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1.
Low Urin Tract Symptoms ; 16(3): e12515, 2024 May.
Article in English | MEDLINE | ID: mdl-38693055

ABSTRACT

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.


Subject(s)
Anti-Bacterial Agents , Intermittent Urethral Catheterization , Spinal Cord Injuries , Urinary Tract Infections , Humans , Male , Female , Urinary Tract Infections/etiology , Urinary Tract Infections/epidemiology , Middle Aged , Adult , Intermittent Urethral Catheterization/adverse effects , Intermittent Urethral Catheterization/instrumentation , Spinal Cord Injuries/complications , Anti-Bacterial Agents/administration & dosage , Anti-Bacterial Agents/therapeutic use , Incidence , Sex Factors , Urinary Catheters/adverse effects , Risk Factors , Aged , Urinary Catheterization/adverse effects , Urinary Catheterization/instrumentation
2.
BJU Int ; 2024 Apr 24.
Article in English | MEDLINE | ID: mdl-38658057

ABSTRACT

OBJECTIVE: To assess the effectiveness of pre- and postoperative supervised pelvic floor muscle training (PFMT) on the recovery of continence and pelvic floor muscle (PFM) function after robot-assisted laparoscopic radical prostatectomy (RARP). PATIENTS AND METHODS: We carried out a single-blind randomised controlled trial involving 54 male patients scheduled to undergo RARP. The intervention group started supervised PFMT 2 months before RARP and continued for 12 months after surgery with a physiotherapist. The control group was given verbal instructions, a brochure about PFMT, and lifestyle advice. The primary outcome was 24-h pad weight (g) at 3 months after RARP. The secondary outcomes were continence status (assessed by pad use), PFM function, and the Expanded Prostate Cancer Index Composite (EPIC) score. RESULTS: Patients who participated in supervised PFMT showed significantly improved postoperative urinary incontinence (UI) compared with the control group (5.0 [0.0-908.0] g vs 21.0 [0.0-750.0] g; effect size: 0.34, P = 0.022) at 3 months after RARP based on 24-h pad weight. A significant improvement was seen in the intervention compared with the control group (65.2% continence [no pad use] vs 31.6% continence, respectively) at 12 months after surgery (effect size: 0.34, P = 0.030). Peak pressure during a maximum voluntary contraction was higher in the intervention group immediately after catheter removal and at 6 months, and a longer duration of sustained contraction was found in the intervention group compared with the control group. We were unable to demonstrate a difference between groups in EPIC scores. CONCLUSION: Supervised PFMT can improve postoperative UI and PFM function after RARP. Further studies are needed to confirm whether intra-anal pressure reflects PFM function and affects continence status in UI in men who have undergone RARP.

3.
IJU Case Rep ; 7(2): 169-172, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38440701

ABSTRACT

Introduction: We present a case of ischemic priapism caused by self intracavernous injection of tadalafil. Case presentation: A 77-year-old man developed priapism due to self-injection of tadalafil into the corpus cavernosum. He presented to our hospital 2 days after the development of priapism and severe penile pain. The blood gas analysis of the corpus cavernosum revealed ischemic priapism. At first, we performed percutaneous distal shunt (T-shunt) and cavernosal irrigation, resulting in slight improvement of penile tumescence. Several hours later, penile tumescence and severe pain reappeared. Bilateral proximal (corpora-spongiosal) shunt was performed under anesthesia again. Penile tumescence was slowly and gradually relieved. His erectile function was declined. Conclusion: We experienced a case of priapism due to self intracavernous administration of tadalafil who needed a proximal shunt to relieve the severe penile pain. This case report may serve as a warning for physicians and patients not to use phosphodiesterase 5 inhibitor inappropriately.

