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. 2012 Feb 15;2012(2):CD003306. doi: 10.1002/14651858.CD003306.pub2

Studer 1996.

Methods Randomised prospective study, with 1 subsequent paper published with longer follow‐up data: Studer 1996 (primary reference)
Studer 1991 
 Median follow‐up: Anti‐reflux nipple 36 months, afferent tubular segment 30 months 
 Drop‐outs: Total 60 patients operated on, but data on 40 presented as follow‐up was more than a year in this subgroup. Total 20 drop‐outs.
Studer 1996 (primary reference) 
 Median follow‐up: Anti‐reflux nipples 57 months, afferent tubular segment 45 months 
 Drop‐outs: None
Participants Incl: radical cystectomy, bladder substitution with ileal segment and male patients only
Excl: Patient follow‐up less than a year, female patients
Studer 1991 
 n (anti‐reflux nipple) = 20 
 n (afferent tubular segment) = 20 
 Sex: All males 
 Mean age: 63.7 years
Studer 1996 (primary reference) 
 n (anti‐reflux nipple) = 35 
 n (afferent tubular segment) = 35 
 Sex: All males 
 Median age: anti‐reflux nipple 66.6 years and afferent tubular segment 63.8 years
Interventions I: Anti‐reflux nipple 
 II: Afferent ileal tubular segment
Outcomes Studer 1991 
 I: Reflux vs No reflux 
 II: Urinary continence (day and night) 
 III: Bacteriuria presence 
 IV: Serum acidosis 
 V: Serum B12 
 VI: Kidney size
Studer 1996 (primary reference) 
 I: Urinary continence (day and night) 
 II: Bacteriuria presence 
 III: Pyelonephritis 
 IV: Uretero‐intestinal strictures requiring re‐operation 
 V: Upper tract dilatation 
 VI: Functional reserve 
 VII: Renal function 
 VIII: Voiding habits 
 IX: Urinary stones
Notes No mention of disease type in the inclusion criteria of the study. Studer 1996 was used as the primary study as this had the longest follow‐up.
Studer 1991 
 Unclear causes of deaths. 18 deaths from "progressive" disease and 3 deaths from "other" causes.
In 3 patients with metabolic acidosis requiring correction, no mention was made of which treatment group these patients originated from.
Studer 1996 (primary reference) 
 Note 22 deaths from progressive bladder cancer.
Conflicting numbers of pyelonephritis in patients compared to Studer 1991. For the purposes of analysis, the numbers from the later report; Studer 1996 were included in the tables.
It was not possible to extract data from Fig. 2 of Studer 1996 paper for the purposes of analysing the incidence of bacteriuria / positive culture.
In upper tract dilatation, the numbers used in the final analysis were from Studer 1996. It should be noted that renal units were used rather than patient numbers.
It was not possible to analyse the outcomes of metabolic acidosis, functional reserve, renal function and voiding habits in both reports as no actual figures were presented.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk not stated
Allocation concealment (selection bias) Unclear risk not stated
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk not stated
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk not stated
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Total 60 patients operated on, but data on 40 presented as follow‐up more than a year in this subgroup. Total 20 drop‐outs.

Incl. = inclusion criteria 
 Excl. = exclusion criteria 
 GFR = Glomerular filtration rate (mls/min)