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

OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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 efficacy of the single-incision mini-sling procedure using surgeon-tailored mesh.

OBJECTIVES: To evaluate the long-term efficacy of a surgeon-tailored single-incision mini-sling procedure (SIMS) for the surgical treatment of stress urinary incontinence (SUI) in terms of objective cure rates, quality of life, and cost-effectiveness. STUDY DESIGN: This retrospective study included 93 women with pure SUI who underwent surgeon-tailored SIMS. All patients were evaluated with a stress cough test and quality of life questionnaire (Incontinence Impact Questionnaire [IIQ-7]) at 1 month, 6 months, 1 year, and last follow-up visit (4-7 years). Early and late (after 1 month) complication rates and the reoperation rate were also evaluated. RESULTS: Mean operative time and follow-up duration were 12 ± 2.5 min and 5.7 years (4-7 years), respectively. Objective cure rates determined by the stress cough test were 83.8%, 94.6%, 93.5%, and 91.3% at 1 month, 6 months, 1 year, and last follow-up, respectively. IIQ-7 scores improved at every visit compared to the preoperative value. There were no cases of hematuria, bladder perforation, or major bleeding requires a blood transfusion. CONCLUSION: Our results suggest that the surgeon-tailored SIMS procedure has high efficacy and low complication rates and offers a practical and inexpensive alternative to commercial high-cost SIMS systems.

Local anesthesia for Altis® single incision sling in women with stress urinary incontinence.

OBJECTIVE: Local anesthesia for single incision slings has shown a good objective and subjective cure rate in women with stress urinary incontinence. The aim of the present study was to verify the efficacy and safety of local anesthesia during Altis® single incision placement. MATERIAL AND METHODS: One hundred sixty-six consecutive patients (83 patients for each group: local resp. spinal anesthesia) were selected from our database for this retrospective study among women who underwent an Altis® implantation for SUI from September 2016 to June 2021, after unsuccessful previous conservative treatment. Primary endpoints were objective and subjective cure rates; secondary endpoint was the evaluation of complications linked to this procedure. RESULTS: A total of 155 included patients completed our 12 months follow-up. Baseline characteristics were similar between the groups. Operative time (percentage difference of 50%; p < 0.05) and the Intraoperative Difficulty Scale resulted lower in spinal patients. No differences were found between populations in terms of objective (cough stress test and urodynamics) and subjective (PGI-I and FSDS questionnaires) cure rate and postoperative complications. CONCLUSION: Local anesthesia for Altis® implantation could be considered a safe alternative to spinal anesthesia and an effective opportunity to avoid general anesthesia, increasing the possibility of outpatient implantation of this sling system.

Clinical and Urodynamic results of the Argus T® sling in moderate and severe male stress urinary incontinence after radical prostatectomy - a 5 year prospective study.

PURPOSE: Sling as a therapeutic option for male stress urinary incontinence (SUI) has been reviewed in the last two decades, as it is a relatively simpliest surgery compared to artificial urinary sphincter and has the ability to modulate urethral compression. This study aims to evaluate the efficacy, rate of complications, quality of life and the effects on bladder emptying of the Argus T® compressive and ajustable sling in moderate and severe male SUI treatment. MATERIALS AND METHODS: Men eligible for stress urinary incontinence treatment after radical prostatectomy were recruited and prospectively evaluated, from March 2010 to November 2016. It was selected outpatient men with moderate and severe SUI, after 12 months of radical prostatectomy, who have failed conservative treatment. All patients had a complete clinical and urodynamic pre and post treatment evaluation, by means of clinical history, physical examination, urine culture, 1-hour pad test and ICIq-SF questionnaire. The UDS was performed after 12, 18 and 24 months postoperatively. RESULTS: Thirty-seven men underwent sling surgery, 19 patients (51.4%) with moderate and 18 (48.6%) with severe SUI. The minimum follow-up time was 5 years. Overall, we had a success rate of 56.7% at 60 months follow-up. After surgery, we did not observe significant changes in the urodynamic parameters evaluated during the follow-up. No patient had urodynamic bladder outlet obstruction (BOO) after sling implantation. Readjustment of the Argus T® sling was performed in 16 (41%) of the patients and 51% of the patients reported some adverse event. CONCLUSION: We demonstrate a long-term efficacy and safety of Sling Argus T® as an alternative to moderate and severe male SUI treatment. Furthermore, in our study bulbar urethra compression does not lead to bladder outlet obstruction.

