Materials and methods
SUI, Defecatory Distress, pain
PROLAPSE, INCONTINENCE
The original trial [An extended follow-up was approved by the Medical Ethics Committee, region Arnhem-Nijmegen, The Netherlands, on 28 April 2014 under no. NL46834. 091.14 and (All participants completed the Dutch version of the validated questionnaires: Patient Global Impression of Improvement questionnaire (PGI-I), EuroQol-5D (EQ-5D), Urogenital Distress Inventory (UDI), Defecatory Distress Inventory (DDI), Incontinence Impact Questionnaire (IIQ), and Visual Analogue Scale (VAS) pain score [The PGI-I is a seven-point Likert scale to rate the patient-reported response of a condition (prolapse) to therapy (surgery), where 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. These mean scores are presented per treatment group as well as the percentage of women reporting their improvement very much better or much better. The EQ-5D records the patient’s self-rated health on a five-point scale (excellent, very good, good, fair, or poor). The UDI, DDI, and IIQ are each subdivided into five domains, with subscales ranging from 0 to 100 and higher scores indicating more bother and worse QoL. The VAS pain ranged from 0 to 10 and was assessed as spontaneous pain and pain on activity.The primary outcome of this extended follow-up study was defined as the difference in PGI-I score between the mesh group and the native tissue repair group. Secondary outcomes were patient-reported retreatment for POP, SUI, and mesh exposure, and further questionnaire scores.Missing data of women who were lost at 12-year follow-up were not imputed. Analysis was carried out according to the intention-to-treat principle. Per protocol analysis was performed to rule out a dilution of real effects due to mesh surgery during repeat surgery in the native tissue repair group. Descriptive statistics with mean scores and standard deviations and numbers with percentage were used to summarize outcomes. Statistical significance was analyzed using independent samples 