Efficacy and Safety of Tolterodine and Pilocarpine in Patients with Overactive Bladder.

PURPOSE: We evaluated the efficacy and safety of a combination of 2 mg tolterodine and 9 mg pilocarpine, vs tolterodine monotherapy in patients with overactive bladder. MATERIALS AND METHODS: We enrolled patients with overactive bladder symptoms in a multicenter, randomized, double-blind, parallel, active control study. Patients were randomized to the combination or 2 mg tolterodine twice daily for 12 weeks. After the double-blind period finished all patients were started on the combination for 12 weeks. Study co-primary end points were the change from baseline in the mean number of daily micturitions and cumulative incidence of dry mouth at the end of 12 weeks. Secondary end points were other overactive bladder symptoms, the total xerostomia inventory score and results of a visual analogue scale for dry mouth at the end of 12 and 24 weeks. RESULTS: The mean change in the number of daily micturitions from baseline to 12 weeks was -1.49 and -1.74 in the combination and tolterodine monotherapy groups, respectively. The mean difference was -0.26 (95% CI -0.79-0.27), confirming noninferiority. At 12 weeks the incidence of dry mouth was lower in the combination group than in the tolterodine monotherapy group (30.0% vs 42.9%, p = 0.009). All secondary and other efficacy outcomes related to overactive bladder symptoms improved in each group with no significant differences between the groups at 12 weeks. Changes from baseline in the total xerostomia inventory score and the visual analogue scale for dry mouth were significantly lower in the combination group than in the tolterodine monotherapy group. CONCLUSIONS: Tolterodine and pilocarpine alleviated dry mouth in patients with overactive bladder while maintaining anticholinergic efficacy similar to that of tolterodine.

Laparoscopic adrenalectomy using the lateral retroperitoneal approach: Is it a safe and feasible treatment option for pheochromocytomas larger than 6 cm?

OBJECTIVES: To evaluate the surgical feasibility of laparoscopic adrenalectomy using the lateral retroperitoneal approach for the treatment of large pheochromocytomas, and to identify the preoperative risk factors for intraoperative hypertension. METHODS: We retrospectively reviewed 51 patients who underwent laparoscopic adrenalectomy using the lateral retroperitoneal approach for the treatment of pheochromocytomas. Patient characteristics and perioperative outcomes were analyzed and compared between the two study groups based on tumor size: group A (n = 27, ≤6 cm) and group B (n = 24, ˃6 cm). RESULTS: There was no significant difference in preoperative characteristics between the two groups except for tumor size (P = 0.001) and urinary metanephrine (P = 0.011). Group B patients required longer operating time (P = 0.008), had a greater estimated blood loss (P = 0.001) and hemoglobin change (P = 0.002). However, no significant differences were observed in perioperative complications and mortality. Multivariate analysis showed that symptomatic pheochromocytomas (P = 0.004) and tumor size (P = 0.007) were significant risk factors for intraoperative hypertension. CONCLUSIONS: Laparoscopic adrenalectomy using the lateral retroperitoneal approach for pheochromocytomas can be regarded as a treatment option, even for tumors measuring >6 cm. Symptomatic pheochromocytomas and large tumor size seem to represent risk factors for intraoperative hypertension.

Efficacy of Desmopressin to Treat Nocturnal Polyuria in Elderly Men: Effects on Sleep Quality.

BACKGROUND: We investigated the efficacy of desmopressin in elderly patients with nocturnal polyuria (NP) to evaluate its effects on sleep quality. METHODS: Patients with NP (defined as the nighttime urine production >33% of total 24-hour urine volume determined from a frequency-volume chart) were recruited. Desmopressin (0.2 mg) was treated orally at bedtime for 12 weeks. The participants completed the Medical Outcomes Study (MOS) Sleep Scale. RESULTS: The mean patient age was 62.7 ± 13.0 (range 42-78 years). The mean symptom duration was 42.2 ± 39.7 months. The number of nocturia episodes (from 3.49 ± 1.83 to 2.03 ± 1.35, p = 0.01), nocturnal urine volume (p = 0.01), NP index (p = 0.01), and nocturia index (p = 0.01) decreased significantly after treatment with desmopressin. Among the MOS Sleep Scale categories, hours slept/night (p = 0.042), shortness of breath (p = 0.019), and adequacy of sleep (p = 0.001) changed significantly with a decrease in the number of nocturia episodes. Adverse events were mild. CONCLUSIONS: Desmopressin is an effective treatment for NP and improved sleep quality in elderly men.

