Project description:AimsTo report the initial clinical experience with selective bladder denervation (SBD) of the trigone in women with refractory overactive bladder (OAB).MethodsFemales with refractory OAB underwent SBD of the bladder sub-trigone region. Patients were treated using a 10-s voltage-controlled radiofrequency (RF) algorithm (RF10) at study onset. The protocol was modified during the study after which point remaining patients received 60-s temperature-controlled RF (RF60). Patients were followed for 12 weeks and evaluated for adverse events and changes in OAB symptoms. Exploratory analyses on the influence of RF duration were performed.ResultsAmong 63 patients, SBD resulted in statistically significant and clinically important improvements for most outcomes. Comparing RF10 (n = 34) to RF60 (n = 29), treatment benefit was greater with RF60 including mean reduction in urgency urinary incontinence (-2.5 vs -0.9; P < 0.01), urinary incontinence (-2.6 vs -0.8; P < 0.001), and total urgency and frequency score (-13 vs -7; P = 0.02); and improvements in symptom bother (-33 vs -18; P < 0.01) and quality of life (28 vs 16; P = 0.02) on the OAB questionnaire. The proportion of urgency urinary incontinence treatment responders (≥50% reduction in episodes) was 79% with RF60 and 31% with RF10. The frequency of device- or procedure-related adverse events was comparable in RF10 versus RF60 groups (14.7% vs 17.2%).ConclusionsThis study demonstrated the feasibility of SBD in alleviating symptoms of refractory OAB. A 60-s RF algorithm using deeper ablations of the sub-trigonal tissues was more effective and comparably safe to a 10-s RF algorithm using more superficial ablations.
Project description:The study is aiming to evaluate the treatment safety and efficacy of greenlight laser photovaporization of the prostate (PVP) combined with transurethral electrovaporization resection (TUVP) for elderly (≥ 70 years) men with lower urinary tract symptoms due to benign prostatic hyperplasia (BPH/LUTS) with a large prostate volume (≥ 80 mL). One hundred twelve BPH/LUTS patients treated with PVP were divided into 2 groups according to prostate volume (PV), the outcomes of the 2 groups were assessed at 12 months after the operation. Patients in the PV ≥ 80 group (n = 51) had a higher level of maximum detrusor pressure (Pdet.max) than those in the PV < 80 group (n = 61) (97.14 ± 36.68 vs 70.70 ± 32.55, P < .001). Pdet.max level of the 2 groups was significantly decreased at the end of follow-up. International Prostate Symptom Score questionnaires (IPSS) score, maximum flow rate (Qmax), and residual urine volume (PVR) were significantly improved in comparison to the preoperative status (P < .001). PVP combined with TUVP can significantly improve outcomes (IPSS, Qmax, PVR) and is a safe and effective technique for elderly BPH/LUTS patients with a large prostate volume.
Project description:PurposeTo identify factors predicting the presence of overactive bladder syndrome (OAB)-wet, compared with OAB-dry.MethodsBetween September 2007 and September 2013, the medical records of 623 women with OAB who completed a 3-day bladder diary and underwent urodynamic studies in a medical center were retrospectively reviewed. OAB-wet was diagnosed in patients who complained of at least one episode of urgency incontinence in the previous month; otherwise, OAB-dry was diagnosed. Multivariable logistic regression analysis was used to predict the presence of OAB-wet.ResultsAge (odds ratio [OR], 1.05; P<0.001), maximal flow rate (Qmax) (OR,1.06; P<0.001), voided volume (OR, 0.996; P=0.001), detrusor pressure at maximal flow rate (PdetQmax) (OR, 1.02; P=0.003), urgency episodes (OR, 1.04; P<0.001) and urodynamic stress incontinence (OR,1.78; P=0.01) were independent predictors for the presence of OAB-wet vs. OAB-dry. If we use bladder contractility index as a variable for multivariable logistic regression analysis, bladder contractility index (OR, 1.012; P<0.001) become an independent predictor for OAB-wet.ConclusionA smaller bladder capacity and more frequent urgency episodes were predictors of OAB-wet, and the above findings indicate that OAB-wet and OAB-dry might be a continuum of OAB. Old age, high Qmax, high PdetQmax and urodynamic stress incontinence were also predictors for OAB-wet, and the above results reveal that OAB-wet and OAB-dry have partially different clinical and urodynamic features. Further studies might be performed to elucidate whether different treatment strategies between OAB-dry and OAB-wet can improve treatment efficacy.