4.
IJU Case Rep ; 7(2): 105-109, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38440710

ABSTRACT

Introduction: We present a case of small intestinal obstruction due to a barbed suture used for peritoneal closure during robot-assisted laparoscopic sacrocolpopexy. Case presentation: A female patient with pelvic organ prolapse underwent robot-assisted laparoscopic sacrocolpopexy uneventfully. Intestinal obstruction developed on postoperative Day 4. Conservative treatment with the ileus tube failed to improve abdominal symptoms. The laparoscopic examination on postoperative Day 14 revealed the barbed suture entangled with the small intestinal mesentery. The tail of the barbed suture was laparoscopically detached from the mesentery without damaging the small intestine. The tail of the barbed suture was trimmed; an antiadhesive material was applied to the peritoneal closure line and the trimmed tail of the barbed suture. Conclusion: We recommend the use of conventional absorbable sutures in the peritoneal cavity because of the potential risk of intestinal obstruction caused by the barbed suture.

5.
Int Rev Neurobiol ; 174: 211-230, 2024.
Article in English | MEDLINE | ID: mdl-38341230

ABSTRACT

Although the loss of dopaminergic neurons in the substantia nigra and consequent motor symptoms are the hallmarks of Parkinson's disease (PD), several non-motor symptoms may appear prior to these typical motor symptoms. While a variety of non-motor symptoms have emerged as the primary predictor of PD patients' quality of life, even though motor symptoms are undoubtedly distressing. According to a study, the prevalence of lower urinary tract symptoms (LUTS) varies between 27% and 64%, suggesting that PD-related lower urinary tract dysfunction may be affected by the disease stage, the presence of concomitant conditions affecting the lower urinary tract, and other autonomic dysfunctions. Animal models can serve as a platform for research into the causes of PD-related dysfunction and the evaluation of cutting-edge therapeutic approaches although the majority of animal research have been directed toward motor symptoms of PD. At present, the cause of lower urinary tract dysfunction in PD has not been fully clarified although the increasing evidence showing the multiple mechanisms underlying PD-related LUTS has emerged. In this chapter we summarize the findings of basic research in the studies of the lower urinary tract dysfunction using with different animal PD models and we try to shed light on the translational aspects for the development of future treatment modalities in PD patients with LUTS.


Subject(s)
Lower Urinary Tract Symptoms , Parkinson Disease , Urinary Bladder, Overactive , Urinary Tract , Animals , Lower Urinary Tract Symptoms/etiology , Lower Urinary Tract Symptoms/therapy , Lower Urinary Tract Symptoms/diagnosis , Models, Animal , Quality of Life , Urinary Bladder, Overactive/etiology , Urinary Bladder, Overactive/therapy , Humans
6.
BMC Pregnancy Childbirth ; 24(1): 95, 2024 Jan 31.
Article in English | MEDLINE | ID: mdl-38297206

ABSTRACT

OBJECTIVE: This study investigated morphological changes in the composition of the pelvic floor muscles, degree of atrophy, and urethral function in a rat of simulated birth trauma induced by vaginal distension (VD) model. METHODS: Female Sprague-Dawley rats were classified into four groups: a sham group, and 1, 2, and 4 weeks post-VD (1 W, 2 W, and 4 W, respectively) groups. We measured the amplitude of urethral response to electrical stimulation (A-URE) to evaluate urethral function. After measuring the muscle wet weight of the pubococcygeus (Pcm) and iliococcygeus (Icm) muscles, histochemical staining was used to classify muscle fibers into Types I, IIa, and IIb, and the occupancy and cross-sectional area of each muscle fiber were determined. RESULTS: There were 24 Sprague-Dawley rats used. A-URE was significantly lower in the 1 W group versus the other groups. Muscle wet weight was significantly lower in the VD groups versus the sham group for Pcm. The cross-sectional area of Type I Pcm and Icm was significantly lower in the VD groups versus the sham group. Type I muscle fiber composition in Pcm was significantly lower in the VD groups versus the sham groupand lowest in the 2 W group. Type I muscle fiber composition in Icm was significantly lower in the 2 and 4 W groups versus the sham group. CONCLUSION: Muscle atrophy and changes in muscle composition in the pelvic floor muscles were observed even after improvements in urethral function. These results may provide insight into the pathogenesis of stress urinary incontinence after VD.


