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Tengfu Hsieh - One of the best experts on this subject based on the ideXlab platform.
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maximum urine flow rate of less than 15ml sec increasing risk of urine retention and Prostate Surgery among patients with alpha 1 blockers a 10 year follow up study
PLOS ONE, 2016Co-Authors: Tsunghsun Tsai, Tengfu HsiehAbstract:Background The aim of this study was to determine the subsequent risk of acute urine retention and Prostate Surgery in patients receiving alpha-1 blockers treatment and having a maximum urinary flow rate of less than 15ml/sec. Methods We identified patients who were diagnosed with benign Prostate hyperplasia (BPH) and had a maximum uroflow rate of less than 15ml/sec between 1 January, 2002 to 31 December, 2011 from Taiwan’s National Health Insurance Research Database into study group (n = 303). The control cohort included four BPH/LUTS patients without 5ARI used for each study group, randomly selected from the same dataset (n = 1,212). Each patient was monitored to identify those who subsequently developed Prostate Surgery and acute urine retention. Results Prostate Surgery and acute urine retention are detected in 5.9% of control group and 8.3% of study group during 10-year follow up. Compared with the control group, there was increase in the risk of Prostate Surgery and acute urine retention in the study group (HR = 1.83, 95% CI: 1.16 to 2.91) after adjusting for age, comorbidities, geographic region and socioeconomic status. Conclusions Maximum urine flow rate of less than 15ml/sec is a risk factor of urinary retention and subsequent Prostate Surgery in BPH patients receiving alpha-1 blocker therapy. This result can provide a reference for clinicians.
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Maximum Urine Flow Rate of Less than 15ml/Sec Increasing Risk of Urine Retention and Prostate Surgery among Patients with Alpha-1 Blockers: A 10-Year Follow Up Study.
PLOS ONE, 2016Co-Authors: Tsunghsun Tsai, Tengfu HsiehAbstract:Background The aim of this study was to determine the subsequent risk of acute urine retention and Prostate Surgery in patients receiving alpha-1 blockers treatment and having a maximum urinary flow rate of less than 15ml/sec. Methods We identified patients who were diagnosed with benign Prostate hyperplasia (BPH) and had a maximum uroflow rate of less than 15ml/sec between 1 January, 2002 to 31 December, 2011 from Taiwan’s National Health Insurance Research Database into study group (n = 303). The control cohort included four BPH/LUTS patients without 5ARI used for each study group, randomly selected from the same dataset (n = 1,212). Each patient was monitored to identify those who subsequently developed Prostate Surgery and acute urine retention. Results Prostate Surgery and acute urine retention are detected in 5.9% of control group and 8.3% of study group during 10-year follow up. Compared with the control group, there was increase in the risk of Prostate Surgery and acute urine retention in the study group (HR = 1.83, 95% CI: 1.16 to 2.91) after adjusting for age, comorbidities, geographic region and socioeconomic status. Conclusions Maximum urine flow rate of less than 15ml/sec is a risk factor of urinary retention and subsequent Prostate Surgery in BPH patients receiving alpha-1 blocker therapy. This result can provide a reference for clinicians.
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Maximum Urine Flow Rate of Less than 15ml/Sec Increasing Risk of Urine Retention and Prostate Surgery among Patients with Alpha-1 Blockers: A 10-Year Follow Up Study.
PloS one, 2016Co-Authors: Hsin-ho Liu, Tsunghsun Tsai, Shang-sen Lee, Yu-hung Kuo, Tengfu HsiehAbstract:The aim of this study was to determine the subsequent risk of acute urine retention and Prostate Surgery in patients receiving alpha-1 blockers treatment and having a maximum urinary flow rate of less than 15ml/sec. We identified patients who were diagnosed with benign Prostate hyperplasia (BPH) and had a maximum uroflow rate of less than 15ml/sec between 1 January, 2002 to 31 December, 2011 from Taiwan's National Health Insurance Research Database into study group (n = 303). The control cohort included four BPH/LUTS patients without 5ARI used for each study group, randomly selected from the same dataset (n = 1,212). Each patient was monitored to identify those who subsequently developed Prostate Surgery and acute urine retention. Prostate Surgery and acute urine retention are detected in 5.9% of control group and 8.3% of study group during 10-year follow up. Compared with the control group, there was increase in the risk of Prostate Surgery and acute urine retention in the study group (HR = 1.83, 95% CI: 1.16 to 2.91) after adjusting for age, comorbidities, geographic region and socioeconomic status. Maximum urine flow rate of less than 15ml/sec is a risk factor of urinary retention and subsequent Prostate Surgery in BPH patients receiving alpha-1 blocker therapy. This result can provide a reference for clinicians.
Edward Giovannucci - One of the best experts on this subject based on the ideXlab platform.
