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OBJECTIVE: To analyze the results of excluding confusable diseases in patients with a presumptive diagnosis of interstitial cystitis (IC). METHODS: We retrospectively reviewed the electronic medical records of consecutive patients with IC between October 2005 and December 2019. RESULTS: Patients with pelvic pain underwent an initial workup. Of these, 646 patients (164 men, 25.4%; 482 women, 74.6%) underwent observational cystoscopy under the suspicion of IC. Fourteen patients had genitourinary tract malignancies (2.2%) (bladder cancer, n = 13; prostate cancer, n = 1). Of the 13 patients with bladder cancer, three were diagnosed during initial observation cystoscopy. The remaining 10 patients were diagnosed during subsequent follow-up cystoscopic surgery. Urinary tuberculosis was identified in seven (1.1%) of 646 patients during the examination. Five (0.8%) of the six patients with suspected urinary tuberculosis at baseline imaging were positive for tuberculosis in the acid-fast bacillus test. One patient developed tuberculous granulomas in the bladder tissue after a cystectomy for intractable pelvic pain. CONCLUSION: Our results show that continuous efforts to rule out bladder tumors or tuberculosis are still essential in the follow up of patients with suspected IC, even if these diseases are not excluded at the initial examination. Imaging studies are necessary to rule out tuberculosis.
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BACKGROUND: Although organs are preserved and quality of life is improved, insufficient evidence is available for the oncologic safety of partial cystectomy in patients with colorectal cancer with suspected bladder invasion. Therefore, we aimed to compare partial and total cystectomy outcomes in patients with pathologically confirmed or clinically suspected bladder invasion. METHODS: Patients with colorectal cancer with suspected bladder invasion who underwent R0 resection from 2000 to 2020 were evaluated. Long-term outcomes were determined in patients with histologically confirmed bladder invasion. RESULTS: Of the 151 consecutive patients, 96 (64.6%) had histologically confirmed bladder involvement, and 105 (69.5%) underwent partial cystectomy. Operative time, estimated blood loss, and reoperation rate in ≤30 days were significantly worse in the total cystectomy group than in the partial cystectomy group. The overall recurrence rate was significantly higher in the total cystectomy group than in the partial cystectomy group (39.1% vs 21.9%; P = .046). Five-year overall survival (75.8% vs 53.2%; P = .006) rates were higher in the partial cystectomy group than in the total cystectomy group; however, disease-free survival (60.8% vs 41.6%; P = .088) rates were similar in patients with suspected bladder invasion. In patients with histologically confirmed bladder invasion, 5-year overall survival rates (78.1% vs 52.1%; P = .017) were higher in the partial cystectomy group than in the total cystectomy group; however, disease-free survival rates (53.4% vs 41.2%; P = .220) did not differ significantly. CONCLUSION: R0 resection is associated with favorable long-term outcomes in patients with locally advanced colorectal cancer. If R0 resection is possible, partial cystectomy is considered safe.
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OBJECTIVE: To evaluate the effect of detrusor underactivity (DUA) on the postoperative outcomes of holmium laser enucleation of the prostate (HoLEP) in patients with benign prostatic hyperplasia (BPH). PATIENTS AND METHODS: Patients with BPH who underwent HoLEP between January 2018 and December 2022 were enrolled in this prospective database study. Patients were divided into DUA (bladder contractility index [BCI] <100) and non-DUA (BCI ≥100) groups. Objective (maximum urinary flow rate [Qmax], post-void residual urine volume [PVR]) and subjective outcomes (International Prostate Symptom Score [IPSS], Overactive Bladder Symptom Score [OABSS], satisfaction with treatment question [STQ], overall response assessment [ORA], and willingness to undergo surgery question [WUSQ]) were compared between the two groups before surgery, and at 3 and 6 months after HoLEP. RESULTS: A total of 689 patients, with a mean (standard deviation [SD]) age of 69.8 (7.1) years, were enrolled. The mean (SD) BCI in the non-DUA (325 [47.2%]) and DUA (364 [52.8%]) groups was 123.4 (21.4) and 78.6 (14.2), respectively. Both objective (Qmax and PVR) and subjective (IPSS, IPSS-quality of life, and OABSS) outcomes after surgery significantly improved in both groups. The Qmax was lower in the DUA than in the non-DUA group postoperatively. At 6 months postoperatively, the total IPSS was higher in the DUA than in the non-DUA group. There were no significant differences in surgical complications between the two groups. Responses to the STQ, ORA, and WUSQ at 6 months postoperatively demonstrated that the patients were satisfied with the surgery (90.5% in the DUA group; 95.2% in the non-DUA group), their symptoms improved with surgery (95.9% in the DUA group; 100.0% in the non-DUA group), and they were willing to undergo surgery again (95.9% in the DUA group; 97.9% in the non-DUA group). There were no significant differences in the responses to the STQ and WUSQ between the two groups. CONCLUSION: Our midterm results demonstrated that patients with BPH and DUA showed minimal differences in clinical outcomes after HoLEP compared to those without DUA. The overall satisfaction was high in the DUA group.