Subject(s)
Parturition , Urinary Incontinence, Stress , Pregnancy , Humans , Rats , Female , Animals , Rats, Sprague-Dawley , Parturition/physiology , Pelvic Floor , Delivery, Obstetric/adverse effects , Urinary Incontinence, Stress/etiology
7.
Adv Ther ; 40(12): 5519-5535, 2023 12.
Article in English | MEDLINE | ID: mdl-37843724

ABSTRACT

INTRODUCTION: Data on the long-term management of neurogenic bladder (NGB) are scarce. We evaluated the current status of NGB management in Japanese children over 24-month follow-up using the JMDC database. METHODS: In this descriptive, observational, retrospective cohort study, patients (≤ 17 years) with NGB were included. Patient characteristics and their management status were investigated. A multivariate analysis evaluating the potential risk factors for the development of urinary tract infection (UTI) was performed. The diagnosis of spina bifida, demographics, baseline comorbidities, and early use of clean intermittent catheterization (CIC) and/or overactive bladder (OAB) drugs were used as independent variables. RESULTS: Of 883 eligible children, 39.3% had spina bifida. Over 12/24-month post-index periods, renal urinary tract ultrasound and urinalysis were performed at least once in > 35%/> 45% patients, respectively, while specific tests (urodynamics, cystourethrography, scintigraphy) were performed in substantially fewer (< 11%/< 13%) patients. Over 24 months, 21.5% patients used OAB medications (mostly anticholinergics) and 10.8% underwent CIC, alone or with medications; 1.2% patients underwent surgery. Lower UTI (23.3%), urinary incontinence (9.7%), and hydronephrosis (7.0%) were the most common incident complications. Multivariate analysis evaluating risk factors for UTI showed significantly higher odds ratios with point estimates of ≥ 2 for CIC (5.70), presence of spina bifida (2.86), and constipation (2.07). Overall, urodynamic assessments were inadequately performed. CONCLUSION: Patients with use of CIC and/or having spina bifida and constipation had a higher risk of UTI, suggesting the need for careful follow-up. More guideline-compliant and diligent patient management is necessary in Japanese children with NGB.


Subject(s)
Spinal Dysraphism , Urinary Bladder, Neurogenic , Urinary Bladder, Overactive , Urinary Tract Infections , Child , Humans , Urinary Bladder, Neurogenic/complications , Urinary Bladder, Neurogenic/diagnosis , Urinary Bladder, Neurogenic/therapy , Follow-Up Studies , Retrospective Studies , East Asian People , Urinary Tract Infections/complications , Urinary Tract Infections/epidemiology , Spinal Dysraphism/complications , Spinal Dysraphism/therapy , Urinary Bladder, Overactive/complications , Constipation/etiology , Constipation/complications , Insurance, Health , Urodynamics
8.
Urol Res Pract ; 49(4): 266-270, 2023 Jul.
Article in English | MEDLINE | ID: mdl-37877829

ABSTRACT

OBJECTIVE: Urodynamics of the storage phase showing detrusor overactivity is com- mon in neurogenic bladder patients. Terminal detrusor overactivity, which is defined by involuntary detrusor contraction that cannot be inhibited, causes urinary incon- tinence. Such incontinence causes a unique voiding in neurogenic bladder patients. During the voiding phase, the detrusor pressure at Qmax (Pdet.Qmax)/maximum flow rate (Qmax) (P/Q) is the gold standard for differentiating between detrusor underactiv- ity and bladder outflow obstruction. We investigated whether a valid identification of lower urinary tract dysfunction could be established from P/Q assessment of detrusor overactivity-related voiding patients. METHODS: This study evaluated 2 types of voiding. Detrusor overactivity-related void- ing is involuntary detrusor contraction that results in micturition or voiding after per- mission to void when detrusor overactivity has occurred, while voluntary voiding is voiding voluntarily after permission to void and without terminal detrusor overactivity. We evaluated female patients with neurogenic bladder who could undergo micturition without catheterization. A pressure flow study compared the 2 groups. RESULTS: Comparison of the detrusor overactivity-related voiding group (n=20) and the voluntary voiding group (n=12) found statistically significant differences with a lower Qmax and higher Pdet.Qmax (P=.01) in the detrusor overactivity-related void- ing group. The linear regression analysis P/Q plot showed the positivity and negativity value of the slope that was reversed in the 2 groups (-0.089 vs. 0.198). CONCLUSION: Current results showed different P/Q plot patterns between 2 types of voiding in patients with neurogenic bladder. These findings suggest there is increased detrusor pressure observed in detrusor overactivity-related voiding that mimics out- flow obstruction.

