Benign Prostatic Hyperplasia Impact Index Research Articles

392 - Quality of life with pharmacological treatment in patients with benign prostatic enlargement: Results from the evolution European prospective multicenter multi-national registry study

Lower urinary tract symptoms due to benign prostate enlargement (LUTS/BPE) can lead to significant disturbances to health-related quality of life (HRQoL) and psychological well-being. The aim of this study was to evaluate the effect of pharmacological treatment of LUTS/BPE on disease specific and generic QOL measures. Evolution was a European prospective, multicenter multi-national, observational registry collecting real-life clinical data over 2 years on the management of LUTS/BPE in primary and secondary care. This study investigated disease-specific QOL using questionnaires such as IPSS Q8, BPH Impact Index (BII) and generic QOL using questionnaires like EuroQOL Five Dimension (EQ5D) which encompassed EQ5D VAS and EQ5D health index. The registry enrolled 1838 BPE patients and 1246 patients were evaluable at the end of 24 months. Nearly 70% of patients in the study were previously treated with medical therapy and 17% of these had already discontinued medical treatment previously for various reasons with lack of efficacy being the most common. The mean time since diagnosis of LUTS in the previously treated group was 4.7 years (0–26 years). Medical management produced statistically significant improvement in QOL (disease specific and generic) in previously untreated patients and an insignificant change in generic QOL in previously treated patients. After 5-years from the onset of symptoms, LUTS/BPE patients previously treated with medication had significantly impaired QOL in patients in a manner comparable to other chronic diseases. Earlier intervention with minimally invasive surgical techniques (MIT) should be considered in LUTS/BPE patients that do not show a significant improvement in QOL with medical therapy.

Quality of life with pharmacological treatment in patients with benign prostatic enlargement: results from the Evolution European Prospective Multicenter Multi-National Registry Study.

Lower urinary tract symptoms due to benign prostate enlargement (LUTS/BPE) can lead to significant disturbances to health-related quality of life (HRQoL) and psychological well-being. The aim of this study was to evaluate the effect of pharmacological treatment of LUTS/BPE on disease specific and generic QOL measures. Evolution was a European prospective, multicenter multi-national, observational registry collecting real-life clinical data over 2years on the management of LUTS/BPE in primary and secondary care. This study investigated disease-specific QOL using questionnaires such as IPSS Q8, BPH Impact Index (BII) and generic QOL using questionnaires like EuroQOL Five Dimension (EQ5D) which encompassed EQ5D VAS and EQ5D health index. The registry enrolled 1838 BPE patients and 1246 patients were evaluable at the end of 24months. Nearly 70% of patients in the study were previously treated with medical therapy and 17% of these had already discontinued medical treatment previously for various reasons with lack of efficacy being the most common. The mean time since diagnosis of LUTS in the previously treated group was 4.7years (0-26years). Medical management produced statistically significant improvement in QOL (disease specific and generic) in previously untreated patients and an insignificant change in generic QOL in previously treated patients. After 5-years from the onset of symptoms, LUTS/BPE patients previously treated with medication had significantly impaired QOL in patients in a manner comparable to other chronic diseases. Earlier intervention with minimally invasive surgical techniques (MIT) should be considered in LUTS/BPE patients that do not show a significant improvement in QOL with medical therapy.

PD33-01 QUALITY OF LIFE WITH PHARMACOLOGICAL TREATMENT IN PATIENTS WITH BENIGN PROSTATIC ENLARGEMENT

INTRODUCTION AND OBJECTIVE: Lower urinary tract symptoms (LUTS) due to benign prostatic enlargement (BPE) can lead to significant disturbances to health-related quality of life (HRQoL) and psychological well-being. There is variability in the relationship between individual symptom severity and the bother reported by patients as symptom scores alone, may not capture their actual impact on men. The aim of this study was to evaluate the effect of pharmacological treatment of LUTS/BPE on disease-specific and generic QoL measures. METHODS: Evolution was a European prospective, multicenter multi-national, observational registry collecting real life clinical data over two years on the management of LUTS/BPE in primary and secondary care. This study investigated disease specific QOL using questionnaires like IPSS Q8, BPH Impact Index (BII) and generic QOL using questionnaires like EuroQOL Five Dimension (EQ5D) which encompassed EQ5D VAS and EQ5D health index. RESULTS: The registry enrolled 1838 BPE patients and 1246 patients were evaluable at the end of the study period (24 months). Nearly 70% of patients in the study were previously treated with medical therapy and 17% of these had already discontinued medical treatment previously for various reasons, lack of efficacy of medication being the most common. The mean time since diagnosis of LUTS in the previously treated group was 4.7 years (0-26 years). Medical management produced statistically successful improvement in QOL (disease specific and generic), albeit significantly better in previously untreated patients. CONCLUSIONS: At an average of five years from the onset of symptoms, LUTS/BPE patients previously treated with medication had significantly impaired QOL in patients in a manner comparable to other chronic diseases. Medical management was successful in producing improvement in QOL when first started in previously untreated patients, but was much less significant in the previously treated patients. We need to rethink how we treat LUTS/BPE in clinical practice in line with emerging evidence, it is imperative to offer other options like Minimally Invasive Therapy (MIT) early, especially in patients previously treated with medical therapy.Source of Funding: Financial disclosure: The Evolution registry was supported by a restricted Grantfrom GlaxoSmithKline© (GSK).

