Dixon 2010.

Methods	RCT or quasi‐RCT: RCT Setting: UK Period: March 2004 ‐ July 2004
Participants	Population: women undergoing surgery for pelvic organ prolapse and/or stress urinary incontinence Inclusion criteria: women electively admitted for surgery for pelvic organ prolapse and/or stress urinary incontinence Exclusion criteria: • women undergoing surgery where postoperative catheterisation is not routinely used • women requiring continuous postoperative bladder drainage Age (median): A: 66 years; B: 57 years Number of participants: · Eligible: · Randomised: 75 · Reported: 72 Dropouts (n of participants + reasons): 2 from group A (operative bladder injury, latex allergy); 1 from group B (cancelled operation) Follow‐up: duration of hospital stay
Interventions	Time of intervention: A (n = 38): indwelling suprapubic catheter inserted in theatre, left on free drainage for 48 hours postoperatively B (n = 37): intermittent catheterisation postoperatively if unable to pass urine within 6 hrs of return from theatre or earlier if uncomfortable or if passing frequent (< 2 hourly), small volumes of urine (< 200ml). Continued until can void > 200 ml with post‐void residual volumes < 100 ml Intended duration of catheterisation: A: 48 hours; B: until able to void > 200 ml and post‐void residual volumes < 100 ml
Outcomes	Primary outcome (symptomatic UTI): A: 10/36; B: 6/36. (P = 0.44) from text A: 9/36; B: 13/36 (P = 0.44) from table Definition of symptomatic UTI: Catheter specimen of urine or a midstream urine specimen showing a single bacterium growing at a colony count of > 105 cfu/ml. Specimen only taken if UTI suspected on the basis of pyrexia > 37.5° C, frequent voiding + discomfort when passing urine and positive urinalysis for leukocytes + nitrites Bacteriuria: Not reported Definition of bacteriuria: Not reported Length of postoperative stay in days (median, range, N): A: 6 (2 ‐ 15); B: 5 (2 ‐ 19) (P = 0.003) Days of catheterisation (median, range, N): A: 5 (4 ‐ 36); 4 (2 ‐ 36). (P = 0.01) Any pain: A: 10/36; B: 6/36 Hayward pain score* (1 ‐ 5 scale, where 1 is no pain) (total score per group, N): A: 31 (36); B: 15 (36) Consumable costs per participant: A: GBP 24.90; B: GBP 10.60 Nursing time (mins/participant): A: 30; B: 90 Nursing time costs per participant: A: GBP 5.40; B: GBP 16.20 Total costs per participant: A: GBP 30.30; B: GBP 26.80 Quality of life: Not reported
Sponsorship/Funding	No funding received
Notes	Contacted Liz Dixon (liz.dixon@nuth.nhs.uk) and received information about median age of each group, and confirmed days of catheterisation is median, range (not SD as reported in trial)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	“The randomization sequence was generated using a random number generator programme” – adequate method of randomisation, low risk of selection bias
Allocation concealment (selection bias)	Low risk	“using opaque sealed envelopes” – adequate method of concealment
Blinding of participants	High risk	“No blinding of patient, surgeon, nurses, or outcome assessor was feasible.”
Blinding of personnel	High risk	“No blinding of patient, surgeon, nurses, or outcome assessor was feasible.”
Blinding of microbiological outcome assessment	Low risk	Symptomatic UTI would be assessed by microbiologist who would not know what catheter the participant had
Blinding of outcome assessment (detection bias) All outcomes	High risk	“No blinding of patient, surgeon, nurses, or outcome assessor was feasible.”
Incomplete outcome data (attrition bias) All outcomes	Low risk	75 randomised, 38 SPC and 37 IC. SPC had 2 withdrawals (1 operative bladder injury, 1 latex allergy), IC had 1 withdrawal (cancelled operation)
Selective reporting (reporting bias)	Low risk	The primary and secondary outcomes all had results reported. Unable to access protocol so uncertainty about reporting bias
Other bias	Low risk	Appears to be free of other sources of bias