What is the optimal length for single-incision tape?

INTRODUCTION AND HYPOTHESIS: The aim of this study was to assess the length of adjustable single-incision midurethral tape (SIMS; Ajust), which is needed to fix this tape to the obturator membrane. From these data, we can deduce the optimal length of the SIMS. METHODS: For this study, we employed the intra-operative data of patients included in a single-center randomized trial comparing the efficacy of Tension free vaginal tape obturator (TVT-O) and Ajust. The length of the Ajust tape was calculated using the formula: total length of the tape minus the length of the stylet used for the tape lock, minus the length of the lock minus the width of the two anchors. The length of the obturator tape was calculated using the formula: total tape length minus the snipped parts of the tape. The correlation coefficient of the tape length to basic biometric parameters, such as height, weight, and body mass index, was calculated. RESULTS: For this study, data from 50 women from each group, TVT-O and Ajust, were used. The mean length of the Ajust tape inside the body is 11.6 cm (SD 0.9), with a minimum length of 9.6 cm and a maximum length of 14.6 cm. The mean length of TVT-O tape inside the body is 20.3 cm (SD 2.1), with a minimum of 14.8 cm and a maximum length of 24.5 cm. CONCLUSIONS: This study demonstrates that to achieve continence it is necessary to use different lengths of single-incision tape. Inappropriate SIMS length could cause failure related to the tape itself and not to the TVT technique.

Adjustable single-incision mini-slings (Ajust®) versus other slings in surgical management of female stress urinary incontinence: a meta-analysis of effectiveness and complications.

BACKGROUND: Adjustable single-incision mini-sling (SIMS) is a new category of SIMS for stress urinary incontinence (SUI). The aim of this study was to compare the efficacy and safety of adjustable single-incision mini-sling with other slings. METHODS: Literature search in databases such as Pubmed, and Conchrane Library was performed up to December, 2015. The outcomes including cure rate, operation time, postoperative pain score and complications were reanalyzed. The pooled relative risk (RR) and mean difference (MD) with their 95% confidence interval (95% CI) were calculated by RevMan v5.0. RESULTS: Eight studies with 1093 SUI female patients were included. There was no significant difference between adjustable SIMS and other slings (transobturator slings and MiniArc) in patients subjective cure rate and objective cure rate. In addition, adjustable SIMS was associated with a significantly shorter operative time and lower postoperative pain score when comparing adjustable SIMS with transobturator tape (MD = - 1.35; 95%CI: -2.24 to - 0.46, P = 0.003). For the complications, there was also no significant difference between adjustable SIMS and transobturator slings. CONCLUSIONS: Adjustable SIMS had equally efficacy for SUI compared with transobturator slings and MiniArc. However, the significantly shorter operative time and lower postoperative pain score than transobturator tape supported the clinical application of adjustable SIMS.

The efficacy and safety comparison of surgical treatments for stress urinary incontinence: A network meta-analysis.

AIMS: Stress urinary incontinence (SUI) is a common problem worldwide. Mainstream surgical procedures include tension-free vaginal tape (TVT), transobturator tape (TOT), tension-free vaginal tape-obturator (TVT-O), tension-free vaginal tape SECUR (TVT-S), and adjustable single-incision sling (Ajust). The aim of this study was to compare the efficacy and safety of these surgical procedures and assess which surgery is most optimal for SUI by adopting a network meta-analysis (NMA). METHODS: Electronic databases including PubMed, Cochrance Library, and Embase database were researched systematically, until March 21, 2017. The randomized controlled trials (RCTs) that compared the efficacy and safety of TVT, TOT, TVT-O, TVT-S, and Ajust were identified. The studies were included in the analysis when met the predefined inclusion criteria. After demographic and outcome data extraction, a network meta-analysis was conducted with software R 3.3.2 and STATA 14.0. Objective cure rate, subjective cure rate, postoperative complication rate, bladder perforation, tape erosion, urinary retention, and postoperative pain were considered as outcomes, and the outcomes were displayed as odds ratios (ORs) and 95% credible intervals (CrI). The consistency of direct and indirect evidence was assessed by node splitting. The ranks based on probabilities of intervention for the different endpoints were performed. RESULTS: Fourty-five RCTs with 7295 participants were analyzed. The NMA results revealed that, TVT, TOT, and Ajust had a higher objective cure rate than TVT-O and TVT-S (TVT-O: OR = 0.76, 95%CI [0.61, 0.94]; TVT-S: OR = 0.41, 95%CI [0.28, 0.60]). TVT, TOT, and TVT-O had a superior subjective cure rate than TVT-S and Ajust (Ajust: OR = 0.45, 95%CI [0.20, 0.91]; TVT-S: OR = 0.29, 95%CI [0.15, 0.56]). With TVT as the reference, TVT-S had a statistically lower postoperative complication rate (TVT-S: OR = 0.39, 95%CI [0.16, 0.89]). TVT-O, TVT-S, and TOT had a significantly lower bladder perforation rate (TOT: OR = 0.076, 95%CI [0.0060, 0.37]; TVT-O: OR = 4.1e-17, 95%CI [6.1e-48, 0.0032]; TVT-S: OR = 3.8e-17, 95%CI [1.8e-48, 0.0052]). There were no obvious differences between the five treatments for tape erosion. TVT-O exhibited a less postoperative retention (TVT-O: OR = 0.35, 95%CI [0.16, 0.74]). Probabilities of ranking results indicated that TOT was the treatment with best ranking in efficacy and a relatively high safety. CONCLUSIONS: Our study recommend TOT as the optimal regimen for SUI with high efficacy and moderate safety when compared with TVT, TVT-O, TVT-S, and Ajust interventions. However, with the limitation of our study, additional high-quality studies are needed to further evaluate the outcomes.

