Community-based studies and surveys have found an association between lower urinary tract symptom... more Community-based studies and surveys have found an association between lower urinary tract symptoms (LUTS) and sexual dysfunction, in particular, erectile dysfunction (ED). The link between ED and LUTS has biologic plausibility. The following 4 theories have been used to explain how these disorders interrelate: 1) decreased or altered nitric oxide synthase/nitric oxide levels in the prostate and penile smooth muscle; 2) autonomic hyperactivity effects on LUTS, prostate growth, and ED; 3) increased Rho-kinase activation/endothelin activity; and 4) prostate and penile atherosclerosis. The relationship of LUTS and sexual dysfunction suggests that treatment of one condition may impact the other.
The relationship between lower urinary tract symptoms secondary to BPH and ED has recently been t... more The relationship between lower urinary tract symptoms secondary to BPH and ED has recently been the subject of significant research due to the prevalence of both conditions concomitantly existing in older men. Many large-scale studies have demonstrated an association between erectile dysfunction and lower urinary tract symptoms. Although the mechanisms underlying the relationship between LUTS and ED are not fully elucidated, several theories are currently proposed in literature: the nitric oxide/cGMP pathway, RhoA/Rho-kinase signaling, pelvic atherosclerosis associated with chronic hypoxia, and autonomic adrenergic hyperactivity. The mechanisms by which these pathways affect the bladder, prostate, pelvic vasculature and spinal cord are also the subject of current research. In this chapter, we examine the randomized, placebo-controlled trials that have evaluated the use of PDE-5Is in LUTS, as well as randomized, controlled trials (RCTs) researching combination PDE-5Is and alpha block...
The purpose of this guideline is to provide a clinical strategy for the diagnosis and treatment o... more The purpose of this guideline is to provide a clinical strategy for the diagnosis and treatment of erectile dysfunction. A systematic review of the literature using the Pubmed, Embase, and Cochrane databases (search dates 1/1/1965 to 7/29/17) was conducted to identify peer-reviewed publications relevant to the diagnosis and treatment of erectile dysfunction. Evidence-based statements were based on body of evidence strength Grade A, B, or C and were designated as Strong, Moderate, and Conditional Recommendations with additional statements presented in the form of Clinical Principles or Expert Opinions. The American Urological Association has developed an evidence-based guideline on the management of erectile dysfunction. This document is designed to be used in conjunction with the associated treatment algorithm. Using the shared decision-making process as a cornerstone for care, all patients should be informed of all treatment modalities that are not contraindicated, regardless of in...
Male lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) is commo... more Male lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) is common in men and can have negative effects on quality of life (QOL). It is the hope that this Guideline becomes a reference on the effective evidence-based surgical management of LUTS/BPH. The evidence team searched Ovid MEDLINE, the Cochrane Library, and the Agency for Healthcare Research and Quality (AHRQ) database to identify studies indexed between January 2007 and September 2017. When sufficient evidence existed, the body of evidence was assigned a strength rating of A (high), B (moderate), or C (low) for support of Strong, Moderate, or Conditional Recommendations. In the absence of sufficient evidence, additional information is provided as Clinical Principles and Expert Opinions (table 1 in supplementary unabridged guideline, http://jurology.com/). This Guideline provides updated, evidence-based recommendations regarding management of LUTS/BPH utilizing surgery and minimally invasive s...
To report 3-year outcomes of a prospective, multi-center, randomized, blinded control trial after... more To report 3-year outcomes of a prospective, multi-center, randomized, blinded control trial after treatment with convective radiofrequency (RF) water vapor thermal therapy for moderate to severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Fifteen centers enrolled and randomized 197 men ≥50 years old with International Prostate Symptom Score (IPSS) ≥13, maximum flow rate (Qmax) ≤15 ml/s and prostate volume 30 to 80 cc to thermal therapy with Rezūm® System or control (2:1). Rigid cystoscopy with simulated active treatment sound effects served as the control procedure. Convective RF thermal energy was delivered into obstructive prostate tissue including the median lobe as needed. After randomized comparison at 3 months, thermal therapy subjects were followed annually for 3 years. Convective RF thermal therapy yielded IPSS improvements 160% when compared to control subjects at 3 months (p<0.0001). Maximal symptom relief of at least 50% improvements ...
