Focusing on long-term complications of mid-urethral slings among women with stress urinary incontinence as a patient safety improvement measure: A protocol for systematic review and meta-analysis.

BACKGROUND: There are 3 different types of mid-urethral sling, retropubic, transobturator and single incision performed for women with stress urinary incontinence. Prior studies comparing these three surgeries merely focused on the successful rate or efficacy. But nevertheless, what is more clinically important dwells upon investigating postoperative complications as a safety improvement measure. METHODS: A systematic review via PubMed, Ovid, and the Cochrane Database of Systematic Review and studies were applied based on the contents with clearly identified complications. Selected articles were reviewed in scrutiny by 2 individuals to ascertain whether they fulfilled the inclusion criteria: complications measures were clearly defined; data were extracted on study design, perioperative complications, postoperative lower urinary tract symptoms, postoperative pain, dyspareunia, and other specified late complications. RESULTS: A total of 55 studies were included in the systemic review. Perioperative complications encompassed bladder perforation, vaginal injury, hemorrhage, hematoma, urinary tract infection. There were postoperative lower urinary tract symptoms including urine retention and de novo urgency. Furthermore, postoperative pain, tape erosion/ extrusion, further stress urinary incontinence surgery, and rarely, deep vein thrombosis and injury of inferior epigastric vessels were also reported. CONCLUSIONS: Complications of mid-urethral sling are higher than previously thought and it is important to follow up on their long-term outcomes; future research should not neglect to address this issue as a means to improve patient safety.

Argus-T adjustable male sling: A follow-up study on urinary incontinence and patient's satisfaction.

AIMS: The use of Argus-T adjustable sling may be a promising alternative option for the treatment of urinary incontinence after radical prostatectomy, however long-term data is lacking. The aim of this study is to evaluate the long-term results of the Argus-T sling on incontinence rates, patient's quality of life and tape-related complications. METHODS: Patients were eligible if persistent stress incontinence was present ≥12 months after radical prostatectomy. Measurements included 24 h frequency volume micturition list, 24 h pad test, 24 h pad count and quality of life questionnaires. Argus-T adjustable sling was placed with a single perineal route incision approach. RESULTS: Seventy-eight patients were included, 69 ± 6 years, pre-intervention 24 h urinary loss 212 (75-385) g. Directly after surgery, 63.6% of the patients was completely dry, 79.2% of the patients reported greater than 90% improvement of their urinary loss and 92.2% > 50% improvement. Median follow-up time was 3.2 (2.5-6.1) years. After 5 years of follow-up, 53.3% of the patients were completely dry, 71.5% reported an improvement greater than 90% and 79.6% reported an improvement of greater than 50%. Patients with preoperative urinary loss less than 250 g reported significantly higher improvement of their urinary loss compared to patients with urinary loss ≥250 g (p = .02). Patients satisfaction was still increased after 5 years follow-up (70 ± 21 vs.16 ± 9, p < .001) and patients quality of life remained high (85 ± 20 vs. 88 ± 13, p = .1). Complications were mainly observed directly after surgery. Two patients (2.6%) needed reimplantation of the sling. CONCLUSION: These data indicate that Argus-T sling is an effective treatment option in obtaining substantial long-term incontinence relief in patients with invalidating moderate stress urinary incontinence after radical prostatectomy.

"Mesh free" autologous transobturator mid urethral sling placement for predominant stress urinary incontinence: A pilot study.

AIMS: To assess the efficacy and safety of autologous mid-urethral sling (MUS) in women with predominant stress urinary incontinence (SUI). MATERIALS AND METHODS: This prospective cohort study included adult women with predominant SUI seen in our urology clinic between January 2018 and March 2019. Patients with: negative cough stress test, history of prior incontinence surgery, urogenital malignancy, pelvic radiation, neurological disease, body mass index more than 40 kg/m2 , the presence of more than Stage I pelvic organ prolapse, active urinary tract infection, maximum flow rate less than 15 ml/sec, postvoid residual urine more than 100 ml, abdominal leak point pressure less than 60 cm of H2 O, and pregnant women were excluded. Eligible patients underwent a transobturator MUS procedure using rectus fascia as a sling. Before the procedure, patients filled the International Consultation on Incontinence Questionnaire-Female Lower Urinary Tract Symptom (ICIQ-FLUTS) and the Female Sexual Function Index (FSFI) questionnaire. Urinary outcomes were assessed at 3- and 12-months while sexual outcomes were assessed at 12-months. RESULTS: Thirty patients with median age of 44.5 years were included. All patients had a negative cough stress test during follow up. A significant improvement was noted in the ICIQ-FLUTS scale, bother scale, filling and incontinence subscales at 3 and 12 month follow-up. A significant improvement was also noted in the FSFI full scale score and FSFI domains of mean sexual desire, arousal and lubrication at 12 months follow-up. Two patients developed voiding dysfunction requiring urethral dilatation. CONCLUSION: Autologous transobturator MUS surgery appears to be safe and efficacious in the short term. More research is needed to clarify its role in the surgical management of SUI in women.

