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TVT Abbrevo and Miniarc suburethral sling in women with stress urinary incontinence - A randomised controlled trial.
Eur J Obstet Gynecol Reprod Biol. 2018 Nov; 230:141-146.EJ

Abstract

INTRODUCTION

Single incision slings (SIS) were introduced in an attempt to decrease the complications associated with retropubic and transobturator slings. The TVT Abbrevo is a modification of the TVT-O with a reduced length and less immediate postoperative pain. The Miniarc SIS has been shown to be equivalent to outside-in transobturator sling, Monarc at 12 month follow-up.

OBJECTIVE

To evaluate objective and subjective outcomes of MiniArc SIS and TVT Abbrevo midurethral sling (MUS) in women with stress urinary incontinence.

METHODS

Female subjects who were assessed and referred for stress urinary incontinence surgery were eligible to participate in this study. Exclusion criteria included women with intrinsic sphincter deficiency previous failed midurethral or fascial sling, untreated detrusor overactivity or significant voiding dysfunction. Patients' randomisation was performed with computer-generated blocks of 4-8, with concealed allocation. Assuming an objective cure rate of 90% for TVT AbbrevoTMwith a power of 80%, a sample size of 79 in each arm was required to detect a clinical difference of 15%, using a one sided alpha of 0.05. The target recruitment number was 220 allowing for an attrition rate of 15%. Institution ethics approval (11261B) was obtained and the trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12611001151921). Routine preoperative assessment was conducted for objective data, whilst patient reported outcome tools (PRO) were utilised for subjective outcomes. These include ICIQ UI SF, ICIQ OAB, IIQ7, EQ5D, PISQ12, PGIs & PGII. TVT AbbrevoTM or MiniarcTMwere performed in a standardized fashion, together with any concomitant prolapse surgery. Review was conducted at 6 weeks and at 6 and 12 months. Objective cure was defined as a negative cough stress test with a comfortably full bladder. Subjective cure was defined as no report of leakage with physical exertion. All Data was collected and outcomes were analysed statistically.

RESULTS

Between February 2011 and January 2016,a total of 246 women were randomized to receive MiniArc (121) or TVT Abbrevo (125). Baseline characteristics were clinically balanced in both groups. At 6 months subjective (94.4% vs 95.7% p=0.74) and Objective (92.9% vs 95.9% p=0.49) cure rates were high and not statistically different. At 12 months there were also no differences in subjective (73.6% vs 76.9% p=0.73) or objective (90.5% vs 96.0% p=0.21) cure rates. No differences were found in functional outcomes or when adjusted for potential confounding factors such as age, parity, BMI or menopausal status.

CONCLUSION

We found no significant differences in subjective and objective cure rates at 6 and 12months between MiniArc and TVT Abbrevo.

Authors+Show Affiliations

Monash Medical Centre, Moorabbin, Melbourne 3165 VIC, Australia. Electronic address: joan.melendez@monashhealth.org.Monash Medical Centre, Moorabbin, Melbourne 3165 VIC, Australia.Monash Medical Centre, Moorabbin, Melbourne 3165 VIC, Australia.Monash Medical Centre, Moorabbin, Melbourne 3165 VIC, Australia.Monash Medical Centre, Moorabbin, Melbourne 3165 VIC, Australia.Monash Medical Centre, Moorabbin, Melbourne 3165 VIC, Australia.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

