Abstract
Introduction and hypothesis
The tension-free vaginal tape (TVT) and inside-out transobturator tape (TVT-O) are first-line surgical treatments for stress urinary incontinence (SUI). However, there is a lack of information regarding the long-term comparative safety of these procedures.
Methods
A total of 140 SUI patients were randomized to the TVT or TVT-O procedure and were interviewed by an independent investigator at the follow-up. The primary outcomes were the proportions of patients with long-term postoperative complications. The secondary outcomes included the cure rates, quality of life (QOL) and sexual function based on validated questionnaires.
Results
One hundred and twenty (85.71 %) patients completed the long-term follow-up. More TVT patients experienced perioperative complications (P < 0.05). However, in a mean follow-up of 95 months, no significant between-group difference was found in the proportions of patients with long-term complications or in the variety of reported complications. The long-term complication rates for TVT and TVT-O were 43.1 % and 27.4 % respectively (P = 0.07). De novo voiding (15.8 %) and storage symptoms (10.8 %) were the primary long-term complications. Tape exposure was possible up to 7 years after TVT-O. The objective cure rates of TVT and TVT-O procedures were 79.30 and 69.35 % respectively, which were not significantly higher than the subjective rates. The Pelvic Floor Impact Questionnaire (PFIQ-7) scores remained improved (P < 0.001) after both procedures, even at the 95-month follow-up. No difference was observed in the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire Short Form (PISQ-12) scores after either procedure.
Conclusions
In the long term, the proportion of patients with complications and the cure rates of the two procedures did not differ significantly. The long-term complication rates were high, but morbidity was low, and the QOL remained improved.
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Acknowledgements
We are grateful for the excellent work of Wenyan Wang (MD, 2004–2009 at Peking Union Medical College Hospital), Xinwen Shi (College Diploma, Department of Obstetrics and Gynaecology, Peking Union Medical College Hospital), and Aimin Liu (College Diploma, Department of Medical Records, Peking Union Medical College Hospital) for acquiring data, organising the follow-up at the Outpatient Department, monitoring the quality of the medical records, and managing the database. They have received compensation for their contributions.
Clinical registration name
A long-term prospective randomized comparative study between TVT and TVT-O in patients with hypermobility stress urinary incontinence
Registration number
ChiCTR-TRC-14004371
URL of registry
http://www.chictr.org/cn/proj/show.aspx?proj=6686
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None.
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Zhang, Z., Zhu, L., Xu, T. et al. Retropubic tension-free vaginal tape and inside-out transobturator tape: a long-term randomized trial. Int Urogynecol J 27, 103–111 (2016). https://doi.org/10.1007/s00192-015-2798-2
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DOI: https://doi.org/10.1007/s00192-015-2798-2