Adjustable sling for the treatment of post-prostatectomy urinary incontinence: systematic review and meta-analysis.

Urinary incontinence after prostatectomy has a significant negative impact on the quality of life of the patient. The surgical treatment includes several models of male slings, such as adjustable slings. The objective of this study was to evaluate the effectiveness and safety of adjustable sling in the treatment of post-prostatectomy urinary incontinence. This is a systematic review of literature. The following electronic databases were searched until January 2018: PubMed®, Embase, CENTRAL and LILACS. The keywords used in the search strategies were: "prostatectomy" [Mesh], "urinary incontinence" [Mesh] and "suburethral slings" [Mesh]. Randomized clinical trials and observational studies, with or without Control Group, and follow-up of more than 12 months were included. Only one randomized study with high risk of bias was included and it concluded the effectiveness equivalence between adjustable and non-adjustable slings. All other studies were cases series with patients of varying levels of incontinence intensity and history of pelvic radiation therapy and previous surgeries. The meta-analysis for 0 pad in 24 hours demonstrated an effectiveness of 53%. For the 0 to 1 pad test in 24 hours, the meta-analysis resulted in an effectiveness of 69%. Risk factors for surgery failure include prior radiation, severity of post-prostatectomy urinary incontinence, and previous surgeries. The meta-analysis of the extrusion rate was 9.8% and the most commonly reported adverse effects were pain and local infection. Evidence of low quality indicates that adjustable slings are effective for treating post-prostatectomy urinary incontinence, with frequency of adverse events similar to the surgical option considered gold standard (the artificial urinary sphincter implant).

Comparison of two retropubic tension-free vaginal tape procedures in women with stress urinary incontinence: a randomized controlled multicenter trial.

PURPOSE: Midurethral slings are a well-established treatment option in women suffering stress urinary incontinence. Various different products and methods are used, therefore, the aim of our study was to compare two inside-out retropubic slings (TVT exact® vs. RetroArc®) inserted in two different ways regarding perioperative and mid-term outcomes. METHODS: In this prospective randomized controlled non-inferiority multicentre trial, primary endpoint was postoperative cure rate, both objective (negative cough test) and subjective (absence of leakage during physical activity using the UDI-6 questionnaire). Secondary endpoints were patients' satisfaction (Likert scale; ICIQ-UI-SF questionnaires). In addition, intra-and postoperative complications were evaluated. The TVT®-group was operated with an empty bladder, a 18 CH catheter was used with a straight inserter as instructed. Patients randomized into the RetroArc®-group were operated without inserter leading to a reduced catheter size (14 CH), bladder was filled (200 ml) during the procedure. RESULTS: Of the 303 women, 152 were randomized to the TVT® and 151 to the RetroArc® operation. At 3 months, n = 288 (95.0%) and at 12 months n = 229 (75.6%) were assessed. In postoperative objective cure the RetroArc®-procedure was not inferior to TVT® (p = 0.144). In subjective cure, however, the TVT exact® procedure achieved significant better results (TVT® 76.1%, RetroArc® 54.3%, p = 0.002). Perioperative complications were in majority voiding difficulties and lower after the TVT exact®-procedure. CONCLUSIONS: Retropubic sling procedures are safe and successful to treat female stress urinary incontinence. However, different materials and techniques result in differences between outcomes also experienced surgeons should be aware of.

