Costantini 2008.

Methods	Trial design: single‐site RCT
Participants	Number of participants randomised: 47 (group A n = 24, group B n = 23) Number of participants analysed: 47 Mean age (mean ± SD): group A = 60 ± 10, group B = 61 ± 13 Inclusion criteria: women age 18 to 75, POP > stage 2 (BW and POPQ), urinary incontinence defined by ICS Exclusion criteria: uterine fibroids, uterine/cervical malignancy, active PID, allergy to synthetic graft/suture materials, pregnancy/lactation, significant illness, inability to provide informed consent or comply with study protocol  Setting: Urology Department, University of Perugia, Italy Timing: January 2002 to June 2006
Interventions	Intervention: group A ‐ sacrocolpopexy + Burch 14, sacrohysteropexy + Burch 10 (n = 24) Comparison: group B ‐ sacrocolpopexy 17, sacrohysteropexy 6, no colposuspension (n = 23) Preoperatively incontinence defined by urodynamics: 13 USI, 30 mixed, 4 occult (incontinence with coughing or Valsalva manoeuvre with the prolapse reduced). Distribution of patients with prolapse and incontinence preoperatively between groups is unclear.
Outcomes	Primary outcome/s: change in incontinence rate measured by combination of bladder diary, number of pads and stress test without clear definition, anatomical outcome of prolapse as measured by B7W and POPQ Secondary outcome/s: changes in subjective symptoms and quality of life measured by questionnaires, postoperative satisfaction as measured by VAS
Notes	CONSORT statement: yes     Intention‐to‐treat analysis: All participants randomised were analysed. Sample size calculation: yes, 47 participants calculated to provided 80% power to detect up to 30% difference in postoperative conditions between the 2 groups Trial registration: yes (post hoc) Clinicaltrials.gov NCT00576004 Funding: not stated. Conflicts of interest: not stated
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated list
Allocation concealment (selection bias)	Unclear risk	No details were provided of the method used to conceal group allocation.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Trial personnel who performed the operations were not blinded.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Outcome assessors were blinded to group allocation.
Incomplete outcome data (attrition bias) All outcomes	Low risk	No loss to follow‐up
Selective reporting (reporting bias)	Unclear risk	All prespecified outcomes appear to have been reported.
Other bias	Unclear risk	Distribution of POP between groups not clear: 24 uterovaginal, 13 vault, 8 cystocoele, 2 cystocoele and rectocoele Methodological problems with this paper include lack of clear and equal distribution of prolapse grading and incontinence between groups preoperatively, inconsistency of preoperative and postoperative incontinence classifications (urodynamics preoperatively and symptoms postoperatively), and lack of definition of success of prolapse grading and data related to perioperative parameters and complications.