLUTD patients employing routine CIC. Further prospective studies are necessary to define the full spectrum of possible risk factors for febrile GUTI in these patients.

Cost-Effectiveness Analysis of Transanal Irrigation for Managing Neurogenic Bowel Dysfunction in Japan.

BACKGROUND: Neurogenic bowel dysfunction (NBD) is a common sequela in Spinal Cord Injury (SCI) patients. Bowel dysfunction symptoms have a significant negative impact on quality of life (QOL) and are often socially disabling. Transanal irrigation (TAI) is a bowel management procedure that significantly mitigates NBD symptoms in patients refractory to standard bowel care (SBC) by reducing the incidence of fecal incontinence, ameliorating constipation, and improving QOL. TAI devices are used across many countries such as the United Kingdom, Germany, and France, and introduction of the devices is being considered in Japan. In this context, a cost-effectiveness analysis specific to Japanese settings is relevant. OBJECTIVES: To analyze the cost-effectiveness of TAI for bowel management of SCI patients with NBD in a Japanese clinical setting. METHODS: A modified version of a previously developed and published Markov model was used to evaluate the cost-effectiveness of TAI. In the model, SCI patients using TAI due to NBD were compared with SCI patients not responding to TAI and continuing with SBC. Quality-adjusted Life Years (QALYs) were used as the primary effectiveness measure, and the analysis was conducted from the payer's perspective. RESULTS: The model predicts a lifetime incremental cost of TAI to be 3 198 687 yen compared with SBC. TAI provided an additional 0.8 QALY, which leads to an incremental cost-effectiveness ratio (ICER) of TAI vs SBC of 4 016 287 yen/QALY. CONCLUSIONS: An ICER of 4 million yen falls within the range of reported willingness to pay (WTP) per QALY gain (5-6.7 million yen) in Japan, and TAI is therefore found to be a cost-effective treatment strategy compared to SBC. The result should be further corroborated in future Japanese trials of TAI.

Botulinum toxin A injection for the treatment of neurogenic detrusor overactivity secondary to spinal cord injury: multi-institutional experience in Japan.

OBJECTIVES: To examine the efficacy and safety of onabotulinumtoxinA (Botox) injection into the bladder wall for the treatment of neurogenic detrusor overactivity secondary to spinal cord injury in Japanese patients. METHODS: We enrolled Japanese spinal cord injury patients with cystometrically confirmed neurogenic detrusor overactivity who experienced urinary incontinence at least once a week either because they were refractory to anticholinergics or had to discontinue treatment because of adverse events. Patients received 200 units of onabotulinumtoxinA injected into the bladder wall after a 2-week washout of anticholinergics, and urodynamic variables were assessed before and 1 month after injection. Catheterization and urinary incontinence data, as well as International Consultation on Incontinence Questionnaire-Short Form scores, were assessed before injection and every month thereafter until the cessation of treatment effects. RESULTS: The study enrolled 19 patients (13 men, six women, age range 22-67 years). One month after injection, the mean number of urinary incontinence episodes decreased from 4.3 to 1.5 times/day (P = 0.004), and the maximum cystometric capacity increased from 100 mL to 296 mL (P = 0.0004). The rate of effective cases whose daily urinary incontinence frequency was decreased to less than 50% was 74%. The duration of efficacy without anticholinergic medication ranged from 3 to 12 months (median 8.5 months). Clinically significant adverse events were not observed. CONCLUSIONS: The present findings show the efficacy and tolerability of onabotulinumtoxinA injection for the treatment of neurogenic detrusor overactivity in Japanese spinal cord injury patients.

Neurogenic bladder associated with pure cervical spondylotic myelopathy: clinical characteristics and recovery after surgery.

