Naik 2005.

Methods	RCT or quasi‐RCT: RCT Setting: UK Period: 1 July 1999 – 31 June 2002
Participants	Population: women treated by radical hysterectomy for early‐stage cervical cancer Inclusion criteria: women undergoing radical hysterectomy for early‐stage cervical cancer Exclusion criteria: not reported Age (median, range): 45 (20 ‐ 78) Number of participants: · Eligible: Not reported · Randomised: 40 · Reported: 36 Dropouts (n of participants + reasons): 4 removed following randomisation – 2 in each group. 1 developed ureteric fistula, 1 developed postoperative confusion, 1 had a stroke, 1 died. Not detailed which groups they were in. Follow‐up: 12 weeks
Interventions	Time of intervention: A (n = 19): suprapubic catheterisation. Insertion of Bonanno suprapubic catheter (Becton Dickenson, Franklin Lakes, New Jersey, USA) at the time of surgery. On free drainage for 5 days. Woman asked to pass urine normally every 4 hours, then measure residual volume using catheter. Catheter was removed when residual volume < 100 ml B (n = 21): intermittent catheterisation. Transurethral indwelling catheter (hydrophilic coated LoFric – Astra Tech Ltd, Stroudwater Business Park, Stonehouse) was inserted at the time of surgery. Removed on day 5, women would pass urine every 4 hours then measure residual volume using intermittent catheter. Intermittent catheterisation ceased when residual volume < 100 ml. Intended duration of catheterisation: Until residual volume < 100 ml
Outcomes	Primary outcome (symptomatic UTI): NR Definition of symptomatic UTI: NR Bacteriuria (“positive CSU/MSU rate”): Day 3: A: 1/17 (6%); B: 8/19 (42%) (P = 0.05) Day 5: A: 3/17 (18%); B: 12/19 (63%) (P = 0.004) Day 7: A: 6/17 (36%); B: 7/19 (37%) (P = 0.4) Day 14: A: 9/17 (53%); B: 4/19 (21%) (P = 0.16) Day 21: A: 2/17 (12%); B: 2/19 (11%) (P = 0.21) Definition of bacteriuria: NR Duration of catheterisation, days(median, range, N): A: 20 (7 ‐ 28), 17; B: 17 (7 ‐ 90), 19 (P = 0.83) Adverse effects: A: 8/17 (symptoms/problems with suprapubic catheter site, of which 4 had positive wound swab requiring antibiotics); B: NR Quality of life: Various questionnaires reported only in terms of between‐group differences expressed in P values, for postoperative weeks 3, 6 and 12
Sponsorship/Funding	Not reported
Notes	All women received a single dose of intraoperative antibiotics. Prophylactic antibiotics were not given at any other time in the trial. Antibiotics were prescribed when clinically indicated, i.e. positive urine sample or positive SPC site swab 2 participants randomised to group A received transurethral indwelling catheter instead because of suprapubic site problems. 1 randomised to group A requested removal of suprapubic catheter and further bladder care by intermittent self catheterisation
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	“Randomisation was performed via sealed envelopes and an independent administrator” – not enough information of method of randomisation to be able to assess risk of selection bias
Allocation concealment (selection bias)	Unclear risk	“Sealed envelopes” no further information given, not enough information to be able to asses risk of selection bias
Blinding of participants	High risk	No information given. As intermittent self catheterisation vs suprapubic, unlikely blinding could take place
Blinding of personnel	High risk	No information given. As intermittent self catheterisation vs suprapubic, unlikely blinding could take place
Blinding of microbiological outcome assessment	Low risk	Bacteriuria would be assessed by microbiologist who would not know what type of catheter the participant had
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No information given
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	40 women randomised – intermittent 21, suprapubic 19 4 participants withdrawn following surgery: intermittent 2, suprapubic 2. (1 developed ureteric fistula, 1 developed postoperative confusion, 1 had perioperative cerebrovascular accident, 1 died). No information on which groups the 4 participants were in.
Selective reporting (reporting bias)	Low risk	All data that were planned to be collected in the Methods have results reported. Unable to access protocol, so some uncertainty surrounding reporting bias
Other bias	Low risk	Appears to be free of other sources of bias