Effect of fixed dose combinations of different α1-blockers with dutasteride on quality of life in patients of lower urinary tract symptoms with benign prostatic hyperplasia

Background: Fixed dose combination (FDC’s) of α1-blockers and 5α-reductase inhibitors have commonly been used in patients with lower urinary tract symptoms (LUTS) and benign prostatic hyperplasia (BPH). This study compared the effect of FDC’s of tamsulosin, alfuzosin and silodosin with dutasteride on quality of life (QoL) in patients of LUTS with BPH.Methods: Ninety-six male patients aged ≥45 years diagnosed with LUTS and BPH were randomized to receive FDC’s of dutasteride with tamsulosin (group 1), alfuzosin (group 2) and silodosin (group 3) over a period of 16 weeks. Quality of life was assessed using International Prostate Symptom Score (IPSS) 8th question, BPH impact index (BII) and modified Patient Perception of Study Medication (PPSM) questionnaire.Results: IPSS 8th question score improved significantly by 61.68%, 57.63% and 63.4% in group 1, 2 and 3 respectively. BPH Impact Index score also improved significantly by 62.95%, 60.13% and 61.82% in group 1, 2 and 3 respectively. All the three treatments were found to be similar in improving the QoL. Majority of patients were satisfied with their treatment and wanted to receive the medication again while a small number of patients were neutral with the study medication. None of the subjects was dissatisfied with any of the treatment.Conclusions: All the FDC’s improved QoL and were found to be satisfactory as per patient perception of study medications.

Rezūm Water Vapor Thermal Therapy for Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: 4-Year Results From Randomized Controlled Study

ObjectiveTo report 4-year outcomes of the randomized controlled trial of water vapor thermal therapy for treatment of moderate to severe lower urinary tract symptoms due to benign prostatic hyperplasia. Materials and MethodsTotal 188 subjects; 135 men ≥50years old, International Prostate Symptom Score ≥ 13, maximum flow rate (Qmax) ≤15 mL/s and prostate volume 30 to 80 cc treated with Rezūm System thermal therapy were followed 4 years; subset of 53 men who requalified for crossover from control to active treatment were followed 3years. ResultsLower urinary tract symptoms were significantly improved within ≤3 months after thermal therapy and remained consistently durable (International Prostate Symptom Score 47%, quality of life 43%, Qmax 50%, Benign Prostatic Hyperplasia Impact Index 52%) throughout 4years (P <.0001); outcomes were similarly sustained in crossover subjects at 3years. Surgical retreatment rate was 4.4% over 4years. No disturbances in sexual function were reported. ConclusionThe minimally invasive thermal therapy provides effective symptom relief and improved quality of life that remains durable for over 4years. It is applicable to all prostate zones with procedures performed under local anesthesia in an office setting.

Phosphodiesterase inhibitors for lower urinary tract symptoms consistent with benign prostatic hyperplasia.

Phosphodiesterase inhibitors for lower urinary tract symptoms consistent with benign prostatic hyperplasia.

First-in-man Safety and Efficacy of the ClearRing Implant for the Treatment of Benign Prostatic Hyperplasia