Epididymal anomalies in boys with undescended testis or hydrocele: Significance of testicular location.

BACKGROUND: Epididymal anomalies and patent processus vaginalis are frequently found in boys with cryptorchidism or hydrocele. We conducted this study to evaluate the association between epididymal anomalies and testicular location or patent processus vaginalis in boys with undescended testis or hydrocele. METHODS: Children undergoing surgery with undescended testis (group A, 136 boys and 162 testes) or communicating hydrocele (group B, 93 boys and 96 testes) were included. Testicular locations and epididymal anomalies were investigated prospectively. An anomalous epididymis was defined as anomalies of epididymal fusion that consisted of loss of continuity between the testis, the epididymis, and the long looping epididymis. The epididymis was considered normal when a normal, firm attachment between the testis, the caput, and the cauda epididymis was present. RESULTS: The mean ages of groups A and B were 24.6 ± 19.7 (range, 8-52 months) and 31.4 ± 20.6 months (range, 10-59 months). The incidence of epididymal anomalies was significantly higher in group A than that in group B (65.4 % vs. 13.5 %, P < .001). The incidence of epididymal anomalies in boys with undescended testis was significantly different according to testis location. Epididymal anomalies were observed in 100 %, 91.4 %, and 39.3 % of cases when the testis was located in the abdomen, inguinal canal, and distal to the external inguinal ring, respectively (P < 0.001). CONCLUSION: We conclude that epididymal anomalies were more frequent in boys with undescended testis than in boys with hydrocele, and that these anomalies were more frequent when undescended testis was at a higher level. These results suggest that testicular location is associated with epididymal anomalies rather than patent processus vaginalis.

Erratum: efficacy and tolerability of anticholinergics in korean children with overactive bladder: a multicenter retrospective study.

[This corrects the article on p. 1550 in vol. 29, PMID: 25408588.].

Morphological effects of mitomycin C on urothelial responses to experimentally-induced urethral stricture in rats.

OBJECTIVES: To analyze the urothelial responses to mitomycin C treatment after urethral injury in rats, as the urothelium might play a role in the pathogenesis of urethral stricture. METHODS: Male Sprague-Dawley rats were divided into four groups (n = 5/group): negative control, positive control without further treatment, experimental control treated with sodium hyaluronate and sodium carboxymethylcellulose, and experimental treated with mitomycin C after internal urethrotomy. RESULTS: Compared with negative controls, positive controls showed a significant increase in cell proliferation and DNA damage accompanied by a considerable decrease in DNA repair in the urothelium, which resulted in urethral stricture. Experimental controls showed a significant increase in cell proliferation, DNA damage and DNA repair compared with negative controls. The mitomycin C-treated group showed a significant decrease in cell proliferation and DNA damage, but a considerable increase in DNA repair compared with the positive and experimental control groups. DNA damage was immediately increased after urethral injury, but DNA repair and cell proliferation showed belated and upregulated expression after mitomycin C treatment. CONCLUSIONS: Mitomycin C could induce healthy re-epithelialization without severe damage in the urothelium. This finding might support the possibility of using mitomycin C as an adjuvant therapy for urethral strictures, and it might also suggest a urothelial role in the process of urethral stricture after urethral injury.

Is larger tumor size a contraindication to retroperitoneal laparoscopic adrenalectomy?

PURPOSE: To evaluate the surgical feasibility of retroperitoneal laparoscopic adrenalectomy for tumors exceeding 5 cm. METHODS: A retrospective review was carried out on all adrenalectomies performed between 2002 and 2011. All surgical procedures were performed or supervised by one of two experienced laparoscopic surgeons. A total of 133 patients who underwent retroperitoneal laparoscopic adrenalectomy were divided according to tumor size: group I (n = 57) had tumors <5 cm and group II (n = 76) had tumors ≥5 cm. The operative outcomes included surgical time, change in hemoglobin level, estimated blood loss, necessity for blood transfusion, time to ambulation, hospitalization duration, postoperative complications according to the Clavien-Dindo classification, and the rate of conversion to open surgery. RESULTS: The estimated blood loss (271.75 ± 232.98 mL vs. 367.24 ± 275.11 mL; p = 0.037), time to ambulation (1.60 ± 0.49 days vs. 1.89 ± 0.31 days; p = 0.001), and postoperative hospitalization (7.88 ± 3.08 days vs. 9.264 ± 3.10 days; p = 0.012) were significantly higher in group II. The operation time and hemoglobin level change were not statistically different between groups. Blood transfusions were performed in 3 patients from group I and 6 patients from group II (5.3 vs. 7.9 %; p = 0.449). No patients experienced conversion to open surgery. CONCLUSIONS: Retroperitoneal laparoscopic adrenalectomy can be used in patients with tumors larger than 5 cm.

