Neurourology and Urodynamics最新文献

Aims: This study aimed to determine the efficacy and safety of iltamiocel investigational autologous muscle cell therapy in females with stress urinary incontinence (SUI).

Methods: Adult females were randomized 2:1 to iltamiocel (150 × 10⁶ cells) or placebo and stratified by severity and prior SUI surgery. The primary objective was efficacy based on the frequency of stress incontinence episodes (SIE) recorded in a 3-day diary at 12 months posttreatment. After 12 months, placebo participants could elect to receive open-label iltamiocel. Efficacy and safety analyses were performed using all patients as treated populations.

Results: The study enrolled 311 patients, 297 were randomized to either iltamiocel (n = 199) or placebo (n = 98). Of the 295 participants that completed 12 months blinded follow-up, the proportion achieving the primary endpoint of ≥ 50% SIE reduction was not statistically different between treatment groups (52% vs. 53.6%; p = 0.798). A significantly greater proportion of iltamiocel participants in the prior SUI surgery stratum group achieved ≥ 75% SIE reduction compared with placebo, (40% vs. 16%; p = 0.037). Treatment response was maintained at 24 months in 78.4% and 64.9% of iltamiocel participants who achieved ≥ 50% and ≥ 75% SIE reduction, respectively, at Month 12. Adverse events related to the treatment were reported in 19 (9.5%) iltamiocel participants and 6 (6.1%) placebo participants.

Conclusion: The study did not meet its primary endpoint however, iltamiocel cell therapy is safe and may be ideally suited to female patients who have undergone prior surgery for SUI. Additional study in this group of patients with high unmet medical needs is warranted.

Trial registration: ClinicalTrials.gov identifier: NCT01893138; EudraCT number: 2014-002919-41.

Aims: Urogynecology and Reconstructive Pelvic Surgery (URPS) fellowship can be pursued after completion of either a urology (URO) or obstetrics and gynecology (GYN) residency. Our aim is to determine differences in graduating fellow cohort (GFC) case logs between URO- and GYN-based URPS programs.

Methods: Accreditation Council for Graduate Medical Education case logs for URPS GFCs in both GYN- and URO-based programs were analyzed for the 2019-2023 academic years (AY). Unpaired t-tests with Welch's correction were used to compare annual mean logged cases between URO- versus GYN-based GFCs for select surgical categories and the top 11 most logged index cases.

Results: GYN-based GFCs logged more cases for all pelvic organ prolapse (POP) categories including surgery on apical POP, anterior wall POP, and posterior wall POP (all p < 0.01), while URO-based GFCs logged more cases for surgery on the urinary system (p = 0.03). For the top 11 logged procedures, URO-based GFCs logged more sacral neuromodulation cases (p = 0.02), whereas GYN-based GFCs logged more slings, vaginal hysterectomies, minimally-invasive hysterectomies, vaginal apical POP, vaginal posterior POP, vaginal anterior POP, and minimally-invasive apical POP cases (all p < 0.01). There was no difference between URO- and GYN-based GFCs for complex urodynamics, cystoscopy with botox injection, or periurethral injection cases.

Conclusions: URO-based URPS fellows tend to graduate with more surgery on the urinary system and sacral neuromodulation cases, while GYN-based fellows perform more slings, hysterectomies, and POP surgery. These findings may help fellowships better understand potential differences in training among graduates from URO- and GYN-based programs and encourage collaboration to lessen these discrepancies.

Introduction: We aim to compare the clinical and urodynamic profile of lower urinary tract symptoms (LUTS) in patients undergoing laparoscopic, open transabdominal, and laparoscopic transabdominal vesicovaginal fistulae (VVF) repair at 3 months of repair, that is, in early postoperative period.

Materials and methods: Fifty-one consecutive patients with endoscopically confirmed VVF were enrolled in our study over 2 years. Malignant fistulae, radiation-induced, and complex fistulae were excluded after cross-sectional imaging. All patients underwent a postoperative assessment for the success of the repair. Then at 3 months, they completed the American Urological Association Symptom Score questionnaire and underwent a dual channel pressure-flow urodynamic study. The results of transvaginal, laparoscopic, and open transabdominal repairs were compared.

Results: All patients belonged to the Indian Caucasian race. The mean age was 35.43 ± 6.63 years. Thirty-two patients had supratrigonal and 19 had trigonal fistulae. Laparoscopic transabdominal repair was done in 15 patients, open transabdominal repair in 22 patients, and transvaginal repair in 14 patients. Forty-six patients reported some LUTS at a median follow-up of 5.83 ± 2.37 months postoperatively. Only 18 (35.2%) of these patients had moderate to severe symptoms The postoperative bladder dysfunction rates in open transabdominal, transvaginal and laparoscopic transabdominal groups were 36.4%, 28.6%, and 20%, respectively. Twenty-seven patients (52.9%) had some urodynamic abnormality, that is, small capacity (5), high voiding pressures (14), genuine stress incontinence (3), and poor compliance (3). Bladder capacity was a significant predictor of bladder dysfunction in our patients.