BackgroundAlthough effective for benign prostatic hyperplasia (BPH), transurethral resection of the prostate (TURP) can be associated with side effects including prolonged recovery, storage and voiding symptoms, and a risk of acute urinary retention. ObjectiveTo test a new minimally invasive device for the treatment of lower urinary tract symptoms (LUTS) due to BPH, involving implantation of a C-shaped nitinol ring (ClearRing) in a circular incision in the prostatic tissue using an electrocuting blade over a dilatation balloon. Design, setting, and participantsThis was a multicenter single-arm clinical trial involving 29 men with severe symptomatic BPH. InterventionImplantation of a ClearRing device under regional anesthesia. Outcome measurements and statistical analysisEffectiveness in alleviating LUTS was assessed in terms of International Prostate Symptom Score (IPSS) at baseline and 3, 6, and 12 mo after the procedure. To evaluate changes from baseline, a general estimating equation model was fitted to IPSS, the Quality of Life (QOL) scale, Benign Prostatic Hyperplasia Impact Index, maximum flow rate (Qmax), and postvoid residual volume. Statistical significance was defined as p<0.05. Results and limitationsThe average age was 71.4 yr, prostate size was 35–50cm3, and IPSS was 21.6. All procedures were successfully completed with one implant in 28 patients and two implants in one patient. No serious complications occurred. Patients experienced symptom relief by 3 mo that was sustained to 12 mo. Mean IPSS, QOL, and Qmax improved by 45%, 41%, and 40% by 3 mo, and 53%, 52%, and 49% by 12 mo, respectively (p<0.05). Adverse events were mild and transient. There were no reports of loss of antegrade ejaculation or any effects on erectile function. Implantation positioning failed in 11/29 patients, who then underwent uneventful TURP. After modification of the delivery device, the success rate for implant positioning improved from 5/13 patients to 13/16 patients. Study limitations include the single-arm nature and the low patient number. ConclusionsWe demonstrated preliminary feasibility of the ClearRing device for minimally invasive treatment of BPH in men. Further studies are needed to confirm the safety and efficacy of this approach. Patient summaryIn this study we tested outcomes after implantation of a ClearRing device in patients with benign prostatic hyperplasia. We found that the device was safe and effective. However, there was a high rate of implantation failure due to malpositioning, which was significantly improved following modification of the delivery device.

Three-Year Outcomes of the Prospective, Randomized Controlled Rezūm System Study: Convective Radiofrequency Thermal Therapy for Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia

To report 3-year outcomes of a prospective, multicenter, randomized, blinded control trial after treatment with convective radiofrequency (RF) water vapor thermal therapy for moderate to severe lower urinary tract symptoms 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 improvement of 160% compared with control subjects at 3 months (P <.0001). Maximal symptom relief of at least 50% improvement in IPSS, quality of life, Qmax, and BPH Impact Index remained durable throughout 3 years (P <.0001). Subjects with a treated median lobe had similar responses. No late-related adverse events occurred, and no de novo erectile dysfunction was reported. The surgical retreatment rate was 4.4% over 3 years. The minimally invasive convective RF thermal therapy is an office or ambulatory outpatient procedure with minimal transient perioperative side effects. It provides early effective and durable relief of BPH symptoms with preservation of sexual function in subjects followed up for 3 years and is applicable to treatment of the median lobe and hyperplastic central zone tissue.

Patient-reported outcomes with medical management of benign prostatic hyperplasia: a prospective study in a tertiary care teaching hospital of rural West Bengal, India

Background: Effectiveness of pharmacotherapy in benign prostatic hyperplasia (BPH) is generally evaluated by clinical measures. Outcome of the treatment from the patient’s perspective however cannot be evaluated which may result communication gap between the patient and the physician. Patient-Reported Outcomes (PRO) studies can bridge this gap. This study was undertaken to evaluate outcomes and to assess the impact of medical management of BPH on general health-related quality of life.Methods: In this prospective, observational study, eligible patients with BPH attending a Urology clinic in a tertiary care rural hospital of West Bengal were enrolled and followed up on third and sixth months from baseline. Symptom assessment of BPH were assessed through International Prostate Symptom Score (I-PSS), BPH Impact Index (BII) and Health Related Quality of life questionnaires. Tools of descriptive statistics were used for analysis of data.Results: In the study population of 66 patients, 50% were treated with monotherapy (alpha blockers) and 50% were treated with combinations (alpha blocker and 5alpha reductase inhibitors). After 6 months of medical management, I-PSS was decreased from 18.86±5.53 to 11.76±3.94 (p &lt;0.001), BII score decreased from 9.65±2.59 to 5.89±2.24 (p &lt;0.001) and VAS score increased from 51.44±10.03 to 54.24±11.38 (p &lt;0.001).Conclusions: We found medical management definitely improved quality of life in BPH patients and significantly decreased symptoms. This study is a step in the direction of development of larger and longer term PRO studies in BPH management.

Efficacy and safety of combination therapy with tamsulosin, dutasteride and imidafenacin for the management of overactive bladder symptoms associated with benign prostatic hyperplasia: A multicenter, randomized, open-label, controlled trial (DIrecT Study)

To evaluate the efficacy and safety of a combination therapy with dutasteride and imidafenacin in patients with benign prostatic hyperplasia and persistent overactive bladder symptoms. A total of 163 patients presenting an enlarged prostate (volume >30 mL) and persistent overactive bladder symptoms despite at least 8 weeks of tamsulosin were randomized to receive tamsulosin and dutasteride, or tamsulosin, dutasteride and imidafenacin at a 1:1 ratio. The primary end-point was the mean change from baseline to week 24 in total overactive bladder symptom score. The mean change in total overactive bladder symptom score from baseline at week 24 was -1.99 (95% confidence interval -2.57 to -1.41) in the tamsulosin and dutasteride group, and -3.12 (95% confidence interval -3.72 to -2.52) in the tamsulosin, dutasteride and imidafenacin group. The tamsulosin, dutasteride and imidafenacin group significantly improved total overactive bladder symptom score at week 24 as compared with the tamsulosin and dutasteride group; the mean difference was -1.18 (-2.02 to -0.34). The between-group difference was statistically significant as early as week 4. The total International Prostate Symptom Score, storage subscore, quality of life index, and benign prostatic hyperplasia impact index also significantly improved in the tamsulosin, dutasteride and imidafenacin group. Tamsulosin, dutasteride and imidafenacin combination therapy improves overactive bladder symptoms and quality of life without causing serious adverse drug reactions in patients with enlarged prostate not responding to tamsulosin. This combination therapy seems to represent a promising therapeutic option in these patients.