Update on Adjustable Trans-Obturator Male System (ATOMS) for Male Incontinence after Prostate Cancer Surgery.

(1) Background: The adjustable trans-obturator male system (ATOMS) is a surgical device developed to treat post-prostatectomy incontinence (PPI) after prostate cancer treatment. We review the current literature on this anti-incontinence device with the intention of assessing the effectiveness, safety and duration of the silicone-covered scrotal port (SSP) ATOMS, the only generation of the device that is currently available. (2) Material and Methods: Non-systematic literature review is performed. Forty-eight full-text articles are assessed for eligibility. Case reports, expert opinions or commentaries without specific data reported (n = 6), studies with patients who underwent intervention before 2014 (IP or SP ATOMS; n = 10), and studies with incontinence after transurethral resection of the prostate (TUR-P; n = 2) are excluded for analysis. Thirty studies with SSP ATOMS are included in a qualitative synthesis that incorporates systematic reviews (n = 3), articles partially overlapping with other previously published studies (e.g., follow-up or series updates; n = 9), and studies focusing on specific populations (n = 8). Only articles revealing outcomes of SSP ATOMS were included in the quantitative synthesis of results (n = 10). (3) Results: the pooled data of 1515 patients from the 10 studies with SSP ATOMS confirmed very satisfactory results with this device after adjustment: dry rate: 63-82%, improved rate: 85-100%, complication rate: 7-33%, device infection rate: 2.7-6.2% and explant rate: 0-19%. The durability of the device is reassuring, with 89% of devices in place 5 years after implantation. (4) Conclusion: Despite the absence of randomized controlled studies, the literature findings confirm results of SSP ATOMS appear equivalent to those of artificial urinary sphincters (AUSs) in terms of continence, satisfaction and complications, but with a lower rate of revision in the long-term. A prospective study identified that patients with daily pad test results <900 mL and a Male Stress Incontinence Grading Scale (MSIGS) of not 4 (i.e., early and persistent stream or urine loss) are the best candidates. Future studies centered on the elder population at higher risk of impaired cognitive ability and in patients including radiation as prostate cancer treatment are needed.

Resurgence of Autologous Fascial Slings in a Challenging Climate for Sling Surgery: A 20-Year Review of Comparative Data.

Importance: Since the US Food and Drug Administration's 2016 ban of transvaginal mesh use in vaginal prolapse surgery, there has been growing public scrutiny over the use of synthetic mesh slings (SSs) for the surgical management of female stress urinary incontinence (SUI). Although long considered the mainstay of current practice, interest in biological alternatives has grown. Objectives: This article reviews the last 20 years of data comparing the success of autologous fascial slings (AFSs) and SSs in the treatment of female SUI. Evidence Acquisition: We reviewed the literature for randomized controlled trials comparing autologous pubovaginal sling and SS for the primary surgical treatment of female SUI using several search engines and databases between January 1, 2000, and March 31, 2020. Study Appraisal and Synthesis Methods: Data were retrieved and compared across studies. Trials were evaluated for study setting, type, population characteristics, sample size, success definition and rate, recurrence rate, operative time, length of hospital stay, complications, and quality of life. Results: Of the 1382 articles reviewed, 8 met eligibility criteria, representing 6 distinct cohorts and 726 subjects. Synthetic slings available for review were either tension-free vaginal tape (TVT) or minisling. The vast majority of studies demonstrated similar short- and long-term success rates of AFS and SS procedures utilizing a range of outcome measures. Both AFS and TVT sling had low recurrence rates in short- and long-term follow-up. However, AFS had significantly longer operative time, and longer hospital stay. Bladder perforation, on the other hand, occurred more commonly in TVT sling. Health-related quality-of-life scores, including sexual function, were similar between groups. Conclusions: Autologous fascial sling and SS are both highly effective surgical procedures for the treatment of female SUI. Although success rates are comparable, AFS is associated with less favorable operative measures. Relevance: This review supports the effectiveness of AFS in treating female SUI as concerns over the use of synthetic materials in vaginal surgery rise. However, clinicians must weigh the risks conferred by this nonsynthetic alternative.

Femistina versus Canephron as a prevention of urinary tract infections after midurethral sling surgery - Non-inferiority study.

