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

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
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 
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)
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
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