Early pyeloplasty for recovery of parenchymal thickness in children with unilateral ureteropelvic junction obstruction.

OBJECTIVE: We compared renal function before and after pyeloplasty in children with unilateral ureteropelvic junction obstruction (UPJO) according to the children's age. METHODS: We reviewed the medical records of 36 children with UPJO who had undergone pyeloplasty and showed improved urine drainage on postoperative diuretic renal scan. The children were divided into two groups according to their age at the time of surgery: group I, ≤1 year of age (n = 15), and group II, >1 year of age (n = 21). Parenchymal thickness (PT) and pelvic anteroposterior diameter measured by ultrasonography and renal function measured by (99m)Tc-MAG3 renal scan were compared before and after surgery. RESULTS: Group I patients, who underwent pyeloplasty within 1 year of birth, showed significant recovery of the PT ratio at follow-up evaluation (from 0.50 ± 0.13 preoperatively to 0.83 ± 0.23 postoperatively; p = 0.029) compared with that in group II (from 0.74 ± 0.23 preoperatively to 0.75 ± 0.18 postoperatively; NS). The mean differences in the PT ratio before and after surgery were 0.29 ± 0.25 and 0.02 ± 0.18 in groups I and II, respectively. CONCLUSION: This result suggests that early surgery improves subsequent parenchymal growth of the involved renal unit.

Efficacy and tolerability of anticholinergics in Korean children with overactive bladder: a multicenter retrospective study.

We investigated the efficacy and tolerability of various anticholinergics in Korean children with non-neurogenic overactive bladder (OAB). A total of 326 children (males:females= 157:169) aged under 18 yr (mean age 7.3±2.6 yr) who were diagnosed with OAB from 2008 to 2011 were retrospectively reviewed. The mean duration of OAB symptoms before anticholinergic treatment was 16.9±19.0 months. The mean duration of medication was 5.6±7.3 months. Urgency urinary incontinence episodes per week decreased from 1.9±3.1 to 0.4±1.5 times (P<0.001). The median voiding frequency during daytime was decreased from 9.2±5.4 to 6.3±4.2 times (P<0.001). According to 3-day voiding diaries, the maximum and average bladder capacity were increased from 145.5±66.9 to 196.8±80.3 mL and from 80.8±39.6 to 121.8±56.5 mL, respectively (P<0.001). On uroflowmetry, maximum flow rate was increased from 17.6±8.4 to 20.5±8.2 mL/sec (P<0.001). Adverse effects were reported in 14 (4.3%) children and six children (1.8%) discontinued medication due to adverse effects. Our results indicate that anticholinergics are effective to improve OAB symptoms and tolerability was acceptable without severe complications in children.

Evaluation of bladder capacity in Korean children younger than 24 months: a nationwide multicenter study.

PURPOSE: Bladder capacity is an important factor in the diagnosis and treatment of children with voiding dysfunction. The purpose of this study was to define the normal maximal voided volume formula in Korean children younger than 2 years. METHODS: We measured the bladder capacities of 151 Korean children between 0 and 24 months of age (83 boys and 68 girls) who did not have clinical voiding dysfunction. The maximal voided volume was determined in all subjects using a 2-day frequency volume chart with a four-hour voiding observation. The largest voided volume for each patient was considered to be the maximal voided volume. Statistical analyses were carried out using linear regression analysis. RESULTS: The maximal voided volume increased with age and weight (P = 0.0001). There was no significant difference between males and females (P = 0.771). A formula that approximates bladder capacity with respect to age is the following: bladder capacity (ml) = [1.6 × age (months)] + 45 (t = 8.757, P = 0.0001). A formula that approximates bladder capacity with respect to weight is the following: bladder capacity (ml) = [4.1 × weight (kg)] + 28 (t = 10.152, P = 0.0001). CONCLUSIONS: These formulas may be useful for the diagnosis of abnormal bladder capacity and the evaluation of voiding dysfunction in Korean children younger than 24 months.

