Mix and Mesh: An Electronic Database of FPMRS Mesh Products Through 2020.

IMPORTANCE: A sequelae of the removal of pelvic organ prolapse (POP) transvaginal mesh products from the U.S. market is that current and future women's health providers may be unfamiliar with mesh products historically used to treat pelvic floor disorders. OBJECTIVES: Our goal was to create an easily accessible resource to address this knowledge gap. STUDY DESIGN: An online database of mesh products used to treat POP and urinary incontinence was created with information, photographs, and videos collated from internet searches; manufacturer materials; and other primary sources. The database was then linked to a free smartphone application. RESULTS: This smartphone application includes, to the best of our knowledge, all mesh products used in the United States for the treatment of POP and stress urinary incontinence through December 2020. Included in the application are product descriptions of mesh color, size, design, and attachment points. Photographs and videos, when available, are included. The application is organized by mesh product name, but it is also searchable by other categories, such as manufacturer name and color.To download the application to a smart phone, go to vaginalmeshcatalogue.glideapp.io/ on a web browser or access via the QR code. Once the website is loaded, you can interact with the mesh catalog as a website or save it to the phone's home screen as an application. CONCLUSIONS: Health care providers of all experience levels can use this free application for educational and clinical purposes to better understand patients' histories, improve preoperative planning, and enhance patient counseling.

Symptom Resolution and Recurrent Urinary Incontinence Following Removal of Painful Midurethral Slings.

OBJECTIVE: To evaluate pain improvement and recurrent stress incontinence (SUI) following painful synthetic midurethral sling (MUS) removal. METHODS: We conducted a retrospective review of patients who underwent synthetic MUS removal at our institution from 2009-2016 for the indication of pain. We recorded sling type (transobturator vs retropubic), complete vs partial removal, and presenting symptoms. Postoperative pain improvement was categorized as resolved (pain resolved, requiring no further therapy), improved (pain less bothersome, may require further therapy), or unresolved (no/minimal improvement, requiring further management). Recurrent incontinence and further reconstructive procedures were assessed. RESULTS: 87 patients (49 complete and 38 partial removal) with pain as the primary indication for removal were included. Median age at intervention was 54 years with median follow-up of 8 months. Overall, pain improved or resolved in 78.1% of cases. Complete removal was associated with significantly greater percentage of pain resolution (63.3%) compared to partial removal (26.3%) (P = 0.002) regardless of sling type. No significant differences in recurrent SUI were noted in complete vs partial removal. Additional reconstructive procedures were performed in 28 patients, most commonly sling placement, with no significant difference in complete (20.4%) vs partial (28.9%) removal groups (P = 0.36). The overall complication rate was low (5.7%), a majority of which were transfusions (4.6%). CONCLUSION: Following MUS removal, most patients experienced resolution or improvement of pain. Complete sling removal was associated with significantly greater percentage of pain resolution compared to partial removal in both retropubic and transobturator slings. Rates of recurrent SUI and reintervention for SUI were not related to the extent of sling removal.

Long-term efficacy and complications of a multicentre randomised controlled trial comparing retropubic and transobturator mid-urethral slings: a prospective observational study.

OBJECTIVE: There are concerns regarding the risks of mid-urethral slings (MUS) for stress urinary incontinence (SUI), particularly because of the lack of long-term data. We compare patient-reported outcomes of a multicentre randomised controlled trial of retropubic (TVT, GYNECARE™) versus transobturator (TOT, MONARC™) tape surgery at 12 years. DESIGN AND SETTING: A multicentre study was performed in 11 tertiary referral centres. POPULATION: A cohort of 180 participants from the original trial, the majority of whom had mixed urinary incontinence. METHODS: Postal questionnaire survey of patient-reported outcome measures using the International Consultation on Incontinence Questionnaire, Patient Global Impression of Improvement questionnaire (PGI-I) and a numeric rating scale pain questionnaire. MAIN OUTCOME MEASURES: Comparison of the efficacy and complications between the TVT and TOT procedures in the long term. RESULTS: A total of 110/180 responses were received: 55 for TVT and 55 for TOT. The mean follow-up was 12.8 ± 0.29 years (SD). TVT was significantly superior to TOT: 41.8% TVT with no SUI, versus 21.8% TOT (P = 0.04). Urgency urinary incontinence (UUI) was the most bothersome urinary symptom: 14.5% of respondents reported UUI after TVT and TOT. This was an improvement from the baseline levels: 61.8% TVT and 76.4% TOT. Seventeen patients (9 TVT and 8 TOT) out of 121 reported moderate or severe pain with severe pain in 3 with TVT and 2 with TOT. Overall, 80% TVT and 77% TOT participants reported their symptoms as improved on the PGI-I. CONCLUSIONS: TVT is superior to TOT for SUI cure. Efficacy is reduced by 12 years. There is low incidence of severe vaginal or groin pain. Careful patient counselling on long-term outcomes is required. The Retropubic tape appears to be an effective treatment for the majority of women with SUI. TWEETABLE ABSTRACT: Retropubic tape has superior efficacy to transobturator tape. Complications are comparable with low rates.

SEAPI Incontinence Classification System: 1-Year Postoperative Results Following Midurethral Sling Placement.

