Single-incision Sling Procedure Research Articles

Three-year Follow-up of a Single Incision Sling Procedure Performed Under Local Anesthesia in an Office Setting

To assess the 3-year success of placing a single-incision midurethral sling (SIMS) using the Dynamic Intraoperative Standing Sling Technique (DISST) in an office setting under local anesthesia. This is a prospective case series of 20 women who underwent in-office SIMS procedure by the DISST from July 2019 to February 2020. This is an extension of our pilot study (11) and all 20 patients were evaluated at a mean follow-up of 34.3months. Success was defined as a composite score of objective success (negative standing cough test at bladder fullness), subjective success based on the modified PGI-I score of "very much better" or "much better," and no retreatment for stress urinary incontinence. Secondary objectives were adverse events, de novo overactivity of the bladder, recurrent urinary tract infections, voiding dysfunction, pain/dyspareunia, and influence on sexual function. The composite success rate was 95% (95% CI [75.1, 99.9]) at the 36-month follow-up. The significant improvement in MESA scores was maintained over the study period. There were no cases of de novo urgency, mesh exposure, postop voiding dysfunction or recurrent urinary tract infections. There were no cases of de novo dyspareunia. SIMS placed by the DISST technique under local anesthesia in an office setting has shown sustained efficacy over a 3-year period with no decrease in cure. Subjects remained dry and reported excellent improvement in symptoms and quality of life at the 36-month follow-up visit.

Long-term outcomes of Altis® single-incision sling procedure for stress urinary incontinence.

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 8years. 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.

P0098 - Long-term efficacy and safety of Altis® single-incision sling procedure for stress urinary incontinence

P0098 - Long-term efficacy and safety of Altis® single-incision sling procedure for stress urinary incontinence

Analysis of outcome and risk factors for failure after single-incision sling procedure

Aim: To assess the effectiveness and safety of a single-incision sling (SIS) and to detect the risk factors for failure after surgery in woman with stress urinary incontinence (SUI).Materials and Methods: The medical records of the one hundred thirty-two patients were analyzed. Preoperatively, medical history was taken and urogynecological examination was made. Patients were asked to answer Urinary Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7). Objective cure of SUI was defined as the absence of leakage of urine on the cough test. Subjective cure was based on negative response to UDI-6, question 3. Patients were divided into two groups according to objective cure rate: cured patients (Group A) and failed patients (Group B). Results: The overall objective and subjective cure was 87.8% and 90.1%, respectively. According to the objective cure rate, there were 116 patients (87.8%) in Group A and 16 patients (12.2%) in Group B. In terms of subjective cure, Quality of Life (QoL) scores (IIQ-7 and stress subdomain of UDI-6) of Group B were statistically improved after surgery (p=0.001 and p=0.005 respectively). When two groups were compared, Group B had higher prevalence of severe SUI (IIQ scores ≥15 points) and reduced urethral mobility (Q-tip ≤ 30°) (0.8% vs 87.5%, p=0.0001 and 3.4% vs 68.7%, p=0.0001, respectively). The overall recommendation rate for surgery was 90%.Conclusion: Our study showed that SIS procedure has high subjective and objective cure rates. The main risk factors for failure were detected as reduced urethral mobility and SUI severity expressed with IIQ scores.

Single-incision slings for the treatment of stress urinary incontinence: efficacy and adverse effects at 10-year follow-up

Single-incision slings are not considered a first-choice surgical treatment owing to a lack of data about long-term outcomes. We aimed to assess the long-term results of urinary incontinence treatment after single-incision sling implantation at 10years' follow-up and to investigate possible deterioration over time. This retrospective study analyzed women with subjective and urodynamically proven stress urinary incontinence who underwent single-incision sling procedure. The objective cure rate was assessed with a 300-ml stress test. The subjective cure rate was determined by the Patient Global Impression of Improvement (PGI-I) questionnaire. International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) questionnaire scores and self-answered patient-satisfaction scales were collected to assess symptom severity. Findings were compared with short-term outcomes in the same patients, available through our previous database, in order to detect possible outcome deterioration over time. The records of 60 patients were analyzed. Nine patients (15%) were lost to follow-up. A total of 51 patients completed the evaluation, with a mean follow-up of 10.3 ± 0.7years. Objective and subjective cure resulted 86.3% and 88.2% respectively. Mean PGI-I scores and ICIQ-SF were 1.5 ± 1.0 and 3.2 ± 4.8 respectively. Patients' satisfaction scored 8.6 ± 2.6 out of 10. No long-term complications occurred. Comparison of short-term (2.6± 1.4years after surgery) and long-term follow-up did not show a significant deterioration of outcome over time. Single-incision slings were shown to be a procedure with a great efficacy and safety profile at very long-term follow-up. Cure rates and functional outcomes did not show any deterioration over time compared with short-term results.