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serum sex steroid hormones and lower urinary tract symptoms in third national health and nutrition examination survey nhanes iii
Urology, 2007Co-Authors: Sabine Rohrmann, Ellen Smit, Edward Giovannucci, William G Nelson, Nader Rifai, Norma Kanarek, Shehzad Basaria, Konstantinos K Tsilidis, Elizabeth A. PlatzAbstract:OBJECTIVES To evaluate the association of circulating sex steroid hormones and sex hormone binding globulin (SHBG) with lower urinary tract symptoms (LUTS). METHODS We included 260 men, 60 years old or older, who participated in Phase 1 (1988 to 1991) of the Third National Health and Nutrition Examination Survey and for whom surplus serum was available. We measured the serum concentrations of testosterone, androstanediol glucuronide (AAG), estradiol, and SHBG. Free testosterone was calculated from the circulating testosterone, SHBG, and albumin. The cases (n = 128) were men with two to four symptoms (nocturia, hesitancy, incomplete emptying, and weak stream), but who had never undergone noncancer Prostate Surgery. The controls (n = 132) were men who neither had symptoms nor had undergone noncancer Prostate Surgery. We adjusted for age, race/ethnicity, waist circumference, cigarette smoking, alcohol consumption, and physical activity in logistic regression models and used sampling weights. RESULTS The cases had statistically significantly greater AAG and estradiol concentrations than did the controls. After multivariate adjustment, the men in the top tertile of AAG (odds ratio 2.62, 95% confidence interval 1.12 to 6.14) had a greater risk of LUTS compared with men in the bottom two tertiles. Also, men with a greater estradiol concentration (odds ratio 1.78, 95% confidence interval 0.91 to 3.49) and a greater estradiol/SHBG molar ratio (odds ratio 2.41, 95% confidence interval 1.39 to 4.17) had a greater risk of LUTS than did men with lower concentrations. No consistent associations were seen for circulating testosterone, free testosterone, or SHBG. CONCLUSIONS In this cross-sectional study representative of older U.S. men, circulating AAG, a metabolite of dihydrotestosterone, and estradiol were associated with an increased risk of having LUTS.
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Associations of Obesity with Lower Urinary Tract Symptoms and Noncancer Prostate Surgery in the Third National Health and Nutrition Examination Survey
American journal of epidemiology, 2004Co-Authors: Sabine Rohrmann, Ellen Smit, Edward Giovannucci, Elizabeth A. PlatzAbstract:The authors examined the association between obesity and lower urinary tract symptoms (LUTS) in the Third National Health and Nutrition Examination Survey. This 1988–1994 US cross-sectional study included 2,797 men aged ≥60 years whose current weight, weight at age 25 years, highest weight ever, height, waist circumference, and body mass index (BMI) were assessed. LUTS cases had at least three of these symptoms: nocturia, incomplete emptying, weak stream, and hesitancy. Controls were men without symptoms or noncancer Prostate Surgery. Odds ratios adjusted for age and race and weighted for selection probability were estimated by logistic regression. The odds of LUTS were lower for men who were obese at age 25 years compared with men whose BMI was normal (odds ratio = 0.49, 95% confidence interval: 0.27, 0.91). An increase in BMI between age 25 years and the highest BMI ever was positively associated with LUTS (odds ratio = 1.90, 95% confidence interval: 0.89, 4.05). Men with a larger waist circumference (≥102 cm) were more likely to have LUTS compared with men with a smaller waist circumference (odds ratio = 1.48, 95% confidence interval: 0.87, 2.54). Results suggest that being overweight in young adulthood may be associated with a lower prevalence of LUTS later in life, whereas weight gain and central adiposity in adulthood are possibly associated with a higher prevalence of LUTS. nutrition surveys; obesity; Prostate; Surgery; urinary tract
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prevalence of and racial ethnic variation in lower urinary tract symptoms and noncancer Prostate Surgery in u s men
Urology, 2002Co-Authors: Elizabeth A. Platz, Ellen Smit, Edward Giovannucci, Gary C. Curhan, Leroy M. NybergAbstract:Abstract Objectives. To estimate the proportion of U.S. men affected by specific lower urinary tract symptoms (LUTS) and to assess whether the prevalence of LUTS varies by race/ethnicity. Methods. Included were 30+-year-old men who took part in the Third National Health and Nutrition Examination Survey. Men were asked whether they experienced nocturia, incomplete emptying, or hesitancy. Men 60+ years old were also asked whether they had a decreased urinary stream or had ever undergone noncancer Prostate Surgery. To obtain the estimated prevalences for the U.S. population, we applied sampling fraction weights. We calculated age-adjusted odds ratios (ORs) of 3+ symptoms or Surgery by race/ethnicity using logistic regression analysis. Results. Only nocturia was common in 30 to 59-year-old men. Among men who had not had Prostate Surgery, 59.9% of men 60 to 69 years old and 75.1% of men 70+ years old had at least one symptom. All four symptoms were reported by 3.0% of men 60 to 69 years and 5.6% of men 70+ years old. Of the men 60 to 69 years old and men 70+ years old, 8.0% and 22.4%, respectively, reported having undergone Surgery. In men 60+ years old, the age-adjusted OR for either having 3+ symptoms or Surgery was 0.8 for non-Hispanic black men compared with non-Hispanic white men. The odds of having 3+ symptoms (OR = 1.6), but not Surgery (OR = 1.1), appeared greater for Mexican-American men than for non-Hispanic white men. Conclusions. Specific LUTS are common in older U.S. men. Older black men were not more likely to have LUTS than were older white men. The apparent modestly higher prevalence of LUTS in older Mexican-American men requires additional study.