Measurement of the Q-tip angle before and after tension-free vaginal tape-obturator (TVT-O): preoperative urethral mobility may predict surgical outcome.

INTRODUCTION AND HYPOTHESIS: The purpose of this study was to compare the results of the Q-tip test before and after the tension-free vaginal tape-obturator (TVT-O) in women with stress urinary incontinence (SUI) to determine the value of the Q-tip test in predicting the outcome of transobturator tape (TOT). METHODS: Between June 2008 and June 2009, 59 women with SUI who underwent the TVT-O procedure and were followed up for at least 6 months were analyzed. Urethral hypermobility was defined as a maximal straining angle greater than 30° as measured by the Q-tip test. Parameters of evaluation included a comprehensive medical history, physical examination, Q-tip test, stress test, and urodynamic study, which included determination of the Valsalva leak point pressure. Cure was defined as no leakage of urine postoperatively either subjectively or objectively, whereas failure was defined as the objective loss of urine during the stress test. RESULTS: The patients were divided into two groups according to their preoperative Q-tip angle: <30° (group 1, n=21) and ≥30° (group 2, n=38). The Q-tip angle decreased significantly in both groups: from 25.9 ± 5.98° preoperatively to 18.4 ± 7.23° postoperatively in group 1 (p=0.04) and from 36.6 ± 6.75° preoperatively to 24.1 ± 5.48° postoperatively in group 2 (p=0.03). The difference was obviously pronounced in group 2. The incontinence cure rate was significantly higher in group 2 (97.4 %) than in group 1 (85.7 %; p=0.04). CONCLUSIONS: Our results suggest that mobility of the proximal urethra is associated with a high rate of success of the TVT-O procedure.

Altered expression of caveolin 2 and 3 in smooth muscle of rat urinary bladder by 17ß-estradiol.

BACKGROUND: The purpose of this study was to investigate the effect of estrogen alteration on the expression of caveolin 2 and 3 in rat smooth muscle of urinary bladder. METHODS: Female Sprague-Dawley rats were divided into three groups: control, bilateral ovariectomy (Ovx), and bilateral ovariectomy followed by subcutaneous injections of 17ß-estradiol (Ovx+Est). After 4 weeks, urodynamic measurements were taken to ascertain the contraction interval and contraction pressure. The expression and cellular localization of caveolin 2 and 3 were determined by Western blot and immunohistochemistry in rat urinary bladder smooth muscle. RESULTS: In cystometrograms, the contraction interval (min) was significantly lower in the Ovx group (3.1±1.5) than in the control group (5.6±1.2), but was increased after estrogen treatment (9.3±1.0). Conversely, the average contraction pressure (mmHg) was higher in the Ovx group (26.2±2.3) than in the control group (21.9±3.1), and was decreased after estrogen treatment (23.8±3.5). Caveolin 2 and 3 expression was localized in the cell membrane of the smooth muscle. The protein expression of both caveolin 2 and 3 was significantly lower after ovariectomy and was restored to the control levels after 17ß-estradiol treatment. CONCLUSIONS: Hormonal alteration causes a significant change in the expression of caveolin 2 and 3 in smooth muscle of rat urinary bladder. These findings suggest that these molecules might have functional roles in the detrusor overactivity that occurs in association with hormonal alteration.

COMP-angiopoietin-1 promotes cavernous angiogenesis in a type 2 diabetic rat model.