A Multicenter Prospective Study Evaluating Efficacy and Safety of a Single-incision Sling Procedure for Stress Urinary Incontinence

The aim of the Altis 522 study was to compare the safety and efficacy of the Altis Single-Incision Sling System (SIS) (Coloplast, Minneapolis, MN) with standard midurethral transobturator and/or retropubic slings through 36 months. In this report, we present data through 12 months of follow-up. Postmarket, prospective, multicenter, nonrandomized cohort design. The study was performed at 23 hospitals in the United States and Canada. Adult female patients with stress urinary incontinence (SUI) clinically indicated for an incontinence sling were treated (n = 355). Altis SIS was compared with any Food and Drug Administration-cleared transobturator or retropubic sling. Collected measures included device- and/or procedure-related serious adverse events, relevant nonserious and all adverse events, and revision surgery. Objective efficacy measures included 24-hour pad weight, dryness (defined as pad weight ≤4.0 g), and cough stress test. Subjective outcome measures included patient global impression of improvement, urogenital distress inventory, Incontinence Impact Questionnaire-Short Form, Surgical Satisfaction Questionnaire, and visual analog scale for pain. At 12 months, 24-hour pad weight success (≥50% reduction), negative cough stress test, patient global impression of improvement, urogenital distress inventory, and Incontinence Impact Questionnaire-Short Form appeared similar between groups. Through 12 months, 2 subjects in the Altis group and 3 subjects in the comparator group experienced a serious device- and/or procedure-related adverse event. In the Altis group, 1 subject (0.5%) experienced a device revision, and 1 subject (0.5%) had the device explanted. In the comparator group, 7 subjects (4.1%) experienced a device revision, and 1 device (0.6%) was explanted before the 12-month visit. The occurrence of relevant nonserious procedure and/or device-related adverse events was similar between groups. At 12-months follow-up, safety and efficacy appeared similar between Altis SIS and standard transobturator and retropubic midurethral slings.

Single Incision Sling Procedure Done by the Dynamic Intraoperative Standing Sling Technique: A 2-Year Analysis

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...

Risk Factors for Failure After Single-incision Sling Procedure in Women With Stress Urinary Incontinence

Risk Factors for Failure After Single-incision Sling Procedure in Women With Stress Urinary Incontinence

Prospective Analysis of the Dynamic Intraoperative Standing Sling Technique A Novel Method of Performing the Single-Incision Sling Procedure

Abstract 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...

Tension-releasing suture appendage on single-incision sling device: A novel approach to postoperative voiding dysfunctions

ObjectiveVoiding 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 MethodsIt 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. ResultsTwelve 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. ConclusionTension-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.

Evaluation of Sexual Function and Quality of Life in Women Treated for Stress Urinary Incontinence: Tension-Free Transobturator Suburethral Tape Versus Single-Incision Sling.

The aim of this study is to investigate the change in quality of life (QoL) and sexual function in women treated for pure stress urinary incontinence (SUI) using tension-free transobturator suburethral tape (TVT-O) and single-incision sling (SIS) procedures. From December 2013 to January 2015, a total of 48 female patients with pure SUI and normotonic urethra were consecutively enrolled and randomized into two treatment groups: TVT-O versus SIS. Both groups were homogeneous in the preoperative evaluation of age, body mass index, comorbidities, and pregnancies. Exclusion criteria included urge urinary incontinence, neurogenic bladder, previous surgery for incontinence, and mental or neurological disorders. The female sexual function and QoL were assessed preoperatively and postoperatively (3-12 months follow-up), using the Female Sexual Function Index (FSFI) and the International Consultation on Incontinence Questionnaire. A total of 42 patients completed both the questionnaires (21 patients in the TVT-O group and 21 patients in the SIS group, whereas 6 patients were lost to follow-up). Of the 19/21 (90.4%) of patients who successfully underwent the SIS procedure, 17 (80.9%) reported a complete resolution of SUI, whereas 2 (9.5%) reported an improvement in urinary incontinence at follow-up. In the TVT-O group, 18/21 (85.7%) of patients reported complete recovery, whereas 4.1% patients reported an improvement in the incontinence. The FSFI score increased significantly in both the SIS groups (from 23:51 ± 3.78 to 27.42 ± 3.34; p < 0.001) and TVT-O group (from 23.96 ± 5:56 to 28.09 ± 3.62) with no statistically significant differences between the two treatment groups. In our study, both slings showed a high rate of continence without any major complications. The sexual function also improved sharply in all the six FSFI domains, with no statistically significant difference between the two treatment groups.