Adjustable sling for the treatment of post-prostatectomy urinary incontinence: systematic review and meta-analysis / Implante de sling ajustável no tratamento da incontinência urinária pós-prostatectomia: revisão sistemática e meta-análise

ABSTRACT Urinary incontinence after prostatectomy has a significant negative impact on the quality of life of the patient. The surgical treatment includes several models of male slings, such as adjustable slings. The objective of this study was to evaluate the effectiveness and safety of adjustable sling in the treatment of post-prostatectomy urinary incontinence. This is a systematic review of literature. The following electronic databases were searched until January 2018: PubMed®, Embase, CENTRAL and LILACS. The keywords used in the search strategies were: "prostatectomy" [Mesh], "urinary incontinence" [Mesh] and "suburethral slings" [Mesh]. Randomized clinical trials and observational studies, with or without Control Group, and follow-up of more than 12 months were included. Only one randomized study with high risk of bias was included and it concluded the effectiveness equivalence between adjustable and non-adjustable slings. All other studies were cases series with patients of varying levels of incontinence intensity and history of pelvic radiation therapy and previous surgeries. The meta-analysis for 0 pad in 24 hours demonstrated an effectiveness of 53%. For the 0 to 1 pad test in 24 hours, the meta-analysis resulted in an effectiveness of 69%. Risk factors for surgery failure include prior radiation, severity of post-prostatectomy urinary incontinence, and previous surgeries. The meta-analysis of the extrusion rate was 9.8% and the most commonly reported adverse effects were pain and local infection. Evidence of low quality indicates that adjustable slings are effective for treating post-prostatectomy urinary incontinence, with frequency of adverse events similar to the surgical option considered gold standard (the artificial urinary sphincter implant).

RESUMO A incontinência urinária pós-prostatectomia tem importante impacto negativo na qualidade de vida do portador. O tratamento cirúrgico inclui slings masculinos e, entre os diversos modelos, os slings ajustáveis. O objetivo deste estudo foi avaliar a efetividade e a segurança do sling ajustável no tratamento da incontinência urinária pós-prostatectomia. Trata-se de revisão sistemática de literatura. Foram pesquisadas as seguintes bases de dados eletrônicas até janeiro de 2018: PubMed®, Embase, CENTRAL e LILACS. As palavras-chaves utilizadas nas estratégias de busca foram: "prostatectomy" [Mesh], "urinary incontinence" [Mesh] e "suburethral slings" [Mesh]. Foram incluídos ensaios clínicos randomizados e estudos observacionais controlados ou não com seguimento maior que 12 meses. Apenas um estudo randomizado com alto risco de viés foi localizado e concluiu a equivalência de efetividade de slings ajustáveis e não ajustáveis. Todos os outros estudos foram série de casos com pacientes de variados níveis de intensidade da incontinência e histórico de radioterapia pélvica e cirurgias prévias. A metanálise para 0 pad em 24 horas demonstrou efetividade de 53%. Para o desfecho 0 a 1 pad em 24 horas, a metanálise resultou em efetividade de 69%. Os fatores de risco para insucesso da cirurgia incluem radiação prévia, gravidade da incontinência urinária pós-prostatectomia e cirurgias anteriores. A metanálise da taxa de extrusão foi de 9,8%, e os efeitos adversos mais relatados foram dor e infecção local. Evidências de baixa qualidade indicam que os slings ajustáveis são efetivos para o tratamento da incontinência urinária pós-prostatectomia, com frequência de eventos adversos semelhantes à opção cirúrgica considerada padrão-ouro (o implante de esfíncter urinário artificial).

Functional outcomes and quality of life after transobturatory slings: hand - made vs. commercial slings

ABSTRACT Surgical correction is the most efficient treatment for stress urinary incontinence (SUI), and transobturator sling (TO) has optimal results. The high cost of commercially available sling kits makes it difficult the access in most Brazilian public health services. Hand-made polypropylene slings, on the other hand, have been previously reported. The aim of the present study was to compare the effectiveness and safety of commercial vs. hand-made polypropylene mesh slings. Data from 57 women who underwent consecutive TO sling surgery to treat SUI were pros- pectively collected between 2012 and 2014, and divided in two groups for further compa- rison. In Group-1, 31 women underwent surgery with commercial slings. In Group-2, 26 women underwent hand-made polypropylene slings. Women were compared according to epidemiological data, perioperative evaluation, quality of life, urodynamic study, cure and complication rates. Results were objectively (stress test with Valsalva maneuver, with at least 200mL vesical repletion) and subjectively evaluated by the Patient Global Impression of Improvement(PGI-I), Visual Analog Scale (VAS) and ICIQ-SF. Success was defined as PGI-I, VAS and negative stress test. Group-1 (n=31) and Group-2 (n=26) had a mean age of 60 vs. 58years (p=0.386). All de- mographic data were similar. The mean VLPP was 75.6cmH2O vs. 76.6cmH2O (p=0.88). The mean follow-up was 24.3 vs. 21.5months (p=0.96). Success rates were 74.2% vs. 80.2% (p=0.556), with ICIQ-SF variation of 12.6 vs.15.5 (p=0.139) and PGI-I of 71% vs. 80% (p=0.225). There was only one major complication (urethrovaginal fistula in Group-1). In conclusion, handmade and commercial slings have similar effectiveness and safety. The manufacture technique has important key-points stated in the present manuscript.