OBJECTIVE: Urinary tract infection (UTI) is relatively common post-operative complication following midurethral sling placement (MUS), even in cases where intraoperative antibiotic prophylaxis was given. The primary aim of this study was to investigate the non-inferiority of Femistina as compared with Canephron in reducing symptomatic UTI in first six months following surgery. STUDY DESIGN: A sample size of 144 patients per group was established, to provide at least 90% power to demonstrate the non-inferiority of phytodrug Femistina versus Canephron as a prevention of post-MUS urinary tract infection. RESULTS: Women suffering from stress urinary incontinence and mixed urinary incontinence (MUI) with predominant SUI symptoms as confirmed by urodymamics (n = 320) were randomized in a 1:1 ratio to Femistina (40 mg, oral, twice daily for 20 days) or Canephron (3 × 5 ml taken orally-three times daily for 4 weeks). Both groups were homogenous for age, type of operation (only TOT outside-in) and severity of illness as indicated by ICIQ-SF questionnaire. We found that symptoms of UTI were significantly lower in patients receiving Femistina. During first 6 months after surgery UTI was confirmed in only 10 patients receiving Femistina (6,25%) when compared to 25 (15,63%) subjects receiving Canephron, p < 0.007. CONCLUSION: Femistina is not inferior to Canephron in preventing lower urinary tract infection after midurethral sling surgery.

Very long-term follow-up of autologous pubovaginal fascia slings in women with stress urinary incontinence.

INTRODUCTION AND HYPOTHESIS: The objective was to report on the very long-term outcome of a published series of autologous pubovaginal slings (PVS) in women with stress urinary incontinence (SUI). METHODS: Following institutional review board approval, a cohort of well characterized, non-neurogenic women who underwent an autologous PVS (primary [PVS1] and secondary [PVS2]) for SUI was re-evaluated for their very long-term outcome status. Data collected included demographics, validated questionnaires (Urogenital Distress Inventory - short form [UDI-6], Incontinence Impact Questionnaire - short form 7, quality of life), SUI retreatment/operations, and subjective patient-reported SUI improvement (%) and symptom recurrence. The primary outcome was success defined as UDI-6 question 3 (SUI) ≤ 1 and no SUI retreatment/operation. Patients not seen in clinic for 2 years were contacted via a standardized phone interview. RESULTS: From 83 patients with 7-year intermediate follow-up data, 34 (PVS1 = 18, PVS2 = 16) had very long-term follow-up based on clinic visit (7) or phone interviews (27). Those lost to follow-up (49), including 5 deceased, did not differ in demographics and intermediate outcomes from the followed cohort, but lived further away (>75 miles). At a mean age of 74 years, and with a median follow-up of 14.5 years, 53% met the success criteria (PVS1 = 44%, PVS2 = 63%). Mean postoperative questionnaire scores did not differ significantly between intermediate and very long-term follow-ups, and long-term outcomes between PVS1 and PVS2 remained similar. CONCLUSIONS: A majority of women with long-term follow-up after PVS for primary and secondary SUI remained successful more than 14 years after their surgery. Both groups, PVS1 and PVS2, fared equally well, confirming the durability of PVS as a treatment alternative for SUI.

Establishing the Queensland Pelvic Mesh Service: Preliminary experience.

BACKGROUND: Transvaginal mesh (TVM) has been used for treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Mesh-related complications are reported in 3% of women receiving mid-urethral sling surgery for SUI and in up to 20% of women who receive TVM for POP. The Australian Senate Enquiry report in March 2018 recommended that each Australian state establish specialist multidisciplinary units for management of TVM complications. AIMS: The aims of this study are to report on the setting up of the Queensland Pelvic Mesh Service (QPMS) and summarise its first 24 months to provide a potential framework for the establishment of similar service models within Australia and internationally. MATERIALS AND METHODS: The planning and implementation of QPMS was a complex two-stage co-design process involving clinicians and consumers representing women with TVM complications. Consumer input in planning was important for the optimal establishment of QPMS to meet women's holistic needs. RESULTS: From April 2019 to April 2021, 484 women had been treated by the medical team; 257 women had undergone cystoscopy and examination under anaesthesia; 91 patients had undergone mesh revision surgery - 65 complete excision and 25 partial excision and one sling division; and 180 women had been discharged from QPMS. CONCLUSIONS: Providing a comprehensive multidisciplinary service for managing TVM complications requires careful planning with consumer involvement before initiation. Addition of these patients to an existing service may not succeed. Emphasis on surgery may be misplaced for many. QPMS patients, as in sufferers with chronic pain conditions, benefit from psychological support and allied healthcare.