9.
Urol Res Pract ; 49(3): 211-215, 2023 May.
Article in English | MEDLINE | ID: mdl-37877872

ABSTRACT

OBJECTIVE: Febrile urinary tract infections, which commonly occur in spina bifida patients, can cause renal dysfunction. To help prevent febrile urinary tract infection occurrence, a better understanding of any seasonal tendencies would be beneficial. MATERIALS AND METHODS: Study points evaluated included: (i) with or without febrile urinary tract infections, (ii) type of urinary management in patients with febrile urinary tract infections, (iii) number of febrile urinary tract infection occurrences, and (iv) season associated with episode. Febrile urinary tract infection was defined by medical records specifically ascribing the term and clinical presentations consistent with the diagnosis. We evaluated febrile urinary tract infection incidence per 1 person, risk odds, expected values, and chi-square analysis. RESULTS: This study examined 140 patients (79 males, 61 females). The patient's age at the first visit ranged from 2 days to 43.7 years old (median: 3.0 years old). The observation period was 0.6-43.7 years (median: 11.5 years). (i) Febrile urinary tract infection occurred in 68 cases, (ii) urinary management included: full clean intermittent catheterization: 49 cases, autoaugmented bladder: 15 cases, self-voiding: 8 cases, clean intermittent catheterization + indwelling catheter at night time: 5 cases, self-voiding + clean intermittent catheterization: 4 cases, vesicocutaneostomy: 2 cases, (iii) number of febrile urinary tract infection episodes: 2 times or less: 40 cases, 3-5 times: 20 cases, over 6 times: 8 cases, and (iv) total number of febrile urinary tract infection episodes was 183, with spring: 41, summer: 44, autumn: 37, and winter: 61. Risk odds of the incidence (one season vs. the other season) were spring: 0.870 (P = .425), summer: 0.954 (P = .784), autumn: 0.755 (P = .120), and winter 1.497 (P = .009).

10.
Low Urin Tract Symptoms ; 15(6): 265-270, 2023 Nov.
Article in English | MEDLINE | ID: mdl-37721189

ABSTRACT

OBJECTIVES: Parkinson's disease caused by the loss of dopaminergic neurons induces not only motor dysfunction but also lower urinary tract dysfunction. Patients with Parkinson's disease have recently been reported to experience both urge urinary incontinence (overactive bladder) and stress urinary incontinence, the latter of which occurs when the pressure of the bladder exceeds that of the urethra. Vibegron is a highly selective novel ß3 -adrenoceptor agonist approved for the treatment of overactive bladder. However, how ß3 -adrenoceptor agonists affect urethral function remains unclear. In a clinical report, the urethral function of patients with Parkinson's disease was shown to be degraded. The present study aimed to investigate the effects of vibegron on lower urinary tract activity in a rat model of Parkinson's disease. METHODS: In a rat model of Parkinson's disease induced by unilateral 6-hydroxydopamine injection into the substantia nigra pars compacta, we examined the effects of vibegron on bladder and urethral activity. RESULTS: Cystometric analysis revealed that, compared with vehicle injection, intravenous injection of 3 mg/kg vibegron significantly increased the inter-contraction interval (p < .05) and reduced voiding pressure (p < .01). However, no significant effects on urethral function were observed. CONCLUSIONS: The results of the present study provide corroborating evidence that bladder dysfunction is suppressed by the administration of vibegron in Parkinson's disease model rats, confirming that vibegron is effective for treating overactive bladder without further worsening urethral function. These findings may contribute to a better understanding of the mechanisms of ß3 -adrenoceptor agonists.


