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

Sabadell, Jordi; Palau-Gené, Marta; Huguet, Eva Tabernero; Montero-Armengol, Anabel; Salicrú, Sabina; Poza, José Luis Lucena de la

doi:10.1007/s00192-016-3221-3

Cited by 10 publications

(11 citation statements)

References 24 publications

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“…The inclusion of women with MUI in our study certainly lowers the percentage of those reporting no leakage at all after the procedure, which was our primary outcome. In any case, the randomized design allows us to compare Ajust® with other slings with an established effect on incontinence, showing no significant difference, which is in agreement with the results of the other studies comparing Ajust® with TVT-O [7, 9–11, 13, 15–17]. Our findings are also in accordance with the results of meta-analyses regarding patient-reported cure rates for both short- and long-term follow-up periods, when comparing conventional mid-urethral slings with SIMS all together and with Ajust separately [29], likewise when comparing SMUS with the group of adjustable SIMS [30].…”

Section: Discussionsupporting

confidence: 86%

“…The post-operative evaluation was carried out through a combination of interview and examination and the observed cure rate of 51.6% is in agreement with our results based on the ICIQ-UI-SF. However, the cure rates reported by the remaining studies evaluating the efficacy of Ajust® up to 2 years are significantly higher at around 85% [4–17]. On the other hand, the cure rate we observed of 71.1–82.9% based on the bladder diary was comparable with these studies and the same was observed for the percentage of women who reported being significantly/much better after both procedures, which was up to 95.1%.…”

Section: Discussionsupporting

confidence: 81%

“…The lack of data is also apparent concerning the new device Ajust®, which is an adjustable mini-sling that works in a similar manner to SMUS, as the tension of the sling can be modified during the procedure. Several studies have evaluated the short- to midterm efficacy of Ajust®, demonstrating a subjective cure rate of 77–94% and a complications profile similar to that of trans-obturator vaginal tape (TVT-O) [4–17]. There is some evidence indicating greater cost-effectiveness compared with TVT-O [18] and Ajust® has been shown to be easier to attach to the obturator complex than other mini-slings [19].…”

Section: Introductionmentioning

confidence: 99%

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Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence: a 3-year follow-up of a randomized controlled trial

et al. 2019

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Introduction and hypothesis The aim of this study was to compare the long-term subjective outcomes of an adjustable single-incision sling (Ajust®) vs standard mid-urethral slings (SMUS) for the treatment of women with stress urinary incontinence. Methods This study was designed as a multicenter prospective randomized trial. Women under 60 years old with objectively verified stress urinary incontinence were included from seven centers in three countries. Women with mixed urinary incontinence were also included. Randomization was held in blocks for operation with either Ajust® or SMUS. Women analyzed at 1-year follow-up received the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF), International Consultation on Incontinence Questionnaire Overactive Bladder, Pelvic Organ Prolapse/Urinary Incontinence/Sexual Function Questionnaire-12, Patient Global Impression of Severity, and Patient Global Impression of Improvement questionnaires, together with a bladder diary to fill out at least 3 years after the procedure. The main outcome evaluated was the subjective cure rate as reported through the ICIQ-UI-SF questionnaire at 3 years. Results In total, 205 women participated in the 3-year follow-up: 107 in the Ajust® and 98 in the SMUS group. No significant difference was observed between the groups regarding subjective cure rate (50.9% vs 51.5%, p = 0.909) or dyspareunia. Both groups demonstrated similar postoperative perception of improvement in addition to reduced urgency and urge urinary incontinence. The postoperative improvement remained at the same level after 3 years as it was at 1-year follow-up for both Ajust® and SMUS. Conclusions Ajust® appears to be equally effective and safe as SMUS with regard to long-term follow-up of patient-reported outcomes.

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Section: Discussionsupporting

confidence: 86%

Section: Discussionsupporting

confidence: 81%

Section: Introductionmentioning

confidence: 99%

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Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence: a 3-year follow-up of a randomized controlled trial

et al. 2019

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“…In a previous trial (60 patients) comparing mini-slings (Ajust) with obturator tapes, 3 patients who received mini-slings reported persistent thigh pain 1 year after surgery, as compared with none who received obturator tapes. 22 In the Trial of Mid-Urethral Slings (597 patients), pain was more commonly reported with obturator tapes than with retropubic tapes (9.4% vs. 4.0%). 23 In the present trial, all 4 patients receiving tape removal for pain at up to 15 months were in the mini-sling group.…”

