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In women with predominant stress urinary incontinence (SUI), recent data are still controversial regarding the short-term outcomes of mini-slings and there is a lack of evidence about the outcomes in the long term. Our aim was to evaluate the long-term effectiveness and complication rates of Altis® (Coloplast). A total of 145 women with clinical SUI were implanted with an Altis® sling between April 2012 and December 2015. Women completed the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) before the intervention and in the following consultations. A telephone interview was performed in January 2021 and 131 women (90%) were available for re-evaluation. The main outcome was treatment success, defined as no self-reported SUI symptoms and no reintervention. Secondary outcomes included response to ICIQ-SF (cure defined as ICIQ-SF = 0) and Patient Global Impression of Improvement (PGI-I) questionnaires, de novo overactive bladder (OAB) symptoms and adverse events. The overall treatment success was 73.3% at a median follow-up of 8 years. The ICIQ-SF cure rate was 66.1%. In the PGI-I, 70.4% answered that they were much better or very much better. Later postoperative complications included 2 cases (1.5%) of vaginal extrusion (requiring surgical removal of the eroded mesh segment), 3 (2.3%) cases of infravesical obstruction (which led to sling section), de novo urgency in 20 patients (15.3%), and mild dyspareunia in 2 (1.5%) patients. The Altis® sling was safe and effective in a long-term follow-up, improving the quality of life in patients with SUI.

Objetives: Single incision slings are the latest generation of suburethral bands that seek to minimize morbidity and major complications of transobturator bands. In short and medium term, their results in terms of success and safety are similar to transobturator and retropubic bands. Nevertheless, there is little data on their long-term outcomes. Our objective was to evaluate safety and efficacy of Altis® mini-sling during the short, medium and long-term follow-up. Methods: Prospective observational study in 67 women who underwent surgery with Altis® for a period of 6 years (2013-2019). The main variables evaluated were: total continence, objective cure and subjective cure (satisfaction). The secondary variables studied were: complications and number of pads used per day after surgery. Statistics: Student t-test or U-Mann-Whitney for quantitative variables, Chi-Square for categorical variables. Results: Objective cure rates were: 96.77%, 87.04%, 87.50%, 85.71%, 76.92% and 50% (from 1 to 6years), and total continence: 85.48%, 72.22%, 64.88%, 50%, 46.15% and 50% (from 1 to 6years). Degree of satisfaction was: 9, 8.2, 8.3, 7.7, 7.6 and 6.5 points (from 1 to 6years). 30 patients (44.78%) had some type of complication and the most common were: “de novo” urinary urgency (20.90%), recurrence of stress urinary incontinence (14.93%) and pain (5.97%). Conclusion: Altis® presents high rates of objective and subjective continence in short and medium-term (1-5years), during 6-year follow-up. It is safe and does not associate severe complications. We found a high percentage of “de novo” urgency and recurrence of stress urinary incontinence, especially after the fifth year.

Objective: To evaluate 2-year outcome of subjects who underwent the single incision midurethral sling procedure by the Dynamic Intraoperative Standing Sling Technique (DISST). Design: A chart revie...

To evaluate and compare the clinical outcomes of the transobturator sling with the single-incision sling, for the treatment of stress urinary incontinence at a long-term follow-up.From October 2008 to October 2010, 94 patients who were enrolled and underwent either TVT-O, one of standard mid-urethral sling or TVT-S, one of single-incision mini-sling (SIMS) procedure. The study population was followed until February 2019. Surgical outcomes were analyzed by subjective and objective evaluations and Chinese version questionnaires. Data were analyzed by IBM 23.0 SPSS Statistics. The level of statistical significance was set at P 0.05.At the 10-year follow-up, 31(64.6%) TVT-O patients and 33(71.7%) TVT-S patients were still available. Objective cure and subjective satisfaction rate were not significantly different for TVT-O compared with TVT-S (P 0.05). However, TVT-S showed a greater drop in success from the second to the tenth year compared with TVT-O (15.1% vs 0% and 9.2% vs 3.2%, respectively). Both groups experienced significantly improved quality of life in the TVT-O group and in the TVT-S group (P 0.05). The total PISQ-12 scores at 10 years postoperatively of the TVT-O and TVT-S groups were 33.4(4.7) compared with 33.6(3.9) before surgery (P = 0.67 0.05) and 35.5(5.9) compared with 31.5(6.3) before surgery (P = 0.045 0.05).It is difficult to state that there is superiority of one sling over another sling without a significant difference. But TVT-O showed superior objective cure and subjective satisfaction rates and a less decline in success during 10 years compared with TVT-S.

Objective: The aim of this research was to assess the 1-year success of the Dynamic Intraoperative Standing Sling Technique™ (DISST™) for the management of stress urinary incontinence (SUI...