Subject(s)
Parkinson Disease , Urinary Bladder, Overactive , Humans , Rats , Animals , Urinary Bladder , Urinary Bladder, Overactive/drug therapy , Urinary Bladder, Overactive/etiology , Parkinson Disease/complications , Parkinson Disease/drug therapy , Adrenergic beta-3 Receptor Agonists/pharmacology , Adrenergic beta-3 Receptor Agonists/therapeutic use , Receptors, Adrenergic/therapeutic use
11.
Int J Urol ; 30(12): 1141-1145, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37649252

ABSTRACT

OBJECTIVES: To survey the utilization of social media (SoMe) in patients with urological disease and their families. METHODS: Among the panel members registered in NEO Marketing Inc. (Tokyo, Japan), 300 people who or whose families were visiting the urological department regularly were included. Study subjects were randomly chosen and surveyed using the questionnaire over the internet. RESULTS: This study included 203 (68%) males and 97 (32%) females. The mean age was 62 (21-85) in males and 49 (22-75) in females. One hundred and ten subjects (37%) had no account for any SoMe. The account holders of YouTube, Twitter, Facebook, Instagram, and TikTok were 119 (40%), 117 (39%), 101 (34%), 90 (30%), and 33 (11%), respectively. The proportions of account holders were different depending on gender, age, and platforms. Frequent viewers on YouTube, Twitter, Facebook, Instagram, and TikTok were 100 (84%), 89 (76%), 63 (62%), 66 (73%), and 24 (73%), respectively. Of 190 who had accounts for any SoMes, 64 (34%) found any information about urological diseases of themselves or their families. Among the all subjects, 162 (54%) thought that they would like to view the medical contents on SoMes submitted by medical societies. CONCLUSIONS: Patients with urological disease and their families in Japan occasionally utilize SoMe to obtain information on their diseases and prefer professional medical information on SoMe. The gender and age of SoMe users and the optimal platform should be considered when posting medical information on SoMe.


Subject(s)
Social Media , Urologic Diseases , Male , Female , Humans , Middle Aged , Japan , Marketing , Societies, Medical
13.
Low Urin Tract Symptoms ; 15(5): 165-172, 2023 Sep.
Article in English | MEDLINE | ID: mdl-37300392

ABSTRACT

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.


Subject(s)
Urinary Tract Infections , Humans , Cross-Sectional Studies , Japan , Urinary Tract Infections/etiology , Catheters/adverse effects , Catheterization/adverse effects , Spinal Cord , Urinary Catheterization/methods
14.
J Clin Med ; 12(9)2023 Apr 28.
Article in English | MEDLINE | ID: mdl-37176632

ABSTRACT

In pediatric patients with neurogenic bladder (NGB), urinary tract evaluation, early diagnosis, and individualized management are important. We aimed to clarify the current status of diagnosis and treatment of NGB in Japanese children. This descriptive, observational, retrospective cohort study using the JMDC claims database included NGB patients aged ≤17 years over a 12-month follow-up period. Of the 1065 pediatric NGB patients, 38.9% had spina bifida. Dermatological and gastrointestinal comorbidities were common in the baseline period. Renal/bladder ultrasound was a commonly performed investigation (38.3%), but urodynamics was infrequently used (3.0%). Of all the overactive bladder medications, anticholinergics were used commonly (17.9% patients), and most patients used anticholinergics alone (without combination therapy). Clean intermittent catheterization (CIC; alone or in combination with medications) was performed in 9.3% of patients, and 3.9% of patients were concomitantly treated with medications. The most common incident complication was lower urinary tract infection (18.1%), which was especially common in patients with open spina bifida (54.1%). Despite guideline recommendations, lower urinary tract dysfunction is not thoroughly evaluated. Adequate understanding of patient status is critical to optimal patient management (behavioral therapy, CIC, and medication) in clinical practice.

16.
Spinal Cord Ser Cases ; 9(1): 3, 2023 02 13.
Article in English | MEDLINE | ID: mdl-36781838

ABSTRACT

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.