[Voiding dysfunction after TVT: A 20-year experience TVT-placement under local anesthesia and sedation]. / Troubles mictionnelles après pose de TVT : 20 ans d'expérience de pose sous diazanalgésie et anesthésie locale.

BACKGROUND: Trans-vaginal tape has become the gold standard for the cure of urinary stress incontinence, but post-operative voiding dysfunction is frequently reported. The purpose of this study is to assess the incidence of voiding dysfunction, dysuria, chronic urinary retention, and necessity of reoperation after retropubic TVT placement under local anaesthesia and sedation. MATERIAL AND METHOD: We perform a retrospective study of a cohort of patient treated with the placement of a retropubic TVT under local anaesthesia and sedation between 1999 and 2019 for a SUI. Post-operative voiding dysfunction and necessity of reoperation were reviewed to access the principal aim of this study. RESULTS: Three hundred and two patients who met the eligibility criteria were included in the study. At 3 months, the dysuria rate and chronic urinary retention rate was 4.3% and 1%. At 12 months it was 2.6% and 0.3% respectively. The 12-month sling section rate was 1% and long-term self-catherization rate was 0.3%. The objective cure rate was 93% and subjective cure was 92%. CONCLUSION: TVT placement under local anaesthesia and sedation resulted in few voiding dysfunctions at medium/long-term, necessity of re-operation for refractory obstructive disorder and well functional results. Even if these results support more frequent use of this type of anaesthesia, it would be interesting to be able to follow them in a prospective study to conclude. LEVEL OF EVIDENCE: 4.

Adoption, Safety, and Retreatment Rates of Prostatic Urethral Lift for Benign Prostatic Enlargement.

PURPOSE: Novel minimally invasive therapies like the prostatic urethral lift are among the many endoscopic options for the treatment of benign prostatic enlargement and lower urinary tract symptoms (BPE/LUTS). To further understand the relative uptake, complications and retreatment rates of contemporary endoscopic procedures for BPE/LUTS across diverse practice types, we performed a retrospective study of inpatient and ambulatory surgery encounters in the Premier Healthcare database. MATERIALS AND METHODS: We included men who underwent endoscopic procedures for BPE/LUTS between 2000 and 2018. We determined the utilization of endoscopic therapies for BPE/LUTS, 30-day and 90-day readmission rates, and retreatment rate. Multivariable logistic regression was used to assess the association of procedure type with outcomes for the 3 most commonly performed procedures. RESULTS: We identified 175,150 men treated with endoscopic surgery for BPE/LUTS. The annual percent utilization of the prostatic urethral lift increased from <1% in 2014 to 10.4% in 2018. Compared to transurethral resection of the prostate and prostate photovaporization, prostatic urethral lift was associated with a lower odds of readmission at 30 (OR 0.58, p <0.01) and 90 (OR 0.55, p <0.01) days and a higher odds of retreatment within 2 years of followup (OR 1.78, p <0.01). CONCLUSIONS: Providers have rapidly adopted prostatic urethral lift which accounted for more than 1 in 10 endoscopic procedures captured for BPE/LUTS in 2018. Men treated with prostatic urethral lift are readmitted less within 30 and 90 days but are more likely to be retreated within 2 years of their index procedure as compared to men treated with transurethral resection of the prostate or prostate photovaporization.

Single-incision Midurethral Sling by the Dynamic Intraoperative Standing Sling Technique as an Office-based Procedure: A Pilot Study.

