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Tension-free Vaginal Tape-Obturator for Treatment of Pure Urodynamic Stress Urinary Incontinence: Efficacy and Adverse Effects at 10-year Follow-up.
Eur Urol. 2017 04; 71(4):674-679.EU

Abstract

BACKGROUND

Inside-out transobturator tape (tension-free vaginal tape-obturator [TVT-O]) is currently one of the most effective and popular procedures for the surgical treatment of female stress urinary incontinence (SUI). However, data reporting long-term outcomes are lacking.

OBJECTIVE

To assess the efficacy and safety of TVT-O 10 yr after implantation for the treatment of female pure SUI.

DESIGN, SETTING, AND PARTICIPANTS

A multicenter, prospective study was conducted in five tertiary referral centers in three countries. All consecutive women with urodynamically proven pure SUI treated by TVT-O were included. Patients with mixed incontinence and/or anatomic evidence of pelvic organ prolapse were excluded.

INTERVENTION

TVT-O implantation.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

Data regarding subjective outcomes (International Consultation on Incontinence Questionnaire-Short Form, Patient Global Impression of Improvement, and patient satisfaction scores), objective cure (stress test) rates, and adverse events were collected during follow-up. Univariable analysis was performed to investigate outcomes.

RESULTS AND LIMITATIONS

One hundred sixty-eight women had TVT-O implantation. At 10-yr follow-up, 160 patients (95%) were available for the evaluation. We did not find any significant change of the surgical outcomes during this time. At 10 yr after surgery, 155 of 160 patients (97%) declared themselves cured (p=0.7). Similarly, at 10-yr evaluation, 148 of 160 patients (92%) were objectively cured. No significant deterioration of objective cure rates was observed over time (p=0.4). The history of failure of previous anti-incontinence procedures (hazard ratio: 5.34; 95% CI, 2.61-11.9; p=0.009) was the only predictor of recurrence of SUI. The onset of de novo overactive bladder was reported by 23 of 160 patients (14%) at 10-yr follow-up. No other late complications were reported.

CONCLUSIONS

The 10-yr results of this study showed that TVT-O is a highly effective and safe option for the treatment of SUI.

PATIENT SUMMARY

At long-term follow up, tension-free vaginal tape-obturator is highly effective and safe for the treatment of stress urinary incontinence.

Authors+Show Affiliations

Department of Obstetrics and Gynecology, University of Insubria, Varese, Italy. Electronic address: mauserati@hotmail.com.Department of Obstetrics and Gynecology, EOC-Beata Vergine Hospital, Mendrisio, Switzerland.First Department of Obstetrics and Gynecology, University of Athens, "Alexandra" Hospital, Athens, Greece.Department of Obstetrics and Gynecology, University of Naples Federico II, Naples, Italy.Department of Obstetrics and Gynecology, EOC-Beata Vergine Hospital, Mendrisio, Switzerland.Department of Obstetrics and Gynecology, Second Faculty, Naples, Italy.Department of Obstetrics and Gynecology, University of Insubria, Varese, Italy.Obstetrics and Gynecology Unit, Vita-Salute University and IRCCS San Raffaele Hospital, Milan, Italy.

Pub Type(s)