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Prevalence of and racial/ethnic variation in lower urinary tract symptoms and noncancer Prostate Surgery in U.S. men ☆
Urology, 2002Co-Authors: Elizabeth A. Platz, Ellen Smit, Gary C. Curhan, Leroy M. Nyberg, Edward GiovannucciAbstract:Abstract Objectives. To estimate the proportion of U.S. men affected by specific lower urinary tract symptoms (LUTS) and to assess whether the prevalence of LUTS varies by race/ethnicity. Methods. Included were 30+-year-old men who took part in the Third National Health and Nutrition Examination Survey. Men were asked whether they experienced nocturia, incomplete emptying, or hesitancy. Men 60+ years old were also asked whether they had a decreased urinary stream or had ever undergone noncancer Prostate Surgery. To obtain the estimated prevalences for the U.S. population, we applied sampling fraction weights. We calculated age-adjusted odds ratios (ORs) of 3+ symptoms or Surgery by race/ethnicity using logistic regression analysis. Results. Only nocturia was common in 30 to 59-year-old men. Among men who had not had Prostate Surgery, 59.9% of men 60 to 69 years old and 75.1% of men 70+ years old had at least one symptom. All four symptoms were reported by 3.0% of men 60 to 69 years and 5.6% of men 70+ years old. Of the men 60 to 69 years old and men 70+ years old, 8.0% and 22.4%, respectively, reported having undergone Surgery. In men 60+ years old, the age-adjusted OR for either having 3+ symptoms or Surgery was 0.8 for non-Hispanic black men compared with non-Hispanic white men. The odds of having 3+ symptoms (OR = 1.6), but not Surgery (OR = 1.1), appeared greater for Mexican-American men than for non-Hispanic white men. Conclusions. Specific LUTS are common in older U.S. men. Older black men were not more likely to have LUTS than were older white men. The apparent modestly higher prevalence of LUTS in older Mexican-American men requires additional study.
Tsunghsun Tsai - One of the best experts on this subject based on the ideXlab platform.
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maximum urine flow rate of less than 15ml sec increasing risk of urine retention and Prostate Surgery among patients with alpha 1 blockers a 10 year follow up study
PLOS ONE, 2016Co-Authors: Tsunghsun Tsai, Tengfu HsiehAbstract:Background The aim of this study was to determine the subsequent risk of acute urine retention and Prostate Surgery in patients receiving alpha-1 blockers treatment and having a maximum urinary flow rate of less than 15ml/sec. Methods We identified patients who were diagnosed with benign Prostate hyperplasia (BPH) and had a maximum uroflow rate of less than 15ml/sec between 1 January, 2002 to 31 December, 2011 from Taiwan’s National Health Insurance Research Database into study group (n = 303). The control cohort included four BPH/LUTS patients without 5ARI used for each study group, randomly selected from the same dataset (n = 1,212). Each patient was monitored to identify those who subsequently developed Prostate Surgery and acute urine retention. Results Prostate Surgery and acute urine retention are detected in 5.9% of control group and 8.3% of study group during 10-year follow up. Compared with the control group, there was increase in the risk of Prostate Surgery and acute urine retention in the study group (HR = 1.83, 95% CI: 1.16 to 2.91) after adjusting for age, comorbidities, geographic region and socioeconomic status. Conclusions Maximum urine flow rate of less than 15ml/sec is a risk factor of urinary retention and subsequent Prostate Surgery in BPH patients receiving alpha-1 blocker therapy. This result can provide a reference for clinicians.
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Maximum Urine Flow Rate of Less than 15ml/Sec Increasing Risk of Urine Retention and Prostate Surgery among Patients with Alpha-1 Blockers: A 10-Year Follow Up Study.
PLOS ONE, 2016Co-Authors: Tsunghsun Tsai, Tengfu HsiehAbstract:Background The aim of this study was to determine the subsequent risk of acute urine retention and Prostate Surgery in patients receiving alpha-1 blockers treatment and having a maximum urinary flow rate of less than 15ml/sec. Methods We identified patients who were diagnosed with benign Prostate hyperplasia (BPH) and had a maximum uroflow rate of less than 15ml/sec between 1 January, 2002 to 31 December, 2011 from Taiwan’s National Health Insurance Research Database into study group (n = 303). The control cohort included four BPH/LUTS patients without 5ARI used for each study group, randomly selected from the same dataset (n = 1,212). Each patient was monitored to identify those who subsequently developed Prostate Surgery and acute urine retention. Results Prostate Surgery and acute urine retention are detected in 5.9% of control group and 8.3% of study group during 10-year follow up. Compared with the control group, there was increase in the risk of Prostate Surgery and acute urine retention in the study group (HR = 1.83, 95% CI: 1.16 to 2.91) after adjusting for age, comorbidities, geographic region and socioeconomic status. Conclusions Maximum urine flow rate of less than 15ml/sec is a risk factor of urinary retention and subsequent Prostate Surgery in BPH patients receiving alpha-1 blocker therapy. This result can provide a reference for clinicians.
