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.

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.

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.

[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.

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.

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.

Road to recovery after transvaginal surgery for urethral mesh perforation: evaluation of outcomes and subsequent procedures.

INTRODUCTION AND HYPOTHESIS: Urethral injury resulting from transvaginal mesh slings is a rare complication with an estimated incidence of <1%. Our objective was to review the surgical management and functional outcomes of women presenting with urethral mesh perforation following midurethral sling (MUS) placement. METHODS: This was a retrospective multicenter review of women who from January 2011 to March 2016 at two institutions underwent mesh sling excision for urethral perforation with Female Pelvic Medicine and Reconstructive Surgery fellowship-trained surgeons. Data comprising preoperative symptoms, operative details, and postoperative outcomes were collected by telephone (n 13) or based on their last follow-up appointment. RESULTS OBTAINED: Nineteen women underwent transvaginal sling excision for urethral mesh perforation. Eight (42%) patients had undergone previous sling revision surgery. Sixty percent of women had resolution of their pelvic pain postoperatively. At follow-up, 92% reported urinary incontinence (UI), and three had undergone five additional procedures for vaginal prolapse mesh exposure (n 1), incontinence (onabotulinum toxin injection n 1, rectus fascia autologous sling n 1), prolapse (colpopexy n 1), and pain (trigger-point injection n 1). Patient global impression of improvement data was available for 13 patients, of whom seven (54%) rated their postoperative condition as Very much better or Much better. CONCLUSIONS: The management of urethral mesh perforation is complex. Most women reported resolution of their pelvic pain and a high rate of satisfaction with their postoperative condition despite high rates of incontinence.

The Adjustable Transobturator Male System in Stress Urinary Incontinence After Transurethral Resection of the Prostate.

OBJECTIVE: To investigate the efficacy and safety of the Adjustable Transobturator Male System (ATOMS) in men with stress urinary incontinence after transurethral resection of the prostate (TURP). MATERIALS AND METHODS: From a large international prospectively administrated ATOMS register, we identified 49 patients with an ATOMS device as a result of persistent stress urinary incontinence after TURP. For evaluation, the men were divided into standard transurethral resection of the prostate (sTURP) and palliative transurethral resection of the prostate (pTURP) in radiated patients. Baseline and follow-up measurements included continence parameters, urodynamics, quality-of-life surveys (Patient Global Impression-Improvement and International Consultation on Incontinence Questionnaire-Short Form), and pain ratings. The dry rate (0-1 security pad/<10 mL urine loss), the success rate (overall improvement), removals, complications, and treatment failures were recorded. A P value of <.05 was considered statistically significant. RESULTS: After a median of 34 and 22 months' follow-up and 2-3 adjustments, the sTURP and pTURP cohorts had 58% and 50% dry rates and 90% and 87% success rates. Hence, no improvement was seen in 10% and 13%. The removal rate was higher in pTURP (50% vs 10%, P = .0171) and infection was the most common side effect (50%) observed. Neither intraoperative nor Clavien-Dindo 4 and 5 adverse events were recorded. In sTURP and pTURP, the median daily pad count and the pad test improved significantly (all P <.001), and quality-of-life parameters shifted to a high satisfaction level (P <.001 and P = .001). Urodynamics remained unchanged and postoperative pain was not an issue. CONCLUSION: The ATOMS device shows promising treatment outcomes in patients after TURP and a similar efficacy as in postprostatectomy incontinence. There is no difference in continence outcome between sTURP and pTURP; however, a higher removal rate was found after pTURP, which may be important for patient counseling.

Retropubic tissue fixation system tensioned mini-sling carried out under local anesthesia cures stress urinary incontinence and intrinsic sphincter deficiency: 1-year data.

OBJECTIVES: To assess the outcomes of the tissue fixation system midurethral sling for the treatment of intrinsic sphincter deficiency. METHODS: We retrospectively studied a total of 96 intrinsic sphincter deficiency patients treated with the tissue fixation system midurethral sling at Yokohama Motomachi Women's Clinic from 2006 to 2015. We evaluated intraoperative and 1-year postoperative results. Regarding the cure rate, we divided patients into three groups: (i) patients with maximum urethral closure pressure <20 and Valsalva leak point pressure <65 combined (n = 17); (ii) patients with maximum urethral closure pressure <20 (n = 55); and (iii) patients with Valsalva leak point pressure <65 (n = 47). RESULTS: The median age was 63 years (range 38-89 years). The median operating time including local anesthesia was 24 min (range 12-55 min) and median blood loss was 5.0 mL (range 3-69 mL). All operations were day surgery under local anesthesia. Postoperative pain was minimal. All patients were discharged the same day. There were no intraoperative complications except one bladder perforation. There were no tape rejections. The 1-year postoperative cure rates were: 88.2% among patients with maximum urethral closure pressure <20 and Valsalva leak point pressure <65, 90.9% for patients with maximum urethral closure pressure <20, and 85.1% among patients with Valsalva leak point pressure <65. CONCLUSIONS: The tissue fixation system midurethral sling operation is a simple, safe and effective operation for older women with intrinsic sphincter deficiency, and it can be carried out under local anesthesia.