Functional outcomes and quality of life after transobturatory slings: hand - made vs. commercial slings.

Surgical correction is the most efficient treatment for stress urinary incontinence (SUI), and transobturator sling (TO) has optimal results. The high cost of commercially available sling kits makes it difficult the access in most Brazilian public health services. Hand-made polypropylene slings, on the other hand, have been previously reported. The aim of the present study was to compare the effectiveness and safety of commercial vs. hand-made polypropylene mesh slings. Data from 57 women who underwent consecutive TO sling surgery to treat SUI were pros-pectively collected between 2012 and 2014, and divided in two groups for further comparison. In Group-1, 31 women underwent surgery with commercial slings. In Group-2, 26 women underwent hand-made polypropylene slings. Women were compared according to epidemiological data, perioperative evaluation, quality of life, urodynamic study, cure and complication rates. Results were objectively (stress test with Valsalva maneuver, with at least 200mL vesical repletion) and subjectively evaluated by the Patient Global Impression of Improvement(PGI-I), Visual Analog Scale (VAS) and ICIQ-SF. Success was defined as PGI-I, VAS and negative stress test. Group-1 (n=31) and Group-2 (n=26) had a mean age of 60 vs. 58years (p=0.386). All de-mographic data were similar. The mean VLPP was 75.6cmH2O vs. 76.6cmH2O (p=0.88). The mean follow-up was 24.3 vs. 21.5months (p=0.96). Success rates were 74.2% vs. 80.2% (p=0.556), with ICIQ-SF variation of 12.6 vs.15.5 (p=0.139) and PGI-I of 71% vs. 80% (p=0.225). There was only one major complication (urethrovaginal fistula in Group-1). In conclusion, handmade and commercial slings have similar effectiveness and safety. The manufacture technique has important key-points stated in the present manuscript.

Reoperations for Female Stress Urinary Incontinence: A Finnish National Register Study.

BACKGROUND: Subjective and objective cure rates after primary surgery for female stress urinary incontinence are good. Still, some women will undergo repeated operations for incontinence. OBJECTIVE: To study the reoperation rate after incontinence surgery and to compare the reoperation rates between different surgery types. DESIGN, SETTING, AND PARTICIPANTS: This national register-based study included all Finnish women who had surgery for stress urinary incontinence during a 23-yr study period (1987-2009), both in inpatient and outpatient hospital settings. Subcohorts for follow-up times of 5-yr and 10-yr were evaluated separately. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Primary operations, reoperation rate, patient age, time until reoperation. RESULTS AND LIMITATIONS: A total of 38 500 women had surgery for stress urinary incontinence from 1987 to 2009. Two thousand and seventy-six women (7.2%) had a reoperation with a rate of 7.8/1000 woman-yr. The reoperation rate was 8.3/1000 women-yr after a Burch colposuspension and 4.8/1000 after a retropubic midurethral sling. In the 10-yr follow-up, reoperation was more common after a Burch compared with a retropubic midurethral sling (odds ratio: 1.6, 95% confidence interval: 1.3-1.9). There was no difference in the reoperation rate between retropubic and transobturator midurethral slings in the 5-yr follow-up. CONCLUSIONS: Reoperation rate is lower after midurethral slings compared with Burch colposuspension. PATIENT SUMMARY: Mesh slings are surgically effective treatments for stress urinary incontinence. There are fewer reoperations after implanting these slings compared with older methods that do not use synthetic material. Different mesh slings have equally good results.

Does Mid-Urethral Sling Surgery in the Treatment of Stress Urinary Incontinence Affect Weight Changes in Women? A Retrospective Cohort Study Using Internal Controls.

