Glavind 2007.
| Study characteristics | ||
| Methods |
Study design: RCT Dates study conducted: December 2004‐April 2006 |
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| Participants |
Number of participants: eligible, not reported; 140 randomised; 134 reported Setting: Aalborg Country: Denmark Population: women Age (mean and range): 61 years (31‐88) Inclusion criteria: women consenting to undergo any type of vaginal prolapse surgery Condition for hospitalisation (e.g. hysterectomy or TURP): vaginal surgery for genital prolapse Exclusion criteria: 1 patient due to bladder perforation during procedure Use of antibiotic prophylaxis: all participants who had a vaginal hysterectomy or high uterosacral suspension operation performed received 1 pre‐operative injection of Cefuroxime. No antibiotic prophylaxis was used in the remaining participants |
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| Interventions |
Group A (n = 66): IUC removed after 3 h post‐operatively Group B (n = 68): IUC removed next morning Size and type of catheter used (e.g. Foley 16F): not reported Study definition of short‐term catheterisation (days): not reported Intended duration of catheterisation for each group: Group A: 3 h post‐op Group B: IUC removed the next morning after operation |
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| Outcomes | Minimal bleeding Menstrual bleed Heavier bleed Haematoma Recathetersation Positive urine culture |
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| Definition of CAUTI or bacteriuria | A positive urine culture was defined as the presence of ≥ 105 cfu/mL. | |
| Sponsorship/funding | Not reported | |
| Ethical approval | All patients who underwent any kind of vaginal prolapse surgery were included in the study after informed consent | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: “Randomisation was performed with sealed envelopes opened at the end of the operation.” Comment: method of randomisation unclear |
| Allocation concealment (selection bias) | Low risk | Quote: “… sealed enveloped opened at the end of the operation” Comment: adequate method of concealment |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: “Patients were surveyed by the nurses in the department” Comment: does not report whether participants or nurses were blinded. Unlikely blinding was possible |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
| Blinding of microbiological outcome (detection bias) | Low risk | Quote: “Patients were contacted by telephone after 3 weeks to be informed about the urine culture after 14 days, and questioned about bleeding and retention.” Comment: likely urine samples were sent to a laboratory where the microbiologist would be unaware which patient belonged to the trial |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: “One patient was excluded from the study because of bladder perforation during the operation. Five patients were excluded because of violation of the protocol, both because they had to have the vaginal pack and catheter removed before time due to pain or because, in error, they did not have the catheter and vaginal pack removed until the next day in spite of belonging to Group 1.” Comment: effect on relevant outcomes unclear |
| Selective reporting (reporting bias) | Low risk | All outcomes reported in methods are the same in the results |
| Other bias | Low risk | Appears to be free from other sources of bias |