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 |
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Interventions | Intervention: group A sacrocolpopexy + Burch colposuspension (n = 34) Comparison: group B sacrocolpopexy alone (n = 32) |
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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 |
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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 |
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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. |