Subject(s)
Urinary Catheters , Urinary Tract Infections , Humans , Urinary Catheters/adverse effects , Cross-Sectional Studies , Urinary Catheterization/adverse effects , Japan/epidemiology , Urinary Tract Infections/epidemiology , Urinary Tract Infections/etiology , Spinal Cord
17.
J Pediatr Urol ; 19(2): 175.e1-175.e10, 2023 04.
Article in English | MEDLINE | ID: mdl-36504158

ABSTRACT

BACKGROUND: Neurogenic detrusor overactivity (NDO) can damage the upper urinary tract leading to chronic renal impairment. Antimuscarinic therapy is used to improve urinary incontinence and protect the upper urinary tract in patients with NDO. OBJECTIVE: This study investigated safety and efficacy of fesoterodine, a muscarinic receptor antagonist, in 6‒<18-year-old patients with NDO (NCT01557244). STUDY DESIGN: This open-label phase 3 study included 2 pediatric cohorts. Patients in Cohort 1 (bodyweight >25 kg) were randomized to fesoterodine 4 or 8 mg extended-release tablets or oxybutynin XL tablets administered over the 12-week active comparator-controlled phase. The safety extension phase evaluated fesoterodine 4 and 8 mg for a further 12 weeks, with patients in the oxybutynin arm allocated to fesoterodine 4 or 8 mg. Patients in Cohort 2 (bodyweight ≤25 kg) were randomized to fesoterodine 2 or 4 mg extended-release beads-in-capsule (BIC) administered over a 12-week efficacy phase and 12-week safety extension phase. Patients with stable neurologic disease and clinically or urodynamically proven NDO were included. The primary endpoint was change from baseline to Week 12 in maximum cystometric bladder capacity (MCC). Secondary efficacy endpoints included detrusor pressure at maximum bladder capacity, bladder volume at first involuntary detrusor contraction, bladder compliance, and incontinence episodes. Safety endpoints included adverse event incidence, and specific assessments of cognition, behavior and vision. The pharmacokinetics of 5-hydroxymethyl tolterodine (5-HMT; fesoterodine's active metabolite) was determined using population-pharmacokinetic analysis. RESULTS: In Cohort 1 (n = 124), fesoterodine 4 and 8 mg treatment resulted in significant increases from baseline in the primary endpoint of MCC at Week 12. In Cohort 2 (n = 57), fesoterodine 2 and 4 mg BIC treatment resulted in improvements in MCC from baseline. Fesoterodine 4 and 8 mg and fesoterodine 4 mg BIC led to improvements in some secondary efficacy endpoints. The most common treatment-related adverse reactions were gastrointestinal effects, such as dry mouth, which occurred more frequently with oxybutynin than fesoterodine. No detrimental effects on visual accommodation or acuity, or on cognitive function or behavior were observed. DISCUSSION: These safety and efficacy results are consistent with limited published data on fesoterodine treatment in pediatric populations with overactive bladder or NDO. Study limitations include the lack of placebo control and the small sample size, which limits the ability to make formal efficacy comparisons and detect rare adverse reactions. CONCLUSION: Fesoterodine has a favorable benefit-risk profile in 6‒<18-year-old patients with NDO and may represent an additional option for pediatric NDO treatment.


Subject(s)
Urinary Bladder, Neurogenic , Urinary Bladder, Overactive , Urinary Incontinence , Humans , Child , Adolescent , Urinary Bladder, Overactive/complications , Treatment Outcome , Mandelic Acids/pharmacology , Mandelic Acids/therapeutic use , Urinary Incontinence/drug therapy , Muscarinic Antagonists/therapeutic use , Urodynamics/physiology
18.
Int J Urol ; 30(2): 128-138, 2023 02.
Article in English | MEDLINE | ID: mdl-36375037

