Multicentre randomized trial of the Ajust™ single-incision sling compared to the Align™ transobturator tape sling.

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: Jordi Sabadell, Marta Palau-Gené, Eva Huguet, Anabel Montero-Armengol, Sabina Salicrú, Jose L Poza
• Journal: International urogynecology journal (Int Urogynecol J) Vol. 28 Issue 7 Pg. 1041-1047 (Jul 2017) ISSN: 1433-3023 [Electronic] England
• PMID: 27921162 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Topics

• Adult
• Aged
• Female
• Gynecologic Surgical Procedures (instrumentation)
• Humans
• Middle Aged
• Suburethral Slings (adverse effects, statistics & numerical data)
• Urinary Incontinence, Stress (surgery)