OBJECTIVE: Stress urinary incontinence (SUI) is a common disorder among women. This is particularly bothersome to physically active women, such as those who serve in the Armed Forces. With the documented success of the midurethral sling (MUS) in the treatment of SUI, more women are electing to undergo surgical treatment. Studies document that women have less inhibition about exercise as a result of decreased incontinence following MUS surgery. We sought to determine if MUS surgery is associated with a change in weight postoperatively resulting from increased levels of activity following surgery. We hypothesized that women, particularly active duty (AD) women, would experience a decrease in weight and body mass index (BMI) in the year following the MUS procedure. METHODS: This retrospective cohort study used the military electronic medical record system. The subjects included AD military and civilian (CV) patients who underwent MUS surgery at tertiary care centers between July 2006 and March 2013. Weight and BMI were recorded for three distinct time periods: 1-year preoperatively, at time of surgery, and 1-year postoperatively. RESULTS: A total of 207 women met inclusion criteria, 76 of which were AD women in the U.S. military. For the group as a whole, we found no significant difference in mean weight or BMI among the three time points examined; however, decreases in BMI and weight were noted in the year following surgery for the subgroups of AD and obese women. Analysis of covariance showed that age, parity, preoperative weight, and concomitant hysterectomy were not significant determinants for change in weight postoperatively. CONCLUSION: Despite its effective treatment of SUI, MUS surgery did not significantly affect the weight of patients postoperatively in our retrospective cohort.

Consensus Statement of the European Urology Association and the European Urogynaecological Association on the Use of Implanted Materials for Treating Pelvic Organ Prolapse and Stress Urinary Incontinence.

CONTEXT: Surgical nonautologous meshes have been used for several decades to repair abdominal wall herniae. Implantable materials have been adopted for the treatment of female and male stress urinary incontinence (SUI) and female pelvic organ prolapse (POP). OBJECTIVE: A consensus review of existing data based on published meta-analyses and reviews. EVIDENCE ACQUISITION: This document summarises the deliberations of a consensus group meeting convened by the European Association of Urology (EAU) and the European Urogynecological Association, to explore the current evidence relating to the use of polypropylene (PP) materials used for the treatment of SUI and POP, with reference to the 2016 EAU guidelines (European Association of Urology 2016), the European Commission's SCENIHR report on the use of surgical meshes (SCENIHR 2015), other available high-quality evidence, guidelines, and national recommendations. EVIDENCE SYNTHESIS: Current data suggest that the use of nonautologous durable materials in surgery has well-established benefits but significant risks, which are specific to the condition and location they are used for. Various graft-related complications have been described-such as infection, chronic pain including dyspareunia, exposure in the vagina, shrinkage, erosion into other organs of xenografts, synthetic PP tapes (used in SUI), and meshes (used in POP)-which differ from the complications seen with abdominal herniae. CONCLUSIONS: When considering surgery for SUI, it is essential to evaluate the available options, which may include synthetic midurethral slings (MUSs) using PP tapes, bulking agents, colposuspension, and autologous sling surgery. The use of synthetic MUSs for surgical treatment of SUI in both male and female patients has good efficacy and acceptable morbidity. Synthetic mesh for POP should be used only in complex cases with recurrent prolapse in the same compartment and restricted to those surgeons with appropriate training who are working in multidisciplinary referral centres. PATIENT SUMMARY: Synthetic slings can be safely used in the surgical treatment of stress incontinence in both male and female patients. Patients need to be aware of the alternative therapy and potential risks and complications of this therapy. Synthetic mesh for treating prolapse should be used only in complex cases with recurrent prolapse in specialist referral centres.

The introduction of mid-urethral slings: an evaluation of literature.