OBJECTIVES: To assess the safety, feasibility, and short-term success of placing Solyx (Boston Scientific, Marlborough, MA) single-incision midurethral sling (SIMUS) using the Dynamic Intraoperative Standing Sling Technique (DISST) in an office setting under local anesthesia. METHODS: The safety and efficacy of the in-office Solyx DISST procedure for treatment of stress urinary incontinence was assessed 6 months from the procedure. Improvement in stress urinary incontinence was measured using validated questionnaires (Medical, Epidemiologic, and Social Aspects of Aging, MESA; Incontinence Impact Questionnaire-7, IIQ-7; Pelvic Organ Prolapse/Urinary Incontinence Sexual Function, PISQ-12) and by a negative standing provocative stress test. Postoperative complications were documented along with subjective pain diaries, return to work/activities, and overall satisfaction. RESULTS: From July 2019 through February 2020, 20 subjects underwent in-office Solyx procedure by the DISST technique. Six of the 20 (30%) subjects required intraoperative sling adjustments. There were no complications as related to the office-based procedure. Participants reported a favorable intraoperative experience. Subjects had excellent postoperative pain control and early return to work and normal activities. At 6 months, all 20 subjects had negative standing provocative stress tests, showed statistically significant improvements on MESA, IIQ-7, and PISQ-12, and reported high satisfaction and acceptance for the procedure and outcomes. There were no late (>6 weeks) complications associated with the Solyx procedure. CONCLUSIONS: It appears safe and feasible to perform Solyx SIMUS by the DISST method in the office. Subjects remained dry and reported excellent improvement in symptoms and quality of life 6 months from surgery.

Five-Year Efficacy of Transobturator Tape Treatment and Quality of Life in Women with Stress Urinary Incontinence.

BACKGROUND: We aimed to assess the results of first- and fifth-year outcomes and the effect on quality of life (QoL) of transobturator tape (TOT) treatment in patients with stress urinary incontinence (SUI). METHODS: The patients who underwent TOT surgery between January 2008 and June 2013 were screened retrospectively. The QoL was evaluated with Incontinence Impact Questionnaire (IIQ-7) and Urogenital Distress Inventory-Short Form (UDI-6). The subjective evaluation of patients in terms of incontinence outcome was classified as worsened (UDI-6 and IIQ-7 if pre-operative < postoperative), improved (UDI-6 and IIQ-7 if pre-operative > postoperative), or cured (UDI-6 and IIQ-7 postoperative <10). The first-year and fifth-year success rates were compared between the IIQ-7 and UDI-6 results. RESULTS: A total of 109 patients were included in the study. There was a significant improvement (P<0.001) in the patients' UDI-6 and IIQ-7 scores when the preoperative and postoperative first-year results were compared. Comparing the postoperative first-year and fifth-year total UDI-6 and IIQ-7 scores, a significant improvement was observed and the patients' complaints were significantly reduced (P<0.001). The results of the IIQ-7 and UDI-6 questionnaire revealed that the TOT surgery success rate was 93.3% at the end of the first year and 88.7% at the end of the fifth year. CONCLUSION: The postoperative first-year and fifth-year data reveal that TOT surgery has a high success rate and positive effects on QoL. Low complication rates and the ease of application make TOT a good alternative to other treatment modalities in surgical treatment of SUI.

Management of urinary incontinence.

Urinary incontinence is a common problem affecting 25-45% women. Effective management can have a huge impact on a patient's quality of life and many treatments are available. Management should be dictated by the degree of bother the symptoms are having, and vary depending on the type on incontinence. Conservative measures should always be initiated, including optimisation of body mass index and smoking cessation. Overactive bladder and urge urinary incontinence can be improved with bladder retraining and avoidance of bladder stimulants. Medical treatment then includes anticholinergic medications or Mirabegron. More invasive options include Botulinum Toxin A (Botox®) injections, sacral nerve stimulation or urological surgery. Stress urinary incontinence should be managed initially with pelvic floor exercises, and input from a specialist nurse or physiotherapist is beneficial. The surgical options for managing stress incontinence have changed considerably over the years, but include bladder neck injections, mid-urethral slings, colposuspension or autologous fascial slings. Mixed urinary incontinence is more challenging to manage, but all conservative measures should be started. Further treatment is directed towards the predominant symptom, but overactivity should be controlled before surgical measures for stress urinary incontinence are performed.

Vaginal posterior isthmic sling: A report of 53 cases.