Section: Discussionmentioning

confidence: 99%

Single-Incision Mini-Slings for Stress Urinary Incontinence in Women

et al. 2022

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BACKGROUNDUntil recently, synthetic midurethral slings (made of mesh or tape) were the standard surgical treatment worldwide for female stress urinary incontinence, if conservative management failed. Data comparing the effectiveness and safety of newer single-incision mini-slings with those of standard midurethral slings are limited. METHODSWe performed a pragmatic, noninferiority, randomized trial comparing minislings with midurethral slings among women at 21 U.K. hospitals during 36 months of follow-up. The primary outcome was patient-reported success (defined as a response of very much or much improved on the Patient Global Impression of Improvement questionnaire) at 15 months after randomization (approximately 1 year after surgery). The noninferiority margin was 10 percentage points. RESULTSA total of 298 women were assigned to receive mini-slings and 298 were assigned to receive midurethral slings. At 15 months, success was reported by 212 of 268 patients (79.1%) in the mini-sling group and by 189 of 250 patients (75.6%) in the midurethral-sling group (adjusted risk difference, 4.6 percentage points; 95% confidence interval [CI], −2.7 to 11.8; P<0.001 for noninferiority). At the 36-month follow-up, success was reported by 177 of 246 patients (72.0%) and by 157 of 235 patients (66.8%) in the respective groups (adjusted risk difference, 5.7 percentage points; 95% CI, −1.3 to 12.8). At 36 months, the percentage of patients with groin or thigh pain was 14.1% with mini-slings and 14.9% with midurethral slings. Over the 36-month follow-up period, the percentage of patients with tape or mesh exposure was 3.3% with mini-slings and 1.9% with midurethral slings, and the percentage who underwent further surgery for stress urinary incontinence was 2.5% and 1.1%, respectively. Outcomes with respect to quality of life and sexual function were similar in the two groups, with the exception of dyspareunia; among 290 women responding to a validated questionnaire, dyspareunia was reported by 11.7% in the mini-sling group and 4.8% in the midurethral-sling group. CONCLUSIONSSingle-incision mini-slings were noninferior to standard midurethral slings with respect to patient-reported success at 15 months, and the percentage of patients reporting success remained similar in the two groups at the 36-month follow-up.

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“…Data searches were performed in Google Scholar, PubMed, Medline, Embase, Scopus, Web of Science and the Cochrane Database of Systematic Reviews. Finally, 29 studies , including a total of 2 986 women, were selected for the meta‐analysis. An SIMS was defined as a midurethral sling placed through a single vaginal incision without skin incision, and included the Mini‐Arc, Contasure‐Needleless, Ophira, tissue fixation system (TFS) and Ajust.…”

Section: Methodsmentioning

confidence: 99%

Clinical outcome of single‐incision slings, excluding TVT‐Secur, vs standard slings in the surgical management of stress incontinence: an updated systematic review and meta‐analysis

Kim

Park

et al. 2018

BJU International

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The aim of the present paper was to assess and compare the long-term efficacy and safety of single-incision mini-slings (SIMSs), except tension-free vaginal tape (TVT)-Secur, with standard midurethral slings (SMUSs) for female stress urinary incontinence through an updated systematic review and meta-analysis of randomized controlled trials (RCTs) comparing these two surgical methods. A literature review of all RCTs comparing SIMSs (Mini-Arc, Contasure-Needleless, Ophira, Tissue Fixation System and Ajust), except TVT-Secur, with SMUSs was performed. The Medline, Embase, Scopus, Web of Science and Cochrane Controlled Trial Register databases were reviewed. We retrieved 29 RCTs (including a total of 2 986 patients) that compared SIMSs, except TVT-Secur, with SMUSs. Meta-analysis of long-term results showed no significant difference in the patient-reported cure rate (odds ratio [OR] 0.67, 95% confidence interval [CI] 0.44-1.60); however, we found that SMUSs had a significantly superior objective cure rate (OR 0.68, 95% CI 0.47-0.99; P = 0.04). SIMSs were associated with a significantly shorter operation time, lower immediate postoperative pain based on a visual analogue scale score, lower intra-operative blood loss, and lower postoperative voiding dysfunction. The meta-analysis showed clear evidence of the superiority of SMUSs over SIMSs, except TVT-Secur, in terms of the objective cure rate, after long-term follow-up; however, SIMSs were superior with respect to immediate postoperative pain, intra-operative blood loss, and postoperative voiding dysfunction.

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

Abstract: 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.

Cited by 10 publications

References 24 publications

Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence: a 3-year follow-up of a randomized controlled trial

Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence: a 3-year follow-up of a randomized controlled trial

Single-Incision Mini-Slings for Stress Urinary Incontinence in Women

Clinical outcome of single‐incision slings, excluding TVT‐Secur, vs standard slings in the surgical management of stress incontinence: an updated systematic review and meta‐analysis

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