Conclusions: In our study, all three surgical approaches were associated with bladder dysfunction, however, it was the least in the laparoscopic transabdominal approach. Postoperative bladder capacity is a significant predictor of bladder dysfunction.

Introduction: Making a treatment decision for female stress urinary incontinence (SUI) can be challenging for patients and healthcare providers. Dutch guidelines advise to counsel both pelvic floor muscle therapy and midurethral sling surgery as primary treatment options in uncomplicated moderate to severe cases. The use of a patient decision aid (PDA) can support decision-making, reduce decisional conflict and decisional regret, and increase knowledge. The aim of this study was to develop and evaluate an online PDA for females (SUI).

Methods: This mixed-methods study was performed in consecutive stages by a multidisciplinary working group. PDA design was based on the International Patient Decision Aids Standards (IPDAS) and on outcomes of needs assessments amongst patients and healthcare providers. Content was based on Dutch guidelines, targeted literature searches and patient information from the Dutch scientific society for gynecology. The concept version was evaluated by patients, patients' advocates, and healthcare providers.

Results: Using the nominal group technique, the working group established the design and format of the PDA. Fifty-six out of 58 applicable items of the IPDAS were met. The PDA contains information on the condition, advice on lifestyle adaptations, and describes surgical and nonsurgical treatment options. The option grid contains comparisons of the primary treatment options. Furthermore, value clarification exercises and narratives were included. Acceptability and usability evaluation of the concept version was performed by 15 healthcare providers, three patients, and two patients' advocates. Comments were processed in the working group, resulting in the final version of the PDA, which was supported by all assessors.

Conclusion: Our multidisciplinary working group developed an online PDA for women with moderate to severe SUI including conservative and surgical treatment options, based on IPDAS criteria, guidelines, scientific evidence, and needs assessments from patients and healthcare providers. This PDA is supported by patients, healthcare providers, scientific societies, and the Dutch patients' association. The next step is to evaluate and implement this PDA in daily practice.

Trial registration: ID 2014-308.

Objectives: To assess the association between overactive bladder syndrome (OAB) and the metabolic syndrome (MetS).

Patients and methods: A population-based study was conducted to compare OAB patients with age-, sex- and ethnicity-matched control subjects regarding the prevalence of the parameters of the MetS, with respect to obesity, hyperlipidemia, hypertension and diabetes mellitus. The characteristics of the OAB population were assessed. Adjusted odds ratios (OR) were calculated by logistic regression.

Results: 110 024 OAB patients and 220 455 controls. were identified. OAB was associated with a higher prevalence of MetS (35.4% vs. 27.5%, p < 0.001). The fully adjusted OR for MetS in patients with OAB compared to controls was 1.44; 95% confidence interval (CI) 1.42-1.46; p < 0.001. Among metabolic parameters, obesity was found to be the strongest factor associated with OAB (OR 1.55, 95% CI 1.53-1.58, p < 0.001), and higher high-density lipoprotein cholesterole levels (>50) had a protective effect on the risk of OAB (OR 0.75, 95% CI 0.73-0.76, p < 0.001).

Conclusions: Data from this cohort suggest that OAB is positively associated with MetS. Clinicians approaching patients with OAB should be aware of this association. A multimodal treatment focusing on the MetS may be considered in these patients.

Objective: To investigate the association between sacral underdevelopment, as defined by subnormal sacral ratio (SR) measurements, with increased maximum detrusor voiding pressure (P det. Max) in infants.

Methods: In this 2007-2015 retrospective cohort study, the medical records of all infants who underwent a pyeloplasty due to congenital ureteropelvic junction obstruction were added. Their P det. Max was evaluated through the suprapubic catheter utilized for urinary drainage intraoperatively, without imposing any additional risk of urethral catheterization on the infant. SR was calculated via the plain kidney, ureter, and bladder (KUB) radiography film obtained during the voiding cystourethrogram (VCUG) evaluation before the surgery. Participants were categorized into SR < 0.74 or SR ≥ 0.74. P det. Max was subsequently compared between these two groups.

Results: A total of 45 patients were included in our analysis. Twenty-eight (62.2%) patients had a (SR < 0.74), while 17 (37.8%) had a (SR ≥ 0.74). P det. Max was shown to be significantly higher in the SR < 0.74 compared to the SR ≥ 0.74 group (167.5 ± 60.8 vs. 55.7 ± 17.9 cmH₂O, p < 0.001). After adjusting for age and sex, SR remained a significant contributor to P det. Max (p < 0.001). Physiologic detrusor sphincter dyscoordination (PDSD) rate was significantly higher in the SR < 0.74 versus SR ≥ 0.74 group (100.0% vs. 70.6%, respectively; p = 0.005).