30286363

Citation

Melendez-Munoz, Joan, et al. "TVT Abbrevo and Miniarc Suburethral Sling in Women With Stress Urinary Incontinence - a Randomised Controlled Trial." European Journal of Obstetrics, Gynecology, and Reproductive Biology, vol. 230, 2018, pp. 141-146.
Melendez-Munoz J, Braverman M, Rosamilia A, et al. TVT Abbrevo and Miniarc suburethral sling in women with stress urinary incontinence - A randomised controlled trial. Eur J Obstet Gynecol Reprod Biol. 2018;230:141-146.
Melendez-Munoz, J., Braverman, M., Rosamilia, A., Young, N., Leitch, A., & Lee, J. K. (2018). TVT Abbrevo and Miniarc suburethral sling in women with stress urinary incontinence - A randomised controlled trial. European Journal of Obstetrics, Gynecology, and Reproductive Biology, 230, 141-146. https://doi.org/10.1016/j.ejogrb.2018.09.032
Melendez-Munoz J, et al. TVT Abbrevo and Miniarc Suburethral Sling in Women With Stress Urinary Incontinence - a Randomised Controlled Trial. Eur J Obstet Gynecol Reprod Biol. 2018;230:141-146. PubMed PMID: 30286363.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - TVT Abbrevo and Miniarc suburethral sling in women with stress urinary incontinence - A randomised controlled trial. AU - Melendez-Munoz,Joan, AU - Braverman,Meirav, AU - Rosamilia,Anna, AU - Young,Natharnia, AU - Leitch,Alison, AU - Lee,Joseph K-S, Y1 - 2018/09/27/ PY - 2018/05/31/received PY - 2018/09/14/revised PY - 2018/09/17/accepted PY - 2018/10/5/pubmed PY - 2019/3/6/medline PY - 2018/10/5/entrez KW - Incontinence surgery KW - Mid-urethral sling KW - Randomised controlled trial KW - Single incision sling SP - 141 EP - 146 JF - European journal of obstetrics, gynecology, and reproductive biology JO - Eur J Obstet Gynecol Reprod Biol VL - 230 N2 - INTRODUCTION: Single incision slings (SIS) were introduced in an attempt to decrease the complications associated with retropubic and transobturator slings. The TVT Abbrevo is a modification of the TVT-O with a reduced length and less immediate postoperative pain. The Miniarc SIS has been shown to be equivalent to outside-in transobturator sling, Monarc at 12 month follow-up. OBJECTIVE: To evaluate objective and subjective outcomes of MiniArc SIS and TVT Abbrevo midurethral sling (MUS) in women with stress urinary incontinence. METHODS: Female subjects who were assessed and referred for stress urinary incontinence surgery were eligible to participate in this study. Exclusion criteria included women with intrinsic sphincter deficiency previous failed midurethral or fascial sling, untreated detrusor overactivity or significant voiding dysfunction. Patients' randomisation was performed with computer-generated blocks of 4-8, with concealed allocation. Assuming an objective cure rate of 90% for TVT AbbrevoTMwith a power of 80%, a sample size of 79 in each arm was required to detect a clinical difference of 15%, using a one sided alpha of 0.05. The target recruitment number was 220 allowing for an attrition rate of 15%. Institution ethics approval (11261B) was obtained and the trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12611001151921). Routine preoperative assessment was conducted for objective data, whilst patient reported outcome tools (PRO) were utilised for subjective outcomes. These include ICIQ UI SF, ICIQ OAB, IIQ7, EQ5D, PISQ12, PGIs & PGII. TVT AbbrevoTM or MiniarcTMwere performed in a standardized fashion, together with any concomitant prolapse surgery. Review was conducted at 6 weeks and at 6 and 12 months. Objective cure was defined as a negative cough stress test with a comfortably full bladder. Subjective cure was defined as no report of leakage with physical exertion. All Data was collected and outcomes were analysed statistically. RESULTS: Between February 2011 and January 2016,a total of 246 women were randomized to receive MiniArc (121) or TVT Abbrevo (125). Baseline characteristics were clinically balanced in both groups. At 6 months subjective (94.4% vs 95.7% p=0.74) and Objective (92.9% vs 95.9% p=0.49) cure rates were high and not statistically different. At 12 months there were also no differences in subjective (73.6% vs 76.9% p=0.73) or objective (90.5% vs 96.0% p=0.21) cure rates. No differences were found in functional outcomes or when adjusted for potential confounding factors such as age, parity, BMI or menopausal status. CONCLUSION: We found no significant differences in subjective and objective cure rates at 6 and 12months between MiniArc and TVT Abbrevo. SN - 1872-7654 UR - https://www.unboundmedicine.com/medline/citation/30286363/TVT_Abbrevo_and_Miniarc_suburethral_sling_in_women_with_stress_urinary_incontinence___A_randomised_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0301-2115(18)30998-9 DB - PRIME DP - Unbound Medicine ER -