Skip to main content
. 2021 Jun 29;2021(6):CD004011. doi: 10.1002/14651858.CD004011.pub4

Joshi 2014.

Study characteristics
Methods Study design: RCT
Dates study conducted: July 2008‐December 2009
Participants Number of participants: eligible, not reported; 70 randomised; 70 reported
Setting: Chandigarh
Country: India
Population: women
Age (mean ±SD): A 46.80 ± 6.90; B 45.09 ± 6.44
Inclusion criteria: women undergoing uneventful abdominal hysterectomy with or without salpingo‐oophorectomy
Condition for hospitalisation: abdominal hysterectomy with or without salpingo‐oophorectomy
Exclusion criteria: anticipated complicated surgical procedure requiring strict fluid replacement post‐operatively; bladder suspension or colporrhaphy surgery; positive or unavailable pre‐operative urine culture report; comorbid illness requiring strict intake output monitoring
Use of antibiotic prophylaxis: all patients received 1 dose of antibiotic prophylaxis at the time of surgery and continued post‐operatively as per department protocol
Interventions Group A (n = 35): immediate removal of IUC in the operating room
Group B (n = 35): IUC removal after 24 h
Size and type of catheter used (e.g. Foley 16F): standard 16F Foley’s catheter with 10 cc balloon
Study definition of short‐term catheterisation (days): not reported
Intended duration of catheterisation for each group:
A: immediate removal of IUC in the operating room
B: removal of IUC 24 h post‐operatively
Outcomes Recatheterisation (defined as inability to pass urine at the end of 12 h, or failure to void after 2 attempts)
Positive urine culture on day 2 post‐op
Positive urine culture 2 weeks post‐op
Febrile morbidity
Pain perception
Definition of CAUTI or bacteriuria “The diagnosis of symptomatic UTI was based on the presence of significant bacteriuria accompanied by at least one of the following symptoms: Fever, dysuria, increased frequency of urination, urinary urgency, suprapubic pain, and burning micturition.”
Sponsorship/funding Not reported
Ethical approval “Informed consent was obtained from enrolled patients and protocol was approved by the Institute’s Ethical Committee.”
Notes Pain was assessed with a pictorial questionnaire that assessed the level of pain and location of pain, that is, bladder or urethra versus surgical site. The questionnaires were site‐specific for the pain. All patients were given same analgesia in the post‐operative period.
Febrile morbidity was defined as 2 consecutive oral temperatures of > 100.4 °F (37.78 °C) measured 6 h apart.
Of 12 culture‐positive most common organism was Escherichia coli. None of these had repeat culture‐positive at 2 weeks. 3/9 culture‐positive cases in late removal group had symptoms of UTI and fever.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: “Randomization was performed by using a computer generated randomization table”
Comment: adequate randomisation method
Allocation concealment (selection bias) Low risk Quote: “Allocation group was kept in sealed envelope. The operating surgeon was made aware of randomization and accordingly the patient was assigned to one of the two groups. In all cases, the envelope was opened at the end of the surgical procedure”
Comment: adequate concealment method
Blinding of participants and personnel (performance bias)
All outcomes High risk Not reported. Blinding not possible due to intervention
Blinding of outcome assessment (detection bias)
All outcomes High risk Quote: “a limitation of our study may exist in the fact that the observer of outcome was not blinded to the randomization”
Comment: observer was not blinded to randomisation
Blinding of microbiological outcome (detection bias) Low risk Quote: “A clear voided midstream urine specimen was obtained on the second postoperative day for culture and sensitivity.”
Comment: urine samples likely were sent to a laboratory and so microbiologist is unlikely to know which patients belong to the trial
Incomplete outcome data (attrition bias)
All outcomes Low risk No withdrawals reported, all participants who were randomised were included in analysis
Selective reporting (reporting bias) Unclear risk Symptomatic UTI does not seem to be reported
Other bias Low risk Appears to be free from other sources of bias