Eltabey et al(2010) HoLEP: 40 RCT Patients with BOO caused by Outcomes reported at 1, 6 and 12 BHP, with related voiding months post-surgery. HoLEP (with TURP: 40 symptoms, prostate size between tissue morcellation) compared to 30–100 g , who had not TURP. responded to pharmacologic therapy, with AUA symptom score Safety outcomes: and Qmax ≥12 ≤15ml/s. blood transfusion urethral stricture incontinence. Effectiveness outcomes: peak flow AUA symptom scores PVR prostate volume Cost-related outcomes: length of operation length of catheterisation length of hospital stay Mavuduru et al HoLEP: 15 RCT Patients eligible for surgery for Outcomes at 3 months and 9 months (2009) symptomatic BPH post-surgery. TURP: 15 (morcellation was only used in one patient) compared to TURP. Safety outcomes: transfusion capsular perforations urethral stricture incontinence Effectiveness outcomes: IPSS symptom scores PVR prostate volume) Cost-related outcomes: length of operation length of catheterisation BOO = Bladder outlet obstruction; PVR=post-void residual volume; AUA Urological Association score; Qmax=peak urinary flow rate. Quality assessment The two additional new studies identified in the updated literature search relevant to the comparison between HoLEP and TURP had an unclear risk of bias. While sequence generation was undertaken by a computer generated table, allocation concealment was not described. No details were given regarding blinding of patients, personnel or outcomes assessors, although this is not unusual in surgery trials (McCulloch et al 2002). It is unlikely however that lack of blinding will have a significant impact on the reported results as the majority of the primary measures of effectiveness are functional outcomes. Follow-up of patients (attribution bias) was generally not well reported. Approach to assessing HoLEP in comparison to OP
Eltabey et al(2010) HoLEP: 40 TURP: 40 RCT Patients with BOO caused by BHP, with related voiding symptoms, prostate size between 30–100 g , who had not responded to pharmacologic therapy, with AUA symptom score ≥12 and Qmax ≤15ml/s. Outcomes reported at 1, 6 and 12 months post-surgery. HoLEP (with tissue morcellation) compared to TURP. Safety outcomes: blood transfusion urethral stricture incontinence. Effectiveness outcomes: peak flow AUA symptom scores PVR prostate volume Cost-related outcomes: length of operation length of catheterisation length of hospital stay Mavuduru et al (2009) HoLEP: 15 TURP: 15 RCT Patients eligible for surgery for symptomatic BPH Outcomes at 3 months and 9 months post-surgery. (morcellation was only used in one patient) compared to TURP. Safety outcomes: transfusion capsular perforations urethral stricture incontinence Effectiveness outcomes: IPSS symptom scores PVR prostate volume) Cost-related outcomes: length of operation length of catheterisation BOO = Bladder outlet obstruction; PVR=post-void residual volume; AUA Urological Association score; Qmax=peak urinary flow rate. Quality assessment The two additional new studies identified in the updated literature search relevant to the comparison between HoLEP and TURP had an unclear risk of bias. While sequence generation was undertaken by a computer generated table, allocation concealment was not described. No details were given regarding blinding of patients, personnel or outcomes assessors, although this is not unusual in surgery trials (McCulloch et al 2002). It is unlikely however that lack of blinding will have a significant impact on the reported results as the majority of the primary measures of effectiveness are functional outcomes. Follow-up of patients (attribution bias) was generally not well reported. Approach to assessing HoLEP in comparison to OP
1149-Assessment-Report-Final-accessible.docx