To report two-year outcomes of a multi-center randomized controlled trial plus one-year results o... more To report two-year outcomes of a multi-center randomized controlled trial plus one-year results of a crossover trial after treatment with convective radiofrequency water vapor thermal energy for lower urinary tract symptoms due to benign prostatic hyperplasia. 197 men at least 50 years old with International Prostate Symptom Scores 13 or greater, maximum flow rate of 15 ml per second or less and prostate size 30 to 80 cc were randomized 2:1 between thermal therapy with the Rezūm® System and control. Rigid cystoscopy with simulated active treatment sounds served as the control procedure. After unblinding at 3 months, control subjects could re-qualify for crossover study. Convectively delivered radiofrequency thermal energy was delivered into obstructive prostate tissue, including the median lobe as needed. The primary efficacy endpoint was change in severity of symptom scores. Convective radiofrequency thermal therapy improved urinary symptoms significantly over controls at 3 months ...
Erectile dysfunction (ED) and benign prostatic hyperplasia (BPH) frequently co-occur in men aged ... more Erectile dysfunction (ED) and benign prostatic hyperplasia (BPH) frequently co-occur in men aged ≥40, along with lower urinary tract symptoms (LUTS) secondary to BPH. Given little real-world evidence on treatment use or satisfaction with treatment for concurrent BPH/LUTS and/or ED, this study examined medication regimens and differences in satisfaction and health-related quality of life (HRQoL) across regimens among men with concurrent BPH and ED. A cross-sectional study was conducted using an Internet survey of participants recruited through an online panel. Respondents (N=736) included men (aged ≥40) who self-reported a diagnosis of both ED and BPH with prescription treatment in the past 3 months for both conditions. Treatment satisfaction (eg, convenience and ease of planning) and HRQoL (eg, International Prostate Symptom Score, sleep quality) were self-reported. Generalized linear models examined the association of regimen with treatment satisfaction and HRQoL, adjusting for cov...
Little is known about how total testosterone and estradiol-17β influence lower urinary tract symp... more Little is known about how total testosterone and estradiol-17β influence lower urinary tract symptoms (LUTS) in men with benign prostatic hypertrophy (BPH). We analyzed data from a subset of men aged ≥18 years randomized to tadalafil 5 mg once-daily or placebo who had ≥6 month history of LUTS and an International Prostate Symptom Score (IPSS)≥13 enrolled in one of three randomized, placebo-controlled tadalafil clinical trials (N = 958). Three specific aims were addressed, as follows: (i) To characterize enrolled men by treatment randomization and testosterone level; (ii) to assess cross-sectional associations of estradiol-17β, testosterone, and LUTS prior to treatment with tadalafil; and, (iii) to assess longitudinal associations between baseline estradiol-17β and testosterone and improvements or worsening of LUTS during a 12-week period of tadalafil or placebo administration. LUTS were assessed by total IPSS, IPSS voiding sub-score (IPSS-V) and IPSS storage sub-score (IPSS-S) for c...
To report the three year results of a multi-center, randomized, patient and outcome assessor blin... more To report the three year results of a multi-center, randomized, patient and outcome assessor blinded trial of the Prostatic Urethral Lift (PUL) in men with bothersome lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). At 19 centers in North America and Australia, 206 subjects = 50 years old with International Prostate Symptom Score (IPSS) ≥ 13, peak flow rate (Qmax) ≤ 12 mL/s, and prostate volume between 30 cc-80 cc were randomized 2:1 to the PUL procedure or sham control. PUL involved placing permanent UroLift implants into the lateral lobes of the prostate to enlarge the urethral lumen. After randomized comparison at 3 months, PUL patients were followed to 3 years. LUTS severity (IPSS), quality of life, Qmax, sexual function, and adverse events were assessed throughout follow up. The therapeutic effect of PUL regarding IPSS was 88% greater than sham at 3 months. Average improvements from baseline through 3 years were significant for total IPSS (41.1%), ...
Claus Roehrborn*, Dallas, TX; Steven Gange, Salt Lake City, UT; Neal Shore, Myrtle Beach, SC; Jon... more Claus Roehrborn*, Dallas, TX; Steven Gange, Salt Lake City, UT; Neal Shore, Myrtle Beach, SC; Jonathan Giddens, Woodbridge, Canada; Damien Bolton, Melbourne, Australia; Barrett Cowan, Denver, CO; Thomas Brown, Daytona Beach, FL; Kevin McVary, Springfield, IL; Peter Chin, Figtree, Australia; Alexis Te, New York, NY; Shahram Gholami, San Jose, CA; Prem Rashid, Port Macquarie, Australia; William Moseley, San Diego, CA; Ronald Tutrone, Towson, MD; Sheldon Freedman, Las Vegas, NV; Peter Incze, Oakville, Canada; K. Scott Coffield, Temple, TX; Fernando Borges, St. Petersburg, FL; Daniel Rukstalis, Winston-Salem, NC
Community-based studies and surveys have found an association between lower urinary tract symptom... more Community-based studies and surveys have found an association between lower urinary tract symptoms (LUTS) and sexual dysfunction, in particular, erectile dysfunction (ED). The link between ED and LUTS has biologic plausibility. The following 4 theories have been used to explain how these disorders interrelate: 1) decreased or altered nitric oxide synthase/nitric oxide levels in the prostate and penile smooth muscle; 2) autonomic hyperactivity effects on LUTS, prostate growth, and ED; 3) increased Rho-kinase activation/endothelin activity; and 4) prostate and penile atherosclerosis. The relationship of LUTS and sexual dysfunction suggests that treatment of one condition may impact the other.
