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Long-term outcomes of transobturator tapes in women with stress urinary incontinence: E-TOT randomised controlled trial.
BJOG. 2017 May; 124(6):973-981.BJOG

Abstract

OBJECTIVE

To assess the long-term patient-reported outcomes and adverse events following surgery using transobturator tension-free vaginal tape (TO-TVT).

DESIGN

Postal follow-up of the E-TOT randomised controlled trial (RCT).

SETTING

A tertiary urogynaecology centre in the UK; all procedures took place in 2005-2007.

POPULATION

A total of 341 women were randomised to receive either 'inside-out' TVT-O (Ethicon Inc., Somerville, NJ, USA) or 'outside-in' TOT-ARIS (Coloplast Corp., Minneapolis, MN, USA) procedure.

METHODS

Long-term follow-up (median 9 years) using validated symptom severity and quality-of-life (QoL) questionnaires. Statistical analysis was performed using spss 22.0 and GraphPad statistics 2014.

MAIN OUTCOME MEASURES

The primary outcome was patient-reported success rate, defined as 'very much/much improved' on the Patient's Global Impression of Improvement (PGI-I) scale. Secondary outcomes included impact on women's QoL and sexual function, adverse events, and re-operations for stress urinary incontinence (SUI).

RESULTS

The adjusted response rate was 67.8% and the median follow-up period was 9.2 years. The overall patient-reported success rate was 71.6%, with a further 14% reporting 'improvement', and there was no significant difference between inside-out and outside-in groups (P = 0.76; odds ratio, OR 0.8676; 95% confidence interval, 95% CI 0.4744-1.5865). The success rate showed a significant reduction compared with 1-year results (71.6 versus 80%; P = 0.004), but a clinically insignificant reduction when compared with the 3-year results (71.6 versus 73.1%). A total of 7.96% underwent further continence surgery, the tape extrusion/erosion rate was 4.5%, and groin pain/discomfort was reported in 4.32%, with only 1.4% requiring treatment.

CONCLUSIONS

This is the largest and longest follow-up randomised trial of TO-TVT. TO-TVT is associated with 71.6% patient-reported success rate, 4% groin pain/discomfort, and 8% continence re-operation rate at a median of 9 years follow-up. The success rate is almost stable after 3 years.

TWEETABLE ABSTRACT

The success rate for TO-TVT is 71% at 9 years, and is almost stable after 3 years; 8% required repeat surgery.

Authors+Show Affiliations

Urogynaecology, University of Aberdeen, Aberdeen, UK.Urogynaecology, University of Aberdeen, Aberdeen, UK.Urogynaecology, University of Aberdeen, Aberdeen, UK.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

28094468

Citation

Karmakar, D, et al. "Long-term Outcomes of Transobturator Tapes in Women With Stress Urinary Incontinence: E-TOT Randomised Controlled Trial." BJOG : an International Journal of Obstetrics and Gynaecology, vol. 124, no. 6, 2017, pp. 973-981.
Karmakar D, Mostafa A, Abdel-Fattah M. Long-term outcomes of transobturator tapes in women with stress urinary incontinence: E-TOT randomised controlled trial. BJOG. 2017;124(6):973-981.
Karmakar, D., Mostafa, A., & Abdel-Fattah, M. (2017). Long-term outcomes of transobturator tapes in women with stress urinary incontinence: E-TOT randomised controlled trial. BJOG : an International Journal of Obstetrics and Gynaecology, 124(6), 973-981. https://doi.org/10.1111/1471-0528.14561
Karmakar D, Mostafa A, Abdel-Fattah M. Long-term Outcomes of Transobturator Tapes in Women With Stress Urinary Incontinence: E-TOT Randomised Controlled Trial. BJOG. 2017;124(6):973-981. PubMed PMID: 28094468.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term outcomes of transobturator tapes in women with stress urinary incontinence: E-TOT randomised controlled trial. AU - Karmakar,D, AU - Mostafa,A, AU - Abdel-Fattah,M, PY - 2017/01/10/accepted PY - 2017/1/18/pubmed PY - 2018/12/12/medline PY - 2017/1/18/entrez KW - ARIS KW - TVT-O KW - stress urinary incontinence KW - tension-free vaginal tapes KW - transobturator tape SP - 973 EP - 981 JF - BJOG : an international journal of obstetrics and gynaecology JO - BJOG VL - 124 IS - 6 N2 - OBJECTIVE: To assess the long-term patient-reported outcomes and adverse events following surgery using transobturator tension-free vaginal tape (TO-TVT). DESIGN: Postal follow-up of the E-TOT randomised controlled trial (RCT). SETTING: A tertiary urogynaecology centre in the UK; all procedures took place in 2005-2007. POPULATION: A total of 341 women were randomised to receive either 'inside-out' TVT-O (Ethicon Inc., Somerville, NJ, USA) or 'outside-in' TOT-ARIS (Coloplast Corp., Minneapolis, MN, USA) procedure. METHODS: Long-term follow-up (median 9 years) using validated symptom severity and quality-of-life (QoL) questionnaires. Statistical analysis was performed using spss 22.0 and GraphPad statistics 2014. MAIN OUTCOME MEASURES: The primary outcome was patient-reported success rate, defined as 'very much/much improved' on the Patient's Global Impression of Improvement (PGI-I) scale. Secondary outcomes included impact on women's QoL and sexual function, adverse events, and re-operations for stress urinary incontinence (SUI). RESULTS: The adjusted response rate was 67.8% and the median follow-up period was 9.2 years. The overall patient-reported success rate was 71.6%, with a further 14% reporting 'improvement', and there was no significant difference between inside-out and outside-in groups (P = 0.76; odds ratio, OR 0.8676; 95% confidence interval, 95% CI 0.4744-1.5865). The success rate showed a significant reduction compared with 1-year results (71.6 versus 80%; P = 0.004), but a clinically insignificant reduction when compared with the 3-year results (71.6 versus 73.1%). A total of 7.96% underwent further continence surgery, the tape extrusion/erosion rate was 4.5%, and groin pain/discomfort was reported in 4.32%, with only 1.4% requiring treatment. CONCLUSIONS: This is the largest and longest follow-up randomised trial of TO-TVT. TO-TVT is associated with 71.6% patient-reported success rate, 4% groin pain/discomfort, and 8% continence re-operation rate at a median of 9 years follow-up. The success rate is almost stable after 3 years. TWEETABLE ABSTRACT: The success rate for TO-TVT is 71% at 9 years, and is almost stable after 3 years; 8% required repeat surgery. SN - 1471-0528 UR - https://www.unboundmedicine.com/medline/citation/28094468/Long_term_outcomes_of_transobturator_tapes_in_women_with_stress_urinary_incontinence:_E_TOT_randomised_controlled_trial_ L2 - https://doi.org/10.1111/1471-0528.14561 DB - PRIME DP - Unbound Medicine ER -