Conclusion: Lumbosacral underdevelopment, as indicated by subnormal sacral ratios, is associated with sphincter-detrusor dyscoordination, which causes PDSD and can ultimately result in higher P det. Max in infants.

Objectives: The focus of this research was to explore any potential link between nocturia and the risk of suicidal ideation.

Methods: Drawing from the National Health and Nutrition Survey, data relating to 25 241 participants was scrutinized. This included 13 421 individuals identifying as male and 11 820 individuals identifying as female. Participants provided information on nocturia and suicidal ideation via self-completed questionnaires. To determine if nocturia was independently related to suicidal ideation, a multivariable logistic regression analysis was employed. Analyses were also undertaken separately for adult males and females.

Results: It was found that around 3.5% of participants had experienced suicidal ideation. The results indicated that nocturia increased the risk for suicidal ideation in all adult groups (odds ratio [OR] = 1.67, 95% confidence interval[CI]: 1.37-2.03, p < 0.0001), including both males (OR = 1.91, 95% CI: 1.38-2.65, p < 0.001) and females (OR = 1.48, 95% CI: 1.158-1.90, p = 0.002). The risk for suicidal ideation increased with the severity of nocturia, with significant trends observed in adult males (p for trend = 0.04) and adult females (p for trend = 0.01). Additionally, subgroup examination showed a significant interaction between nocturia and educational level in adult males (p for interaction = 0.03). Among adult females, a noteworthy interaction was observed between nocturia and body mass index (p for interaction = 0.02).

Conclusion: The research uncovered a connection between nocturia and an elevated risk of suicidal ideation.

Introduction: To quantify and compare recurrent urinary tract infection costs between 1 year before and 1 year after electrofulguration.

Methods: Following IRB approval, a well-characterized cohort of non-neurogenic women with >3 symptomatic urinary tract infections (UTIs)/year, a negative upper and lower urinary tract evaluation, and inflammatory bladder lesions (cystitis) on office cystoscopy who underwent fulguration of these lesions was analyzed. Cost of visits, imaging, labs, and medications were summed for 1-year pre- and post-fulguration using the Medicare Physician Fee Schedule, local pharmacy pricing, and institutional expenses. Before fulguration, all patients underwent clinic visit, noninvasive flow study, and flexible cystoscopy, and post-fulguration, 6-week follow-up visit and 6-month cystoscopy.

Results: Ninety-three women met study criteria (mean age 64), with 100% 1-year follow-up. Before fulguration, 73% of patients used daily antibiotic suppression, 6% self-start antibiotics, and 5% postcoital prophylaxis. Some also used vaginal estrogens (17%), urinary analgesics (13%), and cranberry or d-mannose supplements (7%). At 1 year post-fulguration, 82% had 0-1 infections and no cystoscopy evidence of cystitis, while 14% required additional fulguration for new cystitis sites and recurrent infections. Patients had on average 0.7 infections in the 1-year post-fulguration, which was significantly lower than pre-fulguration (p < 0.05). Mean 1-year pre-fulguration cost was $1328 (median $1071, range $291-$5564). Mean 1-year post-fulguration cost was $617 (median $467, range $275-$4580). On average, post-fulguration costs were $710 lower than pre-EF (p < 0.05).

Conclusion: For women with antibiotic-refractory recurrent urinary tract infections and cystoscopy evidence of cystitis, fulguration was associated with a significant reduction in UTI-related costs in the 1-year post-fulguration.

Objectives: To determine accuracy of negative urinalysis (UA) for predicting negative urine culture and the absence of urinary tract infection (UTI), and optimal urine culture growth cutoff for UTI diagnosis in men with and without urinary catheters.

Subjects and methods: UAs with urine cultures within 1 week from adult men were identified and evaluated. Predictive values for the absence of UTI (absence of ≥1 of the following criteria: documentation of UTI diagnosis, antibiotic prescription, uropathogen presence on culture) were calculated.

Results: In total, 22 883 UAs were included. Negative UA had a high predictive value for negative urine culture (0.95, 95% confidence interval [CI]: 0.94-0.95) and absence of UTI (0.99, CI: 0.99-0.995) in the overall cohort. Negative UA also had a high predictive value for negative urine culture (0.93, CI: 0.90-0.95) and absence of UTI (0.99, CI: 0.98-0.999) in those with indwelling urinary catheters. The traditional threshold of culture growth of 100 000 colony-forming units (CFU)/mL did not capture 22% of UTIs.

Conclusion: UA exhibits high predictive value for negative urine culture and absence of UTI in men, supporting a protocol wherein culture is only performed in the context of abnormal UA. The traditional 100 000 CFU/mL cut-off may have not captured a subset of UTI in the male population, and warrants further investigation.