[Delayed necrotizing fasciitis: a complication of stress incontinence surgery by suburethral sling]. / Fasciite nécrosante tardive : une complication de la chirurgie de l'incontinence urinaire par bandelette sous-urétrale.

We report a 50-year-old woman case with an extensive necrotizing fasciitis (NF). The NF appeared 10 years after a tension free vaginal tape procedure for urinary stress incontinence. Vital prognosis was engaged due to the initial sepsis severity. This kind of complication is rare and could be under estimated. NF usually appear soon after surgery, whatever within the year following implantation. Anyway, NF are always related to a vaginal erosion of the tape.

Changed women: the long-term impact of vaginal mesh complications.

OBJECTIVES: The aim of this study was to describe how women experience vaginal mesh complications after optimized tertiary care level treatment. METHODS: We conducted telephone interviews in 2012 with women at least 6 months after presentation to our tertiary care clinic between 2006 and 2011 for complications related to vaginal mesh and transcribed verbatim responses to 2 open-ended questions about their experiences surrounding vaginal mesh complications. We analyzed data using qualitative description with low-inference interpretation in a team-based setting followed by consensus meetings to arrive at descriptive trajectories of their experiences. RESULTS: Of 111 women, we successfully contacted 88, and 84 agreed to the interview. The mean duration from index mesh surgery to interview was 4.5 years, and the mean duration from presentation to our clinic for complications to the interview was 2.3 years. The effects of mesh complications caused both physical and emotional pain, in addition to the discomfort of the original pelvic floor dysfunction. The women's experiences followed 1 of 3 recovery trajectories. In "cascading health problems," the women experienced a spiral of health problems, anxiety, and desperation. In "settling for a new normal," the women who once considered themselves healthy now believed that they are unhealthy and worked to adjust to their degraded health status. In "returning to health," the women described a return to health. The women still symptomatic discharged from tertiary care clinic expressed hopelessness and abandonment. CONCLUSIONS: Concomitant with ongoing research to improve the safety of vaginal mesh procedures, there must be dedicated efforts to develop and study a range of therapies for holistically treating women with mesh complications.

A randomized controlled trial comparing three vaginal kits of single-incision mini-slings for stress urinary incontinence: surgical data.

OBJECTIVE: Single-incision mini-slings (SIMS) are new minimally invasive devices used for female stress urinary incontinence (SUI). To date, several SIMS are available, but few and uncontrolled comparative data have assessed their safety and feasibility. The aim of the present clinical study was to compare three different SIMS in an ambulatory setting. STUDY DESIGN: One hundred and twenty patients with SUI were randomized to receive three SIMS: Ajust, MiniArc, and TVT Secur System. Surgical data were compared. RESULTS: Significantly (P<0.05) lower surgical difficulty and higher patient satisfaction were detected in the MiniArc group when compared to the Ajust and TVT Secur System groups. A significantly (P<0.05) higher feasibility under local anesthesia and in ambulatory setting was also detected for the MiniArc group. The overall complication rate was significantly (P<0.05) lower in the MiniArc group than in the TVT Secur System group. CONCLUSIONS: MiniArc is simpler to insert under local anesthesia and in an ambulatory setting. It is safer than the TVT Secur System, and is related to higher patient satisfaction.

Late urethral erosion of transobturator suburethral mesh (Obtape): a minimally invasive management under local anaesthesia.

The placement of transobturator sub-urethral synthetic tapes, although with a high success rate of achieving continence, carries the risk of tape erosion to adjacent structures. While vaginal erosion occurs more frequently, urethral erosion has also been reported, usually in the immediate or early postoperative period. We present two different cases of urethral erosion with the Obtape sling, the first one diagnosed 1 year after surgery and the second one, a very late complication, occurring 4 years after the placement of the sling. Although transvaginal urethrotomy with tape resection has been the most popular approach described in the literature, we describe a minimally invasive trans-urethral approach for the management of this complication under local anaesthesia. We also present some "tricks of the trade" on retrieving the tape trans-urethrally while maximizing the length of tape removed.