Project description:ObjectiveThe aim of this study is to evaluate the effect of intravaginal electrical stimulation (IVES) therapies with different treatment frequencies (two or five days in a week) added to bladder training (BT) on incontinence-related quality of life (QoL) and clinical parameters in women with refractory idiopathic overactive bladder (OAB).Material and methodsFifty-two women with refractory idiopathic OAB were randomized into two groups as follows: Group 1 (n:26) received BT and IVES, two times in a week, for 10 weeks and Group 2 (n:26) received BT and IVES five times in a week, for 4 weeks. IVES was performed 20 minutes in a day, a total of 20 sessions for both groups. Women were evaluated for incontinence severity (24h pad test), pelvic floor muscles strength (perineometer), 3-day voiding diary (frequency of voiding, nocturia, incontinence episodes, and the number of pads), symptom severity (OAB-V8), quality of life (IIQ-7), treatment success (positive response rate), cure/improvement rate and treatment satisfaction (Likert scale).ResultsThere was no statistically significant differences in all parameters between the two groups at the end of the treatment. It was found that the treatment satisfaction scores, cure/improvement and positive response rates were not significantly different between two groups (p>0.05).ConclusionWe concluded that the application of IVES twice a week or 5 times a week added to BT were both effective on incontinence-related QoL and clinical parameters in women with refractory idiopathic OAB. These two IVES frequencies had similar clinical efficacy and patient satisfaction with a slight difference between them; 5 times per week IVES has a shorter treatment duration.
Project description:IntroductionThis is a presentation of a study protocol in order to evaluate whether the application of CO2 laser can additionally benefit the improvement of the symptoms of overactive bladder in postmenopausal women who have just started mirabegron as a treatment.Materials and methodsThis is a study protocol of a randomized double-blind placebo-controlled trial. A total of 50 menopausal women will participate in the study. All patients will start treatment with mirabegron 50 mg and will be randomized into two groups. Women in group A (control) will undergo CO2 laser treatments while those in group B (placebo group) will receive placebo CO2 laser treatments. In total, three monthly sessions will be held in both groups. The monitoring and evaluation of the results will be carried out by completing a three-day urination diary, as well as by completing the Female Lower Urinary Tract Symptoms, Overactive Bladder Questionnaire, King's Health Questionnaire, Urinary Distress Inventory, Pelvic Floor Impact Questionnaire, Patient Global Impression of Improvement, before each session and a month after the last one. Differences between groups will be assessed at baseline and every month following the three laser therapies.ResultsThis is an ongoing study protocol, and we are expecting the analysis of the results in 2024.ConclusionsThe use of laser CO2 in postmenopausal women with overactive bladder syndrome may be a well-tolerated alternative treatment. The goal of our study is to evaluate the efficacy of laser treatment in combination with b3-adrenoreceptor agonist therapy.