Journal Article
Observational Study

Language

eng

PubMed ID

27597239

Citation

Serati, Maurizio, et al. "Tension-free Vaginal Tape-Obturator for Treatment of Pure Urodynamic Stress Urinary Incontinence: Efficacy and Adverse Effects at 10-year Follow-up." European Urology, vol. 71, no. 4, 2017, pp. 674-679.
Serati M, Braga A, Athanasiou S, et al. Tension-free Vaginal Tape-Obturator for Treatment of Pure Urodynamic Stress Urinary Incontinence: Efficacy and Adverse Effects at 10-year Follow-up. Eur Urol. 2017;71(4):674-679.
Serati, M., Braga, A., Athanasiou, S., Tommaselli, G. A., Caccia, G., Torella, M., Ghezzi, F., & Salvatore, S. (2017). Tension-free Vaginal Tape-Obturator for Treatment of Pure Urodynamic Stress Urinary Incontinence: Efficacy and Adverse Effects at 10-year Follow-up. European Urology, 71(4), 674-679. https://doi.org/10.1016/j.eururo.2016.08.054
Serati M, et al. Tension-free Vaginal Tape-Obturator for Treatment of Pure Urodynamic Stress Urinary Incontinence: Efficacy and Adverse Effects at 10-year Follow-up. Eur Urol. 2017;71(4):674-679. PubMed PMID: 27597239.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Tension-free Vaginal Tape-Obturator for Treatment of Pure Urodynamic Stress Urinary Incontinence: Efficacy and Adverse Effects at 10-year Follow-up. AU - Serati,Maurizio, AU - Braga,Andrea, AU - Athanasiou,Stavros, AU - Tommaselli,Giovanni A, AU - Caccia,Giorgio, AU - Torella,Marco, AU - Ghezzi,Fabio, AU - Salvatore,Stefano, Y1 - 2016/09/03/ PY - 2016/05/29/received PY - 2016/08/23/accepted PY - 2016/9/7/pubmed PY - 2018/2/13/medline PY - 2016/9/7/entrez KW - Long-term follow-up KW - Sling KW - Stress urinary incontinence KW - TVT-O KW - Tension-free vaginal tape-obturator KW - Urinary incontinence SP - 674 EP - 679 JF - European urology JO - Eur Urol VL - 71 IS - 4 N2 - BACKGROUND: Inside-out transobturator tape (tension-free vaginal tape-obturator [TVT-O]) is currently one of the most effective and popular procedures for the surgical treatment of female stress urinary incontinence (SUI). However, data reporting long-term outcomes are lacking. OBJECTIVE: To assess the efficacy and safety of TVT-O 10 yr after implantation for the treatment of female pure SUI. DESIGN, SETTING, AND PARTICIPANTS: A multicenter, prospective study was conducted in five tertiary referral centers in three countries. All consecutive women with urodynamically proven pure SUI treated by TVT-O were included. Patients with mixed incontinence and/or anatomic evidence of pelvic organ prolapse were excluded. INTERVENTION: TVT-O implantation. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Data regarding subjective outcomes (International Consultation on Incontinence Questionnaire-Short Form, Patient Global Impression of Improvement, and patient satisfaction scores), objective cure (stress test) rates, and adverse events were collected during follow-up. Univariable analysis was performed to investigate outcomes. RESULTS AND LIMITATIONS: One hundred sixty-eight women had TVT-O implantation. At 10-yr follow-up, 160 patients (95%) were available for the evaluation. We did not find any significant change of the surgical outcomes during this time. At 10 yr after surgery, 155 of 160 patients (97%) declared themselves cured (p=0.7). Similarly, at 10-yr evaluation, 148 of 160 patients (92%) were objectively cured. No significant deterioration of objective cure rates was observed over time (p=0.4). The history of failure of previous anti-incontinence procedures (hazard ratio: 5.34; 95% CI, 2.61-11.9; p=0.009) was the only predictor of recurrence of SUI. The onset of de novo overactive bladder was reported by 23 of 160 patients (14%) at 10-yr follow-up. No other late complications were reported. CONCLUSIONS: The 10-yr results of this study showed that TVT-O is a highly effective and safe option for the treatment of SUI. PATIENT SUMMARY: At long-term follow up, tension-free vaginal tape-obturator is highly effective and safe for the treatment of stress urinary incontinence. SN - 1873-7560 UR - https://www.unboundmedicine.com/medline/citation/27597239/Tension_free_Vaginal_Tape_Obturator_for_Treatment_of_Pure_Urodynamic_Stress_Urinary_Incontinence:_Efficacy_and_Adverse_Effects_at_10_year_Follow_up_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0302-2838(16)30527-9 DB - PRIME DP - Unbound Medicine ER -