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Lasers de Estado Sólido , Prostatectomia , Hiperplasia Prostática , Bexiga Inativa , Humanos , Masculino , Idoso , Hiperplasia Prostática/cirurgia , Hiperplasia Prostática/complicações , Lasers de Estado Sólido/uso terapêutico , Resultado do Tratamento , Bexiga Inativa/cirurgia , Bexiga Inativa/fisiopatologia , Pessoa de Meia-Idade , Estudos Prospectivos , Prostatectomia/métodos , Prostatectomia/efeitos adversos , Terapia a Laser/métodos , Satisfação do PacienteRESUMO
PURPOSE: To examine efficacy and safety of ReMEEX implantation in patients with female stress urinary incontinence (SUI) associated with detrusor underactivity (DU), recurrence, or intrinsic sphincter deficiency (ISD). MATERIALS AND METHODS: Retrospective cohort study included 303 females who underwent ReMEEX system (March 2008 to May 2021). Patients were stratified into three groups by purpose of surgery (SUI with DU, reoperation, and SUI with ISD) and evaluated with following criteria: cure (absence of subjective complaint of leakage and objective leakage in the stress test), improvement (rare leakage subjectively, but satisfaction regardless of stress test), and failure. Primary outcome was success rate of surgery assessed through patient interviews and a stress test. Surgical outcomes and complications were evaluated. RESULTS: Mean follow-up was 34.4 months (range, 6.0-145.0 months). At the final follow-up visit, 42.9% and 49.2% of patients were cured and improved. Twenty-one point five percent required tension readjustment (mean number, 1.2). The total complication rate was 19.5% (none for grade ≥4). Preoperative Qmax was significantly higher in the ISD group (p<0.001) and preoperative total International Prostate Symptom Score (IPSS) score was significantly higher in the DU group (p=0.044). Moreover, at postoperative 1 year, both total IPSS score and IPSS quality of life score were significantly higher in the DU group (both p=0.001). CONCLUSIONS: The success rate of ReMEEX system was 92.1% at mean follow-up of 34.4 months in female SUI with DU, reoperation, or ISD. It also enabled postoperative readjustment of sling tension, as needed, up to 130 months after surgery.
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Slings Suburetrais , Doenças Uretrais , Incontinência Urinária por Estresse , Masculino , Humanos , Feminino , Incontinência Urinária por Estresse/cirurgia , Incontinência Urinária por Estresse/complicações , Estudos Retrospectivos , Qualidade de Vida , Estudos de Viabilidade , Slings Suburetrais/efeitos adversos , Resultado do TratamentoRESUMO
A voiding diary is commonly used in clinical practice to monitor urinary tract health. However, manual recording and use of a measuring cup can cause significant inaccuracy and inconvenience. Recently sound-based voided volume estimation algorithms such as proudP have shown potential to accurately measure the voided volumes of patients urination while overcoming these inconveniences. In order to validate the sound-based voided volume estimation algorithm, we chose bodyweight change after urination as a reference value. Total 508 subjects from the United States and Korea were enrolled. 584 data points that have matching bodyweights change data and urination sound data were collected, and fivefold cross validation was performed in order to evaluate the model on all data in the dataset. The mean voided volume estimated by the algorithm was 202.6 mL (SD: ± 114.8) while the mean bodyweight change after urination was 208.0 g (SD: ± 121.5), and there was a strong linear correlation with high statistical significance (Pearson's correlation coefficient = 0.92, p-value < 0.001). Two paired t-test showed the equivalence with bodyweight change data with 10 mL margin. Additionally, a Bland-Altman plot shows a mean difference of - 5.5 mL with LoA (- 98.0, 87.1). The results support high performance of the algorithm across the large population data from multi-site clinical trials.