Project description:BackgroundNocturnal bladder symptoms and sleep disruption commonly coexist in middle-aged and older women. Although sleep disruption is often attributed to nocturnal bladder symptoms in women with overactive bladder syndrome, nonbladder factors also may influence sleep in this population. Many women with overactive bladder are eager to identify nonpharmacologic strategies for both bladder symptoms and sleep disruption, given the potential adverse effects of sedative and anticholinergic bladder medications in this population.ObjectivesTo provide greater insight into the complex relationship between nighttime overactive bladder symptoms and sleep disruption, and to evaluate the effects of a guided slow-paced respiration intervention on sleep outcomes in women with overactive bladder.Study designWe conducted an ancillary study within a randomized trial of slow-paced respiration in women with overactive bladder symptoms. Ambulatory community-dwelling women who reported ≥3 episodes/day of urgency-associated voiding or incontinence were randomized to use either a portable biofeedback device (RESPeRATE; Intercure, Ltd) to practice guided slow-paced respiration exercises daily for 12 weeks (N=79) or an identical-appearing device programmed to play nonrhythmic music without guiding breathing (N=82). At baseline and after 12 weeks, bladder symptoms were assessed by voiding diary, sleep duration, and disruption were assessed by sleep diary corroborated by wrist actigraphy, and poor sleep quality was determined by a Pittsburgh Sleep Quality Index global score >5.ResultsOf the 161 women randomized, 31% reported at least twice-nightly nocturia, 26% nocturnal incontinence, and 70% poor sleep quality at baseline. Of the 123 reporting any nighttime awakenings, 89% averaged 1 or more nighttime awakenings, and 83% attributed at least half of awakenings to using the bathroom. Self-reported wake time after sleep onset increased with increasing frequency of nocturnal bladder symptoms (P=.01 for linear trend). However, even among women without nocturia, average sleep quality was poor (Pittsburg Sleep Quality Index global score mean of 7.3; 95% confidence interval, 6.0-8.6). Over 12 weeks, women assigned to slow-paced respiration (N=79) experienced modest improvements in mean nocturnal voiding frequency (0.4 fewer voids/night), sleep quality (1.1 point score decrease), and sleep disruption (1.5% decreased wake time after sleep onset). However, similar improvements were detected in the music control group (N=81), without significant between-group differences.ConclusionsMany women with overactive bladder syndrome experience disrupted sleep, but not all nocturnal awakenings are attributable to bladder symptoms, and average sleep quality tends to be poor even in women without nocturia. Findings suggest that clinicians should not assume that poor sleep in women with overactive bladder syndrome is primarily caused by nocturnal bladder symptoms. Guided slow-paced respiration was associated with modest improvements in nocturia frequency and sleep quality in this trial, but the results do not support clinician recommendation to use this technique over other behavioral relaxation techniques for improving sleep.
Project description:ObjectivesOveractive bladder (OAB) symptoms are often encountered in patients after transurethral resection of the prostate (TUR-P) or transurethral incision of the prostate (TUI-P) for benign prostatic obstruction (BPO). Either antimuscarinics or β-3 agonist has been found effective in relieving OAB symptoms. However, urologists usually do not prescribe such medication immediately after TUR-P or TUI-P to avoid an increase in postvoid residual and risk of urinary tract infection. If OAB medication can be used and adverse events (AEs) can be reduced to minimum, patients' quality of life after bladder outlet obstruction surgery could be improved. This study compared the safety and efficacy between solifenacin and mirabegron in men undergoing TUR-P or TUI-P.Materials and methodsThis prospective, randomized trial compared the safety and efficacy of OAB medication on the reduction in Urgency Severity Score (USS), OAB Symptoms Score (OABSS), International Prostate Symptom Score, and urgency urinary incontinence episodes in men with BPO undergoing surgical intervention. All patients could void smoothly after catheter removal and were randomly received daily solifenacin 5 mg, mirabegron 50 mg, or no interventions for 4 weeks. At 2 and 4 weeks postoperatively, participants' OAB symptoms and AEs were evaluated.ResultsA total of 57 men were enrolled in this study with a mean age of 70.8 ± 6.1 years. At 2 weeks postoperatively, USS (1.56 ± 1.72 vs. 2.39 ± 1.72 vs. 2.26 ± 1.73, P < 0.011) and OABSS (5.33 ± 3.65 vs. 7.67 ± 4.19 vs. 8.58 ± 4.31, P < 0.000) were significantly reduced in patients taking solifenacin, mirabegron, or control, respectively. Two patients in the solifenacin group developed urinary retention. However, the changes of variables at 4 weeks postoperatively were insignificant among the three groups.ConclusionSolifenacin and mirabegron are two different drug classes both equally effective in treating immediate OAB symptoms after TUR-P or TUI-P. However, OAB symptoms could be relieved at 4 weeks without any medication. Considering AEs, β-3 agonist has a more favorable safety profile than antimuscarinics.