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Maximum Urine Flow Rate of Less than 15ml/Sec Increasing Risk of Urine Retention and Prostate Surgery among Patients with Alpha-1 Blockers: A 10-Year Follow Up Study.
PloS one, 2016Co-Authors: Hsin-ho Liu, Tsunghsun Tsai, Shang-sen Lee, Yu-hung Kuo, Tengfu HsiehAbstract:The aim of this study was to determine the subsequent risk of acute urine retention and Prostate Surgery in patients receiving alpha-1 blockers treatment and having a maximum urinary flow rate of less than 15ml/sec. We identified patients who were diagnosed with benign Prostate hyperplasia (BPH) and had a maximum uroflow rate of less than 15ml/sec between 1 January, 2002 to 31 December, 2011 from Taiwan's National Health Insurance Research Database into study group (n = 303). The control cohort included four BPH/LUTS patients without 5ARI used for each study group, randomly selected from the same dataset (n = 1,212). Each patient was monitored to identify those who subsequently developed Prostate Surgery and acute urine retention. Prostate Surgery and acute urine retention are detected in 5.9% of control group and 8.3% of study group during 10-year follow up. Compared with the control group, there was increase in the risk of Prostate Surgery and acute urine retention in the study group (HR = 1.83, 95% CI: 1.16 to 2.91) after adjusting for age, comorbidities, geographic region and socioeconomic status. Maximum urine flow rate of less than 15ml/sec is a risk factor of urinary retention and subsequent Prostate Surgery in BPH patients receiving alpha-1 blocker therapy. This result can provide a reference for clinicians.
Marcus J. Drake - One of the best experts on this subject based on the ideXlab platform.
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outcomes of a noninferiority randomised controlled trial of Surgery for men with urodynamic stress incontinence after Prostate Surgery master
European Urology, 2021Co-Authors: Paul Abrams, Lynda Constable, David A. Cooper, Marcus J. Drake, Christopher Harding, Graeme Maclennan, Anthony R Mundy, Kirsty MccormackAbstract:Abstract Background Stress urinary incontinence (SUI) is common after radical Prostatectomy and likely to persist despite conservative treatment. The sling is an emerging operation for persistent SUI, but randomised controlled trial (RCT) comparison with the established artificial urinary sphincter (AUS) is lacking. Objective To compare the outcomes of Surgery in men with bothersome urodynamic SUI after Prostate Surgery. Design, setting, and participants A noninferiority RCT was conducted among men with bothersome urodynamic SUI from 27 UK centres. Blinding was not possible due the surgeries. Intervention Participants were randomly assigned (1:1) to the male transobturator sling (n = 190) or the AUS (n = 190) group. Outcome measurements and statistical analysis The primary outcome was patient-reported SUI 12 mo after randomisation, collected from postal questionnaire using a composite outcome from two items in validated International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form questionnaire (ICIQ-UI SF). Noninferiority margin was 15%, thought to be of acceptable lower effectiveness, in return for reduced adverse events (AEs) and easier operation, for the sling. Secondary outcomes were operative and postoperative details, patient-reported measures, and AEs, up to 12 mo after Surgery. Results and limitations A total of 380 participants were included. At 12 mo after randomisation, incontinence rates were 134/154 (87.0%) for male sling versus 133/158 (84.2%) for AUS (difference 3.6% [95% confidence interval {CI} –11.6 to 4.6], pNI = 0.003), showing noninferiority. Incontinence symptoms (ICIQ-UI SF) reduced from scores of 16.1 and 16.4 at baseline to 8.7 and 7.5 for male sling and AUS, respectively (mean difference 1.4 [95% CI 0.2–2.6], p = 0.02). Serious AEs (SAEs) were few: n = 6 and n = 13 for male sling and AUS (one man had three SAEs), respectively. Quality of life scores improved, and satisfaction was high in both groups. All other secondary outcomes that show statistically significant differences favour the AUS. Conclusions Using a strict definition, urinary incontinence rates remained high, with no evidence of difference between male sling and AUS. Symptoms and quality of life improved significantly in both groups, and men were generally satisfied with both procedures. Overall, secondary and post hoc analyses were in favour of AUS. Patient summary Urinary incontinence after Prostatectomy has considerable effect on men’s quality of life. MASTER shows that if Surgery is needed, both surgical options result in fewer symptoms and high satisfaction, despite most men not being completely dry. However, most other results indicate that men having an artificial urinary sphincter have better outcomes than those who have a sling.
