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Long-term outcomes of transobturator tension-free vaginal tapes as secondary continence procedures

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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-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.

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Acknowledgements

We thank Dr. Karmakar (Research Fellow—University of Aberdeen) for sending out the questionnaires and collating the responses. We thank Lindsey Grant for performing the independent data entry cross-check. A special gratitude goes to all the participants whose excellent cooperation over the years made this study successful.

Funding

The initial phase of this study (up to 3-year follow-up) was funded by the Henry Smith Charity. Dr. Karmakar was funded by IUGA Clinical Fellowship Grant 2014.

Authors’ contributions

For this long-term study, MAF and AM conceived the idea, obtained funding and secured the ethics and institutional approvals. AM and GC were involved in data collection. GC was involved in data entry and data analysis. AM and LG (trial coordinator) performed 100% cross-checking of the data entry. GC arranged review of the statistics analysis plan with the statistics clinic in University of Aberdeen. AM supervised the data analysis. GC and MAF wrote the manuscript. All authors critically reviewed the manuscript and approved it. All authors take full responsibility for the integrity of the study and the data presented.

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Authors and Affiliations

  1. Division of Applied Health Sciences, University of Aberdeen, Second Floor, Aberdeen Maternity Hospital, Foresterhill, AB25 2ZD, Aberdeen, UK

    Mohamed Abdel-Fattah & Alyaa Mostafa

  2. University of Aberdeen, Aberdeen, UK

    Gabriel Cao

Authors
  1. Mohamed Abdel-Fattah
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  2. Gabriel Cao
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  3. Alyaa Mostafa
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Corresponding author

Correspondence to Mohamed Abdel-Fattah.

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Conflict of interest

Dr. Abdel-Fattah has previously delivered paid lectures and/or training courses for Bard, Coloplast, AMS, Pfizer and Astellas. He received travel grants from different pharmaceutical companies to attend medical conferences in the past. University of Aberdeen received research grant from Coloplast in 2009. Dr Alyaa Mostafa received travel award from the International Continence Society (ICS) to attend the ICS annual conference in 2012. Gabriel Cao received a travel award from UKCS to attend the UKCS annual conference in 2016.

Ethical approval

The study timely received all required approvals from Research & Development Departments in Glasgow & Aberdeen and the relevant ethics committee WOSRES (Ref05/S0702/6) and was registered on www.clinicaltrials.gov (NCT00136071) in 2005.

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Abdel-Fattah, M., Cao, G. & Mostafa, A. Long-term outcomes of transobturator tension-free vaginal tapes as secondary continence procedures. World J Urol 35, 1141–1148 (2017). https://doi.org/10.1007/s00345-016-1969-1

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  • DOI: https://doi.org/10.1007/s00345-016-1969-1

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