Limited data exist regarding sexual function after single incision sling (SIS) surgery. We compared sexual function 36 months postoperatively between patients undergoing SIS and transobturator sling (TMUS) for treatment of stress urinary incontinence.Assessment of sexual function was a planned secondary objective of this prospective, multi-center study that enrolled women to Solyx SIS or Obtryx II TMUS. The primary study aim was to compare efficacy and safety using non-inferiority design at 36 monthsBaseline characteristics were balanced using propensity score stratification (N=141 SIS, N=140 TMUS). Groups were similar in age, body mass index and concomitant surgery performed. Average length of followup was 30 months. Baseline sexual activity was similar (123/141 SIS, 114/140 TMUS, p=0.18). Severity of urinary incontinence did not correlate with baseline sexual activity. Mean PISQ-12 scores increased significantly from baseline to 36 months for both groups, indicating better sexual function at each visit. There were no significant differences in PISQ-12 scores between groups except at 36 months, where the difference was small (-2.5, 95% CI [-4.7, 0.2]). Among patients undergoing surgical retreatment (9/281, 3%), improvement in sexual function was maintained. De novo dyspareunia was rare following both treatments (SIS 1/141, TMUS 0/140, p=1.00).Patients have significant improvement in sexual function after SIS and TMUS. De novo sexual pain is low after sling surgery.

In the literature the rate of stress incontinence is reported between 29-75%. Compared to the established tension free vaginal tapes, the question arises, whether stabilization of the urethra can also be achieved by minimally invasive single incision slings. The aim of this retrospective analysis is to evaluate the cure rate after insertion of MicroGYNious sling. The study was carried out on 115 patients, who received a MicroGYNious sling. It was used both as a single operation for stress urinary incontinence and as a combined procedure. The degree of incontinence preoperatively and continence rate postoperatively with follow-ups (6 weeks, 6 months, one year, two years and three years) were recorded. Due to a high number of lost to follow-up after one year, only the data up to one year postoperative were included in the analysis. Preoperatively, grade I incontinence was found in 6.1%, grade II 35.7%, grade III 58.3% of the operated women. The continence rate was 96.7% postoperatively, 90 % after 6 weeks, 87.2 % after 6 months, 86.7% after one year. In terms of continence rates, the MicroGYNious sling shows similar results compared to the established procedures. Therefore, this sling provides a good treatment option for the stress urinary incontinence. These good results must be confirmed in prospective randomized trials.

Objetives: Compare the efficacy and post-surgical complications of single-incision sling (SIS) and transobturator band (TO) for the treatment of stress urinary incontinence (SUI) over 7 years’ follow up. Methods: This is a prospective observational study that included 289 women with SUI who went under surgical treatment, either TO (109) or SIS (180). Patients were evaluated pre- and postoperatively through anamnesis, physical examination and ultrasound. Epidemiological information, complications and surgical time were recorded. The primary outcomes were total continence, objective and subjective cure rates at 7-year follow-up. Statistics: T-Student or U-Mann-Whitney for quantitative variables, Chi-Square for qualitative variables. Results: The groups were similar regarding demographic and medical history parameters, except for age and arterial hypertension, which were higher in TO group, and that SIS patients were more physically active tan TO patients. The TO band compared to SIS associated with increased frequency repair of pelvic organ prolapse. Depending on the type of urinary incontinence, pure SUI was more frequent in SIS and mixed in TO. The duration of the surgery was shorter with SIS. During the 7-year follow up there were no differences in the objective cure, subjective cure and complication rates. Conclusion: After 7-years follow-up, no significant differences were found with regard to subjective and objective outcomes, and post-surgery complication rates between the single incisión sling and the transobturator band.

OBJECTIVE To identify urodynamic predictors for de novo overactive bladder (OAB) after single-incision sling implantation. METHODS This retrospective study analyzed women with pure, urodynamically proven stress urinary incontinence, without OAB, between 2008 and 2015, in a university hospital. De novo OAB was investigated during clinical interviews. RESULTS A total of 192 patients were analyzed; 21 patients with de novo OAB were considered as group A while 171 control patients formed group B. Univariate analysis demonstrated that patients with de novo OAB have the first desire to void at a lower bladder volume (124 mL versus 160 mL, P = 0.0052), smaller maximum cystometric capacity (357 mL versus 406 mL, P = 0.0061), lower maximum flow (17 mL/s versus 23 mL/s, P = 0.0006), and higher bladder outlet obstruction index (BOOI; -11 versus -23, P = 0.0022) compared with controls. According to multivariate analysis, maximum cystometric capacity (parameter estimate [PE] =0.008, P = 0.04) and BOOI (PE = -0.029, P = 0.01) were independent urodynamic predictors of de novo OAB. The final model showed good predictive accuracy (area under the curve =0.81). CONCLUSION The present study identified maximum cystometric capacity and BOOI as independent predictors of de novo overactive bladder after single-incision sling implantation. Therefore, preoperative urodynamics may be useful to improve preoperative counseling and to tailor surgical treatment.

