A randomized controlled trial of transurethral microwave thermotherapy. A randomised controlled trial: outcomes of bladder rehabilitation in persons with multiple sclerosis. A randomized trial comparing transurethral resection of the prostate, laser therapy and conservative treatment of men with symptoms associated with benign prostatic enlargement: The CLasP study. Effectiveness of multidimensional exercises for the treatment of stress urinary incontinence in elderly community-dwelling Japanese women: a randomized, controlled, crossover trial. Urodynamics prior to treatment as an intervention: a pilot study. Effectiveness of prompted voiding in treating urinary incontinence in cognitively impaired homebound older adults. A randomized controlled trial of the NEAT expandable tip continence device. A new pelvic muscle trainer for the treatment of urinary incontinence. A randomized trial of behavioral management for continence with older rural women.
To establish the short term clinical and urodynamic effect of transurethral microwave thermotherapy (TUMT) in men with symptomatic uncomplicated benign prostatic hyperplasia (BPH) using a randomized controlled trial comparing the treatment with both 'placebo-like' and untreated control groups.
                The study comprised 120 symptomatic patients with BPH who were candidates for transurethral resection and TUMT. They were randomized to one of three groups: group 1 underwent a standard TUMT, group 2 underwent a simulated treatment identical to group 1 but with no emission of microwaves and group 3 received no treatment. The treatment of the first two groups was 'double-blind' and the heat experienced by the patients during treatment was simulated in both. Patients were assessed on entry to the study and 6 months after treatment using an identical protocol to measure the American Urological Association (AUA) symptom score, maximum urinary flow rate (Qmax), post-void residual urine volume (PVR), minimum urethral opening pressure (Pmuo) and maximum detrusor pressure (Pdet max).
                In the untreated group there were no clinically or statistically significant changes in the median AUA symptom score, Qmax, PVR, Pmuo and Pdet max. In group 1 the AUA score changed significantly, from 19 to 9.5, but the Qmax, PVR, Pmuo and Pdet max did not. In group 2, the AUA score also changed significantly, from 17.5 to 9.5, but Qmax, PVR, Pmuo and Pdet max did not.
                The untreated control group showed no clinically relevant deterioration or improvement. The standard and simulated TUMT groups showed little clinically relevant improvement in 'objective' variables, while the clinically significant symptom improvement was of a similar magnitude in both groups. A stratified, randomised, waitlist controlled study over 12 months assessed the effectiveness of a 6 week bladder rehabilitation programme in persons with multiple sclerosis (pwMS) in an Australian community cohort.
                Patients with definite MS and bladder issues (n=74) recruited from a tertiary hospital database were randomised to a treatment group (n=40) for an individualised bladder rehabilitation programme or to a control waitlist group (n=34). The Urogenital Distress Inventory (UDI6), Neurological Disability Scale (NDS) and the American Urological Association Symptom Index (AUA) assessed bladder impairment and 'activity limitation'; a single Quality of life (QoL) item in the AUA and the Incontinence Impact Questionnaire (IIQ7) measured restriction in 'participation'. Primary outcome measures were assessed at baseline and at 12 months.
                Analysis of per protocol data from 58 patients (treatment n=24, control n=34) showed reduced disability in the treatment group, with significant differences (p<0.001) and large effect sizes (>0.5) in post-treatment UDI6, NDS, AUA total, AUA QoL and IIQ7 scores for the two groups. The treatment group compared with the control group showed improvement: 78% versus 27% for UDI6 and 59% versus 17% improved for IIQ7. More patients in the control group deteriorated over the study period on the UDI6 (30% vs 0%; p<0.001) and IIQ7 (39 vs 0%; p=0.001).
                A multifaceted, individualised bladder rehabilitation programme reduces disability and improves QoL in pwMS compared with no intervention after 12 months of follow-up. Information on specific interventions in different bladder types in MS and the impact on QoL need further evaluation. Australian Clinical trials Registry ACTRNO12605000676617. We evaluated the effectiveness of a new technology (noncontact laser therapy) versus that of standard surgery (transurethral prostatic resection) and conservative management for lower urinary tract symptoms associated with benign prostatic enlargement.
                Men with uncomplicated lower urinary tract symptoms, that is no acute or chronic urinary retention, were randomized to receive laser therapy with a noncontact, side firing neodymium:YAG probe, standard transurethral prostatic resection or conservative management, including monitoring without active intervention, in a large multicenter pragmatic randomized controlled trial called the CLasP study. Primary outcomes were International Prostate Symptom Score (I-PSS), maximum urinary flow rate, a composite measure of success based on I-PSS and maximum urinary flow rate categories, I-PSS quality of life score and post-void residual urine volume. Secondary outcomes included treatment failure, hospital stay and major complications. Followup was 7.5 months after randomization. Intent to treat analysis was done using analysis of covariance, proportional odds models and the Newman-Keuls multiple comparisons procedure.