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Bexiga Urinária , Micção , Humanos , Som , Algoritmos , Valores de ReferênciaRESUMO
This study was performed to investigate the learning curve of transurethral enucleation with bipolar energy (TUEB) for benign prostatic hyperplasia. The study involved 494 consecutive patients who underwent TUEB for benign prostatic hyperplasia from August 2018 to March 2022 by one surgeon (SJJ, Seoul National University Bundang Hospital, Seongnam, Korea). The patients were followed up at 1 week, 1 month, 3 months, and 6 months postoperatively. To evaluate the learning curve of TUEB, perioperative parameters including the enucleation ratio (enucleated tissue weight/transitional zone volume), TUEB efficiency (enucleated tissue weight/operation time), and enucleation efficiency (enucleated tissue weight/enucleation time) were analyzed. Functional outcomes and postoperative complications were also assessed, including the International Prostate Symptom Score (IPSS), IPSS quality-of-life (QoL) score, and uroflowmetry outcomes. The patients' median age was 72 (interquartile range [IQR]: 66-78) years, and the estimated prostate volume and transitional zone volume were 63.0 (IQR: 46.0-90.6) ml and 37.1 (IQR: 24.0-60.0) ml, respectively. The enucleation ratio, TUEB efficiency, and enucleation efficiency were 0.60 (IQR: 0.46-0.54) g ml -1 , 0.33 (IQR: 0.22-0.46) g min -1 , and 0.50 (IQR: 0.35-0.72) g min -1 , respectively, plateauing after 70 cases. The functional outcomes, including total IPSS, IPSS QoL score, and uroflowmetry outcomes, significantly improved at 6 months after TUEB (all P < 0.05), but without significant differences over the learning curve. Sixty-five (13.2%) patients developed complications after TUEB, 21.5% of whom experienced major complications (Clavien-Dindo grade ≥3). The rate of major complications declined as the number of TUEB cases increased ( P = 0.013). Our results suggest that the efficiency of TUEB stabilized within 70 procedures.
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Curva de Aprendizado , Hiperplasia Prostática , Ressecção Transuretral da Próstata , Humanos , Masculino , Hiperplasia Prostática/cirurgia , Hiperplasia Prostática/patologia , Idoso , Ressecção Transuretral da Próstata/métodos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Resultado do Tratamento , Qualidade de Vida , Pessoa de Meia-Idade , Próstata/cirurgia , Próstata/patologiaRESUMO
PURPOSE: Vibegron, a novel, potent ß3 agonist, has been approved for clinical use in overactive bladder (OAB) treatment in Japan and the Unites States. We performed a bridging study to investigate the efficacy and safety of a daily 50-mg vibegron (code name JLP-2002) dose in Korean patients with OAB. METHODS: A multicenter, randomized, double-blind, placebo-controlled study was conducted from September 2020 to August 2021. Adult patients with OAB with a symptom duration of more than 6 months entered a 2-week placebo run-in phase. Eligibility was assessed at the end of this phase and selected patients entered a double-blind treatment phase after 1:1 randomization to either the placebo or vibegron (50 mg) group. The study drug was administered once daily for 12 weeks and follow-up visits were scheduled at weeks 4, 8, and 12. The primary endpoint was the change in mean daily micturition at the end of treatment. The secondary endpoints included changes in OAB symptoms (daily micturition, nocturia, urgency, urgency incontinence, and incontinence episodes, and mean voided volume per micturition) and safety. A constrained longitudinal data model was used for statistical analysis. RESULTS: Patients who took daily vibegron had significant improvements over the placebo group in both primary and secondary endpoints, except for daily nocturia episodes. The proportions of patients with normalized micturition and resolution of urgency incontinence and incontinence episodes were significantly higher in vibegron group than in the placebo. Vibegron also improved the patients' quality of life with higher satisfaction rates. The incidence of adverse events in the vibegron and placebo groups was similar with no serious, unexpected adverse drug reactions. No abnormality in electrocardiographs was observed as well as no significant increase in postvoid residual volume. CONCLUSION: Once daily vibegron (50 mg) for 12 weeks was effective, safe, and well-tolerated in Korean patients with OAB.
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PURPOSE: We evaluated the accuracy and reliability of a new smartphone-based acoustic voided volume (VV) measurement application compared to VV estimation based on the measurement of urine volume in a bladder by ultrasound bladder scan. PATIENTS AND METHODS: A total of 53 subjects from 01/2021 to 09/2021 were prospectively enrolled. Bladder scan-based VV estimation is based on the difference in the volume of urine in a bladder measured before urination and volume measured after urination. The acoustic VV measurement is based on smartphone-based acoustic VV measurement mobile application. VV estimates for the same void were compared between two techniques. Urinary measures were obtained from 49 male subjects resulting in a total of 245 measurements for analysis. VV measures were compared using Pearson's correlation coefficient (PCC), evaluation of observed versus predicted VV measures using linear regression fit indices, and Bland-Altman method. RESULTS: VV between the two techniques revealed strong correlation (PCC 0.811, p < 0.001). Means of the number of measurements per patient and inpatient days for measurements analyzed are 5 and 2.7, respectively. In 245 measurements, VV measured by bladder scan is 238.69 ± 122.32 mL, VV measured by mobile application is 254.69 ± 119.28 mL, and their difference of two measurements is 16 ± 74.29 mL. CONCLUSION: Through the comparison with VV estimated by ultrasound bladder scan, which is a technology to measure the urine volume in a bladder, it was confirmed that the smartphone-based acoustic VV measurement application proudP® is accurate.
