***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: To assess the safety and feasibility of aquablation in a first‐in‐man study . Aquablation is a novel minimally invasive water ablation therapy combining image guidance and robotics ( AquaBeam ® ) for the targeted and heat‐free removal of prostatic tissue in men with lower urinary tract symptoms ( LUTS ) secondary to benign prostatic hyperplasia ( BPH ) In recent years quality of life instruments have been featured as primary outcomes in many r and omized trials . One of the challenges facing the investigator using such measures is determining the significance of any differences observed , and communicating that significance to clinicians who will be applying the trial results . We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change . Using this approach we have established a plausible range within which the minimal clinical ly important difference ( MCID ) falls . In three studies in which instruments measuring  dyspnea , fatigue , and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item , when responses were presented on a seven point Likert scale . Furthermore , we have established ranges for changes in question naire scores that correspond to moderate and large changes in the domains of interest . This information will be useful in interpreting question naire scores , both in individuals and in groups of patients participating in controlled trials , and in the planning of new trials Purpose : We compared the safety and efficacy of Aquablation and transurethral prostate resection for the treatment of lower urinary tract symptoms related to benign prostatic hyperplasia . Material s and Methods : In a double‐blind , multicenter , prospect i ve , r and omized , controlled trial 181 patients with moderate to severe lower urinary tract symptoms related to benign prostatic hyperplasia underwent transurethral prostate resection or Aquablation .  The primary efficacy end point was the reduction in International Prostate Symptom Score at 6 months . The primary safety end point was the development of Clavien‐Dindo persistent grade 1 , or 2 or higher operative complications . Results : Mean total operative time was similar for Aquablation and transurethral prostate resection ( 33 vs 36 minutes , p = 0.2752 ) but resection time was lower for Aquablation ( 4 vs 27 minutes , p < 0.0001 ) . At month 6 patients treated with Aquablation and transurethral prostate resection experienced large I‐PSS improvements . The prespecified study noninferiority hypothesis was satisfied ( p < 0.0001 ) . Of the patients who underwent Aquablation and transurethral prostate resection 26 % and 42 % , respectively , experienced a primary safety end point , which met the study primary noninferiority safety hypothesis and subsequently demonstrated superiority ( p = 0.0149 ) . Among sexually active men the rate of anejaculation was lower in those treated with Aquablation ( 10 % vs 36 % , p = 0.0003 ) . Conclusions : Surgical prostate resection using Aquablation showed noninferior symptom relief compared to transurethral prostate resection but with a lower risk of sexual dysfunction . Larger prostates ( 50 to 80 ml ) demonstrated a more pronounced superior safety and efficacy benefit . Longer term followup would help assess the clinical value of Aquablation Purpose : We sought to establish the safety and effectiveness of aquablation , a novel , image guided , robotic assisted , water jet tissue ablation technology , for the treatment of benign prostatic hyperplasia . Material s and Methods : We performed a prospect i ve , single arm , multicenter trial at a total of 3 centers in Australia and New Zeal and with 1‐year followup . Participants were men 50 to 80 years old with moderate to severe lower urinary tract symptoms as determined by urodynamics . All patients underwent aquablation under image guidance . Primary end points included procedural and perioperative safety . The main clinical end point was the change from baseline in I‐PSS ( International Prostate Symptom Score ) . Other secondary end points included uroflow measures , prostate volume on transrectal ultrasound and detrusor pressure . Detrusor pressure at maximum flow was only measured at 6 months . Results : A total of 21 men  underwent aquablation at a mean age of 69.7 years ( range 62 to 78 ) . Prostate volume was 57.2 ml ( range 30 to 102 ) . Procedural duration averaged 38 minutes with a mean aquablation treatment time of 5 minutes . All but 1 subject were