Project description:ObjectivesThis study aimed to evaluate the efficacy and safety of Vibegron for the treatment of residual overactive bladder (OAB) symptoms after laser vaporization of the prostate (photo-selective vaporization of the prostate, contact laser vaporization of the prostate, and thulium laser vaporization).MethodsThis randomized, open-label, parallel-group, single-center superiority trial with a 12-week observation (jRCTs071190040) enrolled male patients with OAB aged 40 years or older who had undergone laser vaporization of the prostate for not less than 12 weeks and not more than 1 year earlier. Patients were allocated to receive Vibegron 50 mg once daily or follow-up without treatment for 12 weeks.ResultsForty-seven patients were enrolled between January 2020 and March 2023. The median age (interquartile range) was 75.5 (72.5-78.5) years for the Vibegron group and 76.5 (71.0-81.0) years for the control group. The intergroup difference in the mean change (95% confidence interval) in the 24-hour urinary frequency at 12 weeks after randomization was -3.66 (-4.99, -2.33), with a significant decrease for the Vibegron group. The Overactive Bladder Symptom Score, International Prostate Symptom Score, IPSS storage score, and Overactive Bladder Questionnaire score significantly improved for the Vibegron group. Voided volume per micturition also increased for the Vibegron group.ConclusionsThe administration of 50 mg of Vibegron once daily for 12 weeks showed significant improvement compared with follow-up without treatment in bladder storage (OAB) symptoms after laser vaporization of the prostate for symptomatic benign prostatic hyperplasia.
Project description:Greenlight laser transurethral resection of prostate (TURP) is a standard surgical method used to treat patients with prostate gland enlargement, it is safe and effective.We report two cases of sudden occurence of hypotension and bradycardia during greenlight laser TURP. Two patients with benign prostatic hypertrophy were scheduled for greenlight laser TURP under spinal anesthesia. Hypotension and bradycardia were suddenly occurred during the operation. The blood gas analysis revealed no hyponatremia (indicating TURP syndrome) or anemia (indicating hemorrhage). Operation was suspended and inotropic agents were administrated intravenous immediately, then blood pressure and heart rate increased to normal level within some minutes. The patients were discharged from hospital without any complications. We considered parasympathetic reflex was occurred during greenlight laser TURP.Apart from TURP syndrome, hemorrhage, bladder perforation and high spinal anesthesia, the parasympathetic reflex which is caused by operative process can also induce hypotension and bradycardia during TURP.
Project description:We present the rationale for and design of a randomized, open-label, active-control trial comparing the effectiveness of 200 units of onabotulinum toxin A (Botox A®) versus sacral neuromodulation (InterStim®) therapy for refractory urgency urinary incontinence (UUI). The Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment (ROSETTA) trial compares changes in urgency urinary incontinence episodes over 6 months, as well as other lower urinary tract symptoms, adverse events and cost effectiveness in women receiving these two therapies. Eligible participants had previously attempted treatment with at least 2 medications and behavioral therapy. We discuss the importance of evaluating two very different interventions, the challenges related to recruitment, ethical considerations for two treatments with significantly different costs, follow-up assessments and cost effectiveness. The ROSETTA trial will provide information to healthcare providers regarding the technical attributes of these interventions as well as the efficacy and safety of these two interventions on other lower urinary tract and pelvic floor symptoms. Enrollment began in March, 2012 with anticipated end to recruitment in mid 2014.