INTRODUCTION AND HYPOTHESIS: The objective of this study was to evaluate the degree and reliability of evidence used by manufacturers before the introduction of mid-urethral slings (MUS) onto the commercial market. Furthermore, minimum standards for marketed slings are recommended by evaluating recent suggestions for the introduction of gynecological meshes. METHODS: A systematic literature search was conducted using PubMed and commercial internet search engines in order to identify slings introduced by the industry over the last decade. Moreover, manufacturers were contacted by email, mail, and phone to provide data from before the introduction of the slings onto the commercial market. Once contact had been initiated, a 6-month deadline was set for data collection. RESULTS: Forty-one slings introduced between 1996 and 2012 were identified. Ten slings were described in a total of 20 studies with sample sizes varying from 10 to 368. The 41 MUS were produced by a total of 19 different companies. Seven companies never responded to recurrent emails, phone calls or other means of attempted contact. Thirty-one slings (76%) remained without any comparative pre-launch data. CONCLUSIONS: Mid-urethral slings were often introduced without any scientifically proven basis or pre-launch research. The US Food and Drug Administration and the European authorities should undertake immediate action by imposing strict rules before the launch of new MUS comparable with those recently suggested for meshes used in vaginal prolapse surgery.

Surgical management of female SUI: is there a gold standard?

Many surgical options exist for women with stress urinary incontinence (SUI). The traditional gold standards of Burch retropubic colposuspension and pubovaginal slings are still appropriate treatment options for some patients, but randomized controlled trials have demonstrated that synthetic midurethral slings are just as effective as these traditional procedures but with less associated morbidity. Thus, midurethral slings--inserted via a retropubic or transobturator approach--have become the new gold standard first-line surgical treatment for women with uncomplicated SUI. Retropubic midurethral slings are associated with slightly higher success rates than transobturator slings, but at the cost of more postoperative complications. Pubovaginal slings remain an effective option for women with SUI who have failed other procedures, have had mesh complications, or who require concomitant urethral surgery. Single-incision slings have a number of benefits, including decreased operative times and early return to regular activities, but they are yet to be shown to be as effective as midurethral slings. Both retropubic and transobturator midurethral slings are effective for patients with mixed urinary incontinence, but the overall cure rate is lower than for patients with pure SUI. Based on the literature a new gold standard first-line surgical treatment for women with SUI is the synthetic midurethral sling inserted through a retropubic or transobturator approach [corrected].

Long-term outcome of transobturator tension-free vaginal tape: efficacy and risk factors for surgical failure.

PURPOSE: To assess the 5-year efficacy of the inside-out transobturator tension-free vaginal tape (TVT-O) for the treatment of stress urinary incontinence (SUI) and to explore possible predictors for long-term failure. METHODS: Sixty-five consecutive patients who underwent TVT-O were prospectively enrolled. Patients who required concomitant anterior or apical pelvic organ prolapse repair or both and those with urodynamic occult SUI were excluded. Postoperatively, patients were scheduled for evaluation at 1, 3, 6, and 12 months and annually thereafter. Surgical failure was defined as positive stress test, daily episodes of SUI, and negative global satisfaction. Preoperative and interim clinical and urodynamic predictors for long-term failure were analyzed from a computerized database. RESULTS: Sixty-one patients (mean age at surgery 56.6±10.2 years) completed 5 years of follow-up. Of these, 11 (18%) patients were classified as surgical failure, 5 (8%) as improved, and 45 (74%) as cured. Any SUI (100% vs. 10%, p=0.001), daily SUI (100% vs. 0%, p=0.001), overactive bladder (OAB) (100% vs. 48%, p=0.001), and the use of antimuscarinic drugs (64% vs. 26%, p=0.03) were found to be significantly more common among failure cases. Preoperative detrusor overactivity (odds ratio [OR] 7.6, 95% confidence interval [CI] 1.7-32.9), interim 1-year OAB (OR 20.5, 95% CI 1.9-215.4), and interim 1-year SUI (OR 26.4, 95% CI 1.5-475.2) were found to be significant independent risk factors for long-term surgical failure. CONCLUSIONS: An 18% rate of surgical failure was observed 5 years after TVT-O. Larger studies with longer follow-up periods may facilitate the identification of risk factors for failure and, thus, enable better preoperative consultation.

TVT-Secur mini-sling for stress urinary incontinence: a review of outcomes at 12 months.