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Diagnostic Assessment of Lower Urinary Tract Symptoms in Men Considering Prostate Surgery: A Noninferiority Randomised Controlled Trial of Urodynamics in 26 Hospitals
European urology, 2020Co-Authors: Marcus J. Drake, Amanda L Lewis, Grace J Young, Paul Abrams, Peter S Blair, Christopher R Chapple, Cathryn Glazener, Jeremy Horwood, John S Mcgrath, Sian NobleAbstract:Abstract Background Prostate Surgery can improve lower urinary tract symptoms (LUTS) by relieving bladder outlet obstruction (BOO). However, Surgery is less effective without BOO, or if detrusor underactivity is present. Urodynamics (UDS) can identify BOO and measure detrusor activity, but evidence in clinical practice is lacking. Objective Urodynamics for Prostate Surgery Trial: Randomised Evaluation of Assessment Methods (UPSTREAM) aimed to evaluate whether a care pathway including UDS would reduce Surgery without increasing urinary symptoms. Design, setting, and participants UPSTREAM is a pragmatic, noninferiority, randomised controlled trial in men with bothersome LUTS, in whom Surgery was an option, in 26 hospitals in England (ISRCTN56164274). Intervention Participants were randomised (1:1) to routine care (RC) diagnostic tests, or RC plus UDS. Outcome measurements and statistical analysis The primary outcome was the International Prostate Symptom Score (IPSS; patient-reported outcome scale from 0 to 35 points) 18 mo after randomisation, with a noninferiority margin of 1 point. Urological Surgery rates were a key secondary outcome. The primary outcome was compared between the arms using linear regression, analysed on an intention-to-treat basis. Results and limitations Between October 2014 and December 2016, 820 men (median age 68 yr) were randomised (393 and 427 in the RC and UDS arms, respectively). The UDS arm showed noninferiority of the mean IPSSs (UDS 12.6; RC 13.1; adjusted difference at 18 mo −0.33 [95% confidence interval {CI} −1.47, +0.80]). In the UDS arm, 153/408 (38%) received Surgery compared with 138/384 (36%) in the RC arm (adjusted odds ratio 1.05; 95% CI 0.77, 1.43). A total of 428 adverse events (UDS 234; RC 194) were recorded, with related events similar in both arms and 11 unrelated deaths. Conclusions In this population, the UDS randomised group was noninferior to RC for the IPSS but did not reduce surgical rates. This study shows that routine use of UDS in the evaluation of uncomplicated LUTS has a limited role and should be used selectively. Patient summary For men with uncomplicated lower urinary tract symptoms, symptom improvements after treatment and the number of operations performed are similar, irrespective of whether or not urodynamic tests are conducted in addition to routine tests. Accordingly, routine use of urodynamics has a limited role in this population group.
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Male synthetic sling versus artificial urinary sphincter trial for men with urodynamic stress incontinence after Prostate Surgery (MASTER) : Study protocol for a randomised controlled trial
Trials, 2018Co-Authors: Lynda Constable, Cathryn Glazener, Mary Kilonzo, Nikki Cotterill, David A. Cooper, Marcus J. Drake, Mark Forrest, Christopher Harding, Graeme Maclennan, Kirsty MccormackAbstract:Stress urinary incontinence (SUI) is a frequent adverse effect for men undergoing Prostate Surgery. A large proportion (around 8% after radical Prostatectomy and 2% after transurethral resection of Prostate (TURP)) are left with severe disabling incontinence which adversely effects their quality of life and many are reliant on containment measures such as pads (27% and 6% respectively). Surgery is currently the only option for active management of the problem. The overwhelming majority of surgeries for persistent bothersome SUI involve artificial urinary sphincter (AUS) insertion. However, this is expensive, and necessitates manipulation of a pump to enable voiding. More recently, an alternative to AUS has been developed – a synthetic sling for men which elevates the urethra, thus treating SUI. This is thought, by some, to be less invasive, more acceptable and less expensive than AUS but clear evidence for this is lacking. The MASTER trial aims to determine whether the male synthetic sling is non-inferior to implantation of the AUS for men who have SUI after Prostate Surgery (for cancer or benign disease), judged primarily on clinical effectiveness but also considering relative harms and cost-effectiveness. Men with urodynamic stress incontinence (USI) after Prostate Surgery, for whom Surgery is judged appropriate, are the target population. We aim to recruit men from secondary care urological centres in the UK NHS who carry out Surgery for post-Prostatectomy incontinence. Outcomes will be assessed by participant-completed questionnaires and 3-day urinary bladder diaries at baseline, 6, 12 and 24 months. The 24-h urinary pad test will be used at baseline as an objective assessment of urine loss. Clinical data will be completed at the time of Surgery to provide details of the operative procedures, complications and resource use in hospital. At 12 months, men will also have a clinical review to evaluate the results of Surgery (including another 24-h pad test) and to identify problems or need for further treatment. A robust examination of the comparative effectiveness of the male synthetic sling will provide high-quality evidence to determine whether or not it should be adopted widely in the NHS. International Standard Randomised Controlled Trial Registry: Number ISRCTN49212975 . Registered on 22 July 2013. First patient randomised on 29 January 2014.