MP27-18 CROSSOVER STUDY ON THE PROSTATIC URETHRAL LIFT (PUL): 4 YEAR RESULTS

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology II1 Apr 2017MP27-18 CROSSOVER STUDY ON THE PROSTATIC URETHRAL LIFT (PUL): 4 YEAR RESULTS Henry Woo, Jack Barkin, Damien Bolton, Prem Rashid, Anthony Cantwell, William Bogache, Stephen Richardson, Ronald Tutrone, James Fagelson, and Peter Chin Henry WooHenry Woo More articles by this author , Jack BarkinJack Barkin More articles by this author , Damien BoltonDamien Bolton More articles by this author , Prem RashidPrem Rashid More articles by this author , Anthony CantwellAnthony Cantwell More articles by this author , William BogacheWilliam Bogache More articles by this author , Stephen RichardsonStephen Richardson More articles by this author , Ronald TutroneRonald Tutrone More articles by this author , James FagelsonJames Fagelson More articles by this author , and Peter ChinPeter Chin More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.810AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES PUL is a unique, non-thermal approach to treating lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia. We present the 4-year data from a sham to Prostatic Urethral Lift (PUL) crossover study in which each patient served as his own control. METHODS 53 patients underwent control sham procedure as part of a blinded, controlled study. After 3 months, these men with symptomatic LUTS were treated with crossover PUL that involved placing UroLift® implants into the obstructing lateral lobes of the prostate. They were followed for 4 years with validated tools such as International Prostate Symptom Score (IPSS), quality of life score (QoL), BPH Impact Index (BPH II), peak flow rate, sexual function scores, and adverse event reporting. RESULTS Average IPSS improved after sham but returned to near baseline after 3 months, while peak flow rate (Qmax) remained mildly elevated (Fig 1). At 4 years after crossover PUL, average scores for IPSS, QoL, and BPHII remained improved 45%, 49%, and 44% from baseline, respectively (p<0.001). Average peak flow rate increase of at least 50% over baseline was demonstrated at 4 years (p=0.01). On average, patients returned to normal activity within 7 days. Related adverse effects were typically transient and mild to moderate in severity. There were no reported instances of de novo, sustained erectile or ejaculatory dysfunction. CONCLUSIONS Similar to other publications, the 4 year results of the crossover study indicate the PUL procedure can result in rapid and durable improvement in symptoms, quality of life, and peak flow rate. Subjects report minimal adverse effects and return to normal quickly. Sexual function appears to be preserved. This study offers a unique perspective on the effectiveness of PUL, as the sham response is quantified for each patient. PUL is demonstrated to have a significant, non-placebo response that is durable to four years. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e336 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Henry Woo More articles by this author Jack Barkin More articles by this author Damien Bolton More articles by this author Prem Rashid More articles by this author Anthony Cantwell More articles by this author William Bogache More articles by this author Stephen Richardson More articles by this author Ronald Tutrone More articles by this author James Fagelson More articles by this author Peter Chin More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

PD27-01 5 YEAR PROSPECTIVE, RANDOMIZED, CONTROLLED STUDY RESULTS ON THE MINIMALLY INVASIVE PROSTATIC URETHRAL LIFT (PUL)

