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. 2017 Jul 27;2017(7):CD002239. doi: 10.1002/14651858.CD002239.pub3
Methods RCT comparing laparoscopic with open colposuspension, power calculation, telephone randomisation; F/U: 6/12, 1 year, 3 years, 5 years
Participants 60 women Inclusion criteria: age ≥ 30 years, moderate‐severe urodynamically proven USI Exclusion criteria: previous bladder neck surgery, previous major abdominal surgery, hysterectomy, > 1st degree prolapse, diabetes, central nervous system condition severe chronic obstructive airways disease, steroid‐dependent asthma, recurrent UTI, MUCP < 25 cm H2O
Interventions Group 1 (n = 30): laparoscopic colposuspension Group 2 (n = 30): open colposuspension 15 previous laparoscopic colposuspensions to familiarise and standardise technique, transperitoneal approach for laparoscopic colposuspension, same surgeon for all operations, Dexon suture used in both groups, suprapubic catheter
Outcomes Duration of surgery, blood loss, catheterisation time, duration of hospital stay, analgesia use, adverse events, video cystourethrography, urodynamics, residuals, voiding difficulties, 1‐h pad test, urinary diary, VAS symptoms
Notes Adverse events: group 1: 1 bladder perforation, 1 UTI; group 2: 1 bladder perforation, 1 voiding difficulties, 1 wound infection 3 participants in group 1 had repeat surgery (3 open colposuspensions) Losses to F/U: none at 6/12, group 1: 7 (3 at 1 year, 5 at 3 years, 7 at 5 years); group 2: 6 (2 at 1 year, 5 at 3 years, 6 at 5 years)
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Low risk A ‐ Adequate