In Office Single Incision Sling Procedure: A Safe, Cost-Effective Approach for the Surgical Management of Stress Urinary Incontinence

In Office Single Incision Sling Procedure: A Safe, Cost-Effective Approach for the Surgical Management of Stress Urinary Incontinence

Clinical outcomes of single-incision sling procedure (MiniArc)

Abstract 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 Results Postoperative data was available for 85 women. Five women were not able to participate in the follow-up schedule and post-op questionnaire. The objective data for post-operative follow-up was available from 80 women. The average period of follow-up was 1.4 years (range 1.0 to 2.1). A total of 14 women had immediate post-operative urine retention at the first 24 hours and 6 cases were due to over-tensioning of the sling after ultrasound assessment. No case of bladder or bowel injury was recorded and no other major complications noted. Pre and post clinical findings revealed a significant improvement after 1 year follow-up based on the response to UDI-6, IIQ-7 ( 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.

Pregnancy after transvaginal sling for stress urinary incontinence: a case series.

The aim of this study is to assess the incidence, medical course, and outcomes of women who carried a pregnancy to delivery after the placement of a transvaginal mesh sling for treatment of stress urinary incontinence (SUI) in a closed health care system. We conducted a retrospective case series of 15 women identified within the Kaiser Permanente Northern California region based on coding for placement of a sling for SUI. Records were cross-matched against the records of live births. The electronic medical records of subjects were extensively reviewed. Fifteen patients were identified and included in the analysis. Twelve patients had retropubic midurethral slings, 2 patients had transobturator slings, and one had a single-incision sling procedure. Ten of 15 were delivered via cesarean delivery. Five of the 15 patients had concomitant prolapse surgery at the time of sling placement; all of these patients had cesarean deliveries. There were no reports of voiding dysfunction or sling-related complications during pregnancy. Eleven of 15 patients were dry after the sling procedure, and 9 of the 15 were dry after delivery. No patients have had additional procedures or interventions for SUI after pregnancy. Our case series may suggest that vaginal delivery is not contraindicated and sling-related complications during pregnancy are not prevalent.

Short-term outcomes of Altis® single-incision sling procedure for stress urinary incontinence: a prospective single-center study

Data on Altis® (Coloplast), a new adjustable single-incision sling (SIS) procedure for the treatment of female stress urinary incontinence (SUI), are scarce. Our aim was to evaluate the efficacy and complication rates of this procedure. In this prospective observational study, a total of 52 women with SUI were implanted with an Altis sling in an ambulatory setting. Before and after intervention (3, 6, and 12 months), women completed the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF). In addition, patients underwent a cough stress test at each evaluation and a post-voiding residual urine volume estimation at 3 months. The main outcomes measured were subjective cure (ICIQ-SF = 0), subjective improvement (ICIQ-SF >0 and < preoperative ICIQ-SF), and objective cure (negative cough stress test and no pad usage) rates. De novo overactive bladder (OAB) symptoms, changes in voiding habits and adverse events were also analyzed. The subjective cure rate at 12 months was 84.0%, with an additional improvement rate of 8.0%. The objective cure rate was 90.2%. Later postoperative complications included 1 case of vaginal extrusion (requiring surgical removal of the eroded mesh segment), 3 cases of vaginal exposure of the adjustment thread (managed conservatively), de novo urgency in 3 patients, and mild dyspareunia in 2 patients. The Altis sling is a safe and effective SIS procedure for the treatment of SUI with a short-term follow-up.

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

ObjectiveTo 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 designProspective 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. ResultsThere 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%. ConclusionsThe 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.