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Micção , Urodinâmica , Humanos , Masculino , Estudos Prospectivos , Reprodutibilidade dos Testes , AcústicaRESUMO
Background: This study evaluated the efficiency and safety of transurethral enucleation with bipolar energy (TUEB) using a spatula loop according to prostate volume. Methods: We retrospectively evaluated 398 patients who underwent TUEB for benign prostatic hyperplasia at a single tertiary hospital between August 2018 and December 2022. The patients were divided into three groups according to estimated prostate volume (ePV): ≤40 mL (n = 67), 40-80 mL (n = 200), and ≥80 mL (n = 131). To compare the efficiency of TUEB, perioperative parameters including TUEB and enucleation efficiencies, were calculated as enucleated tissue weight per operation time and enucleated tissue weight per enucleation time, respectively. Preoperative and postoperative functional outcomes such as the International Prostate Symptom Score (IPSS), quality-of-life (QoL) score, maximum flow rate (Qmax), and post-void residual urine volume (PVR), were also compared. Results: The IPSS total score, voiding sub-score, Qmax, and PVR improved after TUEB in all groups (all p < 0.05). The TUEB and enucleation efficiencies increased with increasing ePVs (all P < 0.001). When comparing the three prostate volume groups, there were no significant differences in functional outcomes within 12 months after TUEB (all-Bonferroni adjusted P > 0.017). A total of 57 patients experienced adverse events after TUEB, with no significant differences between the three groups (p = 0.507). Conclusion: As prostate volume increases, the perioperative efficiency of TUEB is enhanced. Meanwhile, small prostates did not show significant differences in the improvement of functional outcomes and complications in comparison with larger prostates.
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PURPOSE: The aim of this study was to evaluate the effectiveness of the Prostate Health Index (PHI) and prostate multi-parametric magnetic resonance imaging (mpMRI) in predicting prostate cancer (PCa) and clinically significant prostate cancer (csPCa) during initial prostate biopsy. MATERIALS AND METHODS: In total, 343 patients underwent initial prostate biopsy and were screened by use of PHI and prostate-specific antigen (PSA) levels between April 2019 and July 2021. A subgroup of 232 patients also underwent prostate mpMRI. Logistic regression analysis was performed to evaluate the accuracies of PSA, PHI, and mpMRI as predictors of PCa or csPCa. These predictive accuracies were quantified by using the area under the receiver operating characteristic curve. The different predictive models were compared using the DeLong test. RESULTS: Logistic regression showed that age, PSA, PHI, and prostate volume were significant predictors of both PCa and csPCa. In the mpMRI subgroup, age, PSA level, PHI, prostate volume, and mpMRI were predictors of both PCa and csPCa. The PHI (area under the curve [AUC]=0.693) was superior to the PSA level (AUC=0.615) as a predictor of PCa (p=0.038). Combining PHI and mpMRI showed the most accurate prediction of both PCa and csPCa (AUC=0.833, 0.881, respectively). CONCLUSIONS: The most accurate prediction of both PCa and csPCa can be performed by combining PHI and mpMRI. In the absence of mpMRI, PHI is superior to PSA alone as a predictor of PCa, and adding PHI to PSA can increase the detection rate of both PCa and csPCa.
