Postinjury Bladder Overdistension Deteriorates the Lower Urinary Tract's Storage Function in Patients with Spinal Cord Injury.

INTRODUCTION: A recent article has reported that postinjury bladder overdistension (OD) deteriorates lower urinary tract function in the mouse spinal cord injury (SCI) model. However, there have been no reports examining the effect of postinjury bladder OD on lower urinary tract function in human SCI patients. OBJECTIVE: The aim of the study was to investigate the effect of postinjury bladder OD during the acute bladder-areflexia phase on the subsequent lower urinary tract storage function in patients with SCI. METHODS: Thirty-one patients with OD (OD group) and 19 patients without OD (non-OD group) during the acute bladder-areflexia phase were included in the study. All patients were confirmed to be completely paralyzed. Their lower urinary tract function was retrospectively evaluated through urodynamic studies 1, 3, and 5 years after injury. Qualiveen-30 questionnaire was used for the evaluation of quality of life. RESULTS: No significant difference was observed in the maximum cystometric capacity between the OD and non-OD groups in their urodynamic evaluation; however, the maximum bladder pressure was significantly higher, and the bladder compliance was significantly lower in the OD group. The incidence of detrusor overactivity tended to be higher in the OD group, but no significant difference was observed. The use of anti-muscarinics was significantly higher in the OD group. No significant differences were observed in Quali-veen-30 scores between both groups. CONCLUSIONS: These results suggest that postinjury bladder OD during the acute phase deteriorates lower urinary tract storage function in patients with SCI during the later phase. Thus, it is assumed that a well-planned regular intermittent catheterization in the early spinal shock phase would be important for control of patients' subsequent storage function.

Long-term urodynamic follow-up after external sphincterotomy in patients with spinal cord injury.

AIMS: External sphincterotomy (ES) is a therapeutic option for male spinal cord injury patients with detrusor sphincter dyssynergia. However, some patients need to change their voiding management after ES. One of the potential causes of failure is reportedly detrusor dysfunction, but long-term urodynamic follow-up data after ES is limited. In the present study, we reviewed the urodynamic data before and after ES and analyzed it for possible causes of ES failure. METHODS: A total of 37 patients who were followed up at our center for at least 5 years after ES were included. Mean follow-up period was 16.5 years. Urodynamic assessment was routinely performed every 2 or 3 years after ES, and the data were reviewed and analyzed. RESULTS: Of the 37 patients, 27 are still managed with reflex voiding to a condom catheter (success group), while 10 needed to change their bladder management. Mean maximum bladder pressure (MBP) was preserved at a low level after ES. However, after ES, there was a gradual increase over time in both the mean bladder volume at first neurogenic detrusor overactivity (NDO) and the percentage of patients without NDO. The mean preoperative MBP in the success group was significantly higher than that in the failure group. CONCLUSIONS: MBP is maintained at a low level over 20 years after ES. However, NDO gradually decreases over time, which might be one of the reasons for failure after ES. In addition, low preoperative MBP would be a poor prognostic factor for ES.

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.

[Linguistic validation of Japanese version of Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)].

PURPOSE: To translate the Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) into Japanese and evaluate the linguistic validation of the translated PISQ-IR. METHODS: The translation and evaluation of PISQ-IR were performed through 3 steps: forward translation based on 2 urologists and discussed by another 4 urologists, 1 pharmacoeconomist and 1 nurse; the community review process consists of conducting one-on-one cognitive interviews with 20 patients by a professional interviewer; backward translation by a native English speaker, which was negotiated with the PISQ-IR Working Group comprised original authors in International Urogynecological Association (IUGA). RESULTS: The PISQ-IR Working Group generally approved our translation and had 2 major concerns in the Japanese version; 1) "disagree" in every sentence of English version was not translated into Japanese, and 2) the Japanese expression in "sexual desire" should be more emotional. The former concern was approved by explaining that Japanese does not have the word which is the equivalent of "disagree", and "don't agree" is always used instead of "disagree". The latter concern was compromised by switching to a translation using emotional words. CONCLUSION: The Japanese version of PISQ-IR was translated in a linguistically valid manner. It would be equivalent to the original English questionnaire. It may provide a tool to assess sexual function for Japanese women with prolapse, urinary incontinence and/or fecal incontinence in an internationally harmonized fashion.

[Long-term follow up of sphincterotomy in spinal cord injured men].

OBJECTIVES: The long-term outcome of transurethral sphincterotomy (sphincterotomy) for the management of male quadriplegic patients with neurogenic bladder was examined. MATERIALS AND METHODS: A total of 39 men with at least 5-years follow-up after sphincterotomy at our institute were included in this retrospective analysis. The mean age was 36.2 years (range 15-61). The mean follow-up period was 13.1 years (range 5-27). RESULTS: Of the 39 patients, 30 patients (77%) were successfully maintained in reflex voiding with a condom catheter and remaining 9 patients (23%) have received another urinary management, including 4 suprapubic cystostomy, 2 clean intermittent catheterization and 2 clean intermittent catheterization by care giver. The main reason that required another urinary management was the augmentation in autonomic hyperreflexia due to poor urinary drainage. Analysis of the urodynamic parameters revealed that the detrusor overactivity is hard to occur with time and this would be one of the reasons for the change of urinary management. In addition, the preoperative maximum bladder pressure in patients who has changed the urinary management due to the augmentation in AH was significantly lower than that in patients that has been successfully followed up in reflex voiding. CONCLUSIONS: The long-term outcome of sphincterotomy was relatively good. However detrusor overactivity is hard to occur with time and this would be one of the important points during the postoperative routine follow up.

Up-titration of vardena fi l dose from 10 mg to 20 mg improved erectile function in men with spinal cord injury.

