Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2014 Mar;123(3):553-561.
doi: 10.1097/AOG.0000000000000148.

Transobturator sling compared with single-incision mini-sling for the treatment of stress urinary incontinence: a randomized controlled trial

Lucyana M Djehdian  1 , Maita P Araujo, Claudia C Takano, Carlos A Del-Roy, Marair G F Sartori, Manoel J B C Girão, Rodrigo A Castro
Affiliations
Randomized Controlled Trial

Transobturator sling compared with single-incision mini-sling for the treatment of stress urinary incontinence: a randomized controlled trial

Lucyana M Djehdian et al. Obstet Gynecol. 2014 Mar.

Abstract

Objective: To determine the efficacy and safety of a single-incision mini-sling compared with a transobturator midurethral sling for stress urinary incontinence (SUI) treatment.

Methods: This prospective single-center randomized controlled trial involved 130 women with a diagnosis of SUI. Primary outcomes were the objective and subjective cure rates, defined as negative cough stress and pad tests, and satisfaction rates. Quality of life assessed by the Incontinence Quality of Life Questionnaire and the Urogenital Distress Inventory Short Form, operation time, complications, and reoperation rates were also recorded. The efficacy was analyzed using a noninferiority test with a margin of 15%. For the noninferiority test, a P value >.05 rejects the noninferiority hypothesis of the mini-sling.

Results: Sixty-four patients in the mini-sling group and 56 in the transobturator group completed the 12-month follow-up. The objective cure rates for the mini-sling and the transobturator sling were 68.1% and 81.9% (absolute difference 13.8; 90% confidence interval [CI] 1.5-26.1; P=.439) and the subjective cure rates were 81.1% and 88.5% (absolute difference 7.4%; 90% CI 2.8-17.6; P=.110), respectively. There was a significant improvement in quality of life in both groups. Thigh pain was greater after the transobturator sling, four patients (7.1%) compared with zero (P=.045). The mean operation time was 5 minutes shorter for the mini-sling procedure (P=.000). Five patients (7.8%) in the mini-sling group and one patient (1.8%) in the transobturator group underwent surgical reintervention for persistent SUI (P=.213).

Conclusion: The noninferiority of the mini-sling could not be demonstrated in this study at the 12-month follow-up. The mini-sling was associated with shorter operative time and less postoperative thigh pain.

Clinical trial registration: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01094353.

PubMed Disclaimer

References

    1. Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, et al.; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn 2010;29:4–20.
    1. Paraiso MF, Walters MD, Karram MM, Barber MD. Laparoscopic Burch colposuspension versus tension-free vaginal tape: a randomized trial. Obstet Gynecol 2004;104:1249–58.
    1. Cox A, Herschorn S, Lee L. Surgical management of female SUI: is there a gold standard? Nat Rev Urol 2013;10:78–89.
    1. Kondo A, Isobe Y, Kimura K, Kamihira O, Matsuura O, Gotoh M, et al.. Efficacy, safety and hospital costs of tension-free vaginal tape and pubovaginal sling in the surgical treatment of stress incontinence. J Obstet Gynaecol Res 2006;32:539–44.
    1. Hahn I, Fall M. Objective quantification of stress urinary incontinence: a short, reproducible, provocative pad-test. Neurourol Urodyn 1991;10:475–81.

Publication types

Associated data