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

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.

[Ultrasound comparison of adjustable single-incision (Ajust) and transobturator tapes to assess post-operative fixation and function and clinical efficacy]. / Ultrazvuková studie porovnání kvality fixace pásky a lécebného efektu pásky zavádené z jedné incize (Ajust) a transobturatorní pásky TVT-O.

OBJECTIVE: The aim of this study was to compare fixation and mobility of adjustable single-incision (Ajust) and standard transobturator midurethral sling (TVT-O) tapes based on postoperative ultrasound monitoring of the position of the tape at rest and at maximal Valsava (tape descent). The hypothesis was that fixation of SIMS Ajust is comparable to that achieved by the standard transobturator midurethral sling. SETTING: Gynecology and Obstetrics Department, GUH and 1st Charles University Prague; Gynecology and Obstetrics Department Masarykova nemocnice Ústí nad Labem. DESIGN: Randomized trial, secondary analysis of ultrasound follow-up. METHODS: Between May 2010 and May 2012 100 women with proven urodynamic stress urinary incontinence were included in this randomized trial.All patients underwent a complete urogynecological investigation before the procedure (clinical examination, urodynamics, ultrasound examination), and they filled in the ICIQ and iQol questionnaires; after surgery, to evaluate their satisfaction with the procedure, VAS and Likert scales were added.Ultrasound examination as part of each post-operative check-up was performed the first day after surgery, two weeks, three months and one year after surgery. Ultrasound measurements were taken in a supine position at rest and during maximal Valsalva. Position of the bladder neck was assessed, and the position of the tape with respect to upper and lower tape margins. RESULTS: At one-year follow up no differences in subjective cure rates and objective cure rates were observed. In all checks after surgery there was no difference between the position of the tape at rest and at maximal Valsalva between the Ajust and TVT-O groups.The length of the upper and lower tape descent was similar. In TVT-O patients the mean length of upper tape margin descent increased from 8.8 mm on the first day after surgery to 10.0 mm three months after surgery; afterwards it remained stable. For Ajust patients there was virtually the same development - from 9.1 to 12 mm - and there was no further increase in the tape descent following the three-month measurement. CONCLUSIONS: The quality of the tape fixation after the Ajust procedure is as good as after standard transobturator midurethral sling. We did not observe any statistically significant differences in tape position and descent, indicating that the function is similar to obturator tape, which in turn suggests the same clinical efficacy. Ultrasound monitoring should be the part of post-operative monitoring whenever novel surgical techniques are introduced.

Comparison of the efficacy of tension-free vaginal tape obturator (TVT-O) and single-incision tension-free vaginal tape (Ajust™) in the treatment of female stress urinary incontinence: a 1-year follow-up randomized trial.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to compare the efficacy of the tension-free vaginal tape obturator (TVT-O) and single-incision tension-free vaginal tape (Ajust™) in the treatment of stress urinary incontinence in a randomized two-arm study with a 1-year follow-up. METHODS: This single-centre randomized trial compared the objective and subjective cure rates of TVT-O and Ajust using objective criteria (cough test) and subjective criteria (International Consultation on Incontinence Questionnaire short form, ICIQ-UI SF). The objective cure rate was defined as the number of patients with a negative cough stress test. Subjective cure was defined as no stress leakage of urine after surgery based on the ICIQ-UI SF. The primary outcome was to establish differences in objective and subjective cure rates between the TVT-O and Ajust groups. We also compared postoperative pain profiles using a visual analogue scale (VAS), improvement in quality of life using the ICIQ- UI SF and the Incontinence Quality of Life questionnaire, and overall satisfaction with the surgical procedure using a VAS and a five-item Likert scale. Inclusion criteria were age over 18 years, signed informed consent, and urodynamic stress urinary incontinence. Following a power calculation, 50 patients were enrolled into each group (Ajust and TVT-O). RESULTS: The mean follow-up after surgery was 445 days (SD 157.6 days) in the TVT-O group and 451.8 days (SD 127.6 days) in the Ajust group (p = 76.6 %). At 1 year, 47 patients were evaluated in the TVT-O group and 49 in the Ajust group. No differences in subjective cure rates or objective cure rates were observed. In the Ajust and TVT-O groups, the rates for no subjective stress leakage were 89.8 % and 91.5 %, respectively (p = 1.0, OR 1.22, 95 % CI 0.24 - 6.58), and the rates for a negative stress test were 89.8 % and 87.2 %, respectively (p = 0.76, OR 0.77, 95 % CI 0.17 - 3.32). In the Ajust group two patients reported de novo pain during sexual intercourse. CONCLUSIONS: After a 1-year-follow-up, no significant differences were found with regard to subjective and objective outcomes between the single-incision tape Ajust and TVT-O.

