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Multicentre randomized trial of the Ajust™ single-incision sling compared to the Align™ transobturator tape sling.
Int Urogynecol J. 2017 Jul; 28(7):1041-1047.IU

Abstract

INTRODUCTION AND HYPOTHESIS

Tension-free suburethral tapes have become the first-line surgical treatment for female stress urinary incontinence. Single-incision midurethral slings (SIMS) were introduced with the aim of offering similar efficacy with reduced morbidity, particularly postoperative pain. The objective of this study was to compare the effectiveness and complications of the Ajust™ SIMS and the Align™ transobturator tape sling.

METHODS

We performed a randomized controlled trial with a noninferiority design. Women with pure stress urinary incontinence or stress-predominant mixed urinary incontinence were eligible. The primary outcome was the cure/improvement rate at 1 year, defined according to combined objective and subjective criteria. Rate differences for cure/improvement with the two procedures were calculated along with their 95% confidence intervals. The Sandvik incontinence severity index and the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) were completed before surgery and at 1 year. Complications were also reported.

RESULTS

We randomized 30 women to the Ajust™ group and 28 to the Align™ group. At 1 year the cure/improvement rates were 93.3% in the Ajust™ group and 96.4% in the Align™ group. The rate difference for cure/improvement was of -3.1% (95% CI -14.4 % to 8.2%). The study was sufficiently powered to conclude the noninferiority of Ajust™ SIMS under the pre-established criteria. Three women in the Ajust™ group reported persistent thigh pain 1 year after surgery, but none in the Align™ group reported pain.

CONCLUSIONS

At 1 year, the Ajust™ SIMS showed non-inferior effectiveness compared with the Align™ transobturator sling. Although not statistically significant, unexpectedly, more women reported persistent thigh pain in the Ajust™ group.

Authors+Show Affiliations

Urogynecology and Pelvic Floor Unit, Department of Obstetrics and Gynecology, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Passeig Vall d'Hebron 119-129, 08035, Barcelona, Spain. jsabadell@vhebron.net.Department of Gynecology, Hospital de Viladecans, Universitat de Barcelona, Barcelona, Spain.Department of Gynecology, Hospital de Viladecans, Universitat de Barcelona, Barcelona, Spain.Urogynecology and Pelvic Floor Unit, Department of Obstetrics and Gynecology, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Passeig Vall d'Hebron 119-129, 08035, Barcelona, Spain.Urogynecology and Pelvic Floor Unit, Department of Obstetrics and Gynecology, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Passeig Vall d'Hebron 119-129, 08035, Barcelona, Spain.Urogynecology and Pelvic Floor Unit, Department of Obstetrics and Gynecology, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Passeig Vall d'Hebron 119-129, 08035, Barcelona, Spain.

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

27921162

Citation

Sabadell, Jordi, et al. "Multicentre Randomized Trial of the Ajust™ Single-incision Sling Compared to the Align™ Transobturator Tape Sling." International Urogynecology Journal, vol. 28, no. 7, 2017, pp. 1041-1047.
Sabadell J, Palau-Gené M, Huguet E, et al. Multicentre randomized trial of the Ajust™ single-incision sling compared to the Align™ transobturator tape sling. Int Urogynecol J. 2017;28(7):1041-1047.
Sabadell, J., Palau-Gené, M., Huguet, E., Montero-Armengol, A., Salicrú, S., & Poza, J. L. (2017). Multicentre randomized trial of the Ajust™ single-incision sling compared to the Align™ transobturator tape sling. International Urogynecology Journal, 28(7), 1041-1047. https://doi.org/10.1007/s00192-016-3221-3
Sabadell J, et al. Multicentre Randomized Trial of the Ajust™ Single-incision Sling Compared to the Align™ Transobturator Tape Sling. Int Urogynecol J. 2017;28(7):1041-1047. PubMed PMID: 27921162.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Multicentre randomized trial of the Ajust™ single-incision sling compared to the Align™ transobturator tape sling. AU - Sabadell,Jordi, AU - Palau-Gené,Marta, AU - Huguet,Eva, AU - Montero-Armengol,Anabel, AU - Salicrú,Sabina, AU - Poza,Jose L, Y1 - 2016/12/05/ PY - 2016/09/26/received PY - 2016/11/21/accepted PY - 2016/12/7/pubmed PY - 2018/4/18/medline PY - 2016/12/7/entrez KW - Ajust™ KW - Midurethral sling KW - Single incision sling KW - Stress urinary incontinence KW - Suburethral tape complications KW - Transobturator tape SP - 1041 EP - 1047 JF - International urogynecology journal JO - Int Urogynecol J VL - 28 IS - 7 N2 - INTRODUCTION AND HYPOTHESIS: Tension-free suburethral tapes have become the first-line surgical treatment for female stress urinary incontinence. Single-incision midurethral slings (SIMS) were introduced with the aim of offering similar efficacy with reduced morbidity, particularly postoperative pain. The objective of this study was to compare the effectiveness and complications of the Ajust™ SIMS and the Align™ transobturator tape sling. METHODS: We performed a randomized controlled trial with a noninferiority design. Women with pure stress urinary incontinence or stress-predominant mixed urinary incontinence were eligible. The primary outcome was the cure/improvement rate at 1 year, defined according to combined objective and subjective criteria. Rate differences for cure/improvement with the two procedures were calculated along with their 95% confidence intervals. The Sandvik incontinence severity index and the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) were completed before surgery and at 1 year. Complications were also reported. RESULTS: We randomized 30 women to the Ajust™ group and 28 to the Align™ group. At 1 year the cure/improvement rates were 93.3% in the Ajust™ group and 96.4% in the Align™ group. The rate difference for cure/improvement was of -3.1% (95% CI -14.4 % to 8.2%). The study was sufficiently powered to conclude the noninferiority of Ajust™ SIMS under the pre-established criteria. Three women in the Ajust™ group reported persistent thigh pain 1 year after surgery, but none in the Align™ group reported pain. CONCLUSIONS: At 1 year, the Ajust™ SIMS showed non-inferior effectiveness compared with the Align™ transobturator sling. Although not statistically significant, unexpectedly, more women reported persistent thigh pain in the Ajust™ group. SN - 1433-3023 UR - https://www.unboundmedicine.com/medline/citation/27921162/Multicentre_randomized_trial_of_the_Ajust™_single_incision_sling_compared_to_the_Align™_transobturator_tape_sling_ L2 - https://dx.doi.org/10.1007/s00192-016-3221-3 DB - PRIME DP - Unbound Medicine ER -