Cartilage oligomeric matrix protein-angiopoietin-1 (COMP-Ang1) is an angiogenic factor for vascular angiogenesis. The aim was to investigate the effect of an intracavernosal injection of COMP-Ang1 on cavernosal angiogenesis in a diabetic rat model. Male Otsuka Long-Evans Tokushima Fatty (OLETF) rats made up the experimental group (1 yr old) and Long-Evans Tokushima Otsuka (LETO) rats made up the control group. The experimental group was divided into vehicle only, 10 µg COMP-Ang1, and 20 µg COMP-Ang1. COMP-Ang1 was injected into the corpus cavernosum of the penis. After 4 weeks, the penile tissues of the rats were obtained for immunohistochemistry and Western blot analysis. The immunoreactivity of PECAM-1 and VEGF was increased in the COMP-Ang1 group compared with the vehicle only group. Moreover, the expression of PECAM-1 and VEGF was notably augmented in the 20 µg Comp Ang-1 group. In the immunoblotting study, the expression of PECAM-1 and VEGF protein was significantly less in the OLEFT rats than in the control LETO rats. However, this expression was restored to control level after intracavernosal injection of COMP-Ang1. These results show that an intracavernosal injection of COMP-Ang1 enhances cavernous angiogenesis by structurally reinforcing the cavernosal endothelium.

Initial experience of transurethral resection with pediatric resectoscope for incomplete anterior urethral stricture.

PURPOSE: Endoscopic urethrotomy is an alternative method in treatment of urethral stricture. However, it have high recurrence rate because of the remained fibrotic tissue. Removal of the fibrotic tissue can maintain the patency of the urethral lumen after the procedure. We report the therapeutic efficacy of our initial experience using pediatric resectoscope for treating anterior urethral stricture in 16 cases. MATERIALS AND METHODS: From January 2009 to April 2011, transurethral resection with pediatric resectoscope was primarily performed on 16 patients with anterior urethral stricture. Retrograde urethrography, uroflowmetry, postvoid residual volume, IPSS score and QoL score were performed preoperatively. We used 11.5Fr pediatric resectoscope (Wolf) and monopolar electrosurgical generator. The stricture was incised under vision at the 12 o'clock location or the site of maximum scar tissue or narrowing in asymmetric strictures for working space. After incision, transurethral resection with pediatric resectoscope was performed to all scar tissues. Monopolar cutting current was set on 45 watt and coagulation current was set on 30 watt, fulgurate mode. Postoperatively, drainage of the bladder was performed for 7 days using an 18F latex catheter. Patients were followed up by IPSS score, QoL score, uroflowmetry and postvoid residual volume. RESULTS: Successful results without recurrence were achieved in 11 of 16 patients. Postoperative urethral dilation had been performed average 2.4 times (0~6 times). When we classified the results by etiology, the number of successful results in strictures with a trauma, iatrogenic, or unknown cause was 5 (7/11), 3 (3/4) and 1 (1/1), respectively. In 5 patients who failed treatment, we repeated transurethral resection with pediatric resectoscope in 1 patient, and periodic urethral dilation in 4 patients. No operative complications occurred in any patients. CONCLUSIONS: Transurethral resection with pediatric resectoscope is an effective therapeutic method for anterior urethral stricture. More long-term follow-up and large scale studies are needed to confirm the efficacy of this procedure.

Spontaneous electrical activity of cultured interstitial cells of cajal from mouse urinary bladder.

Interstitial cells of Cajal (ICCs) from the urinary bladder regulate detrusor smooth muscle activities. We cultured ICCs from the urinary bladder of mice and performed patch clamp and intracellular Ca(2+) ([Ca(2+)]i) imaging to investigate whether cultured ICCs can be a valuable tool for cellular functional studies. The cultured ICCs displayed two types of spontaneous electrical activities which are similar to those recorded in intact bladder tissues. Spontaneous electrical activities of cultured ICCs were nifedipine-sensitive. Carbachol and ATP, both excitatory neurotransmitters in the urinary bladder, depolarized the membrane and increased the frequency of spike potentials. Carbachol increased [Ca(2+)]i oscillations and basal Ca(2+) levels, which were blocked by atropine. These results suggest that cultured ICCs from the urinary bladder retain rhythmic phenotypes similar to the spontaneous electrical activities recorded from the intact urinary bladder. Therefore, we suggest that cultured ICCs from the urinary bladder may be useful for cellular and molecular studies of ICCs.

Clinical significance of distally located periurethral calcification in patients with lower urinary tract symptoms of benign prostate hyperplasia.