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statistical analysis plan for the urodynamics for Prostate Surgery trial randomised evaluation of assessment methods upstream
Trials, 2017Co-Authors: Grace J Young, Amanda L Lewis, Marcus J. Drake, Athene J Lane, Helen L Winton, Peter S BlairAbstract:Current management for men with lower urinary tract symptoms (LUTS) is a pathway that results in Prostate Surgery in a significant proportion. While helpful in relieving benign prostatic obstruction (BPO), Surgery may be ineffective for men suffering from difficulties not relating to BPO. The UPSTREAM trial started recruitment in October 2014 with the aim of establishing whether a care pathway including urodynamics (a diagnostic tool for BPO and thus an indication of whether Surgery is needed) is no worse for men, in terms of symptomatic outcome, than one without (routine care). This analysis plan outlines the main outcomes of the study and specific design choices, such as non-inferiority margins. The trial is currently recruiting in 26 hospitals across the UK, randomising men to either urodynamics or routine care, with recruitment set to end on the 31 December 2016. All outcomes will be measured 18 months after randomisation to allow sufficient time for surgical procedures and recovery. The primary outcome is based on a non-inferiority design with a margin of 1 point on the International Prostate Symptom Score (IPSS) scale. The key secondary outcome for this trial is Surgery rate per arm, which is estimated to be at least 18% lower in the urodynamics arm. Surgery rates, adverse events, flow rate, urinary symptoms and sexual symptoms are secondary outcomes to be assessed for superiority. This is an update to the UPSTREAM protocol, which has already been published in this journal. This a priori statistical analysis plan aims to reduce reporting bias by allowing access to the trial’s objectives and plans in advance of recruitment end. The results of the trial are expected to be published soon after the trial end date of 30 September 2018. ISRCTN registry, ISRCTN56164274 . Registered on 8 April 2014.
Cathryn Glazener - One of the best experts on this subject based on the ideXlab platform.
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Diagnostic Assessment of Lower Urinary Tract Symptoms in Men Considering Prostate Surgery: A Noninferiority Randomised Controlled Trial of Urodynamics in 26 Hospitals
European urology, 2020Co-Authors: Marcus J. Drake, Amanda L Lewis, Grace J Young, Paul Abrams, Peter S Blair, Christopher R Chapple, Cathryn Glazener, Jeremy Horwood, John S Mcgrath, Sian NobleAbstract:Abstract Background Prostate Surgery can improve lower urinary tract symptoms (LUTS) by relieving bladder outlet obstruction (BOO). However, Surgery is less effective without BOO, or if detrusor underactivity is present. Urodynamics (UDS) can identify BOO and measure detrusor activity, but evidence in clinical practice is lacking. Objective Urodynamics for Prostate Surgery Trial: Randomised Evaluation of Assessment Methods (UPSTREAM) aimed to evaluate whether a care pathway including UDS would reduce Surgery without increasing urinary symptoms. Design, setting, and participants UPSTREAM is a pragmatic, noninferiority, randomised controlled trial in men with bothersome LUTS, in whom Surgery was an option, in 26 hospitals in England (ISRCTN56164274). Intervention Participants were randomised (1:1) to routine care (RC) diagnostic tests, or RC plus UDS. Outcome measurements and statistical analysis The primary outcome was the International Prostate Symptom Score (IPSS; patient-reported outcome scale from 0 to 35 points) 18 mo after randomisation, with a noninferiority margin of 1 point. Urological Surgery rates were a key secondary outcome. The primary outcome was compared between the arms using linear regression, analysed on an intention-to-treat basis. Results and limitations Between October 2014 and December 2016, 820 men (median age 68 yr) were randomised (393 and 427 in the RC and UDS arms, respectively). The UDS arm showed noninferiority of the mean IPSSs (UDS 12.6; RC 13.1; adjusted difference at 18 mo −0.33 [95% confidence interval {CI} −1.47, +0.80]). In the UDS arm, 153/408 (38%) received Surgery compared with 138/384 (36%) in the RC arm (adjusted odds ratio 1.05; 95% CI 0.77, 1.43). A total of 428 adverse events (UDS 234; RC 194) were recorded, with related events similar in both arms and 11 unrelated deaths. Conclusions In this population, the UDS randomised group was noninferior to RC for the IPSS but did not reduce surgical rates. This study shows that routine use of UDS in the evaluation of uncomplicated LUTS has a limited role and should be used selectively. Patient summary For men with uncomplicated lower urinary tract symptoms, symptom improvements after treatment and the number of operations performed are similar, irrespective of whether or not urodynamic tests are conducted in addition to routine tests. Accordingly, routine use of urodynamics has a limited role in this population group.