Introduction Mid-urethral slings, including transobturator tape (TOT), tension-free vaginal tape (TVT), tension-free vaginal tape-obturator (TVT-O), and a single incision sling, are the most popular procedures for the treatment of stress urinary incontinence (SUI). Although the classical TOT procedure is a minimally invasive technique, we believe that this technique can be further improved. Aim To determine whether there was a difference in success and complication rates between the classical TOT technique and a novel technique called “modified transobturator tape” (mTOT), which avoids periurethral dissection. Material and methods In total, 98 patients who underwent incontinence surgery between July 2011 and January 2017 were recruited for this prospectively planned study. Of the 98 patients, 47 patients underwent classical TOT, and 51 patients underwent the new mTOT procedure. Incontinence Impact Questionnaire-7 (IIQ-7) and visual analogue scale (VAS) scores were obtained preoperatively and postoperatively. Average or serious symptomatic scores in IIQ-7 were considered as subjective failure. Results Nerve damage, vascular damage, retropubic hematomas, and bladder-urethra erosion were not observed in either group. There were no significant between-group differences in IIQ-7 scores. There were also no between-group differences in postoperative 1-month, 6-month, and 1-year VAS scores, but postoperative first day scores of the mTOT group were significantly lower than those of the classical TOT group (p < 0.05). Conclusions The proposed modified technique provides the same efficiency and reliability as the classic technique but is more advantageous in terms of reduced pain and resumption of earlier sexual activity.

To determine the clinical outcomes of adding a tension-releasing suture (TRS) appendage for manipulation of over-tensioned single-incision slings (SIS) as a means to relieve postoperative voiding dysfunction. A retrospective observational study conducted from January 2010 to July 2017. The records of patients with urodynamic stress incontinence (USI) without needing concurrent procedures who underwent anti-incontinence surgery using MiniArc, Solyx, and Ajust with voiding dysfunction were collated and analyzed. The primary outcome measure was the recovery of normal post-void residual urine (PVR) after TRS manipulation. The secondary outcome measures were the pain intensity noted during manipulation (quantified by visual analog scale) and the continence rate [assessed by (1) objective cure: 1-h pad test weight

Study Objective To assess whether single-incision sling (SIS) is non-inferior to transobturator (TOT) sling regarding efficacy for treating women with confirmed stress-predominant urinary incontinence (SUI). Design Prospective, parallel, non-blinded, multicenter, randomized controlled study. Setting Two tertiary, academic hospitals. Patients or Participants Ninety-nine patients were followed 6 and 12 months after surgery. Interventions Mid-urethral TOT sling (Obtryx II® – Halo; n=50) with regional anesthesia or SIS (Solyx®; n=49) with local anesthesia. Intention-to-treat analysis was performed. Measurements and Main Results The primary outcome was improvement in the Patient Global Improvement (PGI-I) and Kings Health Questionnaire (KHQ) instruments after treatment. Secondary outcomes were subjective improvement (improved/cured), number of reoperations, estimated blood loss (EBL), operative room (OR) time, post-op complications. Both groups were homogeneous (p=NS) regarding age(p=0.728), race(p=0.112), body mass index(p=0.082), menopausal status(p=0.359), vaginal deliveries(p=0.839), tobacco use(p=0.385) and sexual activity(p=0.605). There was no difference in the PGI after 6(p=0.067) and 12 months(p=0.128) of treatment between the groups. KHQ scores were better improved in the TOT group for the following domains: role limitations(p=0.049), physical limitations(p=0.0105) and severity measures(p=0.0416). The other domains (general health, incontinence impact, personal relationships, emotions, sleep/energy) were not different between the groups. After 12 months, TOT group was only superior to SIS in the general health domain(p=0.0189). However, the TOT group presented higher subjective improvement after 6 months (93.62 vs 75%; p=0.013) than SIS group, with no significant difference after 12 months. Six patients from the SIS group were reoperated versus three from the TOT group(p=0.309). The SIS group presented a smaller EBL (17.95 vs 33.9 ml; p= Conclusion TOT and SIS groups were equally effective after 6 and 12 months after treatment according to the PGI-I and KHQ instruments. Subjective improvement was higher in the TOT group after 6 months, with no difference after 12 months.

AIMS The aim of the study was to identify in a pure stress urinary incontinence (SUI) population risk factors for recurrence after single-incision slings (SIS). METHODS This retrospective study analyzed women with complaints of SUI symptoms and urodynamically proven SUI. Exclusion criteria were recurrent SUI, overactive bladder syndrome/detrusor overactivity, preoperative postvoid residual >100 mL, reduced urethral mobility ( I stage and previous history of radical pelvic surgery. Objective cure rate was assessed with stress test. RESULTS A total of 192 patients were analyzed. Objective cure rate was obtained in 86.5% of patients. According to univariate analysis, recurrences had higher prevalence of severe ICIQ-SF score (≥18 points), higher prevalence of reduced urethral mobility (Qtip ≤30°), higher prevalence of low detrusor pressures during voiding phase (opening pressure

