Results:
Of the 180 participants of the original trial, there were 8 deceased. Invitations were sent to the remaining 172 patients to participate in the follow-up study. 132 responses were received, of which 11 declined to participate. Of the remaining 121 returned questionnaires, 11 were excluded from paired analysis for 1 year versus 12 years due to missing 1 year follow up data. There were consequently 110 participants for paired analysis of endpoint i.e. 61% of the original trial. No response was received from 40 patients. There was an equal number of retropubic and transobturator tape procedures performed in each group: 55 TVT and 55 TOT participants. Mean follow up was 12.8 years (Range = 12.2 years to 13.4 years, STD +/- 0.29 years).
Primary outcome :
Cure of Stress Urinary Incontinence: ICIQ FLUTS
In the TVT group 23 participants (41.8%) reported no SUI at 12 years compared with 41 participants (74.6%) at 1 year. The difference between periods was significant 32.8% (95% CI -49.0 to 14.5% p < 0.001). In the TOT group 12 participants (21.8%) reportedno SUI at 12 years compared with 38 participants (69.1%) at 1 year. The difference between periods was also significant 45.7% (95% CI -62.2 to -30.3%, p < 0.001) (Table 1). There was a significant difference between the TVT and TOT groups in cure of SUI at 12 years in favour of TVT (p = 0.045). For the remainder of the participants who reported SUI at 12 years i.e. 32 and 43 for TVT and TOT participants respectively, 20(36.5%) and 20(36.5%) had SUI ‘occasionally’, 5(10%) and 11(19.3%) had SUI ‘sometimes’, 5(8.3%) and 8(14%) had SUI ‘most of the time’, and 2(3.3%) and 4(8%) had SUI ‘all of the time’.