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clinical and patient reported outcome measures in men referred for consideration of Surgery to treat lower urinary tract symptoms baseline results and diagnostic findings of the urodynamics for Prostate Surgery trial randomised evaluation of assessme
European urology focus, 2019Co-Authors: Amanda L Lewis, Grace J Young, Paul Abrams, Peter S Blair, Christopher R Chapple, Cathryn Glazener, Jeremy Horwood, John S Mcgrath, Sian M Noble, Gordon T TaylorAbstract:Abstract Background Clinical evaluation of male lower urinary tract symptoms (MLUTS) in secondary care uses a range of assessments. It is unknown how MLUTS evaluation influences outcome of therapy recommendations and choice, notably urodynamics (UDS; filling cystometry and pressure flow studies). Objective To report participants’ sociodemographic and clinical characteristics, and initial diagnostic findings of the Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM). UPSTREAM is a randomised controlled trial evaluating whether symptoms are noninferior and Surgery rates are lower if UDS is included. Design, setting, and participants A total of 820 men (≥18 yr of age) seeking treatment for bothersome LUTS were recruited from 26 National Health Service hospital urology departments. Intervention Care pathway based on routine, noninvasive tests (control) or routine care plus UDS (intervention arm). Outcome measurements and statistical analysis The primary outcome is International Prostate Symptom Score (IPSS) and the key secondary outcome is Surgery rates 18 mo after randomisation. International Consultation on Incontinence Questionnaires were captured for MLUTS, sexual function, and UDS satisfaction. Baseline clinical and patient-reported outcome measures (PROMs), and UDS findings were informally compared between arms. Trends across age groups for urinary and sexual PROMs were evaluated with a Cuzick’s test, and questionnaire items were compared using Pearson’s correlation coefficient. Results and limitations Storage LUTS, notably nocturia, and impaired sexual function are prominent in men being assessed for Surgery. Sociodemographic and clinical evaluations were similar between arms. Overall mean IPSS and quality of life scores were 18.94 and 4.13, respectively. Trends were found across age groups, with older men suffering from higher rates of incontinence, nocturia, and erectile dysfunction, and younger men suffering from increased daytime frequency and voiding symptoms. Men undergoing UDS testing expressed high satisfaction with the procedure. Conclusions Men being considered for Surgery have additional clinical features that may affect treatment decision making and outcomes, notably storage LUTS and impaired sexual function. Patient summary We describe initial assessment findings from a large clinical study of the treatment pathway for men suffering with bothersome urinary symptoms who were referred to hospital for further treatment, potentially including Surgery. We report the patient characteristics and diagnostic test results, including symptom questionnaires, bladder diaries, flow rate tests, and urodynamics.
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Male synthetic sling versus artificial urinary sphincter trial for men with urodynamic stress incontinence after Prostate Surgery (MASTER) : Study protocol for a randomised controlled trial
Trials, 2018Co-Authors: Lynda Constable, Cathryn Glazener, Mary Kilonzo, Nikki Cotterill, David A. Cooper, Marcus J. Drake, Mark Forrest, Christopher Harding, Graeme Maclennan, Kirsty MccormackAbstract:Stress urinary incontinence (SUI) is a frequent adverse effect for men undergoing Prostate Surgery. A large proportion (around 8% after radical Prostatectomy and 2% after transurethral resection of Prostate (TURP)) are left with severe disabling incontinence which adversely effects their quality of life and many are reliant on containment measures such as pads (27% and 6% respectively). Surgery is currently the only option for active management of the problem. The overwhelming majority of surgeries for persistent bothersome SUI involve artificial urinary sphincter (AUS) insertion. However, this is expensive, and necessitates manipulation of a pump to enable voiding. More recently, an alternative to AUS has been developed – a synthetic sling for men which elevates the urethra, thus treating SUI. This is thought, by some, to be less invasive, more acceptable and less expensive than AUS but clear evidence for this is lacking. The MASTER trial aims to determine whether the male synthetic sling is non-inferior to implantation of the AUS for men who have SUI after Prostate Surgery (for cancer or benign disease), judged primarily on clinical effectiveness but also considering relative harms and cost-effectiveness. Men with urodynamic stress incontinence (USI) after Prostate Surgery, for whom Surgery is judged appropriate, are the target population. We aim to recruit men from secondary care urological centres in the UK NHS who carry out Surgery for post-Prostatectomy incontinence. Outcomes will be assessed by participant-completed questionnaires and 3-day urinary bladder diaries at baseline, 6, 12 and 24 months. The 24-h urinary pad test will be used at baseline as an objective assessment of urine loss. Clinical data will be completed at the time of Surgery to provide details of the operative procedures, complications and resource use in hospital. At 12 months, men will also have a clinical review to evaluate the results of Surgery (including another 24-h pad test) and to identify problems or need for further treatment. A robust examination of the comparative effectiveness of the male synthetic sling will provide high-quality evidence to determine whether or not it should be adopted widely in the NHS. International Standard Randomised Controlled Trial Registry: Number ISRCTN49212975 . Registered on 22 July 2013. First patient randomised on 29 January 2014.
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The effect of urinary incontinence on health utility and health-related quality of life in men following Prostate Surgery.