The relationship between lower urinary tract symptoms secondary to BPH and ED has recently been t... more The relationship between lower urinary tract symptoms secondary to BPH and ED has recently been the subject of significant research due to the prevalence of both conditions concomitantly existing in older men. Many large-scale studies have demonstrated an association between erectile dysfunction and lower urinary tract symptoms. Although the mechanisms underlying the relationship between LUTS and ED are not fully elucidated, several theories are currently proposed in literature: the nitric oxide/cGMP pathway, RhoA/Rho-kinase signaling, pelvic atherosclerosis associated with chronic hypoxia, and autonomic adrenergic hyperactivity. The mechanisms by which these pathways affect the bladder, prostate, pelvic vasculature and spinal cord are also the subject of current research. In this chapter, we examine the randomized, placebo-controlled trials that have evaluated the use of PDE-5Is in LUTS, as well as randomized, controlled trials (RCTs) researching combination PDE-5Is and alpha block...
The purpose of this guideline is to provide a clinical strategy for the diagnosis and treatment o... more The purpose of this guideline is to provide a clinical strategy for the diagnosis and treatment of erectile dysfunction. A systematic review of the literature using the Pubmed, Embase, and Cochrane databases (search dates 1/1/1965 to 7/29/17) was conducted to identify peer-reviewed publications relevant to the diagnosis and treatment of erectile dysfunction. Evidence-based statements were based on body of evidence strength Grade A, B, or C and were designated as Strong, Moderate, and Conditional Recommendations with additional statements presented in the form of Clinical Principles or Expert Opinions. The American Urological Association has developed an evidence-based guideline on the management of erectile dysfunction. This document is designed to be used in conjunction with the associated treatment algorithm. Using the shared decision-making process as a cornerstone for care, all patients should be informed of all treatment modalities that are not contraindicated, regardless of in...
Male lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) is commo... more Male lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) is common in men and can have negative effects on quality of life (QOL). It is the hope that this Guideline becomes a reference on the effective evidence-based surgical management of LUTS/BPH. The evidence team searched Ovid MEDLINE, the Cochrane Library, and the Agency for Healthcare Research and Quality (AHRQ) database to identify studies indexed between January 2007 and September 2017. When sufficient evidence existed, the body of evidence was assigned a strength rating of A (high), B (moderate), or C (low) for support of Strong, Moderate, or Conditional Recommendations. In the absence of sufficient evidence, additional information is provided as Clinical Principles and Expert Opinions (table 1 in supplementary unabridged guideline, http://jurology.com/). This Guideline provides updated, evidence-based recommendations regarding management of LUTS/BPH utilizing surgery and minimally invasive s...
To report 3-year outcomes of a prospective, multi-center, randomized, blinded control trial after... more To report 3-year outcomes of a prospective, multi-center, randomized, blinded control trial after treatment with convective radiofrequency (RF) water vapor thermal therapy for moderate to severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Fifteen centers enrolled and randomized 197 men ≥50 years old with International Prostate Symptom Score (IPSS) ≥13, maximum flow rate (Qmax) ≤15 ml/s and prostate volume 30 to 80 cc to thermal therapy with Rezūm® System or control (2:1). Rigid cystoscopy with simulated active treatment sound effects served as the control procedure. Convective RF thermal energy was delivered into obstructive prostate tissue including the median lobe as needed. After randomized comparison at 3 months, thermal therapy subjects were followed annually for 3 years. Convective RF thermal therapy yielded IPSS improvements 160% when compared to control subjects at 3 months (p<0.0001). Maximal symptom relief of at least 50% improvements ...