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Imageamento por Ressonância Magnética Multiparamétrica , Neoplasias da Próstata , Masculino , Humanos , Próstata/diagnóstico por imagem , Próstata/patologia , Antígeno Prostático Específico , Neoplasias da Próstata/diagnóstico por imagem , Neoplasias da Próstata/patologia , Imageamento por Ressonância MagnéticaRESUMO
PURPOSE: To evaluate possible benefits and clinical feasibility of retrograde bladder filling method prior to intra-vesical catheter removal after transurethral prostatectomy (TURP) for benign prostatic hyperplasia (BPH). MATERIALS AND METHODS: Male patients undergoing TURP for BPH from January 2019 to October 2019 were randomized in a 1:1 ratio into either retrograde filling (RF) or spontaneous voiding (SV) methods at a single institution to determine safety and efficacy of RF (NCT04309032), with surgeons blinded to allocation. Perioperative outcomes including postoperative complications were compared between two groups. Clinician/patients' satisfaction level which was evaluated with postoperative questionnaires were also compared. RESULTS: A total of 56 patients were randomized into two groups and 56 were included in final analysis (28 men in RF group, 26 in SV group). No significant differences in baseline characteristics including age, prostate volume, or perioperative uroflowmetry were observed. However, RF significantly facilitated time to void (67.0±63.2 vs. 144.0±78.7 min; p<0.001) and time to discharge (168.4±57.2 vs. 218.9±106.9 min; p=0.046). Immediate postoperative complications were comparable in both methods with no significant difference. Overall patient and medical staff satisfaction showed tolerable and similar response by either procedure. CONCLUSIONS: RF method for intra-vesical catheter removal is a safe and satisfactory method that can facilitate early voiding detection and shorten the time to discharge. Further trials are required to further validate our results.
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Hiperplasia Prostática , Ressecção Transuretral da Próstata , Humanos , Masculino , Ressecção Transuretral da Próstata/efeitos adversos , Ressecção Transuretral da Próstata/métodos , Hiperplasia Prostática/complicações , Bexiga Urinária/cirurgia , Estudos Prospectivos , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/cirurgia , Catéteres , Resultado do TratamentoRESUMO
We aimed to compare the complications and pathological outcomes between systematic 12-core transrectal ultrasonography guided prostate biopsy (TRUS-PB) and magnetic resonance imaging-TRUS fusion targeted prostate biopsy (MRI-TRUS FTPB). We examined 10,901 patients who underwent prostate biopsy from May 2003 to December 2017 retrospectively. Among them, 10,325 patients underwent 12-core TRUS-PB and 576 patients underwent MRI-TRUS FTPB. The clinicopathological features and complications in both groups were compared. After propensity score matching, there were no significant differences in the clinical features and complication rates between both groups (Pâ >â .05). In the multivariate analyses, the prostate volume was shown to be the only significant predictor of overall complications, infectious complications, bleeding related complications, and Clavien-Dindo gradeâ ≥â 2 complications after prostate biopsy (Pâ <â .001). The present study demonstrates the safety of MRI-TRUS FTPB in terms of complications, compared with that of TRUS-PB. Although the combination of MRI-TRUS FTPB and 12-core TRUS-PB provides enhanced diagnostic power, MRI-TRUS FGB alone could provide a reasonable diagnostic value for prostate cancer if the apparent diffusion coefficient suspicious grade of prostate cancer is ≥4. When the Likert suspicious grade of prostate cancer on the apparent diffusion coefficient map of multiparametric MRI was 3, 13.9% (27/194) of the patients were diagnosed with clinically significant prostate cancer (csPCa); 44.4% (12/27) of them were confirmed as csPCa at the MRI-targeted cores. When the apparent diffusion coefficient suspicious grade was ≥4, 43.0% (108/251) were diagnosed with csPCa; 76.8% (83/108) of them were confirmed to have csPCa at the MRI-targeted cores.
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Imagem por Ressonância Magnética Intervencionista , Neoplasias da Próstata , Humanos , Biópsia Guiada por Imagem/efeitos adversos , Imageamento por Ressonância Magnética , Masculino , Próstata/diagnóstico por imagem , Próstata/patologia , Neoplasias da Próstata/patologia , Estudos Retrospectivos , Ultrassonografia , Ultrassonografia de IntervençãoRESUMO
OBJECTIVE: Despite efforts to improve screening and early detection of prostate cancer (PC), no available biomarker has shown acceptable performance in patients with prostate-specific antigen (PSA) gray zones. We aimed to develop a deep learning-based prediction model with minimized parameters and missing value handling algorithms for PC and clinically significant PC (CSPC). MATERIALS AND METHODS: We retrospectively analyzed data from 18â824 prostate biopsies collected between March 2003 and December 2020 from 2 databases, resulting in 12â739 cases in the PSA gray zone of 2.0-10.0 ng/mL. Dense neural network (DNN) and extreme gradient boosting (XGBoost) models for PC and CSPC were developed with 5-fold cross-validation. The area under the curve of the receiver operating characteristic (AUROC) was compared with that of serum PSA, PSA density, free PSA (fPSA) portion, and prostate health index (PHI). RESULTS: The AUROC values in the DNN model with the imputation of missing values were 0.739 and 0.708 (PC) and 0.769 and 0.742 (CSPC) in internal and external validation, whereas those of the non-imputed dataset were 0.740 and 0.771 (PC) and 0.807 and 0.771 (CSPC), respectively. The performance of the DNN model was like that of the XGBoost model, but better than all tested clinical biomarkers for both PC and CSPC. The developed DNN model outperformed PHI, serum PSA, and percent-fPSA with or without missing value imputation. DISCUSSION: DNN models for missing value imputation can be used to predict PC and CSPC. Further validation in real-life scenarios are need to recommend for actual implementation, but the results from our study support the increasing role of deep learning analytics in the clinical setting. CONCLUSIONS: A deep learning model for PC and CSPC in PSA gray zones using minimal, routinely used clinical parameter variables and data imputation of missing values was successfully developed and validated.
