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 |