To report two-year outcomes of a multi-center randomized controlled trial plus one-year results o... more To report two-year outcomes of a multi-center randomized controlled trial plus one-year results of a crossover trial after treatment with convective radiofrequency water vapor thermal energy for lower urinary tract symptoms due to benign prostatic hyperplasia. 197 men at least 50 years old with International Prostate Symptom Scores 13 or greater, maximum flow rate of 15 ml per second or less and prostate size 30 to 80 cc were randomized 2:1 between thermal therapy with the Rezūm® System and control. Rigid cystoscopy with simulated active treatment sounds served as the control procedure. After unblinding at 3 months, control subjects could re-qualify for crossover study. Convectively delivered radiofrequency thermal energy was delivered into obstructive prostate tissue, including the median lobe as needed. The primary efficacy endpoint was change in severity of symptom scores. Convective radiofrequency thermal therapy improved urinary symptoms significantly over controls at 3 months ...
Erectile dysfunction (ED) and benign prostatic hyperplasia (BPH) frequently co-occur in men aged ... more Erectile dysfunction (ED) and benign prostatic hyperplasia (BPH) frequently co-occur in men aged ≥40, along with lower urinary tract symptoms (LUTS) secondary to BPH. Given little real-world evidence on treatment use or satisfaction with treatment for concurrent BPH/LUTS and/or ED, this study examined medication regimens and differences in satisfaction and health-related quality of life (HRQoL) across regimens among men with concurrent BPH and ED. A cross-sectional study was conducted using an Internet survey of participants recruited through an online panel. Respondents (N=736) included men (aged ≥40) who self-reported a diagnosis of both ED and BPH with prescription treatment in the past 3 months for both conditions. Treatment satisfaction (eg, convenience and ease of planning) and HRQoL (eg, International Prostate Symptom Score, sleep quality) were self-reported. Generalized linear models examined the association of regimen with treatment satisfaction and HRQoL, adjusting for cov...
Little is known about how total testosterone and estradiol-17β influence lower urinary tract symp... more Little is known about how total testosterone and estradiol-17β influence lower urinary tract symptoms (LUTS) in men with benign prostatic hypertrophy (BPH). We analyzed data from a subset of men aged ≥18 years randomized to tadalafil 5 mg once-daily or placebo who had ≥6 month history of LUTS and an International Prostate Symptom Score (IPSS)≥13 enrolled in one of three randomized, placebo-controlled tadalafil clinical trials (N = 958). Three specific aims were addressed, as follows: (i) To characterize enrolled men by treatment randomization and testosterone level; (ii) to assess cross-sectional associations of estradiol-17β, testosterone, and LUTS prior to treatment with tadalafil; and, (iii) to assess longitudinal associations between baseline estradiol-17β and testosterone and improvements or worsening of LUTS during a 12-week period of tadalafil or placebo administration. LUTS were assessed by total IPSS, IPSS voiding sub-score (IPSS-V) and IPSS storage sub-score (IPSS-S) for c...
To report the three year results of a multi-center, randomized, patient and outcome assessor blin... more To report the three year results of a multi-center, randomized, patient and outcome assessor blinded trial of the Prostatic Urethral Lift (PUL) in men with bothersome lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). At 19 centers in North America and Australia, 206 subjects = 50 years old with International Prostate Symptom Score (IPSS) ≥ 13, peak flow rate (Qmax) ≤ 12 mL/s, and prostate volume between 30 cc-80 cc were randomized 2:1 to the PUL procedure or sham control. PUL involved placing permanent UroLift implants into the lateral lobes of the prostate to enlarge the urethral lumen. After randomized comparison at 3 months, PUL patients were followed to 3 years. LUTS severity (IPSS), quality of life, Qmax, sexual function, and adverse events were assessed throughout follow up. The therapeutic effect of PUL regarding IPSS was 88% greater than sham at 3 months. Average improvements from baseline through 3 years were significant for total IPSS (41.1%), ...
Claus Roehrborn*, Dallas, TX; Steven Gange, Salt Lake City, UT; Neal Shore, Myrtle Beach, SC; Jon... more Claus Roehrborn*, Dallas, TX; Steven Gange, Salt Lake City, UT; Neal Shore, Myrtle Beach, SC; Jonathan Giddens, Woodbridge, Canada; Damien Bolton, Melbourne, Australia; Barrett Cowan, Denver, CO; Thomas Brown, Daytona Beach, FL; Kevin McVary, Springfield, IL; Peter Chin, Figtree, Australia; Alexis Te, New York, NY; Shahram Gholami, San Jose, CA; Prem Rashid, Port Macquarie, Australia; William Moseley, San Diego, CA; Ronald Tutrone, Towson, MD; Sheldon Freedman, Las Vegas, NV; Peter Incze, Oakville, Canada; K. Scott Coffield, Temple, TX; Fernando Borges, St. Petersburg, FL; Daniel Rukstalis, Winston-Salem, NC
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