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Sistemas de Apoio a Decisões Clínicas , Aprendizado Profundo , Neoplasias da Próstata , Biópsia/métodos , Humanos , Masculino , Próstata/patologia , Antígeno Prostático Específico , Neoplasias da Próstata/diagnóstico , Curva ROC , Estudos RetrospectivosRESUMO
PURPOSE: DA-8010 is a novel muscarinic M3 receptor antagonist with significant selectivity for bladder over salivary gland in preclinical studies. We evaluated the clinical efficacy and safety of DA-8010 in overactive bladder (OAB) patients. METHODS: This phase 2, randomized, double-blind, parallel-group, active reference- and placebo-controlled trial was conducted at 12 centers in South Korea (NCT03566134). Patients aged ≥19 years with OAB symptoms for ≥3 months were enrolled. Three hundred six patients (30.07% male) were randomized to 12 weeks of treatment among 4 groups; 2 experimental groups (DA-8010 2.5 or 5 mg), an active reference group (solifenacin 5 mg), and a placebo group. The change from the baseline of (=∆) 24-hour frequency at 12 weeks (primary endpoint), episodes of urgency, overall/urgency urinary incontinence, average/ maximum voided volume, nocturia, and patients' subjective responses were analyzed. RESULTS: In the full analysis set, the mean (standard deviation) [median] values for ∆ 24-hour frequency at 12 weeks were -1.01 (2.44) [-1.33] for placebo, -1.22 (2.05) [-1.33] for DA-8010 2.5 mg, and -1.67 (2.25) [-1.67] for DA-8010 5 mg; DA-8010 5 mg showed a significant decrease compared with placebo (P=0.0413). At 4 and 8 weeks, both DA-8010 2.5 mg (P=0.0391 at 4 weeks, P=0.0335 at 8 weeks) and DA-8010 5 mg (P=0.0001 at 4 weeks, P=0.0210 at 8 weeks) showed significant decrease in ∆ 24-hour frequency compared with placebo. DA-8010 5 mg achieved a significant decrease in ∆ number of urgency episodes, compared with placebo at 4 (P=0.0278) and 8 (P=0.0092) weeks. Adverse drug reactions (ADRs) were observed in 3.95% of placebo, 6.67% of DA-8010 2.5 mg, 18.42% of DA-8010 5 mg, and 17.33% of solifenacin 5 mg groups. No serious ADRs were observed in any patient. CONCLUSION: Both DA-8010 2.5 mg and 5 mg showed therapeutic efficacy for OAB without serious ADRs. Therefore, both dosages of DA-8010 can advance to a subsequent large-scale phase 3 trial.
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PURPOSE: We aimed to identify risk factors for transurethral coagulation (TUC) using bipolar electrocautery for hemostasis during holmium laser enucleation of the prostate (HoLEP) surgery for benign prostatic hyperplasia (BPH). METHODS: We analyzed the clinical outcomes of HoLEP surgery performed by a single surgeon between January 2010 and April 2020 at the Seoul National University Hospital. Patient characteristics and perioperative parameters were used to identify the risk factors for TUC. The TUC group was defined as a case of conversion to hemostasis using electrocautery during the hemostasis step after enucleation. RESULTS: Of 1,563 patients, 357 underwent TUC (TUC group; 22.8%) as an adjuvant (n=299, 19.1%) or salvage (n=58, 3.7%) therapy. Patients in the TUC group were older (mean±standard deviation, 70.6±7.3 years vs. 69.3±7.0 years; P=0.002), had more 5-alpha reductase inhibitor (5-ARI) use (35.6% vs. 25.9%, P<0.001), higher serum prostate-specific antigen (PSA) (5.4 ±4.8 ng/mL vs. 3.8 ±4.5 ng/mL, P <0.001), larger total prostate volume (TPV) (89.5 ±44.7 mL vs. 66.0 ±32.6 mL, P<0.001), and larger transitional zone volume (TZV) (57.3±34.9 mL vs. 37.7±24.2 mL, P<0.001) than those who did not undergo TUC (non-TUC group). In univariate logistic regression analysis, age, 5-ARI use, PSA, TPV, and TZV correlated with TUC, whereas in multivariate logistic regression analysis, only TZV was associated with TUC. The odds ratios (ORs) of TUC were analyzed per TZV quartile. Compared to TZV<22.3 mL, the OR was 2.42 in 34.1 mL≤TZV<53.5 mL (95% confidence interval [CI], 1.58-3.72; P<0.001), 5.17 in ≥53.5 mL (95% CI, 3.44-7.77; P<0.001). CONCLUSION: The risk of TUC during HoLEP surgery increases in patients with TZV >35 mL. Therefore, TUC may be potentially necessary in patients with a large transition zone volume in patients with BPH.
