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Randomized trial of a comparison of the efficacy of TVT-O and single-incision tape TVT SECUR systems in the treatment of stress urinary incontinent women--2-year follow-up.
Int Urogynecol J. 2012 Oct; 23(10):1403-12.IU

Abstract

INTRODUCTION AND HYPOTHESIS

The aim of this study was to compare the efficacy of the use of tension-free vaginal tape obturator (TVT-O) and single-incision TVT SECUR, hammock and U approach (TVT-S, H and U), in the treatment of urodynamic stress urinary incontinence (SUI).

METHODS

This single-center randomized three-arm trial compared the objective and subjective efficacy and early failure rate of the TVT-O and TVT-S H and U approach by objective criteria (cough test) and subjective criteria using the International Consultation on Incontinence Questionnaire--Short Form (ICIQ-UI SF). The objective efficacy rate was defined as the number of patients with a negative cough stress test. Subjective cure was defined by no stress leakage of urine after surgery based on the evaluation of ICIQ-UI SH (when patients ticked "Never"/"Urine does not leak" in answer to question 6: When does urine leak?). Objective and subjective efficacy were evaluated using Last Failure Carried Forward analysis, i.e., final analysis also included patients with early failure. To describe outcome at different time points, the Last Observation Carried Forward method was also implemented.

RESULTS

One hundred ninety-seven women with proven SUI were randomized into three groups--TVT-O (n = 68), TVT-S H (n = 64), and TVT-S U (n = 65). Each patient allocated to a treatment group received the planned surgery. There were no differences in each group in preoperative characteristics. Median follow-up after surgery was 2 years (SD, 0.8; range, 0.1 to 3.8 years). Of the subjects, 92.6% in the TVT-O group, 68.8% in the TVT-S H group, and 69.2% in the TVT-S U group had negative stress test (p < 0.001). Of the subjects, 85.3 % in the TVT-O group, 68.8% in the TVT-S H group, and 61.5% in the TVT-S U group were subjectively continent (p = 0.02).

CONCLUSIONS

Our study demonstrated a significantly lower subjective and objective cure rate in the single-incision TVT group compared to the TVT-O group.

Authors+Show Affiliations

Department of Obstetrics and Gynaecology, 1st Medical Faculty, Charles University and General Teaching Hospital, Prague, Czech Republic. masata@volny.czNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22314891

Citation

Masata, Jaromir, et al. "Randomized Trial of a Comparison of the Efficacy of TVT-O and Single-incision Tape TVT SECUR Systems in the Treatment of Stress Urinary Incontinent Women--2-year Follow-up." International Urogynecology Journal, vol. 23, no. 10, 2012, pp. 1403-12.
Masata J, Svabik K, Zvara K, et al. Randomized trial of a comparison of the efficacy of TVT-O and single-incision tape TVT SECUR systems in the treatment of stress urinary incontinent women--2-year follow-up. Int Urogynecol J. 2012;23(10):1403-12.
Masata, J., Svabik, K., Zvara, K., Drahoradova, P., El Haddad, R., Hubka, P., & Martan, A. (2012). Randomized trial of a comparison of the efficacy of TVT-O and single-incision tape TVT SECUR systems in the treatment of stress urinary incontinent women--2-year follow-up. International Urogynecology Journal, 23(10), 1403-12.
Masata J, et al. Randomized Trial of a Comparison of the Efficacy of TVT-O and Single-incision Tape TVT SECUR Systems in the Treatment of Stress Urinary Incontinent Women--2-year Follow-up. Int Urogynecol J. 2012;23(10):1403-12. PubMed PMID: 22314891.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized trial of a comparison of the efficacy of TVT-O and single-incision tape TVT SECUR systems in the treatment of stress urinary incontinent women--2-year follow-up. AU - Masata,Jaromir, AU - Svabik,Kamil, AU - Zvara,Karel, AU - Drahoradova,Petra, AU - El Haddad,Rachid, AU - Hubka,Petr, AU - Martan,Alois, PY - 2011/07/18/received PY - 2012/01/02/accepted PY - 2012/2/9/entrez PY - 2012/2/9/pubmed PY - 2013/4/11/medline SP - 1403 EP - 12 JF - International urogynecology journal JO - Int Urogynecol J VL - 23 IS - 10 N2 - INTRODUCTION AND HYPOTHESIS: The aim of this study was to compare the efficacy of the use of tension-free vaginal tape obturator (TVT-O) and single-incision TVT SECUR, hammock and U approach (TVT-S, H and U), in the treatment of urodynamic stress urinary incontinence (SUI). METHODS: This single-center randomized three-arm trial compared the objective and subjective efficacy and early failure rate of the TVT-O and TVT-S H and U approach by objective criteria (cough test) and subjective criteria using the International Consultation on Incontinence Questionnaire--Short Form (ICIQ-UI SF). The objective efficacy rate was defined as the number of patients with a negative cough stress test. Subjective cure was defined by no stress leakage of urine after surgery based on the evaluation of ICIQ-UI SH (when patients ticked "Never"/"Urine does not leak" in answer to question 6: When does urine leak?). Objective and subjective efficacy were evaluated using Last Failure Carried Forward analysis, i.e., final analysis also included patients with early failure. To describe outcome at different time points, the Last Observation Carried Forward method was also implemented. RESULTS: One hundred ninety-seven women with proven SUI were randomized into three groups--TVT-O (n = 68), TVT-S H (n = 64), and TVT-S U (n = 65). Each patient allocated to a treatment group received the planned surgery. There were no differences in each group in preoperative characteristics. Median follow-up after surgery was 2 years (SD, 0.8; range, 0.1 to 3.8 years). Of the subjects, 92.6% in the TVT-O group, 68.8% in the TVT-S H group, and 69.2% in the TVT-S U group had negative stress test (p < 0.001). Of the subjects, 85.3 % in the TVT-O group, 68.8% in the TVT-S H group, and 61.5% in the TVT-S U group were subjectively continent (p = 0.02). CONCLUSIONS: Our study demonstrated a significantly lower subjective and objective cure rate in the single-incision TVT group compared to the TVT-O group. SN - 1433-3023 UR - https://www.unboundmedicine.com/medline/citation/22314891/Randomized_trial_of_a_comparison_of_the_efficacy_of_TVT_O_and_single_incision_tape_TVT_SECUR_systems_in_the_treatment_of_stress_urinary_incontinent_women__2_year_follow_up_ L2 - https://dx.doi.org/10.1007/s00192-012-1662-x DB - PRIME DP - Unbound Medicine ER -