This study evaluated the association of periurethral calcification (PUC) with uroflowmetric parameters and symptom severity in male patients with lower urinary tract symptoms (LUTS) of benign prostatic hyperplasia (BPH). The data were collected from a prospectively maintained database of 1321 men with LUTS of BPH who visited Chonnam National University Hospital (Gwang-ju, Korea) from January 2015 to December 2019. PUC severity and location were evaluated on the midsagittal plane during transrectal ultrasonography. Relationships among age, prostate-related parameters, International Prostate Symptom Score (IPSS), and uroflowmetric parameters were assessed. Among the 1321 patients in this study, 530 (40.1%) had PUC. Patients with PUC had significantly higher IPSS (mean ± standard deviation [s.d.]: 15.1 ± 8.7 vs 13.1 ± 7.9; P < 0.001) and lower peak flow rate (Qmax; mean ± s.d.: 12.4 ± 6.6 ml s-1 vs 14.7 ± 13.3 ml s-1; P < 0.001), compared with patients who did not have PUC. Analyses according to PUC severity revealed that patients with severe PUC had higher prostate-specific antigen (PSA) level (P = 0.009), higher total IPSS (P < 0.001), lower Qmax (P = 0.002), and smaller prostate volume (P < 0.001), compared with patients who had non-severe (mild or moderate) PUC. Multivariate analysis showed that distal PUC was independently associated with high total IPSS (P = 0.02), voiding symptom score (P = 0.04), and storage symptom score (P = 0.023), and low Qmax (P = 0.015). In conclusion, PUC was significantly associated with worse LUTS parameters in terms of IPSS and Qmax. Furthermore, distally located PUC was independently associated with worse LUTS of BPH in men.

Decreased Expression of Urethral Caveolin-1, -2, and -3 in the Rat Model of Overactive Bladder: Potential Mediator of Functional Interaction of Urethra and Urinary Bladder.

PURPOSE: To investigate the effect of detrusor overactivity (DO) on the urethral expression of caveolin (CAV)-1, -2, and -3 of urethra in an animal model of cyclophosphamide (CYP)-induced cystitis rat. METHODS: Female Sprague-Dawley rats were divided into the control group (n=20) and the cystitis group (n=20). Cystitis was induced by intraperitoneal injection of CYP (200 mg/kg). An urodynamic study was done 3 days after the CYP injection to measure functional change of the urinary bladder and urethra. Cellular localization and expression of CAV-1, -2, and -3 in the rat urethra were determined by immunohistochemistry (IHC) and Western blot. RESULTS: Urodynamic experiments demonstrated a decreased contraction interval in the cystitis group compared to the control (3.9±1.0 minutes vs. 6.6±1.2 minutes, P<0.05). Conversely, contraction pressure increased significantly in the cystitis group compared to the control (22.4±0.7 mmHg vs. 11.5±0.4 mmHg, P<0.05). The urethral pressure was decreased in the cystitis group compared to the control (4.05 ±2.5 mmHg vs. 5.8 ±2.8 mmHg, P <0.05). The IHC and Western blot data showed that CAV-1, -2, and -3 expression decreased significantly in the cystitis group compared control group (P<0.05). CONCLUSION: The decreased urethral CAV-1, -2, and -3 in the DO rats suggests that CAVs might be related with the functional change of urethra in association with DO of urinay bladder.

Current status of female urologists in Korea.

PURPOSE: The number of female urologists, including residents, has gradually increased and has recently exceeded 50. This study aimed to investigate the current status of female urologists in South Korea. MATERIALS AND METHODS: Total number of female and male urology specialists and residents, annual new Korean board-certified female and male urologists recent 5 years were obtained from the Korean Urological Association database. Data on working status, region, and subspecialty were collected via a telephone survey. RESULTS: Fifty-four female urologists including 40 urology specialists and 14 urology residents participated in the study. Since the first female doctor received a urology board in 1999, zero to five female doctors have obtained urology board annually. Approximately 50% of female specialists and residents worked in metropolitan areas. The proportion of female urology physicians working in university hospitals was 52.5%. Three had only urology-oncology subspecialties, while the rest had non-oncologic or both subspecialties. CONCLUSIONS: Female urologists are evenly distributed across the country, following the population distribution of Korea. Female urologists are employed in various fields. More female urologists chose non-oncology and double majors as subspecialties than they chose oncology. It is necessary to pay attention to female urologists, who form a minority within the Korean Urological Association, so that they can be continuously produced and actively engaged in various fields.

A Randomized, Double-Blind, Placebo-Controlled, Bridging Study to Evaluate the Efficacy and Safety of Vibegron in Treating Korean Patients With Overactive Bladder.

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.