• Synthetic mid-urethral slings (MUSs) are considered the first choice surgical procedure for stress urinary incontinence. Recent publications have raised concerns about the efficacy of third generation single-incision mini-slings. The present paper is a systematic review of studies reporting 12-month outcomes after the TVT-Secur (TVT-S) procedure. • Pubmed/Medline online databases, abstracts from recent International Continence Society and International Urogynecological Association annual scientific meetings and the Clinicaltrials.gov and Controlled-trials.com online trial registries were searched for English-language articles containing the terms 'TVT-Secur', 'TVT Secur' or 'mini-sling'. The primary outcomes were objective and subjective cure rates at 12 months. Secondary outcomes included peri-operative (vaginal perforation, urinary retention, urinary tract infection [UTI]) and postoperative (mesh exposure, de novo overactive bladder (OAB), dyspareunia and return to theatre) complication rates. • Among 1178 women undergoing the TVT-S procedure, from 10 studies, both objective and subjective cure rate at 12 months was 76%, with objective cure significantly higher in women undergoing the 'U-type' approach. Vaginal perforation was a complication in 1.5% of cases, with a 2.4% incidence of mesh exposure in the first year. The incidence of de novo OAB symptoms was 10%. Rates of urinary retention (2.3%), UTI (4.4%), dyspareunia (1%) and return to theatre for complications (0.8%) were low. In the first year after a TVT-S procedure 5% of women required repeat continence surgery. • Longer-term studies and randomized comparisons with more established MUSs are required before TVT-S should be routinely used in the surgical treatment of stress urinary incontinence.

Worse long-term surgical outcomes in elderly patients undergoing SPARC retropubic midurethral sling placement.

OBJECTIVE: • The purpose of our study was to evaluate long-term clinical outcomes following placement of a retropubic mid-urethral sling in patients aged 70 and over and to compare outcomes with those of a younger cohort of patients. MATERIALS AND METHODS: • Patients with stress urinary incontinence undergoing retropubic polypropylene sling (SPARC(TM) ) placement were entered into a prospective, institutional review board-approved database. • Patients with at least 12 months follow-up were sent postoperative questionnaires assessing outcomes. Results of these questionnaires were compared for patients aged 70 or older and those younger than 70 years. RESULTS: • A total of 337 patients who underwent SPARC sling placement in an 8-year period were identified. Of these, 290 patients had a minimum of 12 months follow-up, and among these patients, 235 (81%) answered postoperative mailed questionnaires. Average follow-up was 45.2 months. • Thirty-seven patients were 70 or older, and 198 were younger than 70. The older group had significantly lower success (53.1% vs 83.6%) and dry (6.1% vs 35.3%) rates than the younger cohort. • Assessment of preoperative variables determined that the older cohort had significantly more vaginal deliveries and a higher percentage of patients who had undergone either hysterectomy, previous prolapse and/or incontinence surgery. • There was no significant difference in Valsalva leak-point pressure, percentage of patients with intrinsic sphincteric deficiency or type 0 stress urinary incontinence between the two groups. CONCLUSIONS: • Experience at our Institution shows that there are clearly lower success rates in older patients undergoing a SPARC sling as compared with a younger cohort of patients. • Parity, hysterectomy and previous pelvic organ prolapse/anti-incontinence surgery may also play a role in the difference in outcomes.

Maintaining standards for surgery for female urinary incontinence.

MAINTAINING STANDARDS IN SURGERY FOR FEMALE URINARY INCONTINENCE: Operations for female stress urinary incontinence (SUI) are among the most common operations performed. In particular, recent advances in surgical technique and materials available for this type of surgery have made these operations more accessible, but even if an operation is characterized as "minimally invasive" surgeons must aim to maintain the highest possible standards in the interest of their patients. STANDARDS IN PATIENT SELECTION: Great care has to be taken to do a thorough workup of a patient about to undergo surgery. A detailed history and a good clinical evaluation including a clinical stress test is a prerequisite. It is highly recommended to do an urodynamic investigation prior to any surgery which affects bladder storage and micturition in order to confirm the presumptive diagnosis and to exclude patients who should not undergo surgery (e.g. with voiding disorders). STANDARDS IN SURGERY: Before taking a patient to theatre the surgeon must be clear in him or her mind about which operation to do. In other words preoperative selection of the appropriate type of operation is of the greatest importance. For this reason every surgeon has to be familiar with a certain range of incontinence procedures from which she can choose in a particular instance. There is no doubt that tension-free mid-urethral slings have become the procedures of choice in most cases of stress urinary incontinence. However, there will be cases where other procedures are called for such as traditional colposuspension or fascial slings. It is the responsibility of every surgeon not to use procedures which are outdated or not recommended. To maintain standards in incontinence surgery every surgeon has to familiarize him or herself with the procedure, to learn the procedure, to practice the procedure with the help of experienced peers, and finally to achieve the highest level of competence him or herself. So-called Industry sponsored "training centres" can be helpful but there are no shortcut to use all possible resources to learn and practice new surgery. Guidelines have become very important in evaluating new procedures and in categorizing the available evidence. They focus on specific recommendations which we can and should use in our daily practice. Again we still have the responsibility to follow the medical literature closely and to adapt our practice as new evidence becomes available-even before it is incorporated into guidelines. STANDARDS IN FOLLOW-UP: Last but not least we have to follow standards when following up on our patients. As far as possible in the context of the health care system where we practice we should aim to see the patient we have operated on at least once 6-12 weeks after surgery. We must also make sure that the patient has access to care in case a problem develops later. And we ourselves must be familiar with the complications and consequences of surgery for stress urinary incontinence and must be able to manage a patient who is not completely satisfied after surgery.