                Of symptomatic patients 117, 117 and 106 were randomized to receive laser therapy, transurethral prostatic resection and conservative management, respectively. Baseline characteristics were similar. All primary outcomes indicated that transurethral prostatic resection and laser therapy were superior to conservative management, and resection was superior to laser therapy. As measured by combined improved symptoms and maximum urinary flow, a successful outcome was achieved in 81%, 67% and 15% of men who underwent transurethral prostatic resection, laser therapy and conservative management, respectively. Hospital stay was significantly shorter and complications fewer for laser therapy than for resection but catheters were in place significantly longer. Men treated conservatively did not have deterioration or treatment failure.
                Laser therapy and transurethral prostatic resection are effective for decreasing lower urinary tract symptoms and post-void residual urine volume as well as improving quality of life and maximum urinary flow in the short term in men presenting with moderate to severe symptoms. Transurethral prostatic resection is superior to laser therapy in terms of effectiveness but some patients may elect laser therapy due to the shorter hospital stay and lower risk of complications. Conservative management may be acceptable and safe in men with lower urinary tract symptoms since we observed no marked deterioration in the short term. To evaluate the effectiveness of pelvic floor muscle (PFM) and fitness exercises in reducing urine leakage in elderly women with stress urinary incontinence (UI).
                Randomized, crossover, follow-up trial.
                Urban community in Japan.
                Seventy women aged 70 and older who reported urine leakage one or more times per month; 35 were randomly assigned to intervention and the other 35 to control.
                The intervention group attended an exercise class aimed at enhancing PFMs and fitness. Duration of the exercise was 60 minutes per session twice a week for 3 months. After 3 months of exercise, the intervention group was followed for 1 year.
                Body mass index (BMI), urine leakage, walking speed, and muscle strength were measured at baseline, after the intervention, and at follow-up.
                In the intervention group, maximum walking speed and adductor muscle strength increased significantly after the intervention; there were no significant changes in the control group. After 3 months of exercise, 54.5% of the intervention group and 9.4% of the control group reported being continent. Within the cured group of UI, a significantly higher proportion had decreased their BMI at 3 months (P=.03) and increased walking speed at 3 (P=.04) and 12 (P=.047) months.
                Decrease in BMI and increase in walking speed may contribute to the treatment of UI, although the data do not support a positive correlation between strengthening of adductor muscle and improvement of UI, which needs more research. To evaluate whether the treatment based on urodynamics (UDS) leads to better treatment response compared to where the treatment is based on symptoms alone.
                All patients referred with lower urinary tract symptoms (LUTS) were offered the opportunity to participate in this patient preference trial. Patients were asked to complete a Kings Health Questionnaire (KHQ) and a 3-day bladder diary. The patients were then offered treatment based on their preference for conservative therapy based on either symptoms alone or with additional UDS or randomization to the same two alternatives, if they had no preference. The primary outcomes studied were improvement in KHQ and reduction in Incontinence Episode Frequency (IEF) at 6 months. Logistic regression analysis was done to evaluate the effect of choice of treatment and effect of incontinence on KHQ.
                There was no statistically significant difference between the KHQ scores pre and post UDS in patient preference or randomized groups. Follow up attendance rates were significantly better in those who chose to undergo urodynamics when compared to those who chose conservative treatment.
                This study suggests although UDS does not improve IEF, it may have utility in patient choice and subsequent compliance. Another relevant finding was the previously unreported high uptake of UDS by women when given the choice of whether to undergo UDS first or have treatment based on symptoms alone.
                (c) 2009 Wiley-Liss, Inc. The objective of this study was to examine the short-term effectiveness of prompted voiding (PV) in cognitively impaired homebound older adults.
                This was a prospective, controlled exploratory study with a cross-over design where usual care controls crossed-over to the intervention following an 8-week observation period.
                Adults aged 60 years and older with urinary incontinence and who met Center for Medicare and Medicaid Services criteria for being homebound were referred to the study by home care nurses from 2 large Medicare-approved home health agencies in a large metropolitan county in southwestern Pennsylvania. Nineteen cognitively impaired older adults were randomly assigned to either the PV intervention or a usual care attention control group.
                Measures used included structured continence and medical histories. Older American Research and Service Physical and Instrumental Activities of Daily Living scales, Folstein Mini Mental State Examination, Clock Drawing Test, Geriatric Depression Scale, Performance-Based Toileting Assessment, bladder diaries, and physical examination.