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology IV1 Apr 2017PD27-01 5 YEAR PROSPECTIVE, RANDOMIZED, CONTROLLED STUDY RESULTS ON THE MINIMALLY INVASIVE PROSTATIC URETHRAL LIFT (PUL) Claus Roehrborn, Steven Gange, Neal Shore, Jonathan Giddens, Damien Bolton, Barrett Cowan, Anthony Cantwell, Kevin McVary, Peter Chin, Alexis Te, Shahram Gholami, Prem Rashid, William Moselely, Ronald Tutrone, Sheldon Freedman, Peter Incze, K. Scott Coffield, Fernando Borges, and Daniel Rukstalis Claus RoehrbornClaus Roehrborn More articles by this author , Steven GangeSteven Gange More articles by this author , Neal ShoreNeal Shore More articles by this author , Jonathan GiddensJonathan Giddens More articles by this author , Damien BoltonDamien Bolton More articles by this author , Barrett CowanBarrett Cowan More articles by this author , Anthony CantwellAnthony Cantwell More articles by this author , Kevin McVaryKevin McVary More articles by this author , Peter ChinPeter Chin More articles by this author , Alexis TeAlexis Te More articles by this author , Shahram GholamiShahram Gholami More articles by this author , Prem RashidPrem Rashid More articles by this author , William MoselelyWilliam Moselely More articles by this author , Ronald TutroneRonald Tutrone More articles by this author , Sheldon FreedmanSheldon Freedman More articles by this author , Peter InczePeter Incze More articles by this author , K. Scott CoffieldK. Scott Coffield More articles by this author , Fernando BorgesFernando Borges More articles by this author , and Daniel RukstalisDaniel Rukstalis More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.1222AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The Prostatic Urethral Lift (PUL) has been previously shown to rapidly and durably address lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia with minimal side effects. The 5 year concluding data from the largest multi-center, randomized, controlled, study on PUL is herein presented. METHODS PUL procedure involves placing permanent UroLift® implants into the lateral lobes of the prostate to enlarge the urethral lumen. Enrollment criteria included age = 50 years, IPSS (International Prostate Symptom Score) = 13, peak flow rate = 12 ml/s, and prostate volume 30 - 80 cc. At 19 centers in North America and Australia, 206 men with symptomatic LUTS were randomized to PUL (N = 140) or sham control (N = 66). Patients and assessors were kept blinded to treatment arm for 3 months. Assessments for PUL subjects continued through 5 years. RESULTS PUL patients experienced symptom relief by 1 month (IPSS: 44% and QoL: 42%, p < 0.001) and remained improved through 5 years (IPSS: 38% and QoL: 54%, p < 0.001). Peak urinary flow rate remained improved 41% at 5 years. Sexual function was preserved in the PUL cohort, as assessments show stable erectile function average score and improved ejaculatory function and ejaculatory bother average scores (p<0.001). Further, no patient was found to experience de novo, sustained erectile or ejaculatory dysfunction. Adverse events were typically mild and transient. CONCLUSIONS The final long term data from the largest study on the PUL procedure demonstrates that this minimally invasive approach improves symptoms durably. Quality of life, BPH impact index and peak flow rate improvements are also sustained. As assessed by questionnaires and adverse event reporting, erectile and ejaculatory function are preserved. The final 5 year analysis indicates stable symptom relief and facilitates the understanding of the long term effects of the PUL procedure. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e511 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Claus Roehrborn More articles by this author Steven Gange More articles by this author Neal Shore More articles by this author Jonathan Giddens More articles by this author Damien Bolton More articles by this author Barrett Cowan More articles by this author Anthony Cantwell More articles by this author Kevin McVary More articles by this author Peter Chin More articles by this author Alexis Te More articles by this author Shahram Gholami More articles by this author Prem Rashid More articles by this author William Moselely More articles by this author Ronald Tutrone More articles by this author Sheldon Freedman More articles by this author Peter Incze More articles by this author K. Scott Coffield More articles by this author Fernando Borges More articles by this author Daniel Rukstalis More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Combination of alfa blocker with low dose tadalafil in benign prostatic hyperplasia with erecticle dysfunction management

Objective: To study the combination therapy with daily low dose tadalafil (5mg) and alpha blockers for the treatment of BPHLUTS and Erecticle dysfunction (ED). Materials and Methods: The medical records of 168 patients who had medical management for symptomatic BPH/LUTS with or without ED from January 2010 to December 2013 were reviewed retrospectively. All patients were divided into 2 groups. Group1(n: 74) included patients received a single daily dose of tamsulosin 0.4mg or alfuzosin 10mg . Group-2 (n:75) patients with LUTS and BPH who were previously managed with alpha blockers (tamsulosin 0.4mg or alfuzosin 10mg) were included in our study by addition of 5mg phosphodiesterase type 5 inhibitor (tadalafil), which has been reported to be useful in the management of BPH/LUTS and ED. We analysed the International Prostate Symptom Score (IPSS), IIEF Score, BPH Impact Index (BII) and Quality of Life (QoL). Results: Before the inclusion of tadalafil patients exclusively on alpha blockers had a mean IPSS score of 21.51 ± 2.89). IPSS improved to a mean of 11.34 ± 1.56 ( p

Tadalafil 5 mg Once Daily Improves Lower Urinary Tract Symptoms and Erectile Dysfunction: A Systematic Review and Meta-analysis.

