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. 2018 Aug 19;2018(8):CD013108. doi: 10.1002/14651858.CD013108

Costantini 2007.

Methods Trial design: single‐centre randomised controlled trial
Participants Number of participants randomised: 66 (group A 34, group B 32)
Number of participants analysed: 66
Mean age (mean ± SD): group A = 63 ± 9, group B = 61 ± 8
Inclusion criteria: continent women (women with negative stress test before and after prolapse reduction, no preoperative symptoms of urinary incontinence, negative symptom questionnaire, and no leakage during urodynamics) with 'severe' uterovaginal and vault prolapse (not clearly defined)
Exclusion criteria: not stated
Setting: University of Perugia, Itali
Timing: January 2000 to December 2004
Interventions Intervention: group A sacrocolpopexy + Burch colposuspension (n = 34)
Comparison: group B sacrocolpopexy alone (n = 32)
Outcomes Primary outcome/s: changes in continence status, anatomical outcome of prolapse repair
Secondary outcome/s: changes in subjective symptoms, quality of life measured by IIQ‐7 and UDI‐6
Notes Urinary incontinence was clinically classified "on the basis of the ICS definition and graded on the Ingelman Sunderberg scale".
Intention‐to‐treat analysis: All randomised participants were analysed.
Sample size calculation: yes, 66 participants calculated to provide 80% to 85% power to detect a 25% to 30% difference in proportion of postoperative incontinence between groups
Trial registration: no
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
Allocation concealment (selection bias) Unclear risk No details provided of method used to conceal group allocation.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Trial personnel who performed the surgery were not blinded. No details of blinding of participants were provided.
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 3/34 group A and 2/32 group B participants lost to follow‐up
Selective reporting (reporting bias) Unclear risk Preoperative UDI scores were given, but no postoperative UDI scores were available.
Other bias Unclear risk Primary continence assessments were based on a non‐defined stress test and symptoms from the UDI Questionnaire.