STUDY DESIGN: Retrospective study. OBJECTIVE: To examine the prevalence of lower urinary tract symptoms (LUTS) and neurogenic bladder (NB), and surgical outcomes in pure cervical spondylotic myelopathy. SUMMARY OF BACKGROUND DATA: The inclusion of various types of cervical diseases, NB, and no obvious definition of NB provided the wide range of NB prevalence frequency among previous reports. METHODS: Of the 220 operated patients with cervical myelopathy, 54 were selected by excluding other cervical and/or concomitant diseases contributing to LUTS. All patients with LUTS were referred to urologists and recommended to undergo urodynamic study (UDS). The presence of NB was judged by abnormal findings of UDS according to the most recent criteria and a congruity between LUTS and the course of cervical myelopathy. Patients were divided into 4 groups: no symptoms, positive symptoms without UDS examination, positive symptoms with positive NB, and positive symptoms with negative NB. Evaluation scores were compared among the groups before and after surgery. RESULTS: There were no particular LUTS in NB patients. Prevalence of LUTS was 53.7% and that of NB was at least 20.4% in the patients with pure cervical spondylotic myelopathy. The scores of all 4 groups improved after surgery (P < 0.05); however, the recovery rate of NB group (47.1%) was the worst among the groups (no-symptoms group, 69.3%; negative-NB group, 53.5%; and positive symptoms without UDS group, 57.1%). Preoperative part scores showed no difference among the groups, whereas NB group demonstrated lower scores in finger and lower extremity postoperatively. A post hoc analysis confirmed a significantly poorer recovery rate related to the NB group only in the lower extremities. CONCLUSION: This study is the first to describe the prevalence of LUTS and NB according to the most recent criteria in patients with pure cervical spondylotic myelopathy, which demonstrated that neurological functions in NB patients may recover; however, the extent will be limited to two-thirds of those in patients with no-NB; moreover, the remaining symptoms derive from poor lower limb function.

Inhibition mechanism of Gosha-jinki-gan on the micturition reflex in rats.

We investigated the actions of Gosha-jinki-gan, a traditional Japanese medicine containing processed Aconiti tubers, on urinary bladder function in anesthetized rats. In cystometrical investigations, Gosha-jinki-gan (1.0 g/kg, i.d.) increased bladder capacity as well as micturition threshold pressure. In addition, it decreased the frequency of distension-induced rhythmic bladder contractions. However, it did not influence the amplitude of bladder contractions induced by electrical stimulation of the pontine micturition center. The inhibitory effect of Gosha-jinki-gan on bladder motility was abolished by pretreatment with nor-binaltorphimine (10 mg/kg, s.c.), and was diminished by the concomitant use of anti-dynorphin A antiserum (10 microg, i.t.), yohimbine (10 microg, i.t.), or methysergide (20 microg, i.t.). Processed Aconiti tuber extract (27 mg/kg, i.d.) also suppressed bladder motility, and the effect was abolished by nor-binaltorphimine. These results suggest that Gosha-jinki-gan attenuates bladder sensation via the kappa-opioid receptor-stimulating action of processed Aconiti tuber. Gosha-jinki-gan may be a useful anti-pollakiuria agent that does not influence bladder contractility at micturition.

Inhibition of urinary bladder motility by a spinal action of U-50488H in rats.

We examined the effect of a kappa agonist, U-50488H, upon the bladder motility of anaesthetized rats. The frequency of distension-induced rhythmic bladder contractions was reduced by the intravenous (10 mg kg(-1)) or intrathecal (10-100 microg) administration of U-50488H. The effect of intravenous U-50488H was inhibited by pre-treatment with nor-binaltorphimine (10 mg kg(-1), s.c.). The inhibition of bladder contractions by intrathecal U-50488H (30 microg) was eliminated with the concomitant use of nor-binaltorphimine (10 mg kg(-1), s.c.), and diminished by reserpine (4 mg kg(-1), i.p.), yohimbine (10 microg, i.t.) or methysergide (20 microg, i.t.). The amplitude of bladder contractions induced by an electrical stimulation of the pontine micturition centre was not inhibited by intrathecal U-50488H (30 and 100 microg). These results suggested that a kappa agonist could inhibit micturition reflex as well as other opioids, and at least part of the inhibition was due to the diminishment of bladder sensation based on the activation of the descending monoaminergic systems through the spinal kappa-opioid receptors.