Introduction The prevalence of urinary incontinence is increasing. Two major risk factors are overweight and age. We present objective and subjective cure rates of elderly and overweight patients treated with an adjustable single-incision sling system (AJUST™, C.R. BARD, Inc.). Materials and Methods Between 04/2009 and 02/2012 we treated 100 female patients with the single incision sling. Patients were retrospectively evaluated by Stamey degree of incontinence, cough test, pad use, and overall satisfaction. The primary outcomes of the study were objective and subjective cure rates, secondary outcomes were the safety profile of the sling and complications. Results The overall success rate in this population was 84.6% with a mean follow-up of 9.3 months. The average usage of pads per day decreased from 4.9 to 1.6 and was significantly lower in patients with a BMI

Background: Being overweight or obese is a risk factor for incontinence and has negative impacts on the surgical outcomes. Compared with trans-obturator sling (TOS), single incision sling (SIS) is a new generation of anti-incontinence surgery. However, the data on SIS in overweight and obese women remains limited. Methods: This retrospective study analyzed the objective and subjective cure rate of overweight and obese women who underwent sling surgeries. Other evaluations included valid questionnaires to assess quality of life and 1-hour pad test to quantify urine leakage. Surgical characteristics and adverse events were also analyzed. Results: A total of 217 patients were analyzed with a median follow-up period of 37.3 months (range, 9&ndash, 84 months). For overweight and obese patients, the objective and subjective cure rate were comparable (all p &gt, 0.05). However, the SIS group had worse post-operative incontinence-related symptom distress (p &lt, 0.001) and 1-hour pad test (p = 0.047). On the other hand, SIS had a shorter surgery time (p = 0.017) and lower pain score (p &lt, 0.001). Conclusions: Compared with TOS, SIS had non-significant cure rates in the overweight and obese women. SIS had worse urine leakage and incontinence symptoms, but less surgical and wound pain in obese women. Thorough pre-operative counseling is necessary.

INTRODUCTION AND OBJECTIVES:Compare patient-reported outcomes(PROs) after single incision sling(SIS) and transobturator mid-urethral sling(TMUS).METHODS:This is a planned secondary analysis of a pr...

For the treatment of stress urinary incontinence (SUI), various retropubic and transobturator techniques have demonstrated high cure rates. Single-incision tapes, such as Contasure-Needleless® (C-NDL), have demonstrated similar cure rates to the inside-out transobturator sling (TVT-O®). The aim of this study was to analyse if C-NDL® is equally as effective as an outside-in transobturator sling (Monarc®) for the treatment of SUI. We carried out a prospective, single-centre, randomised trial. The results were analysed for a non-inferiority test with a minimum postoperative follow-up of 12 months. The objective and subjective cure rates were evaluated by a stress test and a postoperative Sandvik Severity Index respectively. Patient satisfaction and operative complications were registered. The cure was defined by a negative stress test and SSI 0. A total of 187 patients were included, 89 and 98 undergoing C-NDL® and Monarc® respectively. Epidemiological and clinical data did not show and significant differences between both groups except a high prevalence of women who smoke (15.7% C-NDL® vs 6.1% Monarc®, p 0.03). The negative stress test was negative in 72 patients (80.9%) in C-NDL® compared with 85 (88.5%) in Monarc® (p 0.082). The SSI was 0 in 47 (66.2%) for C-NDL® and 61 (70.1%) for the Monarc® group (p 0.01). There were 14 (16.1%) and 8 (8.3%) dissatisfied patients for the C-NDL® and Monarc® groups respectively (p 0.068). The rate of complications was similar in both groups. According to the non-inferiority test, C-NDL® is not inferior to Monarc® (post-surgical SSI test), but it is inferior in the comparison of a negative stress test and patient satisfaction.

Aims Evaluate the Altis single-incision sling for treatment of female stress urinary incontinence through 24 months. Methods This was a prospective, multi-center, industry-sponsored (Coloplast Corp.), single-arm trial with primary efficacy defined as ≥50% reduction in 24 h pad weight from baseline at 6-months. Device- and procedure-related complications were collected for safety. Secondary measures included cough stress test, Urogenital Distress Inventory-Short Form, Incontinence Impact Questionnaire-Short Form, and Patient Global Impression of Improvement. Results Of the 113 women implanted, 94 remained at 24-months. The average procedure time was 12.8 ± 8.4 min across all settings. Of those with paired baseline and follow-up data at 24-months, 90.0% (81/90) achieved ≥50% reduction in pad weight, 81.1% (73/90) were dry (pad weight ≤4.0 g), and 87.9% (80/91) had a negative cough stress test. Significant median reductions of 44.4 in Urogenital Distress Inventory (P-value