A comparison between adjustable single-incision sling and tension-free vaginal tape-obturator in treating stress urinary incontinence.

PURPOSE: To compare the subjective and objective cure rates, postoperative pain, postoperative complications, and postoperative quality of life of adjustable single-incision sling (Ajust®) versus tension-free vaginal tape-obturator (TVT-O™) in the treatment of female stress urinary incontinence (SUI). METHODS: Female patients with SUI (N = 368) were randomized to receive either Ajust® (N = 184) or TVT-O™ procedure (N = 184) between January 2012 and October 2013. Efficacy was evaluated using cure rate, postoperative complications, postoperative pain profile (using Visual Analogue Scale), Patient Global Impression of Improvement Scale, and International Consultation on Incontinence Questionnaire-Short Form. RESULTS: The patients from Ajust® and TVT-O™ groups had no statistically significant difference in subjective and objective cure rates (94.4 vs 90.7 %, P = 0.171; 97.2 vs 90.7 %, P = 0.195). Compared with the TVT-O™ group, patients in the Ajust® group had significantly less postoperative pain, shorter operative duration, and less intraoperative blood loss (all P values < 0.05). No significant difference in perioperative complications was observed between these two groups. Patients in Ajust® group had shorter recovery time (P < 0.001) compared to TVT-O™ group. The postoperative quality of life of patients in these two groups was significantly improved compared to baseline; however, no significant difference was observed in the average improvement of life between these two groups (P = 0.115). CONCLUSIONS: Ajust® procedure is simple, safe, and effective for the treatment of SUI. Compared with TVT-O™, patients receiving Ajust® had less intraoperative blood loss, less postoperative pain, and shorter recovery time.

[Comparison of quality of life of patients treated for SUI by surgical approaches AJUST and TVT-O - a 3-month results from randomized trial]. / Porovnání kvality zivota pacientek lécených pro stresovou inkontinenci moci operacními prístupy AJUST a TVT-O - trímesícní výsledky randomizované studie.

OBJECTIVE: The aim of this study is to compare quality of life in 3-month follow-up after the use of transobturator tape TVT-O and single incision tape AJUST in the treatment of urodynamic stress urinary incontinence (USI). DESIGN: Randomized trial. SETTING: Gynekologicko-porodnická klinika LF UK a FN Plzen, Gynekologicko-porodnická klinika 1. LF UK a VFN Praha. MATERIALS AND METHODS: Between May 2010 and May 2012 100 women with proven urodynamic stress urinary incontinence were included in this randomized trial. These patients were randomly chosen and devided into two group: 50 patients for TVT-O procedure and 50 patients for AJUST procedure. All of the patients underwent a complete urogynecological examination prior to the actual procedure (clinical examination, urodynamic examination, ultrasound examination) and filled in ICIQ-SF and iQol questionnaires. After the surgery, the patients satisfaction was evaluated by visual analoque scale (VAS) and Likert scale and by ICIQ-SF and iQol questionnaires. The intensity and length of postoperative pain was monitored using the visual analogue scale. The patients underwent an examination after 3 months. RESULTS: In both groups of participants no significant differences regarding age, BMI, parity, history of surgery for gynecological disorders, were found. Preoperative urodynamic, ICIQ-SF and iQol parameters were also not significantly different. In the 3-month follow-up 48 participants from TVT-O group and 50 participants from the AJUST group were monitored. No statistically significant differences in subjective and objective parameters were found. Subjectively stress incontinence was not present in 97.9% in the TVT-O and 96.0% in the group AJUST. Objectively stress test was negative in 93.8% in the TVT-O and 94% in group AJUST. By evaluating the ICIQ and iQol were found no statistical differences in the quality of life in both operating groups. CONCLUSION: At 3-months follow up we did not find any statistical difference between subjective and objective outcome for single incision tape AJUST and TVT-O. In the AJUST group lower intensity and shorter duration of postoperative pain were observed.