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Objectives: To evaluate the usefulness of a novel acoustic uroflowmetry- (UFM-) based mobile application (app) voiding diary (VD) focusing on the (1) compliance and (2) correlation with a conventional paper-based VD. Materials and Methods: A total of 78 patients were included between December 2019 and June 2020, and a subsequent review of all data was performed. The analyzed data were as follows: (1) survey of convenience/satisfaction/preference comparing the two methods, (2) compliance regarding the completeness of both methods, and (3) correlation of each metric (24-hour urine volume, nocturnal urine volume, nocturnal polyuria index, total number of voids, number of daytime voids, number of nocturnal voids, and maximal bladder capacity) between the two methods. Results: The survey results of convenience, satisfaction, and preference were as follows. With regard to convenience and satisfaction area, higher scores are reported in the mobile app VD (mean ± standard deviation (SD); convenience: 7.47 ± 2.19 [app] vs. 4.20 ± 2.49 [paper]; satisfaction: 7.36 ± 2.17 [app] vs. 5.07 ± 2.65 [paper]). The median score of the overall preference for using the mobile app instead of the paper-based VD was 9 out of 10 (mean ± SD7.82 ± 2.68). We also found a good correlation between the two methods for nocturnal urine volume (r = 0.55, p = 0.04), nocturnal polyuria index (r = 0.66, p = 0.23), total number of voids (r = 0.9, p = 0.02), number of nocturnal voids (r = 0.83, p = 0.02), and maximal bladder capacity (r = 0.89, p = 0.04). Conclusion: The acoustic UFM-based mobile app VD demonstrated favorable findings compared to the conventional paper-based VD.
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Aplicativos Móveis , Noctúria , Acústica , Feminino , Humanos , Masculino , Poliúria , MicçãoRESUMO
To investigate the association between pelvic floor muscle strength and erectile function in a prospectively collected observational cohort. 270 male volunteers were prospectively collected and grouped by International Index of Erectile Function-5 (IIEF-5) scores. Pelvic floor muscle strength was compared. Patients with obvious neurologic deficits, abnormal pelvic bones, history of pelvic radiation therapy, prostatectomy, or urinary incontinence were excluded. We analyzed 247 patients with mean (± standard deviation, SD) age of 62.8 (± 10.1) years. Mean (± SD) maximal and average strength were 2.0 (± 1.5) and 1.1 (± 0.8) kgf, respectively. Mean (± SD) endurance and IIEF-5 scores were 7.2 (± 2.6) seconds and 13.3 (± 7.9), respectively. Patients with IIEF-5 scores ≤ 12 tended to be older, with a higher occurrence of hypertension and lower body mass index. Age [odds ratio (OR) 1.08, 95% confidence interval (CI) 1.04-1.12, p < 0.001], and maximal strength < 1.9 kgf (OR 2.62, 95% CI 1.38-4.97, p = 0.003) were independent predictors for IIEF-5 scores ≤ 12 in multivariate regression analysis. Patients with erectile dysfunction were older and showed lower pelvic floor muscle maximal strength. Future prospective trials needed for using physiotherapy are required to verify our results.