Objective Voiding dysfunction following a midurethral sling procedure is still a relevant consequence that can affect patients' quality of life. Various invasive methods have been described to manage this problem. We hypothesize that we if we could diagnose the condition early using noninvasive tools, we would be able to offer appropriate effective management. We sought to study the effectiveness of attaching a tension-releasing suture on a single-incision sling (SIS) tape as a prophylactic measure for the treatment of immediate postoperative voiding dysfunctions, and secondarily, to evaluate the objective and subjective cure rates of the treatment for stress urinary incontinence. Materials and Methods It is a prospective observational study. A tension-releasing suture was prepared by appending a polyglactin suture to one end of the MiniArc sling tip fiber, which could be used to manipulate the sling tip when postoperative voiding dysfunction was identified. Primary outcome measure was the number of patients requiring tension-releasing suture manipulation to treat postoperative voiding dysfunctions successfully. Results Twelve of the 131 (9.2%) patients who underwent SIS procedure for urodynamic stress incontinence surgery required tension-releasing suture manipulation due to voiding dysfunction during the immediate postoperative period with a good outcome. Postoperative overall objective and subjective cure rates were 90.5% and 88.9% (126 available patients at 1-year follow up, mean 19.2 ± 8.0 months), respectively. The subanalysis of the objective and subjective cure rates of the group with tension-releasing suture manipulation were 91.7% (11/12) and 91.7% (11/12), and those of the group without tension-releasing suture manipulation were 90.4% (103/114) and 88.6% (101/114), respectively, at 1-year follow up. Conclusion Tension-releasing suture is effective in the management of immediate postoperative voiding dysfunction in an SIS procedure. SIS operation has good short-term objective and subjective cure rates for female urodynamic stress incontinence.

Study Objective To compare the efficacy of the Altis single incision sling (SIS) to traditional trans-obturator (TOT) slings for the treatment of female stress urinary incontinence (SUI). Design Single center prospective non-randomized cohort study. Setting Academic Healthcare Facility. Patients or Participants 149 patients with SUI who were undergoing a mid-urethral sling placement with a SIS or a TOT sling between March 2018 and April 2019. Interventions Placement of Altis SIS or TOT sling. Measurements and Main Results Of the 149 patients who were treated for SUI, 73 had an Altis SIS placed and 76 had a TOT sling placed. Patients completed the Incontinence Questionnaire Short Form (ICIQ-SF) and the Patient Global Impression of Improvement (PGI) Form at 3, 6 and 12 months; which reflected subjective outcomes. Objective outcome was evaluated with a cough stress test at 3, 6 and 12 month intervals. At the 3 month mark there was a statistically significant difference in both subjective and objective outcomes in favor of the Altis SIS compared with the TOT sling, (p 0.05). Subjectively there was a 88% success rate for the Altis sling and 83% for the TOT sling, with objective cure rates being 91.8% and 90.2% for the Altis SIS and TOT sling respectively. Intra-operative and postoperative complications including bleeding, transient urinary retention and pain showed no statistical significance between the 2 slings. Three sling erosion (4.1%) requiring revision were seen in the Altis SIS group compared with 1 (1.3%) in the TOT group, (p>0.05). Conclusion Findings from this study suggests that the objective and subjective outcomes as well as operative complications for the Altis SIS and the TOT sling are comparable, indicating that both slings are equally efficacious in treating patients with SUI after a short-term follow up.

Objective: To evaluate the clinical outcome among women who had undergone Miniarc™ in the treatment of stress urinary incontinence (SUI). Study design: In this retrospective study from March 2010 to December 2011 patients with clinically confirmed SUI and urodynamic stress incontinence (USI) underwent Single Incision Sling Procedure (SIS). Objective cure of SUI was defined as no urinary leakage on provocative filling cystometry and 1-hour pad test of 0.05). Conclusions: In conclusion, Miniarc™ was noted to have improvement in both subjective and objective clinical outcomes. Urethral indentation was noted and resolved by tape release on immediate post-operative voiding dysfunction.

Objective To evaluate the safety and efficacy of a procedure using surgeon-tailored polypropylene mesh (STM) through a needle-less single-incision technique for treating stress urinary incontinence (SUI), aiming to decrease the cost of treatment, which is important in developing countries. Patients and methods In all, 43 women diagnosed using a cough stress test were treated from January 2011 to June 2013 at the Urology and Gynaecology Departments (dual-centre), Cairo University Hospitals. Previous surgery was not a contra-indication. Patients with a postvoid residual urine volume of >100 mL, a bladder capacity of

To evaluate the effectiveness and safety of the MiniArc single-incision sling in the treatment of urodynamic stress incontinence (USI) through 5 years.Retrospective observational study (Canadian Task Force classification II-2).Tertiary referral center.Eighty-five patients with USI without needing concurrent procedures who underwent anti-incontinence surgery using the MiniArc SIMS from February 2010 to December 2011.Anti-incontinence surgery.Objective cure was defined as no demonstrable leakage of urine on the cough stress test and 1-hour pad test weight2 g. Subjective cure was based on negative response to Urinary Distress Inventory question 3, no leakage on coughing, sneezing, or laughing. Most patients were postmenopausal, overweight, and multiparous. Postoperative USI significantly improved (p .001) through 3 years, and the 1-hour pad test showed significant improvement through 5 years (p .001). Although 13 patients had recurrence of USI, no repeat surgery was done. The cumulative cure rates may show a declining trend of cure, yet subjective cure was 80.0% and objective cure 84.7%, with age as a significant risk factor for sling failure.MiniArc maintains its effectiveness and safety in treatment of USI through 5 years with high objective and subjective cure rates and low incidence of complications.