We carried out a systematic review and meta-analysis to assess tadalafil 5 mg once-daily for the treatment of lower urinary tract symptoms (LUTS) and erectile dysfunction (ED). A literature review was performed to identify all published randomized double-blind, placebo-controlled trials of tadalafil 5 mg once-daily for the treatment of LUTS and ED. The search included the following databases: MEDLINE, EMBASE, and the Cochrane Controlled Trials Register. The reference lists of the retrieved studies were also investigated. Thirteen publications involving a total of 3973 patients were used in the analysis, including 13 RCTs that compared tadalafil 5 mg once-daily with placebo. We found that tadalafil 5 mg once-daily was effective in improving LUTS suggestive of BPH and treating ED over 12 weeks in our meta-analysis. Total International Prostate Symptom Score (IPSS) (SMD = - 2.02, 95% CI = - 2.52 to -1.53, P < 0.00001); Benign Prostatic Hyperplasia Impact Index (BPH-II) (SMD = -0.58, 95% CI = -0.84 to -0.33, P < 0.00001); International Index of Erectile Function-erectile function (IIEF) domain (standardized mean difference [SMD] = 5.18, 95% confidence interval [CI] = 4.13-6.23, P < 0.00001) indicated that tadalafil 5 mg once-daily was more effective than the placebo. Safety assessments included discontinuations due to adverse event (odds ratio (OR) = 1.79, 95% CI = 1.12-2.85, P = 0.01) indicated that tadalafil 5 mg once-daily was well tolerated. This meta-analysis indicates that tadalafil 5 mg once-daily to be an effective treatment for LUTS and ED with a low occurrence of side effects.

24-month durability after crossover to the prostatic urethral lift from randomised, blinded sham.

To evaluate the 24-month effectiveness of the prostatic urethral lift (PUL) procedure in men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) assessed through a crossover study. In all, 53 patients underwent a sham procedure as part of the blinded, randomised L.I.F.T. (Luminal Improvement Following prostatic Tissue approximation for the treatment of LUTS secondary to BPH) study at 19 centres and elected to enrol in this crossover study. The crossover procedure involved placement of permanent implants (UroLift® system) into the prostatic lateral lobes. Patients were followed for 3months after the sham procedure and then for 24months after crossover to PUL, with assessments of urinary symptom relief, quality of life (QoL), urinary flow rate, sexual function, and adverse events. At 24months after crossover to PUL, the International Prostate Symptom Score (IPSS), QoL, BPH Impact Index, and maximum urinary flow rate improved 36%, 40%, 54%, and 77% from baseline, respectively. Each IPSS parameter on average improved significantly from baseline (P<0.005) and remained stable throughout follow-up. Symptom response after the sham procedure indicated initial improvement at 1month with significant decay by 3months. Adverse events were typically mild to moderate and patients returned rapidly to normal activity. Four patients (8%) required intervention with transurethral resection of the prostate and one patient required additional PUL implants within the 24-month period. There were no reported instances of de novo sustained erectile or ejaculatory dysfunction. The PUL procedure is associated with rapid symptom relief, increased urinary flow rate and QoL improvement that remain stable over 24months. Morbidity is low and sexual function is preserved.

Correlation of prostate volume with 'International Prostate Symptom Score' and 'Benign Prostatic Hyperplasia-Impact Index' in benign prostatic hyperplasia

Introduction: Benign prostatic Hyperplasia is a common disorder and cause of morbidity in the ageing men. The evaluation symptoms and the bother associated with it are important for management. International Prostate Symptom Score (IPSS), Quality of life (QOL) and Benign Prostatic Hyperplasia Impact Index (BII) are practiced to quantify the severity of the disease. The size of prostate gland does not correlate with lower urinary tract symptoms. Correlation among above scoring is also not clear. Aim of the study is to evaluate correlation of prostate volume with International Prostate Symptom Score, Benign Prostatic Hyperplasia Impact Index and prostate size.Methods: Prospective study. Ninety-eight patients were included. Patients were assessed preoperatively with the International Prostate Symptom Score, Benign Prostatic Hyperplasia Impact Index and prostate volumes by trans abdominal ultrasound.Results: The mean age was 66.7 ± 7.3 years (50- 84) the mean IPSS, QOL, BII and prostate volumes were 23.6 ±6.0, 5.1 ± 0.9, 7.1±2.4 and 47.5±16.63 respectively. There was positive correlation between the IPSS and BII, IPSS and QOL and BII and QOL (rs= 0.89, 0.585 and 0.530 respectively) and no correlation between IPSS and BII with prostatic weight. (rs= -0.04 and -0.07 respectively).Conclusion: Management of the benign prostate hyperplasia should be considered on the bother symptoms and not on the size of the prostate.Journal of Society of Surgeons of Nepal Vol.17(1) 2014: 6-10

Can we use baseline characteristics to assess which men with moderately symptomatic benign prostatic hyperplasia at risk of progression will benefit from treatment? A post hoc analysis of data from the 2-year CONDUCT study