Evaluation of safety and efficacy of single-incision mid-urethral short tape procedure (MiniArc™ tape) for stress urinary incontinence under local anaesthesia.

INTRODUCTION AND HYPOTHESIS: The aim of this study was to assess complications and short-term results (3 months and 1 year) from a single-incision mid-urethral tape for stress urinary incontinence. METHODS: Seventy-four women underwent single-incision mid-urethral tape under local anaesthesia, 59 of whom completed a 1-year follow-up. Thirty-seven (50%) suffered urodynamic stress urinary incontinence. The International Consultation on Incontinence Questionnaire--Short Form (ICIQ-SF) was completed in the context of the case history pre-operatively and post-operatively. The duration of follow-up ranged from 91 to 466 days. RESULTS: The use of MiniArc™ tape in our study resulted in the objective cure rate (negative cough stress test) of 74% and 66% at 3 months and 1 year, respectively. Scores with ICIQ-SF questionnaire improved significantly at 3 months and 1 year (p < 0.0001). No major intra-operative complication was reported in our study. CONCLUSIONS: Despite the advantage of being done under local anaesthetic, the overall cure rate is 66% at 1 year.

A 2-year observational study to determine the efficacy of a novel single incision sling procedure (Minitape) for female stress urinary incontinence.

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 <1 g) and no desire for further treatment for stress urinary incontinence. RESULTS: All procedures were completed with local anaesthesia, with no additional sedation in 82% of cases. Intra-operative and immediate postoperative complications were rare. Twelve women (20%) experienced mesh complications, half of which were considered to be serious adverse events requiring exit from the study. At 2 years following Minitape insertion, six women (10%) were defined as cured. CONCLUSIONS: Although feasible to perform, this procedure is associated with a substantially lower cure rate than that published previously for other procedures. Cure rates decline over the 2 year follow-up period, especially during the first 6 months.

Hyperbaric oxygen therapy as adjunctive treatment for postoperative cellulitis involving intrapelvic mesh.

Placement of intrapelvic mesh has become an integral tool in pelvic reconstructive surgery. Infection is a serious complication of mesh placement, which not only compromises the surgical objective, but also may be disfiguring or potentially lethal. We report a case of serious postoperative cellulitis, where the combination of antibiotics and hyperbaric oxygen contributed to the patient's recovery with complete preservation of her surgical repair. A 45-year-old woman underwent surgery for the treatment of cystocele, rectocele, and stress urinary incontinence. Surgical polypropylene and porcine acellular mesh was placed intraoperatively, and intravenous antibiotics were given preoperatively and postoperatively, followed by a course of oral prophylaxis. On postoperative day 8 the patient reported temperature elevation and a painful swelling in her left buttock. She had an area of cellulitis involving the operative site at the buttock extending anteriorly to the labia majora and posterior to the midgluteal area. Intravenous antibiotics were administered along with hyperbaric oxygen. The patient made an uneventful recovery during the following 9 days, preserving her repair. Cellulitis involving operative sites with artificial or naturally derived materials is a serious complication that may pose a threat to the repair at minimum, and may be life threatening at worst. The case reported illustrates the value of adjunctive hyperbaric therapy where the infection is presumed to be aggressive.

Necrotizing fasciitis following transobturator tape treated by extensive surgery and hyperbaric oxygen.

The transobturator sling procedure (TVT-O) was developed to minimize surgical risks involved in treating genuine stress incontinence. All data suggest that most risks associated with the retropubic route such as injuries to the bladder, intestines or vessels are practically obsolete with the obturator route. However, severe soft-tissue infections have been reported with this new technique. In this case report, necrotizing fasciitis (NF) developed shortly after a TVT-O procedure. This life-threatening complication required extensive debridements, a diverting colostomy, antibiotics, and eight sessions of hyperbaric oxygen (HBO) therapy. We emphasize the importance of a unified interdisciplinary clinical approach in severe NF with rapid progression and systemic toxemia. Primary, aggressive but tissue-saving debridements together with antibiotics are the cornerstones of therapy. HBO therapy can oxygenate infected hypoxic tissues to help marginally viable tissues survive, reduce the inflammatory response, improve leukocyte bacterial oxidative killing capacity, and achieve infection control and healing.