INTRODUCTION: Sacrospinofixation is used for fundic vaginal vault's prolapse or to prevent mid-level or posterior prolapse. It can lead to complications such as dyspareunia, chronic pain, and quality of life impairment. Anchoring a posterior isthmic sling to the two sacrospinous ligaments is an alternative to classic Richter's sacrospinofixation. Objective of this study is to report the first cases of vaginal posterior isthmic slings. METHODS: This study is retrospective and unicentric. It includes women who had posterior isthmic sling at the time of a surgery with a mesh for anterior prolapse by vaginal way between 2010 and 2016 in the gynecologic department of a teaching hospital. Report of efficacy and tolerance was performed. RESULTS: Between 2010 and 2016, 53 women were included with a posterior isthmic sling and a mesh for an anterior prolapse. POP-Q evolution during the follow-up in the posterior isthmic sling group assess of a good efficacy of the sling. Four women (7.5%) required second surgery in 28 months following initial surgery (only 1 for excision). Four women (7.5%) had a prolapse recurrence in a mean time of 30 months without recurrent surgery. Women's satisfaction level was high (8.0/10 [7,1-8,8]). CONCLUSION: Efficacy and tolerance of the posterior isthmic sling seems good. It might then be an option for mid-level prolapses in case of vaginal surgery with mesh for anterior prolapse. A non-inferiority trial should be performed to be able to conclude on the place of this alternative to Richter's sacrospinofixation.

A Novel Approach to Managing Post Retropubic Vaginal Sling Pain.

OBJECTIVE: To describe a novel technique of using peripheral nerve neuromodulation (PNNM) for the treatment of refractory, mesh-induced chronic pelvic pain. Chronic pelvic pain associated with mesh can be a debilitating complication and there is currently no consensus on treatment. PNNM has been shown to be successful in the treatment of post-traumatic neuralgias but has yet to be studied in mesh complications. MATERIALS AND METHODS: We present a case of a 50-year-old woman who had unrelenting pelvic pain after retropubic sling placement. She failed multiple therapies including medications, mesh removal, pelvic floor physical therapy, pudendal neuromodulation, and pelvic floor onabotulinumtoxinA trigger point injections. RESULTS: The only treatment that provided temporary relief of this patient's pain was transvaginal trigger point injections along with a right pudendal nerve block using 40 mg triamcinolone and 0.5% ropivacaine. To help define if treatment at the site of her pain would provide relief, a series of blocks were done by advancing a needle retropubically to her area of pain and injecting triamcinolone and 0.5% ropivacaine. This injection, which corresponded to the previous tract of her retropubic sling, provided temporary, but profound, relief. PNNM was then done with placement of the electrode in the retropubic space at the site of her pain. This provided instantaneous relief of almost all of her pain symptoms. Twelve months postoperatively, the patient continued to have >90% improvement in her pain. CONCLUSION: Focused PNNM is a simple procedure and can provide symptomatic relief for refractory postvaginal mesh pain.

The Tissue Fixation System: How obsolete and potentially dangerous technology continues to be 'sold'.

Gynaecologists have been at the receiving end of much regulatory intervention in recent years, some of it inappropriate and heavy-handed such as the recent ban on midurethral slings in the National Health Service, others appropriate and, if anything, occurring too late. Regulatory agencies have failed, and so have individual doctors and their organisations. An example of individual and systemic failure involves the Tissue Fixation System. It is an Australian story that is not yet widely known, which is why the author has decided to acquaint the readers of ANZJOG with the situation in this country, where the Tissue Fixation System was invented, manufactured and used on thousands of patients over a period of eight years before its manufacture, sale and export from Australia ended in 2014.

Autologous transobturator sling as an alternative therapy for stress urinary incontinence.

OBJECTIVE: To evaluate efficacy and outcomes of the autologous transobturator midurethral sling for treatment of stress urinary incontinence (SUI). METHODS: In a prospective cohort study, an autologous transobturator mid-urethral sling was used to treat SUI among women attending a university hospital in Montevideo, Uruguay, from June 2017 to July 2018. In the first phase, autologous tissue of the abdominis rectus fascia was collected. In the second phase, the midurethral sling was placed via the transobturator approach. Outcomes were measured every 3 months by the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS) Score. Preoperative and postoperative results were compared by Wilcoxon test. RESULTS: Eighteen women with a median age of 51 years were enrolled. The median follow-up was 9 months (range 6-15 months). Overall, 17 women showed symptomatic improvement after the procedure. In a comparison of preoperative versus postoperative ICIQ-FLUTS questionnaires, improvement in the incontinence subscore was observed at 3 (P<0.001), 6 (P<0.001), and 12 (P=0.008) months. No severe complications were observed. CONCLUSION: Use of an autologous transobturator urethral sling was found to be technically feasible and safe for SUI, with good short-term outcomes. Longer follow up and larger series are needed to validate the procedure.