Prospective randomized trial of TVT and TOT as primary treatment for female stress urinary incontinence with or without pelvic organ prolapse in Southeast China.

OBJECTIVE: To compare the outcomes of tension- free vaginal tape (TVT) and transobturator tape (TOT) in the treatment of female stress urinary incontinence with or without concomitant pelvic organ prolapse (POP). METHODS: One hundred and forty patients with SUI were randomly allocated to TVT (n=70) or TOT (n=70). The objective outcomes were assessed with a stress test, 1-h pad test. Subjective outcomes were assessed with UDI-6/(IIQ-7) questionnaires. RESULTS: The surgical outcomes revealed no significant difference between TVT and TOT surgical route. Both the subjective and objective cure rates were 91.4% in the TOT group, while 90 and 92.8% in the TVT group, respectively. The results showed the association to pelvic floor surgical techniques did not diminish a year later. TOT procedure has a shorter operative time for patients without concomitant surgery. CONCLUSION: The efficacy and safety of TVT procedure were similar to that of TOT procedure for female stress urinary incontinence with or without concomitant POP.

Outcomes following mid-urethral sling placement in patients with intrinsic sphincteric deficiency: comparison of Sparc and Monarc slings

Purpose: The treatment of patients with intrinsic sphincteric deficiency (ISD) remains difficult. It is theorized that differing vectors of support provided by retropubic versus transobturator mid-urethral sling routes may affect outcomes. We sought to compare outcomes of patients undergoing SPARC versus MONARC sling types in patients with Valsalva leak point pressures (VLPPs) below 60 cm H2O. Materials and Methods: A retrospective review of female patients with stress urinary incontinence undergoing SPARC™ (n = 97) or MONARC™ (n = 39) placement following urodynamic diagnosis of ISD was performed, with minimum 12-month follow-up required. Outcomes were assessed using a questionnaire comprising validated incontinence questionnaires (UDI-6, IIQ-7) and additional items addressing satisfaction. Results: Success rates of 76 percent and 77 percent were observed in the SPARC (mean follow-up 36 months) and MONARC (mean follow-up 32 months) cohorts, respectively (p > 0.05). Superior UDI scores were demonstrated in the MONARC cohort (3.8 vs. 5.3, p = 0.04)), in contrast to similar IIQ scores across both groups (3.7 vs. 3.1, p > 0.05). A deterioration in success rates was seen in both cohorts with more extended follow-up and with lower VLPPs. However, this finding was limited by low patient numbers in these cohorts. A complication rate of 7 percent and 3 percent was noted in SPARC and MONARC cohorts (p > 0.05). Conclusions: We observed no significant differences in subjective outcomes when comparing patients undergoing SPARC versus MONARC sling placement in the treatment of SUI with VLPP < 60 cm H2O. A deterioration in continence rates was seen with extended follow-up. These data may be affected by low patient numbers and related study power, in particular with more extended follow-up.

New minimally invasive slings: TVT Secur.

Single-incision slings are now approved by the US Food and Drug Administration. TVT Secur (Ethicon, Somerville, NJ), the first mini sling available for use, offers a minimally invasive approach to the surgical treatment of stress incontinence, with its greatest benefit being reduced patient discomfort in the immediate postoperative period. Although little data are available regarding the safety and efficacy of this new generation of slings, TVT Secur appears to be relatively safe. Long-term efficacy has not yet been determined, but short-term efficacy rates seem to compare with traditional midurethral mesh slings. Long-term follow-up is warranted and comparative studies are needed to determine its true efficacy.