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Força Muscular , Diafragma da Pelve/fisiologia , Ereção Peniana , Adulto , Idoso , Índice de Massa Corporal , Disfunção Erétil/diagnóstico , Disfunção Erétil/etiologia , Disfunção Erétil/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Dinamômetro de Força Muscular , Estudos ProspectivosRESUMO
PURPOSE: To identify the prevalence of detrusor overactivity with impaired contractility (DOIC) in the community-dwelling elderly and explore whether it is from a single or two independent bladder dysfunctions. MATERIALS AND METHODS: Based on a 10-year urodynamic database of the SEOUL Study Group, elderly patients who met inclusion criteria were selected. Bladder sensation, capacity, and compliance were designated as evaluation elements for storage function, and free maximal flow rate (Qmax) and post void residual volume, detrusor pressure at maximal flow (PdetQmax), and bladder voiding efficiency for voiding function. RESULTS: The prevalence rate of DOIC was 18.8% and 5.5% among 2,571 men and 688 women, respectively, and increased significantly with age. In men, patients with DOIC showed no differences in storage parameters and significantly lower free Qmax and PdetQmax among voiding parameters, compared to those with detrusor overactivity (DO) only. Compared to men with detrusor underactivity (DU) only, those with DOIC had worse parameters in the majority of storage and voiding functions. In women, most of the storage and voiding functions were worse in patients with DOIC than in those with DO only. On the other hand, women with DU showed lower PdetQmax and worse voiding functions than those with DOIC, although some parameters did not reach statistical significance. CONCLUSIONS: It seems that DOIC is developed from a coincidental combination of two independent DO and DU in men. In contrast, DOIC is likely to be an intermediate step during the process of progression from DO to DU in women.
Assuntos
Sintomas do Trato Urinário Inferior/fisiopatologia , Bexiga Urinária Hiperativa/fisiopatologia , Bexiga Urinária/fisiopatologia , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Sintomas do Trato Urinário Inferior/etiologia , Masculino , Contração Muscular , Músculo Liso/fisiopatologia , Prevalência , República da Coreia/epidemiologia , Fatores Sexuais , Bexiga Urinária Hiperativa/complicações , Bexiga Urinária Hiperativa/epidemiologia , Micção , UrodinâmicaRESUMO
PURPOSE: Advances in the diagnosis and treatment of prostate cancer have increased the patients' stress level and decreased the quality of life. A variety of instruments are currently available to evaluate patients with prostate cancer. However, only a few tools are available to assess Korean patients, and therefore we demonstrated a linguistic validation of Korean Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP). METHODS: EPIC-CP was translated into Korean and the linguistic validation was evaluated. The evaluation process includes permission for translation, forward translation, reconciliation, backward translation, cognitive debriefing, and proofreading. Two bilingual translators independently translated the original questionnaire, discussed the feasibility and naturalness of initial translation, followed by revision to the reconciled version. Another translator then performed a backward translation into English. Ten patients with prostate cancer completed the translated questionnaire and performed cognitive debriefing. RESULTS: The original EPIC-CP was translated into 2 Korean versions. The different wording in both versions and the ordinary words in the initial translations were changed considering the nuances and meanings of medical terms. During the backward translation, the panels made slight changes to clarify the meaning and nuances of the translated questionnaire. During cognitive debriefing, 10 patients answered the questionnaire and offered their opinions regarding comprehensibility and naturalness. Most patients agreed that the translation was comprehensible in general. CONCLUSION: Our study provides a successful linguistic validation of the EPIC-CP questionnaire. The translation is a helpful diagnostic tool to ensure the quality of life of patients with prostate cancer attending crowded clinics.
RESUMO
AIMS: This study aimed to investigate the efficacy and safety of mirabegron for Parkinsonism patients with overactive bladder (OAB) symptoms in a randomized, placebo-controlled, multicenter study. MATERIALS AND METHODS: Inclusion criteria are Parkinsonism with OAB symptoms for 4 weeks or more, OAB symptom score (OABSS) questionnaire scores greater than 2, and OABSS urgency question scores greater than 1. After a 2-week wash-out period, the patients were randomized into placebo and mirabegron groups at visit 2. Visit 3 was performed after 4 weeks of medication. Mirabegron was prescribed to the two groups for the rest of the study period at visit 4. RESULT: The mean age was 68.1 ± 8.1 years and 72 males and 64 females were included. A total of 136 patients were screened, 117 patients were randomized, and 25 patients dropped out. The OABSS scores were significantly different between the two groups at Weeks 4 and 8. The OABSS scores became the same in the two groups at Week 12 (visit 5). The postvoid residual urine volume showed a mild increase to 64 ml in the mirabegron group compared to the placebo group at visit 4. Adverse events occurred in 27 patients (23.1%). The degree was mild in 26 cases (78.8%), moderate in five (15.2%), and severe in two (6.1%). Only 13 cases (39.4%) showed medication-related adverse events. Acute urinary retention occurred in a single case. The treatment satisfaction questionnaires showed no significant differences between the two groups. CONCLUSION: Mirabegron was effective in treating OAB symptoms in patients with Parkinsonism with acceptable adverse events.