Stekkinger 2011.

Methods	RCT or quasi‐RCT: RCT Setting: Deventer Ziekenhuis, Deventer, Netherlands Period: July 2005 ‐ August 2007
Participants	Population: patients undergoing cystocoele repair Inclusion criteria: All women scheduled for anterior colporrhaphy (AC) surgery ± hysterectomy, ± PRS for pelvic prolapse Exclusion criteria: Those without AC, those with incontinence surgery; h/o urinary retention, urologic disease, renal insufficiency; those with preoperative UTI by dipstick; those unable to read and write Dutch Number of participants: Eligible: 168 Randomised: 126 Reported: 126 Age (mean, SD): A: 61.7 (11.2) years; B: 62.2 (11.5) years Dropouts (n of participants + reasons): suprapubic group (2 never placed, 3 clogged, 5 fell out), but analysed with ITT.
Interventions	A (n = 62): indwelling urethral catheterisation using 14 French (brand not specified) placed intra‐operatively, removed in the afternoon of postoperative day 3; measurements begun in morning of postoperative day 4 B (n = 64): suprapubic catheterisation using 15Fr Cystofix™ SPT catheter, sutured to participant's skin (B. Braun Medical, Oss, Netherlands) placed intra‐operatively, clamped on the 3rd night after surgery; measurements begun in the morning of postoperative day 4 All participants received pre‐operative antibiotics (1 g Cefazolin and 500 mg of Metronidazole) Duration of Intervention: Until participant returned to adequate voiding (PVR < 150 ml)
Outcomes	Primary outcome (symptomatic UTI): not reported Bacteriuria: A: 6/62; B: 6/64 (P = 0.93) (NS) Definition of bacteriuria: Presence of > 10⁴ cfu/ml in culture Proportion of participants with inadequate post‐operative voiding (PVR > 150 ml) on postoperative day 4: A: 14; B): SPC 13, (P = 0.76) (NS) Proportions able to void spontaneously: A: 60/62; B: 62/64 (NS) Number of days until residual volume < 150 ml (days)(median, minimum‐maximum): A: 4 (3 ‐ 18); B: SPC 4 2 ‐ 69); (P = 0.024) (NS) PVR volume (ml)(median, minimum‐maximum): A: 56 (0 ‐ 700); B: 85 (0 ‐ 650) (P = 0.76) (NS) Length of hospital stay (days)(median, minimum‐maximum): A: 4 (3 ‐ 7); B: 4 (3 ‐ 13) (P = 0.71) (NS) PVR volume > 500 ml: A: 5/62; B: 5/64; (P = 0.96) (NS) Need for recatheterisation: A: 11/62; B: 11/64 (P = 0.94) (NS) Catheter‐related complications: A: 7/62; B: 30/64 ‐Catheter fell out: A: 0/62; B: 5/64 (P = 0.058) (NS) ‐Serious haematuria: A: 0/62; B: 5/64 (P = 0.058) (NS) ‐Urine leakage: A: 4/62; B: 17/64 (P = 0.003) (Significant Difference) ‐Catheter blockage: A: 3/62; B: 3/64 (P = 1.0) (NS)
Sponsorship/Funding	Not reported
Notes	Although there was no statistically significant difference for the primary outcome, the sample size of 114 was calculated for a difference of 15% between groups; therefore the trial did NOT have the power to detect a lesser difference (only 2%) in this sample. Complication rate was reported as total number of complications, although participants may have developed more than one complication, thereby lowering the reported rate. All women received a single dose of prophylactic antibiotics (cefazolin 1 g and metronidazole 500 mg) during surgery
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"women were randomly assigned to two groups... sequentially numbered sealed, opaque envelopes that were opened before surgery" ‐ adequate method of randomisation
Allocation concealment (selection bias)	Low risk	" sequentially numbered sealed,opaque envelopes" ‐ adequate method of allocation concealment
Blinding of participants	High risk	No information given but as suprapubic vs transurethral can assume blinding did not occur
Blinding of personnel	High risk	No information given but as suprapubic vs transurethral can assume blinding did not occur
Blinding of microbiological outcome assessment	Low risk	Symptomatic UTI would be assessed by microbiologist who would not know which catheter participant had
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No information given on other outcomes
Incomplete outcome data (attrition bias) All outcomes	Low risk	126 randomised. None lost to follow‐up
Selective reporting (reporting bias)	Low risk	All primary and secondary outcomes mentioned in Methods are reported in Results. Unable to access protocol, so some uncertainty around selective reporting
Other bias	Low risk	Appears to be free from other sources of bias