Introduction and hypothesis The objective of this study was to evaluate the efficacy and safety of the Miniarc Precise® single-incision sling (American Medical Systems, Minnetonka, MN, USA) placed at the time of a robotic sacrocolpopexy. Methods This was a prospective study of a single-incision suburethral sling placed at the time of robotic sacrocolpopexy in women with stress urinary incontinence (SUI) and pelvic organ prolapse. Primary outcome measure was cure at 1 year, defined objectively by a negative cough stress test (CST) and subjectively by a score of “0 or 1” on question 17 of the Pelvic Floor Distress Inventory (PFDI-20): “Do you experience urine leakage related to coughing/sneezing/laughing?” Secondary outcome measures included the change in Urinary Distress Inventory (UDI-6) and Urinary Impact Questionnaire (UIQ-7) scores at 1 year. All sling-related complications were reported. Paired Student’s t test and the Wilcoxon signed-rank test were used for statistical analysis. Results One hundred and one patients were included between August 2010 and July 2012. One-year follow-up was available for 97 out of 101 patients (96 %). Objective cure was 90 % and subjective cure was 87 %. Baseline UDI-6 scores improved from 34.8 ± 25.1 to 6.7 ± 11.2 at 1 year (p

Objectives: The Solyx System was developed to be easier and safer to use than other slings. It was the objective of this study to retrospectively assess the long-term safety and efficacy of the SolyxTM SIS Sling System. Methods: After IRB approval and informed consent, chart reviews with follow up phone questionnaires of 69 subjects implanted with the Solyx Sling were collected at 2 sites. All of the patients had SUI and had urethral hypermobility with a q-tip test of >30 degrees. All subjects underwent surgery from 12/2008 to 01/2010 with a mean follow up of 43 months (range 39 -49). Subjects included in this data collection had a mean age of 67 years (range 30 -87). The dominant type of incontinence within the study patients was SUI while 17/69 (25%) of the subjects also had a component of urge incontinence. 38/69 (55%) of study patients had concomitant procedures. Results: Long-term Solyx results showed 64/69 (93%) of patients were subjectively dry by questionnaire and were satisfied with their outcome. 63/69 (91%) would have the procedure again. There were 4 cases of denovo urge incontinence and 2 reports of transient retention. There were no serious adverse events including no bladder, bowel, vessel or nerve perforations and no erosions or extrusions. No pain was reported that was attributed to the implant. Conclusions: Chart review with follow phone questionnaires indicated that the Solyx Sling was a safe, efficacious and less-invasive option for patients requiring SUI surgery and that these results were sustainable for an average of 43 months.

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. 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. 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. 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.

The aim of this study was to evaluate the effectiveness and overall safety of the Ajust® Adjustable Single-Incision Sling in the treatment of female stress urinary incontinence. This was a prospective, multicenter study conducted in women diagnosed with stress urinary incontinence. The Ajust® Sling was implanted and patients were followed postoperatively for up to 29 months. Evaluations were performed to assess postoperative rate of continence, complications, and patient quality of life (QOL). From November 2008 through May 2009, 52 patients were enrolled and underwent a procedure to implant the Ajust® Sling. Overall, 86.3 % of the patients who successfully received the Ajust® Sling demonstrated total restoration or improvement of continence at the last study visit. QOL scores related to global bladder feeling and lifestyle improved. Only one patient reported the occurrence of mild pain which resolved without treatment or sequelae. In long-term follow-up, the Ajust® Sling was safe and effective, restoring or improving continence in 86.3 % of patients.

OBJECTIVE To investigate the success and complication rates for Mini-Arc(TM) single incision sling in the treatment of female stress urinary incontinence (SUI). MATERIALS AND METHODS A total of 119 female patients with pure SUI were enrolled in a prospective study. From these, 105 were available with a minimum follow-up of 6 months and a mean follow-up of 12 months. Success, as determined by patient- reported outcomes, and complication rates, as well as impact of learning curve, body mass index (BMI), intrinsic sphincter deficiency (ISD), incontinence severity and age were investigated. RESULTS Cure rate was 80% and improvement rate was 11%. Pain intensity was minimal on a visual analogue scale and transient urinary retention occurred in three patients, one requiring sling section. De novo urgency was reported by 6% of women. Severe incontinence was less likely to be cured: 70% if >5 pads per day (ppd); 94% if

