Mohamed Abdel-Fattah1, Gabriel Cao2, Alyaa Mostafa3. 1. Division of Applied Health Sciences, University of Aberdeen, Second Floor, Aberdeen Maternity Hospital, Foresterhill, AB25 2ZD, Aberdeen, UK. m.abdelfattah@abdn.ac.uk. 2. University of Aberdeen, Aberdeen, UK. 3. Division of Applied Health Sciences, University of Aberdeen, Second Floor, Aberdeen Maternity Hospital, Foresterhill, AB25 2ZD, Aberdeen, UK.
Abstract
PURPOSE: To assess the long-term patient-reported outcomes following TO-TVT as a secondary continence procedure in women with recurrent stress urinary incontinence (R-SUI). METHODS: A secondary analysis of the 9-year follow-up of the E-TOT study was performed: 341 women with predominant SUI symptoms were randomised to undergo either Inside-out or Outside-inTO-TVT between April 2005 and April 2007. Forty-six women had R-SUI following previously failed continence surgery at time of randomisation and are the basis of this analysis as a one single cohort. Primary outcome was the patient-reported success rate defined as very/much improved on Patient's Global Impression of Improvement (PGI-I). Secondary outcomes included late adverse events and impact on women's quality of life and sexual function. Statistical analysis was performed using SPSS version 23. RESULTS: Sixty-three per cent completed the 9-year follow-up. The success based on the PGI-I was 62.1% with no significant difference between groups (OR 5.33; 95% CI 1.03, 27.76; p = 0.094). Clinically significant improvement in QoL was found in 84.2%. Adverse events included vaginal erosions (n = 3) and groin pain (n = 2). The small sample size is a limitation in this study; nevertheless, this is one of the largest cohorts reported for women with R-SUI and the first to report the long-term outcomes of TO-TVT as a secondary continence procedure. CONCLUSIONS:TO-TVT operations are associated with good patient-reported success rates (62%) in women with previous failed continence surgery with up to 9-years follow-up. There is a non-significant trend towards better outcomes with the inside-out TO-TVT.
RCT Entities:
PURPOSE: To assess the long-term patient-reported outcomes following TO-TVT as a secondary continence procedure in women with recurrent stress urinary incontinence (R-SUI). METHODS: A secondary analysis of the 9-year follow-up of the E-TOT study was performed: 341 women with predominant SUI symptoms were randomised to undergo either Inside-out or Outside-in TO-TVT between April 2005 and April 2007. Forty-six women had R-SUI following previously failed continence surgery at time of randomisation and are the basis of this analysis as a one single cohort. Primary outcome was the patient-reported success rate defined as very/much improved on Patient's Global Impression of Improvement (PGI-I). Secondary outcomes included late adverse events and impact on women's quality of life and sexual function. Statistical analysis was performed using SPSS version 23. RESULTS: Sixty-three per cent completed the 9-year follow-up. The success based on the PGI-I was 62.1% with no significant difference between groups (OR 5.33; 95% CI 1.03, 27.76; p = 0.094). Clinically significant improvement in QoL was found in 84.2%. Adverse events included vaginal erosions (n = 3) and groin pain (n = 2). The small sample size is a limitation in this study; nevertheless, this is one of the largest cohorts reported for women with R-SUI and the first to report the long-term outcomes of TO-TVT as a secondary continence procedure. CONCLUSIONS: TO-TVT operations are associated with good patient-reported success rates (62%) in women with previous failed continence surgery with up to 9-years follow-up. There is a non-significant trend towards better outcomes with the inside-out TO-TVT.
Authors: Evangelia Bakali; Eugenie Johnson; Brian S Buckley; Paul Hilton; Ben Walker; Douglas G Tincello Journal: Cochrane Database Syst Rev Date: 2019-09-04