ABSTRACT

This Asia-Pacific (AP) AMS 800™ artificial urinary sphincter (AUS) consensus statement aims to provide a set of practical recommendations to assist surgeons with the AMS 800 device surgery. The AP consensus committee consisted of key opinion leaders with extensive experience with AMS 800 surgery across several AP countries. The panel reviewed and discussed relevant findings with emphasis on locoregional and specific clinical challenges relevant to the AP region. Recommendations were made in key areas namely (1) patient selection and informed consent process; (2) preoperative assessment; (3) dealing with co-existing urological disorders; (4) surgical principles and intraoperative troubleshooting; (5) postoperative care; (6) special populations; and (7) cost analysis and comparative review. The AMS 800 device should be offered to males with moderate to severe stress urinary incontinence (SUI). Full informed consent should be undertaken, and emphasis is placed on surgical contraindications and high-risk candidates. The presence of a surgical mentor or referral to experts is recommended in complex AUS candidates. Preoperative cystoscopy with or without multichannel urodynamic study is necessary and patients with pre-existing urological disorders should be treated adequately and clinically stable before surgery. Adherence to strict patient selection and safe surgical principles are critical to ensure excellent clinical outcomes and minimize complications. Given that InhibiZone-coated device is not available in many AP countries, the use of prophylactic antibiotics pre-and post-operatively are recommended. The AMS 800 device should be prepared according to the manufacturer's guidelines and remains a cost-effective treatment for male SUI. The AMS 800 device remains the surgical benchmark for male SUI but is associated with certain mechanical limitations and a unique set of complications.


Subject(s)
Urinary Incontinence, Stress , Urinary Sphincter, Artificial , Humans , Male , Urinary Incontinence, Stress/surgery , Treatment Outcome , Postoperative Care , Asia
19.
Nihon Hinyokika Gakkai Zasshi ; 114(2): 35-52, 2023.
Article in Japanese | MEDLINE | ID: mdl-38644185

ABSTRACT

(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.


Subject(s)
Urinary Bladder, Neurogenic , Humans , Urinary Bladder, Neurogenic/physiopathology , Surveys and Questionnaires , Female , Male , Language , Middle Aged , Adult , Asian People , Japan , Aged , Translations , East Asian People
20.
Int J Urol ; 29(12): 1498-1504, 2022 12.
Article in English | MEDLINE | ID: mdl-36102589

ABSTRACT

OBJECTIVES: To estimate the surgical and quality-of-life outcomes of artificial urinary sphincter implantation in patients with diabetes mellitus (DM). Subanalyses were performed using the same population as that in our previous multicenter, prospective, observational study. METHODS: A total of 135 male patients who underwent primary artificial urinary sphincter implantation were divided into two groups: those with and without DM. The revision-free rates, that is, the percentage of patients who did not require revision surgery, were compared between patients with and without DM. The number of urinary pads required per day, International Consultation on Incontinence Questionnaire-Short Form, and King's Health Questionnaire were used to compare the continence status and quality of life (QOL) between the two groups preoperatively and at 1, 3, and 12 months after surgery. RESULTS: Revision-free rates were significantly lower in the DM group (83.9%, 77.4%, and 67.8% at 1, 2, and 3 years after implantation, respectively) than in the non-DM group (95.5%, 92.5%, and 85.5% at 1, 2, and 3 years after implantation, respectively). Both continence status and QOL, assessed by questionnaires, markedly improved after surgery in patients with and without DM. CONCLUSIONS: Despite differences in the durability of the artificial urinary sphincters, patients with DM can obtain as much benefit from artificial urinary sphincter implantation regarding continence and quality-of-life improvement as patients without DM. Therefore, DM was not considered a comorbidity that contraindicated artificial urinary sphincter implantation. Additional large-scale studies are required to verify our findings.


Subject(s)
Diabetes Mellitus , Urinary Incontinence, Stress , Urinary Sphincter, Artificial , Humans , Male , Urinary Sphincter, Artificial/adverse effects , Quality of Life , Prospective Studies , Treatment Outcome , Diabetes Mellitus/epidemiology , Urinary Incontinence, Stress/surgery , Retrospective Studies , Prosthesis Implantation/adverse effects
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