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

Carter‐Brooks 2018.

Study characteristics
Methods Study design: RCT
Dates study conducted: February 2016‐March 2017
Participants Number of participants: eligible not reported, 57 reported
Setting: Connecticut
Country: USA
Population: women
Age (mean and SD): A 64.9 ± 11.5; B 65.2 ± 10.3
Inclusion criteria: surgical management of pelvic organ prolapse requiring an overnight hospital admission
Condition for hospitalisation: pelvic organ prolapse
Exclusion criteria: same‐day surgery, non‐ambulatory (allowed to use an assistive device), inability to provide informed consent, age < 21 years, pregnancy or desire for future pregnancy, systematic disease known to affect bladder function (Parkinson's disease, multiple sclerosis, spina bifida, spinal cord injury or trauma and neurogenic bladder), known pre‐operative urinary retention (defined as a post‐void residual > 100 mL), an untreated UTI at the time of surgery, treatment at the time of surgery for UTI, symptoms of UTI on the day of surgery
Use of antibiotic prophylaxis: not reported
Interventions Group A (n = 27): IUC removal 4 h post‐op
Group B (n = 30): IUC removal 6 am on post‐op day 1
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: voiding trial 4 h post‐operatively
Group B: voiding trial at 6 am day 1 post‐operative
Outcomes Number of participants requiring recatheterisation*
Incidence of UTI
Patient comfort or discomfort VAS pain scores**
Time to first void (h)
Length of hospitalisation (h)
Psychological outcome measures e.g. Hospital Anxiety and Depression Scale. Anxiety measured by State‐Trait Anxiety Inventory state subscale (STAI‐S)
Definition of CAUTI or bacteriuria “Defined as a positive culture or symptoms and antibiotic treatment”
Sponsorship/funding “This project was supported by the Clinical Research Trainee Award from Magee‐Womens Research Institute and the National Institutes of Health through grant number UL1‐TR‐000005.”
Ethical approval “This study was approved by the Institutional Review Board of the University of Pittsburgh (PRO15100653 approved 1/14/16)”
Notes *Derived from outcome “Spontaneous void after 1st voiding trial attempt”
**Pain scores were measured using the VAS, a continuous scale comprising a horizontal line 10 cm in length, anchored by the verbal descriptors “no pain” and “worst imaginable pain”.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: “Randomization was computer generated with 1:1 group allocation to an early or standard voiding trial in fixed blocks of 6.”
Comment: adequate method of randomisation
Allocation concealment (selection bias) Low risk Quote: “Randomization was concealed by a research assistant not involved in trial enrolment using consecutively numbered opaque envelopes”
Comment: adequate method of concealment
Blinding of participants and personnel (performance bias)
All outcomes High risk Blinding not possible
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not reported
Blinding of microbiological outcome (detection bias) Low risk Not reported. Assume urine samples were sent to a laboratory where the microbiologist would not know which patients were in the trial
Incomplete outcome data (attrition bias)
All outcomes Low risk ITT analysis and per‐protocol analysis reported. No withdrawals
Selective reporting (reporting bias) Low risk Outcomes appear to be reported in full
Other bias Low risk Appears to be free from other sources of bias