PurposeTo investigate (in a post hoc analysis of the 2-year CONDUCT study) the characteristics and clinical outcomes of men with moderately symptomatic benign prostatic hyperplasia (BPH) at risk of progression who benefitted from lifestyle changes alone.MethodsPatients were given lifestyle advice and randomized to a fixed-dose combination (FDC) of dutasteride and tamsulosin or watchful waiting (WW) and followed for 24 months. Patients in the WW group were escalated to tamsulosin if any follow-up International Prostate Symptom Score (IPSS) was equal or greater than the baseline value. Improvements in symptoms (change in IPSS) and quality of life [measured by BPH Impact Index (BII) and question 8 of the IPSS (IPSS-Q8)] were analysed in the FDC group, men who initiated tamsulosin (WW-TAM) and men who received no medical intervention (WW-no treatment) and the impact of baseline variables on IPSS determined.ResultsThe adjusted mean decrease in IPSS, BII and IPSS-Q8 at each post-baseline visit over 24 months appeared greater in the FDC (n = 369) and WW-no treatment groups (n = 144) than in the WW-TAM group (n = 229). IPSS improvements appeared similar in the FDC group and WW-no treatment subgroup, except in patients with the greatest degree of bother at baseline (BII 7–13).ConclusionBII at baseline may be a more relevant indicator than symptom severity as to whether a patient with moderate symptoms should receive medical therapy or not.

Use of Structural Equation Modeling to Demonstrate the Differential Impact of Storage and Voiding Lower Urinary Tract Symptoms on Symptom Bother and Quality of Life during Treatment for Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia

Lower urinary tract symptoms associated with benign prostatic hyperplasia typically respond well to medical therapy. While changes in total I-PSS (International Prostate Symptom Score) are generally accepted as measurement for treatment response, I-PSS storage and voiding subscores may not accurately reflect the influence of symptom improvement on patient bother and quality of life. Structural equation modeling was done to evaluate physiological interrelationships measured by I-PSS storage vs voiding subscore questions and measure the magnitude of effects on bother using BII (Benign Prostatic Hyperplasia Impact Index) and quality of life on I-PSS quality of life questions. Pooled data from 4 randomized, controlled trials of tadalafil and placebo in 1,462 men with lower urinary tract symptoms/benign prostatic hyperplasia were used to investigate the relationship of storage vs voiding lower urinary tract symptoms on BII and quality of life. The final structural equation model demonstrated a sufficient fit to model interdependence of storage, voiding, bother and quality of life (probability for test of close fit <0.0001). Storage aspects had a twofold greater effect on voiding vs voiding aspects on storage (0.61 vs 0.28, each p <0.0001). The direct effect of storage on bother was twofold greater than voiding on bother (0.64 vs 0.29, each p<0.0001). Bother directly impacted quality of life by the largest magnitude of (-0.83), largely driven by storage lower urinary tract symptoms (p<0.0001). Total I-PSS is a reliable instrument to assess the therapeutic response in lower urinary tract symptoms/benign prostatic hyperplasia cases. However, an improvement in storage lower urinary tract symptoms is mainly responsible for improved bother and quality of life during treatment. Care should be taken when evaluating the accuracy of I-PSS subscores as indicators of the response to medical therapy.

