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 |