Kringel 2010.
| Methods |
RCT or quasi‐RCT: 3‐arm RCT Setting: Germany |
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| Participants |
Population: women undergoing anterior colporrhaphy plus an optional further procedure Inclusion criteria: women undergoing anterior colporrhaphy plus an optional further procedure (i.e. hysterectomy). Exclusion criteria: Preoperative asymptomatic bacteriuria, symptomatic UTI, previous vaginal prolapse surgery, unable to give consent Number of participants:
Age (mean, SD): A 63.5 (11.3) years; B 61.1 (9.92) years Dropouts (n of participants + reasons): None |
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| Interventions | A (n = 100): Indwelling urethral catheter (silicone Foley) placed intraoperatively, left indwelling for 24 hours B (n = 100): Indwelling urethral catheter (silicone Foley) placed intraoperatively, left indwelling for 96 hours C (n = 32): Suprapubic catheter (silicone Foley) placed intraoperatively, left for 96 hours Intended duration of Intervention: 24 or 96 hours |
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| Outcomes |
Primary outcome (symptomatic UTI): A: 2/100; B: 6/100; C: 0/32. (P = 0.155) Definition of symptomatic UTI: urine sample on postoperative day 4. Defined using CDC definition of catheter‐associated UTI Bacteriuria: A: 27/100; B: 25/100; C: 1/32 (P = 0.016; higher rates of Asymptomatic bacteriuria (ASB) in treatment groups) Definition of bacteriuria: urine sample on postoperative day 4. ASB defined using CDC definition Overall catheter‐related complications: A: 5/100; B: 5/100; C: 7/32 (P = 0.003; higher complication rate in group C) Urinary retention: A: 3/100; B: 2/100; C: 2/32 Pyelectasia: A: 0/100; B: 0/100; C: 1/32 Catheter blockage: A: 0/100; B: 0/100; C: 4/32 Dysuria without UTI: A: 2/100; B: 3/100; C: 0/32 Subjective well‐being score (1 (optimal) to 6 (bad)) (mean, SD): A: 2.22 ± 0.91; B: 2.27 ± 1.06; C: 2.96 ± 1.33 (P = 0.003; group C less tolerable) Mean hospital stay (mean, SD) (days): A: 5.62 ± 1.10; B: 5.95 ± 1.78; C: 6.25 ± 1.08 (P = 0.043) |
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| Sponsorship/Funding | University of Rostock (Germany) | |
| Notes | UTI and bacteruria were defined using CDC criteria UA and urine culture were performed before and 96 hours after surgery Subjective well‐being score: 1 was optimal and 6 was poor tolerability According to the power analysis, the investigators needed 100 participants per arm to show no significant difference between groups. However, they stopped the suprapubic arm with only 32 participants, due to "complications" and tolerability index, but the complication rate at which they would stop the trial was NOT defined prior to the trial Clinical characteristics of participant subgroups ‐ significant difference in preoperative bladder control problems (P = 0.029) and preoperative recurrent UTIs (P = 0.047). 96‐hour SUC had greater incidence of bladder control problems and recurrent UTIs All participants received 2 g Cefotiam i.v. before starting surgery as antibiotics prophylaxis |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "as randomization procedure, the permuted block randomization with variable block length was used" ‐ adequate method of randomisation |
| Allocation concealment (selection bias) | Unclear risk | "using sealed envelopes" ‐ not specified if envelopes were transparent or opaque |
| Blinding of participants | High risk | No information given but as suprapubic vs urethral can assume blinding did not occur |
| Blinding of personnel | High risk | No information given but as suprapubic vs urethral can assume blinding did not occur |
| Blinding of microbiological outcome assessment | Low risk | Symptomatic UTI and bacteriuria would be assessed by microbiologist who would not know which catheter the participant had |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information given |
| Incomplete outcome data (attrition bias) All outcomes | High risk | At randomisation, 100 randomised to IUC 24 hours and IUC 96 hours each, and 32 to SPC 96 hours due to "preterm discontinuation of the SUC arm after pre‐planned interim data monitoring" |
| Selective reporting (reporting bias) | Low risk | Reported all primary and secondary outcomes in Methods. Unable to access protocol, some uncertainty about selective reporting |
| Other bias | Low risk | Appears to be free from other sources of bias |