Neurourology and urodynamics, 2012Co-Authors: Brian S Buckley, Marie Carmela M. Lapitan, Cathryn GlazenerAbstract:Aims The impact of urinary incontinence (UI) on health-related quality of life (HRQoL) has been less well researched in men than women and the general population. This study aims to assess the association between UI and HRQoL in men 1 year after Prostate Surgery. Methods Planned secondary analysis of data from two parallel randomized controlled trials of active conservative treatment for UI in 853 men following radical Prostatectomy (RP) and transurethral resection of the Prostate (TURP). Men of any age were eligible for trial inclusion if they were experiencing UI 6 weeks after undergoing RP or TURP at 34 centers in the United Kingdom. Univariate and multivariate analysis considered associations between health status (SF-12 and EQ-5D) and self-reported UI. Multivariate analysis controlled for age, obesity, UI prior to Surgery, and concomitant fecal incontinence. Results Mean age of 411 men in the RP trial was 62.3 years (SD 5.7) and 442 men in the TURP trial was 68.0 (SD 7.9). Of men with UI at 6 weeks after Surgery, 76.7% in the RP group and 63.2% in the TURP group still had UI at 12 months. Any UI at 12 months was significantly associated with reduced HRQoL in the RP group and lower EQ-5D and SF-12 Mental Component Scores in the TURP group. Conclusion Any UI is a significant factor in reduced HRQoL in men following Prostate Surgery, particularly younger men who undergo RP. Its importance to patients as an adverse outcome should not be underestimated. Neurourol. Urodynam. 31:465–469, 2012. © 2012 Wiley Periodicals, Inc.
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Conservative treatment for urinary incontinence in Men After Prostate Surgery (MAPS): two parallel randomised controlled trials.
Health technology assessment (Winchester England), 2011Co-Authors: Cathryn Glazener, Charles Boachie, Brian S Buckley, Claire Cochran, Grace Dorey, Alistair Grant, Suzanne Hagen, Mary Kilonzo, Alison Mcdonald, Gladys McphersonAbstract:Objective To determine the clinical effectiveness and cost-effectiveness of active conservative treatment, compared with standard management, in regaining urinary continence at 12 months in men with urinary incontinence at 6 weeks after a radical Prostatectomy or a transurethral resection of the Prostate (TURP). Background Urinary incontinence after radical Prostate Surgery is common immediately after Surgery, although the chance of incontinence is less after TURP than following radical Prostatectomy. Design Two multicentre, UK, parallel randomised controlled trials (RCTs) comparing active conservative treatment [pelvic floor muscle training (PFMT) delivered by a specialist continence physiotherapist or a specialist continence nurse] with standard management in men after radial Prostatectomy and TURP. Setting Men having Prostate Surgery were identified in 34 centres across the UK. If they had urinary incontinence, they were invited to enroll in the RCT. Participants Men with urinary incontinence at 6 weeks after Prostate Surgery were eligible to be randomised if they consented and were able to comply with the intervention. Interventions Eligible men were randomised to attend four sessions with a therapist over a 3-month period. The therapists provided standardised PFMT and bladder training for male urinary incontinence and erectile dysfunction. The control group continued with standard management. Main outcome measures The primary outcome of clinical effectiveness was urinary incontinence at 12 months after randomisation, and the primary measure of cost-effectiveness was incremental cost per quality-adjusted life-year (QALY). Outcome data were collected by postal questionnaires at 3, 6, 9 and 12 months. Results Within the radical group (n = 411), 92% of the men in the intervention group attended at least one therapy visit and were more likely than those in the control group to be carrying out any PFMT at 12 months {adjusted risk ratio (RR) 1.30 [95% confidence interval (CI) 1.09 to 1.53]}. The absolute risk difference in urinary incontinence rates at 12 months between the intervention (75.5%) and control (77.4%) groups was -1.9% (95% CI -10% to 6%). NHS costs were higher in the intervention group [£ 181.02 (95% CI £ 107 to £ 255)] but there was no evidence of a difference in societal costs, and QALYs were virtually identical for both groups. Within the TURP group (n = 442), over 85% of men in the intervention group attended at least one therapy visit and were more likely to be carrying out any PFMT at 12 months after randomisation [adjusted RR 3.20 (95% CI 2.37 to 4.32)]. The absolute risk difference in urinary incontinence rates at 12 months between the intervention (64.9%) and control (61.5%) groups for the unadjusted intention-to-treat analysis was 3.4% (95% CI -6% to 13%). NHS costs [£ 209 (95% CI £ 147 to £ 271)] and societal costs [£ 420 (95% CI £ 54 to £ 785)] were statistically significantly higher in the intervention group but QALYs were virtually identical. Conclusions The provision of one-to-one conservative physical therapy for men with urinary incontinence after Prostate Surgery is unlikely to be effective or cost-effective compared with standard care that includes the provision of information about conducting PFMT. Future work should include research into the value of different surgical options in controlling urinary incontinence.
