Tags

Type your tag names separated by a space and hit enter

Single-incision sling compared with transobturator sling for treating stress urinary incontinence: a randomized controlled trial.
Int Urogynecol J. 2013 Sep; 24(9):1459-65.IU

Abstract

INTRODUCTION AND HYPOTHESIS

We tested the hypothesis that the single-incision sling, TVT-Secur (TVT-S), placed in U position is not inferior to transobturator midurethral sling (TVT-O) for treating stress urinary incontinence (SUI).

METHODS

This was a noninferiority, prospective, randomized controlled trial in which women with SUI, confirmed by physical and urodynamic evaluation, were randomly assigned to receive either TVT-O (n = 56) or TVT-S (n = 66). Exclusion criteria were voiding dysfunction, detrusor overactivity (DO), and pelvic organ prolapse (POP) beyond the hymen. The primary outcomes were objective and subjective cure rates, which were assessed at the 12-month follow-up visit, defined as negative stress, pad, and urodynamic tests and absence of self-reported SUI symptoms. Secondary outcomes were quality of life (QoL) by King's Health Questionnaire (KHQ) validated for Portuguese language, postoperative pain, and complication rate. The power of the study was 80 % to test the hypothesis that TVT-S is not inferior to TVT-O by >15 %. Statistical significance was fixed at 5 % (p < 0.05).

RESULTS

Groups were similar regarding demographic and clinical preoperative parameters. Objective cure rates for TVT-S and TVT-O groups were 84.1 % vs 87 % [90 % confidence interbal (CI) -15 to 9.8], and subjective cure rates were 92.1 % vs 90.7 % (95 % CI -11.4 to 6.7), respectively. TVT-S resulted in less postoperative general and thigh pain (p < 0.001). A few, but not statistically significant different complications, were observed in both groups: vaginal mucosa perforation, urinary retention, urinary infection, tape exposure, and de novo urgency. There was a significant improvement in all KHQ domains in both groups (p < 0.001).

CONCLUSION

TVT-S was not inferior to TVT-O for treating SUI at 12-month follow-up.

Authors+Show Affiliations

Sector of Urogynecology and Vaginal Surgery, Department of Gynecology, Federal University of São Paulo, Alameda Jaú 759, apt 71, São Paulo, SP, Brazil, 01420-001. anamariahmb@yahoo.com.brNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

23208003

Citation

Bianchi-Ferraro, Ana Maria H M., et al. "Single-incision Sling Compared With Transobturator Sling for Treating Stress Urinary Incontinence: a Randomized Controlled Trial." International Urogynecology Journal, vol. 24, no. 9, 2013, pp. 1459-65.
Bianchi-Ferraro AM, Jarmy-Di Bella ZI, Castro Rde A, et al. Single-incision sling compared with transobturator sling for treating stress urinary incontinence: a randomized controlled trial. Int Urogynecol J. 2013;24(9):1459-65.
Bianchi-Ferraro, A. M., Jarmy-Di Bella, Z. I., Castro, R. d. e. . A., Bortolini, M. A., Sartori, M. G., & Girão, M. J. (2013). Single-incision sling compared with transobturator sling for treating stress urinary incontinence: a randomized controlled trial. International Urogynecology Journal, 24(9), 1459-65. https://doi.org/10.1007/s00192-012-1998-2
Bianchi-Ferraro AM, et al. Single-incision Sling Compared With Transobturator Sling for Treating Stress Urinary Incontinence: a Randomized Controlled Trial. Int Urogynecol J. 2013;24(9):1459-65. PubMed PMID: 23208003.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Single-incision sling compared with transobturator sling for treating stress urinary incontinence: a randomized controlled trial. AU - Bianchi-Ferraro,Ana Maria H M, AU - Jarmy-Di Bella,Zsuzsanna I K, AU - Castro,Rodrigo de A, AU - Bortolini,Maria Augusta T, AU - Sartori,Marair G F, AU - Girão,Manoel J B C, Y1 - 2012/12/04/ PY - 2012/07/03/received PY - 2012/11/07/accepted PY - 2012/12/5/entrez PY - 2012/12/5/pubmed PY - 2014/5/29/medline SP - 1459 EP - 65 JF - International urogynecology journal JO - Int Urogynecol J VL - 24 IS - 9 N2 - INTRODUCTION AND HYPOTHESIS: We tested the hypothesis that the single-incision sling, TVT-Secur (TVT-S), placed in U position is not inferior to transobturator midurethral sling (TVT-O) for treating stress urinary incontinence (SUI). METHODS: This was a noninferiority, prospective, randomized controlled trial in which women with SUI, confirmed by physical and urodynamic evaluation, were randomly assigned to receive either TVT-O (n = 56) or TVT-S (n = 66). Exclusion criteria were voiding dysfunction, detrusor overactivity (DO), and pelvic organ prolapse (POP) beyond the hymen. The primary outcomes were objective and subjective cure rates, which were assessed at the 12-month follow-up visit, defined as negative stress, pad, and urodynamic tests and absence of self-reported SUI symptoms. Secondary outcomes were quality of life (QoL) by King's Health Questionnaire (KHQ) validated for Portuguese language, postoperative pain, and complication rate. The power of the study was 80 % to test the hypothesis that TVT-S is not inferior to TVT-O by >15 %. Statistical significance was fixed at 5 % (p < 0.05). RESULTS: Groups were similar regarding demographic and clinical preoperative parameters. Objective cure rates for TVT-S and TVT-O groups were 84.1 % vs 87 % [90 % confidence interbal (CI) -15 to 9.8], and subjective cure rates were 92.1 % vs 90.7 % (95 % CI -11.4 to 6.7), respectively. TVT-S resulted in less postoperative general and thigh pain (p < 0.001). A few, but not statistically significant different complications, were observed in both groups: vaginal mucosa perforation, urinary retention, urinary infection, tape exposure, and de novo urgency. There was a significant improvement in all KHQ domains in both groups (p < 0.001). CONCLUSION: TVT-S was not inferior to TVT-O for treating SUI at 12-month follow-up. SN - 1433-3023 UR - https://www.unboundmedicine.com/medline/citation/23208003/Single_incision_sling_compared_with_transobturator_sling_for_treating_stress_urinary_incontinence:_a_randomized_controlled_trial_ L2 - https://dx.doi.org/10.1007/s00192-012-1998-2 DB - PRIME DP - Unbound Medicine ER -