The advent of the mid-urethral sling (MUS) 15 years ago has drastically changed the surgical management of stress urinary incontinence (SUI). Both retropubic and transobturator MUS can be placed in the ambulatory setting with excellent results. The tension-free vaginal tape (TVT) sling has the most robust and long-term data, but more recent literature suggests that the transobturator tape sling may offer comparable efficacy in appropriately selected patients. Single incision sling (SIS) is the newest addition to the MUS group and was developed in an attempt to minimize morbidity and create an anti-incontinence procedure that could be performed in the office. The efficacy of SIS remains unknown as the current literature regarding SIS lacks long-term results and comparative trials. The suprapubic arc sling appears to have equally effective outcomes in at least the short-term when compared with TVT. Although evolution of the SIS has led to a less invasive procedure with decreased post-op pain and reduced recovery time, durability of efficacy could be the endpoint we are sacrificing. Until longer-term data and more quality comparison trials are available, tailoring one's choice of MUS to the individual patient and her unique clinical parameters remains the best option.

The aim of this study was to test the safety and efficacy of the Solyx single-incision sling (SIS) in women with stress urinary incontinence (SUI). A retrospective study of 63 women who had undergone implantation at three medical centers (December–March 2009) was conducted. Mean patient age was 51 years (range, 30–87 years); 37 (59%) patients had concomitant urogynecological procedures. At a mean follow-up of 6.5 months (range, 5–8 months), 95% of patients were dry on the basis of subjective and objective assessment. Two patients experienced transient urinary retention, which resolved spontaneously. No complications of the procedure were reported, including no bladder, bowel, vessel, or nerve perforations and no erosions or extrusions. No pain was reported that was attributed to the implant. The very early efficacy results indicate that the Solyx SIS system is an attractive treatment option for SUI. The minimal number of steps involved in the procedure will facilitate uptake of the technique.

Please cite this paper as: North C, Hilton P, Ali-Ross N, Smith A. A 2-year observational study to determine the efficacy of a novel single incision sling procedure (Minitape™) for female stress urinary incontinence. BJOG 2010;117:356–360. Objective Assessment of the 2 year outcome of the Minitape™ procedure. Design A prospective observational study of women undergoing the Minitape™ procedure for urodynamic stress incontinence. Setting Two tertiary referral urogynaecology units in the north of England. Population Sixty women between November 2002 and March 2006. Methods Women attended a research clinic where they completed a standardised 1 hour pad test and were examined. Women were assessed preoperatively and postoperatively at 6 months, 1 year and 2 years. Main outcome measures Success was determined by a negative 1 hour pad test (gain of

Urinary incontinence, the complaint of involuntary leakage of urine, may affect up to 50 % of women at some point in their lifetime. Incontinence negatively impacts psychological health and women who live with incontinence have a significantly lower quality of life compared to continent women. The surgical options available to treat urinary incontinence are extensive and have evolved significantly over the years. This chapter focuses on those techniques used to treat incontinence that involve the use of prosthetics.

The objective was to compare the efficacy and safety of an innovative single-incision sling (SIS) with the inside-out transobturator sling (TOT) in the treatment of female stress urinary incontinence (SUI).A prospective randomized trial was performed in a tertiary referral urogynecology center from January 2012 to December 2013. The study included women with pure urodynamic SUI. Patients were randomized to either the SIS or the TOT anti-incontinence procedure. Surgery duration, blood loss, and groin pain scores were recorded for each patient. The 1-year follow-up visit included objective and subjective cure parameters, postoperative de novo urgency, complications, and the impact on the patient's life quality.Of 285 patients assessed for eligibility, a total of 93 patients (32.6 %) were randomized into TOT (n = 48) and SIS groups (n = 45). There were no significant differences in either operating time or blood loss. A statistically significant difference between the two groups was found in pain scores three (5.6 ± 1.8 vs 3.1 ± 2.1, p 0.001) and 12 h postoperatively (3.8 ± 1.7 vs 2.1 ± 1.7, p 0.001). After 1 year, there were no significant differences between the TOT and SIS groups in objective cure rates (87.0 % vs 90.9 %; p = 0.399) or patient-reported success rates (91.3 % vs 93.2 %; p = 0.999). Incidence of postoperative de novo urgency did not differ between TOT and SIS patients. Both groups registered a significant improvement in quality of life.The Ophira SIS procedure has 1-year success rates comparable to standard TOT with significantly less groin pain in the early postoperative period. Both methods were safe and effective in terms of postoperative urgency and life quality improvement.

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). 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. 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

In recent years, surgical treatment of stress urinary incontinence has become minimally invasive owing to the introduction of the transobturator route first and then single incision devices for positioning of mid-urethral slings. Although a number of case reports in the literature describe pregnancies successfully terminated both by vaginal delivery and cesarean section following mid-urethral sling positioning, there is still no definitive consensus on which is the preferred mode of delivery in these patients. We report a case of spontaneous vaginal delivery at term in a 41-year-old multiparous woman two years after the positioning of a single incision sling (TVT-Secur). The patient remained continent throughout the gestation and in the following 24 months. This case seems to further support the concept that sling procedures for stress urinary incontinence do not represent an absolute contraindication to spontaneous vaginal delivery, although the preferred mode of delivery must be assessed on an individual basis.

