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. 2021 Jan 25;2021(1):CD012863. doi: 10.1002/14651858.CD012863.pub2

Suprasert 2002.

Study characteristics
Methods Study design: a prospective randomised study
Study setting: Chiang Mai University Hospital in Thailand
Study duration: September 1998 to June 1999
Participants 81 stage IB1‐IIA cervical cancer patients who underwent radical hysterectomy with pelvic lymphadenectomy (RHPL). At the end of the RHPL operation, the participants were allocated immediately into the intermittent self‐catheterisation (N=38) or the suprapubic catheterisation (N=33) group before abdominal closure.
Exclusion criteria included abnormal preoperative bladder function or urinary analysis, urinary tract infection more than 2 times per year, history of renal stone, bladder calculi, urinary incontinence, intraoperative bowel or urinary tract complication, and inability to perform Intermittent self‐catheterisation (ISC).
Interventions ‐ Control group: suprapubic catheterisation
Suprapubic catheter was placed through a small bladder incision and exited through a separated skin incision. The catheter in this group was clamped on day 7 postoperatively for 4 hours and was released after self‐voiding to check the post voiding residual (PVR) urine.
‐ Intervention group: intermittent self‐catheterisation (ISC)
The ISC group was managed by indwelling transurethral Foley’s catheter for 7 days. On day 6, the patient was instructed to do ISC until she could confidently perform by herself. When the Foley’s catheter was removed on day 8, the ISC was performed every 4 hours after each voiding and the PVR urine was recorded.
‐ In both groups, ISC and SPC were discontinued when the PVR was < 75 ml for 2 consecutive voids.
Outcomes ‐ Febrile morbidity
‐ The voiding time (days)
‐ Rate of urinary tract infection
Notes ‐ Urine analysis was performed weekly until the ISC or SPC was discontinued.
‐ Bacteriuria was defined as urinary culture showed the organism more than 105 colonies/mL.
‐ Prolonged bladder dysfunction was defined as the voiding time was longer than 30 days.
‐ Febrile morbidity was defined as two consecutive oral temperatures ≥ 38˚ C, at least 6 hours apart excluding the first 24 hours after operation.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Assigned by computerised randomisation
Allocation concealment (selection bias) Low risk Sealed in the envelope
Blinding of participants and personnel (performance bias)
All outcomes Low risk Participants were not blinded to the intervention that they received. However, the outcomes of interest were unlikely to be affected by lack of blinding of participants and personnel.
Blinding of outcome assessment (detection bias)
All outcomes Low risk No statement regarding the blinding of outcome assessment. However, the outcomes of interest were unlikely to be affected by lack of blinding of outcome assessor.
Incomplete outcome data (attrition bias)
All outcomes Low risk No participants lost to follow‐up
Selective reporting (reporting bias) High risk No data on rate of spontaneous voiding recovery 1 week after surgery, QoL, post‐void residual urine volume at 1, 6 and 12 months after surgery, or subjective urinary symptoms were reported.
Other bias Low risk No information indicating an important risk of other bias