Altman 2011.
Methods | Trial design: multi‐centre, parallel‐group, randomised controlled trial involving 58 surgeons at 53 centres | |
Participants | Number of participants randomised: 410 (transvaginal mesh = 206, colporrhaphy = 204) Number of participants analysed: 389 (transvaginal mesh = 200, colporrhaphy = 189) Mean age (mean ± SD): transvaginal mesh = 64.3 ± 9.8, colporrhaphy = 65.1 ± 9.8 Inclusion criteria: > 18 years, ≥ stage 2 symptomatic cystocoele POPQ Exclusion criteria: previous cancer of any pelvic organ, systemic glucocorticoid treatment, insulin‐treated diabetes, an inability to participate or to provide consent, need for concomitant surgery Setting: hospitals throughout Sweden, Norway, Finland, and Denmark Timing: December 2007 to December 2008 |
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Interventions | Intervention: Gynecare transvaginal anterior mesh (Prolift), absorbable sutures, excessive vaginal trimming discouraged, catheter care discretion surgeon (191 underwent surgery as assigned) Comparison: anterior colporrhaphy slow absorption monofilament thread, sham skin markings, excessive trimming vagina discouraged (182 underwent surgery as assigned) Follow‐up at 2 and 12 months |
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Outcomes |
Primary outcome: a composite measure defined as POPQ stage 0 or 1 of the anterior vaginal wall (i.e. point Ba of the anterior vaginal wall positioned more than 1 cm above the hymen) + the answer ”no” to the question on vaginal bulging (item 16 of the Urogenidal Distress Inventory (UDI)) Secondary outcomes: individual components of the primary outcome (Ba < ‐1 on POPQ, Q16 on UDI‐ve, surgical complications, adverse events, patient‐reported UDI (compared to baseline at 2 months and 1 year post surgery), sexual function as measured on the PISQ‐12 questionnaire (compared to baseline at 1 year post surgery) |
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Notes | Intention‐to‐treat analysis: stated in the protocol that ITT will be used as well as per‐protocol analysis Sample size calculation: yes Trial registration: ClinicalTrials.gov NCT00566917 Funding: funded by grants from the Swedish Society of Medicine, the Karolinska Institutet Research Foundations; regional agreement on clinical research between the Stockholm County Council, the Karolinska Institutet, and Ethicon Conflicts of interest: statement in text of manuscript asserting that although Ethicon co‐sponsored the trial, the manufacturer did not provide the products used and had no involvement in data collection and analysis or in the decision to submit the results for publication. Author financial disclosures are available from the New England Journal of Medicine website as supplementary material; however this does not include other members of the Nordic Transvaginal Mesh Group who were reviewers of surgery |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisations |
Allocation concealment (selection bias) | Low risk | Secure concealment with remote computer |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants were blinded to surgical intervention through the use of sham skin markings and were not aware of their group assignment until 1‐year follow‐up had been completed |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | When possible, postoperative examination was performed by a gynaecologist other than the operating surgeon Reviewers: surgeon 1/3, non‐surgeon 2/3 Participant‐completed questionnaires Statistical analysis was conducted by an independent statistician blinded to group assignment until data analysis for primary outcome has been completed |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Patient flow accounted for completely in both groups Women who underwent surgery as per group assignment: transvaginal mesh: 191, colporrhaphy: 182 Loss to follow‐up: 21 participants (6% overall), transvaginal mesh: 14 (7%), colporrhaphy: 7 (4%) Analysed at one year: transvaginal mesh: 186, colporrhaphy: 182 |
Selective reporting (reporting bias) | Unclear risk | All prespecified outcomes are reported on |
Other bias | Unclear risk | Groups appear balanced at baseline |