Objective: To ascertain whether low preoperational maximal urethral closure pressure (MUCP) affects the outcomes of single incision sling (SIS) procedures and changes MUCP values postsurgery. Material and methods: There were 112 (MUCP ≥ 40 cmH2O, n = 88; MUCP

We describe the safety and efficacy of the Altis(®) Single Incision Sling System for the treatment of female stress urinary incontinence through 12 months.In this study we collected a variety of safety and efficacy measures relevant to the assessment of urinary incontinence. The primary efficacy end point was improvement in 24-hour pad weight test. Other efficacy measures included the cough stress test, Urogenital Distress Inventory-Short Form, Incontinence Impact Questionnaire-Short Form, Patient Global Impression of Improvement and 3-day voiding diary. Safety was evaluated through assessment of device and procedure related adverse events.Of 116 surgical attempts 113 subjects were implanted with the Altis sling. Of these patients 103 had primary efficacy data at baseline and 6 months, and 101 had efficacy data at baseline and 12 months. Consequently 88 (85.4%) subjects at 6 months and 91 (90.1%) at 12 months achieved a 50% or greater reduction in pad weight. The cough stress test was negative for 95 (92.2%) subjects at 6 months and 91 (90.1%) at 12 months. A decrease in median leaks per day was observed at 6 months and improvements in all patient reported measures were observed through 12 months. A majority of subjects reported feeling much better or very much better at 6 and 12 months, respectively. There were no reports of mesh erosion or migration and no unanticipated adverse events through 12 months.The Altis sling appears to be safe and efficacious, and performs as intended in the treatment of stress urinary incontinence through 12 months.

Single-incision slings are the newest midurethral slings developed for the surgical treatment of stress urinary incontinence. We report the case of a patient who underwent single-incision sling placement who presented with recurrent stress incontinence 3 years after the procedure. She was found to have a 1.7-cm bladder stone that formed around the single-incision sling polypropylene barb.

This study compared transobturator tension-free vaginal tape (TVT-O®) and Contasure-Needleless (C-NDL®) at long-term follow-up . Non-inferiority, prospective, single-centre , quasi-randomised trial started in September 2006 and finished in April 2011 to compare C-NDL ® with transobturator vaginal tape (TVT-O®) mesh in the treatment of stress urinary incontinence (SUI) . Epidemiological information, intraoperative and postoperative complications, subjective estimates of blood loss and pain levels were recorded. We also analysed the postoperative stress test, the subjective impression of improvement using the Sandvik Severity Index and the quality of life during follow-up using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) . Two hundred and fifty-seven women with primary SUI were scheduled to receive TVT-O ® or C-NDL ® and were followed up at least 3 years after the procedure . One hundred and eleven women in the C-NDL ® group (84.7 %) had a negative stress test, compared with 54 women (88.9 %) in the TVT-O ® group (p = 0.0065 for the non-inferiority test). The postoperative Sandvik Severity Index was 0 or better than the preoperative score in 90.7 % of patients in the C-NDL ® group and 95.4 % of patients in the TVT-O ® group (p = 0.0022). The complication rate was similar in both groups. There were significant differences (p = 0.02) in postoperative pain within the TVT-O ® group. The degree of satisfaction was not statistically significant between the two groups. The outcomes for the C-NDL ® group were similar to those of the TVT-O ® group, adding the concept of “single incision tape” to the tension-free sling option.

The MiniArc™ sling is a next generation midurethral sling that is placed through a single incision with anchoring tips that fix into the obturator muscles. A new study reports 12-month success rates for this sling ranging from 85–91%, depending on the outcome measure evaluated, with a low rate of adverse events. Despite these encouraging results, long-term data are needed to demonstrate distinct advantages of the MiniArc™ over existing slings, combined with proven efficacy and safety.

MiniArc® Sling for the Treatment of Female Stress Urinary Incontinence Treatment of female stress urinary incontinence (SUI) has been revolutionized over the years and many corrective procedures have been described showing varying degrees of success. A recent development in this direction has been the introduction of MiniArc® sling which avoid blind needle passage in the retropubic space and the groin. Despite of its surgical principle, MiniArc® did not avoid the known complications associated with other mid-urethral slings (MUS). In addition, the data regarding MiniArc® effectiveness was insufficient and conflicting. We recommend the use of MiniArc® sling in the setting of clinical trials till it proves its safety and longterm efficacy relative to MUS.

1 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. 2 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. 3 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. 4 Conclusions The cure rates of the Ajust and MiniArc procedures are very good with the follow-up of 24 months.