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. 2021 Jun 29;2021(6):CD004011. doi: 10.1002/14651858.CD004011.pub4

Gong 2017.

Study characteristics
Methods Study design: RCT
Dates study conducted: February 2012‐April 2015
Participants Number of participants: 210 eligible; 198 randomised; 198 reported
Setting: First Affiliated Hospital of Chongqing Medical University (FAH‐CMU)
Country: China
Population: women
Age (mean ± SD): A 46.14 ± 8.33; B 45.70 ± 9.63
Inclusion criteria: patients with cervical cancer FIGO stage IB‐IIB
Condition for hospitalisation: radical hysterectomy
Exclusion criteria: patients were excluded if they had urinary incontinence, interstitial cystitis, cognitive impairment or difficulties in completing the training sheet
Use of antibiotic prophylaxis: not reported
Interventions Group A (n = 70): IUC for 48 h with intermittent clamping
Group B (n = 128): IUC for 48 h without intermittent clamping
Size and type of catheter used: not reported
Study definition of short‐term catheterisation (days): not reported
Intended duration of catheterisation for each group:
A: 48 h
B: 48 h
Outcomes Recatheterisation
Residual urine volume 24 h after removal
CAUTI
Duration of first catheterisation (days)
Definition of CAUTI or bacteriuria Symptomatic UTI was defined as bacteriuria with fever, frequent or painful urination or burning on urination
Sponsorship/funding None
Ethical approval The Institutional Review Board of Chongqing Medical University approved the study (File No.: 2012045), and all patients provided written informed consent.
Notes In the clamping group, bladder reconditioning was performed 2 days before IUC removal. The participants did the intermittent clamping, while the nurses performed the catheter insertion and removal. A designed training sheet was handed to the participants, who were educated on how to clamp the IUC and finish the sheet. In detail, IUCs were clamped for 4 h or until participants had urination desire, followed by a 5‐min urinary drainage, a cycle repeated in the daytime for 2 days. The schedule was chosen because it appeared to mimic a normal pattern of bladder filling and emptying
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "All patients were randomised on 2:1 using a computer‐generated list into two groups, the clamping group and the control group"
Comment: adequate method of randomisation
Allocation concealment (selection bias) Unclear risk Not reported
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "Both the researchers and the patients were not blind to the group assignment due to the procedure of the study"
Comment: not possible to blind participants due to type of intervention
Blinding of outcome assessment (detection bias)
All outcomes High risk Quote: "Outcome assessors were not blinded in the study..."
Comment: outcome assessors not blinded
Blinding of microbiological outcome (detection bias) Low risk Urine samples would be sent to a laboratory where the allocation of a participant would not be known
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "Five patients were excluded from the clamping group (three failed to record the training sheet, two had severe urine leakage during clamping because of the unfitted catheters and the catheters were removed without training). Seven patients in the control group dropped out because the catheters were removed in other hospitals and the data were missing.”
Comment: adequate reasons for exclusion
Selective reporting (reporting bias) Low risk Outcomes mentioned under Methods section are reported in Results. All outcomes expected from the objective of this trial are reported.
Other bias Low risk Appears to be free from other sources of bias