catheterized for 1 day only and 19 of 21 were discharged home the day after the procedure . Detrusor pressure at maximum flow decreased from 65 cm H2O at baseline to 39 cm H2O at 6 months ( p < 0.0027 ) . Prostate volume decreased from 57 ml at baseline to 35 ml ( p < 0.0001 ) . Mean I‐PSS score improved from 23.0 at baseline to 6.8 at 12 months ( p < 0.0001 ) and maximum urinary flow increased from 8.7 to 18.3 ml per second ( p < 0.0001 ) . There were no important perioperative adverse events . No urinary incontinence developed and sexual function was preserved postoperatively . Conclusions : This phase II study provides early evidence to support the safety and effectiveness of aquablation for symptomatic benign prostatic hyperplasia Introduction TURB is the st and ard approach to bladder tumors but suffers from several disadvantages . Waterjet hydrodissection is a new technology for removing superficial tumors in the GI tract promising to preserve the histological structures of biopsy specimens with favorable long-term results as recent studies have shown . The aim of this study was to show the feasibility and applicability of waterjet hydrodissection for removing papillary superficial bladder tumors . Material s and methods In five patients diagnosed with superficial papillary bladder tumor , transurethral submucosal dissection was conducted using the T-type I-Jet HybridKnife ( Erbe , Tuebingen ) . The resection edges were labeled by means of electrical coagulation with the HybridKnife . Subsequently , a submucosal fluid cushion specific to the tissue layer was formed by the waterjet implementation function of the HybridKnife , thereby elevating the tumorous tissue . The tumor was endoscopically extracted with a retrieval bag . Biopsy specimens of the tumor edges and base were subsequently collected . Results All tumors could be resected en bloc , and the lamina propria was intact in all specimens , allowing the pathologist to distinguish between superficial and invasive tumors . Pathological analysis confirmed R0 resection in all sample s. Conclusion These initial results prove the feasibility of waterjet hydrodissection for removing bladder tumors . In contrast to conventional TURB , this new technique allows the pathologist to assess the entire lamina propria and the resection edges due to the en-bloc resection and to determine invasiveness as well as R0 versus R1 resection . These first results are promising , long-term oncological follow-up , and prospect i ve r and omized surveys investigating the recurrence rate have to be evaluated PURPOSE We analyzed data from the placebo arm of the MTOPS trial to determine clinical predictors of BPH progression . MATERIAL S AND METHODS A total of 3,047 patients with LUTS were r and omized to either placebo , doxazosin ( 4 to 8 mg ) , finasteride ( 5 mg ) , or a combination of doxazosin and finasteride . Average length of followup was 4.5 years . The primary outcome was time to overall clinical progression of BPH , defined as either a confirmed 4-point or greater increase in AUA SS , acute urinary retention , incontinence , renal insufficiency , or recurrent urinary tract infection . We analyzed BPH progression event data from the 737 men who were r and omized to placebo . RESULTS The rate of overall clinical progression of BPH events in the placebo group was 4.5 per 100 person-years , for a cumulative incidence ( among men who had at least 4 years of followup data ) of 17 % . The risk of BPH progression was significantly greater in patients on placebo with a baseline TPV of 31 ml or greater vs less than 31 ml ( p < 0.0001 ) , a baseline PSA of 1.6 ng/dl or greater vs PSA less than 1.6 ng/dl ( p = 0.0009 ) , a baseline Qmax of less than 10.6 ml per second vs 10.6 ml per second or greater ( p = 0.011 ) , a baseline PVR of 39 ml or greater vs less than 39 ml ( p = 0.0008 ) and baseline age 62 years or older vs younger than 62 years ( p = 0.0002 ) . CONCLUSIONS Among men in the placebo arm , baseline TPV , PSA , Qmax , PVR and age were important predictors of the risk of clinical progression of BPH To present early safety and feasibility data from a multicentre prospect i ve study ( WATER II ) of aquablation in the treatment of symptomatic men with large‐volume benign prostatic hyperplasia ( BPH ) Non-r and omised studies of the effects of interventions are critical to many areas of healthcare evaluation , but their results may be biased . It is therefore important to underst and and appraise their strengths and weaknesses . We developed ROBINS-I ( “ Risk Of Bias In Non-r and omised Studies - of Interventions ” ) , a new tool for evaluating risk of bias in estimates of the comparative effectiveness ( harm or benefit ) of interventions from studies that did not use r and omisation  to allocate units ( individuals or clusters of individuals ) to comparison groups . The tool will be particularly useful to those undertaking systematic review s that include non-r and omised studies Background No study has compared the bothersomeness of all lower urinary tract symptoms ( LUTS ) using a population -based sample of adults . Despite this lack of evidence , investigators have often cited their LUTS of interest as the “ most bothersome ” or “ one of the most bothersome . ” Objective To compare the population - and individual-level burden of LUTS in men and women . Design , setting , and participants In this population -based cross-sectional study , question naires were mailed to 6000 individuals ( 18–79 yr of age ) r and omly identified from the Finnish Population Register . Outcome measurements and statistical analysis The vali date d Danish Prostatic Symptom Score question naire was used for assessment of bother of 12 different LUTS . The age-st and ardized prevalence of at least moderate bother was calculated for each symptom ( population -level burden ) . Among symptomatic individuals , the proportion of affected individuals with at least moderate bother was calculated for each symptom ( individual-level bother ) . Results and limitations A total of 3727 individuals ( 62.4 % ) participated ( 53.7 % female ) . The LUTS with the greatest population -level burden were urgency ( 7.9 % with at least moderate bother ) , stress urinary incontinence ( SUI ) ( 6.5 % ) , nocturia ( 6.0 % ) , postmicturition dribble ( 5.8 % ) , and urgency urinary incontinence ( UUI ) ( 5.0 % ) . Burden from incontinence symptoms was higher in women than men , and the opposite was true for voiding and postmicturition symptoms . At the individual level , UUI was the most bothersome for both genders . Although the response proportion was high , approximately a third did not participate . Conclusions Both men and women with UUI report moderate or major bother more frequently than individuals with other LUTS . At the population level , the most prevalent bothersome symptoms are urgency , SUI , and nocturia . Patient summary Urinary urgency was the most common troubling symptom in a large population -based study ; however , for individuals , urgency incontinence was the most likely to be rated as bothersome BACKGROUND Despite widespread adoption of the six-item erectile function ( EF ) domain of the International Index of Erectile Function ( IIEF ) as a clinical trial end point , there are currently no objective data on what constitutes a minimal clinical ly important difference ( MCID ) in the EF domain . OBJECTIVE Estimate the MCID for the IIEF EF domain . DESIGN , SETTING , AND PARTICIPANTS Anchor-based MCIDs were estimated using data from 17 r and omized , double-blind , placebo-controlled , parallel-group clinical trials of the phosphodiesterase type 5 inhibitor ( PDE5-I ) tadalafil for 3345 patients treated for 12 wk . MEASUREMENTS The anchor for the MCID is the minimal improvement measure calculated using change from baseline to 12 wk on IIEF question 7 : " Over the past 4 weeks , when you attempted sexual intercourse how often was it satisfactory for you ? " MCIDs were developed using analysis of variance (ANOVA)- and receiver operating characteristic (ROC)-based methods in a subset of studies ( n=11 ) by comparing patients with and without minimal improvement ( n=863 ) . MCIDs were vali date d in the remaining six studies ( n=377 ) . RESULTS AND LIMITATIONS The ROC-based MCID for the EF domain was 4 , with estimated sensitivity and specificity of 0.74 and 0.73 , respectively . MCIDs varied significantly ( p<0.0001 ) according to baseline ED severity ( mild : 2 ; moderate : 5 ; severe : 7 ) . MCIDs consistently distinguished between patients in the validation sample classified as no change or minimally improved overall and by geographic region , ED etiology , and age group . MCIDs did not differ by age group , geographic region , or ED etiology 
    Output:
    
Based on short-term ( up to 12 months ) follow-up , the effect of Aquablation on urological symptoms is probably similar to that of TURP ( moderate-certainty evidence ) .
The effect on quality of life may also be similar ( low-certainty evidence ) .