                Nineteen subjects were randomly assigned to a PV (n = 9) or delayed attention-control group (n = 10). Treatment subjects with complete pretreatment and posttreatment data (n = 6) experienced a mean 60% reduction in daytime incontinent episodes compared with a mean 37% reduction among control subjects (n = 10). Following the control phase, subjects crossed over to the treatment protocol. A total of 15 subjects completed the PV protocol. Among all subjects completing the treatment protocol, there was a 22% reduction in daytime incontinent episodes compared with true baseline (immediately following the control phase for those crossing over from the control group).
                The PV intervention resulted in clinically significant reductions in urinary incontinence for many of the participants, which may be achievable for many cognitively impaired homebound older adults. Urethral devices are one conservative management option for stress and mixed urinary incontinence, but there is little published data about their use. The aims of this study were to assess the safety and efficacy of a new urethral device (NEAT) and compare it with the Reliance Insert. The ease of use of both devices was then evaluated. Twenty-four women with mixed or stress urinary incontinence, patients at our tertiary care urogynecology unit and who met the inclusion and exclusion criteria, were enrolled in the study. Study subjects were blinded and randomly assigned to a device group. Device efficacy was assessed by pad weighing at 0 and 4 months. Success was defined as a 50% or greater reduction in urine loss using the formula 100[(pad weight without device -pad weight with device)/pad weight with device]. Safety was evaluated using urinalysis and urine cultures. Ease of use assessment scales were also completed. Eleven patients were randomized to the Reliance Insert and 13 to the NEAT device. There were no significant differences between the two groups in age, height, weight, duration of incontinence, pad weight, leakage score, parity or quality of life score. Based on the pad weight success formula, there was no significant difference in device success between the two groups at 4 months. Women who were postmenopausal had a trend towards a higher level of success in reduction of their pad weight. Previous treatment, diagnosis and hormone replacement therapy all had no relationship to device success. Leakage score data showed that subjects had a significant decrease in urine leakage when using either device. There was no statistically significant difference in ease of use between the two devices. Adverse symptoms most commonly noted were awareness of the device (62.5%), urgency (29.2%), and urethral discomfort or pain (20.8%). One urinary tract infection (UTI) was observed. The most common finding on urinalysis was trace hematuria (15.8%). Our conclusions are that the NEAT device appears to be at least as effective and safe as the Reliance Insert. Both devices are effective at decreasing urine leakage in patients with stress or mixed urinary incontinence. The risk of UTI is low, but these devices may cause trace hematuria. To describe a new device for home treatment of urinary incontinence (UI) by comparing 3 conservative techniques and monitoring compliance and performance.
                Thirty-two patients with UI were allocated to 1 of 3 intervention groups: pelvic floor muscle exercises (PFME; n=11) alone; PFME combined with biofeedback (n=10); or PFME combined with electrical stimulation (n=11). The outcomes assessed were: changes in quality of life score (QLS), urodynamic and perineometric parameters, episodes of urine loss, subjective assessment of improvement, and actual compliance and performance with treatment.
                Increased pelvic muscle contraction strength (P<0.05), improvement in QLS (P<0.02), and fewer episodes of urine leakage were observed in all 3 groups (P<0.05). Compliance was similar among the groups (P=0.201).
                All 3 techniques were effective for home treatment of UI, with significant control of symptoms and improved quality of life. The device effectively monitored compliance and performance of exercises. Urinary incontinence (UI) is a commonly underreported and underdiagnosed condition. The purpose of this trial was to implement and evaluate behavioral management for continence (BMC), an intervention to manage symptoms of UI with older rural women in their homes. Participants were randomized into BMC or a control group, and 178 were followed for between 6 and 24 months. The intervention involved self-monitoring, bladder training, and pelvic muscle exercise with biofeedback. The primary outcome variable-severity of urine loss-was evaluated by pad test. Secondary variables were episodes of urine loss, micturition frequency, voiding interval, quality of life, and subjective report of severity. Urine loss severity at baseline evaluation was not significantly different in the two groups. But using the generalized linear mixed model analysis, at the four follow-ups, severity of urine loss, episodes of urine loss, quality of life, and subjective report of severity were significantly different. At 2 years the BMC group UI severity decreased by 61%; the control group severity increased by 184%. Self-monitoring and bladder training accounted for most of the improvement. The results support the use of simple strategies based on bladder diaries before implementing more complex treatments.
                Copyright 2002 John Wiley & Sons,
There were insufficient data to determine which intervention is best for urethral stricture disease in terms of balancing efficacy, adverse effects and costs. Well designed, adequately powered multi-centre trials are needed to answer relevant clinical questions regarding treatment of men with urethral strictures.