AIM: Vardenafil is a highly selective phosphodiesterase type-5 inhibitor for the treatment of erectile dysfunction (ED). Efficacy of vardenafil has been demonstrated in various ED populations, but that in Japanese patients with spinal cord injury (SCI) has not been assessed. METHODS: This was an open-label, multicenter, flexible dose, 12-week study in patients with ED due to SCI. Following a 4-week observation period, patients received vardenafil 10 mg for 4 weeks, and based on efficacy, tolerability and patient preference, doses for the remaining 8 weeks were decided by investigators. The primary efficacy parameter was erectile function domain score of the International Index of Erectile Function. RESULTS: Ten patients took 10 mg all through the study, while 22 patients took 20 mg after completing 4 weeks' treatment with 10 mg. The erectile function domain score increased from 12.2 at baseline to 25.0 at Last Observation Carried Forward (LOCF) in the former group and from 10.3 to 22.5 in the latter group, respectively. Importantly, there was a 5.0 point increase in erectile function domain score after up-titration in the latter group. Drug-related adverse events were observed in 22% of patients including hot flushes (9%) and headache (6%), but these were transient and mild in intensity. Serious adverse events and adverse events leading to discontinuation of the study drug were not reported. CONCLUSIONS: Vardenafil 10 and 20 mg was well tolerated and improved erectile function in patients with SCI. Of interest, erectile function was further improved by 20 mg in patients who were not sufficiently treated with 10 mg.

Efficacy and safety of tadalafil 5, 10, and 20 mg in Japanese men with erectile dysfunction: results of a multicenter, randomized, double-blind, placebo-controlled study.

OBJECTIVES: To investigate the efficacy and safety of tadalafil, a phosphodiesterase type 5 inhibitor, in Japanese men with erectile dysfunction (ED). METHODS: This multicenter, randomized, double-blind, placebo-controlled, 12-week study enrolled 343 Japanese men with ED. The men were stratified into those with mild, moderate, or severe ED and then randomly assigned 1:1:1:1 to placebo and 5 mg, 10 mg, and 20 mg tadalafil. Co-primary outcomes were the International Index of Erectile Function erectile function domain score, the percentage of "yes" responses to the Sexual Encounter Profile Diary Questions 2 and 3, and tolerability. Secondary outcomes included the International Index of Erectile Function intercourse satisfaction and overall satisfaction domain scores and the percentage of "yes" responses to a global assessment question. RESULTS: The least square mean change from baseline was 7.5, 9.1, and 9.4 for 5, 10, and 20 mg tadalafil versus 2.1 for placebo for the International Index of Erectile Function erectile function domain; 28.5, 36.0, and 36.5 for 5, 10, and 20 mg tadalafil versus 8.6 for placebo for Sexual Encounter Profile question 2; and 34.3, 47.3, and 50.8 for 5, 10, and 20 mg tadalafil versus 12.3 for placebo for Sexual Encounter Profile question 3, respectively (P <0.001 for all doses and all measures). Patients taking tadalafil had significantly greater changes from baseline for the intercourse satisfaction and overall satisfaction domains compared with patients taking placebo (P <0.001). Also, 76.5%, 81.4%, and 83.7% of patients taking 5, 10, and 20 mg tadalafil, respectively, reported improved erections (global assessment question) versus 31.4% of patients taking placebo (P <0.001). Most (98%) treatment-emergent adverse events were mild or moderate in severity. One patient (tadalafil 5 mg) discontinued because of an adverse event (ureteral calculus). Of the 343 patients, 302 (88%) completed the study. No deaths were reported. CONCLUSIONS: All doses of tadalafil studied were efficacious and well tolerated in Japanese men with ED.

[Men's health study: current status of erectile dysfunction of 6,112 ambulatory patients at general practitioners offices in Japan].

OBJECTIVES AND METHODS: The present study was performed to assess the current status of erectile dysfunction (ED) and so-called male climacteric disorders in male ambulatory patients through a self-administered questionnaire survey throughout Japan. The survey was especially focused on the relationship between ED, depression, and benign prostatic hyperplasia, the effect of ED on quality of life, and current status of ED treatment. RESULTS: The total number of completed questionnaire forms was 6,112 from 447 outpatient clinics. ED was strongly correlated with prostate disease, diabetes mellitus, and heart disease. Patients evaluated as ED by the shortened version of International Index of Erectile Function, IIEF-5, accounted for 81% of the evaluable replies. Thirty-two percent of these patients had either severe or moderate ED. Severity of ED was related to depression, dysuria, and perceived poor health condition. The proportion of ED patients who had received some ED treatments was 10%. Among ED patients, 22% of them were willing to receive pharmacotherapy for ED and the need was significantly high in patients with severer ED. CONCLUSIONS: ED is one of the symptoms frequently observed among male ambulatory patients. Physicians should be encouraged to ask their patients about their ED, in order to identify their unmet need for treatment.

Men's Health Study: epidemiology of erectile dysfunction and cardiovascular disease.

The present study collected data about 6,112 Japanese male patients from 447 outpatient clinics. Of those who underwent medical examination by a general practitioner on an outpatient basis, up to 81% had some degree of erectile dysfunction (ED), ranging from mild to severe. ED was noted to be predominant among patients affected by cardiovascular disease (CVD) or diabetes mellitus (DM), and the presence of CVD increased the risk of ED. In an aging society, patients undergoing treatment for ED as part of their routine medical care are highly likely to have concomitant CVD. As shown in the present survey, clinicians need to be aware of the high incidence of ED among such patients, because ED represents a symptom originating from damage to the vascular endothelium. A total of 41% of ED patients are either willing to receive pharmacotherapy for ED or will consider treatment. Active treatment of ED with sildenafil is suitable for patients with CVD.