Changes in sexual function and quality of life after single-incision mid-urethral sling for treatment of female stress urinary incontinence

ObjectivesTo evaluate the effectiveness and assess the changes in sexual function and quality of life after placement of a single-incision sling for the treatment of female stress urinary incontinence. Study designA prospective study of women diagnosed with stress urinary incontinence. The single-incision sling was implanted and patients were followed postoperatively for 6 months. The postoperative rate of continence, complications, changes in sexual function, and patient-reported quality of life were evaluated. Female Sexual Function in sexually active patients was evaluated before and after the single-incision sling procedure using the Female Sexual Function Index. From January 2009 to November 2011, 73 patients were enrolled and underwent the procedure to implant the MiniArc® or Ajust® single-incision sling. ResultsOverall, 93.2% of the patients who successfully received a single-incision sling demonstrated total restoration of continence (83.6%) or improved continence (9.6%) at the 6-month postoperative visit. Improvements were seen in the quality of life scores related to global bladder feeling (87.7%) and the Female Sexual Function Index (preoperative score 23.86±5.67 vs postoperative score 27.25±4.66 [P<0.0001]). ConclusionSingle-incision sling treatment for stress urinary incontinence led to improvements in continence and sexual function at 6 months of postoperative follow-up.

895 Altis® single-incision sling procedure for stress urinary incontinence: Short term outcomes from a single centre

895 Altis® single-incision sling procedure for stress urinary incontinence: Short term outcomes from a single centre

Three-dimensional ultrasound assessment and middle term efficacy of a single-incision sling

The aim of this study was to evaluate the functional outcome of a single-incision sling procedure for the treatment of female stress urinary incontinence (SUI) and to correlate the cure rate with a pelvic floor ultrasound examination Fifty-seven patients treated with a single-incision sling procedure between January 2009 and September 2010 were included in the study. Functional outcome was evaluated as objective cure rate assessed with stress test and subjective cure rate determined by the International Consultation on Incontinence-Short Form and Patient Global Impression of Improvement scores. Women underwent perineal ultrasound examination by a combined 2D translabial and 3D transvaginal approach to assess bladder neck and tape mobility, tape position along the urethral axis, and tape anchorage. According to the position of self-fixating tips, we divided patients into group A (both tips crossed the obturator membrane), group B (only one tip crossed the obturator membrane) and group C (none of the tips crossed the obturator membrane). Objective cure rate and type of anchorage were compared with all ultrasound parameters. At an average follow-up of 13 months objective cure rate was 87.7 % with a significant subjective improvement. A significant difference in tape mobility was noted between group A and group C. Bladder neck mobility significantly increased in failures. Sling was significantly closer to mid-urethra in cured than in failures. In 77 % of patients MA didn't reach the obturator membrane on both sides. This feature conditioned significantly bladder neck mobility but not the efficacy of the procedure. Tape position seems to be the most important factor for success.

Sexual function and quality of life following retropubic TVT and single-incision sling in women with stress urinary incontinence: results of a prospective study

PurposeThe objective of this prospective cohort study was to compare effectiveness, morbidity, quality of life (QoL) and sexual function in women treated with tension-free vaginal tape (TVT) versus single-incision sling (SIS) in the treatment of female stress urinary incontinence (SUI).MethodsRetropubic TVT sling or SIS was implanted in local anesthesia and patients were followed post-operatively for 6 months. Evaluation was performed to assess post-operative rate of continence, complications, changes in sexual function and patient reported quality of life. Female sexual function was evaluated before and after sling procedure using Female Sexual Function Index (FSFI) in sexually active patients.ResultsFrom January 2009 to December 2011, 150 patients were enrolled and underwent a procedure to implant the retropubic TVT (n = 75) or the MiniArc® and Ajust® SIS (n = 75). Overall, 93.3 % of the patients who successfully received SIS demonstrated total restoration (84 %) or improvement of continence (9.3 %) at the 6 month post-operative study visit. In TVT group we found 88 % total continence and 6.7 % improvement, respectively. Improvements were seen in the QoL scores related to global bladder feeling (89.3 %) in SIS group and 96 % for TVT. Post-operative FSFI score improves significantly and were comparable in both groups (SIS pre-operative 24.30 ± 4.56 to 27.22 ± 4.66 (P < 0.001) post-operative; TVT 24.63 ± 6.62 to 28.47 ± 4.41, respectively).ConclusionsThe SIS procedure appears to be as effective in improving incontinence-related quality of life and sexual function as the TVT through 6 months of post-operative follow-up. No differences in complications and sexual function were demonstrated between the groups.