PD21-02 PROSPECTIVE, RANDOMIZED, BLINDED STUDY OF PROSTATIC URETHRAL LIFT (PUL): FOUR YEAR RESULTS

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology I1 Apr 2016PD21-02 PROSPECTIVE, RANDOMIZED, BLINDED STUDY OF PROSTATIC URETHRAL LIFT (PUL): FOUR YEAR RESULTS Claus Roehrborn, Steven Gange, Neal Shore, Jonathan Giddens, Damien Bolton, Barrett Cowan, Anthony Cantwell, Kevin McVary, Peter Chin, Alexis Te, Shahram Gholami, Prem Rashid, William Moseley, Ronald Tutrone, Sheldon Freedman, Peter Incze, K. Scott Coffield, Fernando Borges, and Daniel Rukstalis Claus RoehrbornClaus Roehrborn More articles by this author , Steven GangeSteven Gange More articles by this author , Neal ShoreNeal Shore More articles by this author , Jonathan GiddensJonathan Giddens More articles by this author , Damien BoltonDamien Bolton More articles by this author , Barrett CowanBarrett Cowan More articles by this author , Anthony CantwellAnthony Cantwell More articles by this author , Kevin McVaryKevin McVary More articles by this author , Peter ChinPeter Chin More articles by this author , Alexis TeAlexis Te More articles by this author , Shahram GholamiShahram Gholami More articles by this author , Prem RashidPrem Rashid More articles by this author , William MoseleyWilliam Moseley More articles by this author , Ronald TutroneRonald Tutrone More articles by this author , Sheldon FreedmanSheldon Freedman More articles by this author , Peter InczePeter Incze More articles by this author , K. Scott CoffieldK. Scott Coffield More articles by this author , Fernando BorgesFernando Borges More articles by this author , and Daniel RukstalisDaniel Rukstalis More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.02.1469AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The Prostatic Urethral Lift (PUL) procedure offers rapid, durable improvement in lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia with minimal adverse effects. PUL was assessed through a large, multi-center, randomized, blinded trial with 4 year follow up. METHODS 206 men with symptomatic LUTS secondary to benign prostatic hyperplasia (BPH) were randomized to PUL (N=140) or sham control (N=66) at 19 centers in North America and Australia. Enrollment criteria included age = 50 years, IPSS (International Prostate Symptom Score) = 13, peak flow (Qmax) = 12 ml/s, and prostate volume 30 - 80 cc. With endoscopic guidance, small, permanent metallic implants were transurethrally placed into the lateral lobes of the prostate. The lobes were held in a retracted, open position which reduced urinary obstruction. Through 3 month post index procedure, patients and assessors were kept blinded to treatment arm. PUL participants were assessed through 4 years via IPSS, quality of life (QOL), BPH Impact Index (BPH II), Qmax, Sexual Health Inventory for Men (SHIM), and Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD). RESULTS Average IPSS reduction was 44% by 1 month and 46% at 4 years (p value < 0.0001). Adverse events such as hematuria, dysuria, pelvic pain, urgency, and urge incontinence were typically mild and transient. There were no reported de novo, sustained erectile or ejaculatory adverse events. Sexual function assessments (SHIM, MSHQ-EjD) show stable erectile function average score and statistically improved average ejaculatory scores. For those subjects who have reached their 4 year follow up, 19 subjects have undergone repeat PUL or other procedure. CONCLUSIONS PUL patients suffer from little morbidity and on average achieve rapid, clinically meaningful LUTS relief. This preliminary data from the largest and longest study of the PUL procedure demonstrates that relief can be sustained to 4 years. In addition, sexual function is preserved, both in terms of erection and ejaculation. Durability will be assessed through protocol driven follow up through 5 years. © 2016FiguresReferencesRelatedDetails Volume 195Issue 4SApril 2016Page: e456-e457 Advertisement Copyright & Permissions© 2016MetricsAuthor Information Claus Roehrborn More articles by this author Steven Gange More articles by this author Neal Shore More articles by this author Jonathan Giddens More articles by this author Damien Bolton More articles by this author Barrett Cowan More articles by this author Anthony Cantwell More articles by this author Kevin McVary More articles by this author Peter Chin More articles by this author Alexis Te More articles by this author Shahram Gholami More articles by this author Prem Rashid More articles by this author William Moseley More articles by this author Ronald Tutrone More articles by this author Sheldon Freedman More articles by this author Peter Incze More articles by this author K. Scott Coffield More articles by this author Fernando Borges More articles by this author Daniel Rukstalis More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Quality of life in patients with lower urinary tract symptoms associated with BPH: change over time in real-life practice according to treatment—the QUALIPROST study

PurposeTo evaluate change in quality of life (QoL) and symptoms in patients with lower urinary tract symptoms/benign prostatic hyperplasia (LUTS/BPH) in conditions of current clinical practice.MethodsProspective, longitudinal, multicenter open-label study was carried out in urology outpatient clinics. Patients were ≥40 years of age with an International Prostate Symptom Score (IPSS) score ≥8. QoL and symptoms were measured at baseline and 6 months using the Benign Prostatic Hyperplasia Impact Index (BII) and the IPSS.Results1713 patients were included for analysis. Mean (SD) IPSS and BII scores at baseline were 16.8 (5.4) and 6.8 (2.6), respectively. 8.9 % (n = 153) of study participants did not receive treatment (watchful waiting, WW), 70.3 % (n = 1204) were prescribed monotherapy (alpha-adrenergic blockers [AB]; phytotherapy [PT, of which 95.2 % was the hexanic extract of Serenoa repens, HESr]; or 5-alpha-reductase inhibitors [5ARI]), and 20.8 % (n = 356) received combined treatment (AB + 5ARI; AB + HESr; others). At 6 months, improvements in QoL were similar across the different medical treatment (MT) groups, both for monotherapy (AB: mean improvement [SD] of 2.4 points [2.4]; PT: 1.9 [2.4]; 5ARI: 2.5 [2.3]) and combined therapy (AB + 5ARI: 3.1 [2.9]; AB + PT: 3.1 [2.5]). There were no clinically significant differences between MT groups and all showed significant improvement over WW (p < 0.05). HESr showed similar efficacy to AB and 5ARI both as monotherapy and in combination with AB. Results on the IPSS were similar.ConclusionsImprovements in QoL and symptoms were equivalent across the medical treatments most widely used in real-life practice to manage patients with moderate or severe LUTS. HESr showed an equivalent efficacy to AB and 5ARI with fewer side effects.