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. 2017 Jul 26;2017(7):CD001754. doi: 10.1002/14651858.CD001754.pub4
Methods RCT randomisation by date of birth method. 2 arms. Odd days assigned to TVT arm, even days PVS. Follow‐up 3, 12 and 24 months
Participants 63 women who complained of SUI were recruited, 3 eventually declined to undergo surgery, therefore a total of 60 women (29‐PVS, 31‐TVT) with urodynamic stress or mixed incontinence were included. Diagnosis made by a cough‐stress test, a 60 min pad‐weighing test, and urodynamic studies
Interventions A (29): PVS
B (31): TVT
Outcomes The primary outcome measure was cure of SUI. Objective cure was defined as the complete absence of leakage during the cough‐stress test with 250 or 300 mL of water in the bladder. Subjective cure was consistent with complete dryness or a few drops of water with strong exercises.
Other outcome measures (6‐parameter analysis): operation time, numbers of analgesics required in a perioperative period, , changes in haematocrit, length of a Foley catheter, and length of stay
Not cured at 24 months (subjective): A: 7/21, B: 4/23
Not cured at 24 months (objective): A: 11/21, B: 7/23
Operative time (mean (SD)): A: 87.1 (13.3), B: 43.9 (17.3) min
Length of hospital stay (mean (SD)): A: 9.2 (0.9), B: 9.2 (0.6) days
Time to catheter removal (mean (SD)): A: 1.4 (0.5), B: 1.3 (0.1) days
Complications: all complications: A: 11/29, B: 9/31; bladder perforation: A: 7/29, B: 7/31; urethral injury: A:0/29, B: 1/31; subcutaneous haematoma: A: 0/29, B: 1/31; voiding dysfunction: A: 4/29, B: 0/31; release of sling surgery: A: 4/29, B: 0/31; de novo detrusor urgency: A: 3/29, B: 2/31
Notes Follow‐up 24 months. Women who underwent concomitant surgery (5‐PVS, 8‐TVT) and/or had revision surgery were excluded from the 6‐parameter analysis because extra interventions made a comparison difficult. Participants for the assessment reduced to 23 women in the TVT and 21 in the PVS group
Data updated from new publication
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Date‐of‐birth method
Allocation concealment (selection bias) High risk Date of birth
Blinding (performance bias and detection bias) All outcomes Unclear risk No mention
Incomplete outcome data (attrition bias) All outcomes Low risk Similar loss across groups at follow‐up, 72% remained in sling arm and 74% in Burch