Prospective Randomized Study of MiniArc and Ajust Single Incision Sling Procedures.

OBJECTIVES: The aim of this study was to evaluate the efficacy of the Ajust and MiniArc system mini-sling anti-incontinence procedures for female stress urinary incontinence, at a minimum of 24 months after surgery. METHODS: This prospective, randomized, multicenter study included 66 women with previously untreated stress urinary incontinence, and 63 patients completed the study. These women were randomly divided into two groups; the first group of patients underwent operations using the Ajust (n = 33) technique, while the second group were treated with the MiniArc (n = 33) technique. The efficacy of the Ajust and MiniArc procedures (n = 31/32) was evaluated at an average of 28/29 months (minimum24 months) after the procedures. Subjective assessment of the cure rate and the leakage of urine was based on the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-UI SF) and five-point Likert scale. Objective assessment of leakage of urine was assessed by the cough test. RESULTS: Subjective assessment by the ICIQ-UI SF questionnaire showed that 93.5-96.9% of patients were dry or improved 28/29 months after the Ajust/MiniArc operations. Based on evaluation by means of the Likert scale, 83.9/81.3% of patients in the Ajust/MiniArc group were dry or improved. Objective assessment by cough test showed that 93.5/81.3% of patients had negative results for this test 28/29 months after the Ajust/MiniArc procedures. CONCLUSIONS: The cure rates of the Ajust and MiniArc procedures are very good with the follow-up of 24 months.

[Ajust(®): prospective study and 1-year follow-up - a series of 60 female patients]. / Ajust(®) : étude prospective et suivi à un an d'une série de 60 patientes.

OBJECTIVES: Evaluate functional and anatomical outcomes as well as complications, 1year after the implantation of the Ajust(®) sub-urethral adjustable single-incision sling. STUDY DESIGN: Prospective study on 60 female patients suffering from stress urinary or mixed urinary incontinence with quality of life assessment. Ambulatory surgeries were performed under local anesthesia with or without sedation. Pain was evaluated using the VAS scale. Postoperative follow-up was performed at 2 and 12months. RESULTS: Forty-eight patients suffered from stress incontinence only, with one of them suffering from sphincter deficiency, and the remaining 12 suffered from mixed urinary incontinence. Mean surgery time was 7.15minutes. All patients received a local anesthesia, and 33 were sedated. Per-operative pain level was equal to 31.8/100, and 17/100 upon discharge. A 100mL per-operative hemorrhage was described. At 2-month follow-up, four de novo urgency, four de novo dysuria, one urinary infection, 11 palpable lateral cords, 12 moderate postoperative pain were described. At 1-year follow-up, two mesh exposures formed, including one expelled anchor for one of them. At 1year, cure rate, improvement and failure rate were respectively 89.6%, 6.9% and 3.4%. Quality of life indexes were significantly improved. One patient required a new surgery at 2months, due to initial failure. CONCLUSIONS: The efficacy of this mini-invasive sling, without specific complication, must be compared with the other classic sub-uretral slings.

Tension-free vaginal tape obturator versus Ajust adjustable single incision sling procedure in women with urodynamic stress urinary incontinence.

OBJECTIVE: To assess the efficacy and complications of inside-out transobturator tension-free vaginal tape (TVT-O) in comparison with a single incision sling procedure (Ajust) for the treatment of urodynamic stress urinary incontinence. STUDY DESIGN: Prospective closely matched controlled study. In total, 171 patients were included in the study: 86 women underwent the TVT-O procedure, while in other 85 cases the Ajust procedure was performed. Subjective and objective cure, improvement and failure rates, mean operative time, hospital stay and incidence of complications were assessed. RESULTS: There was no statistically significant difference between the two groups for age, body mass index, parity, menopausal status and severity of prolapse. No major intraoperative complications occurred. There was no significant difference in the mean operative time and the duration of hospital stay between the two groups. The mean follow-up time of the study was 22.3 months (range 12-36 months). For the TVT-O group the objective cure rate was 86%, the improvement rate was 5.9% and the failure rate was 8.1%, while the subjective cure rate was 82.6%. For the Ajust group the objective cure rate was 84.7%, the improvement rate was 4.7%, 10.6% of patients showed no change in their symptoms and the subjective cure rate was 81.2%. CONCLUSIONS: The Ajust sling procedure presents success rates, at 22 months' mean follow up, comparable to the TVT-O method. Both techniques seem to be safe and effective for the treatment of urodynamic stress urinary incontinence.