OBJECTIVE: There are limited long-term data that has examined postoperative quality-of-life measures following placement of midurethral sling (MUS) for stress urinary incontinence (SUI). The SEAPI incontinence questionnaire includes 5 data points that rate severity of specific urinary symptoms. Our aim was to describe changes in SEAPI questionnaire outcomes 1 year following sling placement. METHODS: We retrospectively reviewed women who underwent MUS for SUI from 2005 to 2012. We included those women who had completed preoperative and postoperative (>12 months) SEAPI scores. Individual S, E, A, P, I score cure was defined as postoperative score of 0 (>0 preoperative). Logistic regression analysis was used to model the effects of patient characteristics on incontinence cure and S, E, A, P, I scores. RESULTS: A total of 584 women were included. Median follow-up was 25.4 months (12-126.8 months). Follow-up duration and baseline S, P, and I scores were associated with significantly lower odds of overall incontinence cure, whereas rectocele grade has positive association (odds ratio, 1.31; P = 0.040). Type of sling did not impact overall incontinence cure or cure of individual SEAPI scores. CONCLUSIONS: Preoperative S, P, and I scores had negative association with stress incontinence cure. Cure of individual S, E, A, P, I scores was impacted differently by various patient factors. The SEAPI questionnaire provides a unique profile of patient-reported and functional measures in women with SUI and may be helpful in those who undergo MUS.

An overview of the ATOMS generations: port types, functionality and risk factors.

BACKGROUND: We report the multicentre comparison of the different port types of the adjustable transobturator male incontinence system (ATOMS, A.M.I., Austria). METHODS: Between 10/09 and 10/16, 383 patients received an ATOMS. Of these, 63% received the inguinal port (IP, 2009-2013), 23% the intraoperative manually connectable scrotal port (SP, 2013-2015), and 14% the pre-connected fully silicone-covered scrotal port (SSP, 2014-2016). During the follow-up period, continence parameters, pain and quality of life ratings and postoperative port-associated complications were evaluated and compared. Statistical analysis was performed with GraphPad Prism 7®, p < 0.05 considered as significant. RESULTS: Regarding preoperative parameters (BMI, ASA score, previous radiotherapy/incontinence surgery, and preoperative 24-h pad count/24-h pad test), no significant differences were found. Regarding perioperative parameters, the mean operative time was significantly shorter for the SP and SSP (IP vs. SP p < 0.0001, IP vs. SSP p = 0.0048, SP vs. SSP p = 0.697). Comparison of the postoperative 24-h pad count, 24-h pad test and uroflowmetry data revealed no significant differences. However, the postoperative ICIQ-SF score was significantly better for the SSP (p = 0.0232) than the SP. A significant difference was also observed in postoperative port-associated complications. According to the Clavien-Dindo classification, we identified one grade I and 29 grade IIIb complications for the IP, 1 grade I and 6 grade IIIb complications for the SP, but only 2 grade IIIb complications for the SSP (IP vs. SP p = 0.0231, IP vs. SSP p = 0.0189 and SP vs. SSP p = 0.0453). CONCLUSION: The SSP shows fewer complications while retaining comparable efficacy.

The AdVance and AdVanceXP male sling in urinary incontinence: is there a difference?

PURPOSE: To compare the efficacy and perioperative complications of the AdVanceXP with the original AdVance male sling. METHODS: We retrospectively enrolled 109 patients with an AdVance and 185 patients with an AdVanceXP male sling. The baseline characteristics and complication rates were analyzed retrospectively. Functional outcome and quality of life were evaluated prospectively by standardized, validated questionnaires. The Chi2-test for categorical and Mann-Whitney U test for continuous variables were performed to identify heterogeneity between the groups. RESULTS: Regarding operation time, there was no significant difference between the slings (p = 0.146). The complication rates were comparable in both groups except for postoperative urinary retention. This occurred significantly more often in patients with the AdVanceXP (p = 0.042). During follow-up, no differences could be identified regarding ICIQ-SF, PGI or I-QoL or number of pad usage. CONCLUSIONS: The AdVance and AdVanceXP are safe and effective treatment options for male stress urinary incontinence. However, the innovations of the AdVanceXP sling did not demonstrate a superiority over the original AdVance sling regarding functional outcome.

Repeat versus primary slings in patients with intrinsic sphincter deficiency.

INTRODUCTION AND HYPOTHESIS: Our goal was to compare outcomes of repeat vs. primary synthetic slings in patients with stress urinary incontinence (SUI) with intrinsic sphincter deficiency (ISD). MATERIALS AND METHODS: We reviewed patients who underwent a sling for SUI with ISD from 2003 to 2010. The patients were divided into two groups according to whether they underwent primary or repeat sling. Surgical success was defined as no incontinence and no reintervention (i.e., urethral bulking) during follow-up. Statistical analysis included the unpaired t test, Wilcoxon rank sums test, chi-squared/Fisher's exact tests, and logistic regression to identify risk factors associated with failure. RESULTS: Six hundred and thirty-seven patients with ISD underwent a sling procedure at our institution; 557 (87 %) a primary sling and 80 (13 %) a repeat sling. Patient demographics were similar. Preoperatively, patients with recurrent SUI reported more subjective bother. Mean follow-up was 66.5 weeks (24-374). Success was achieved in 81 % of primary compared with 55 % of repeat slings (p<0.0001). Repeat patients were 3.4 times more likely to fail surgery [odds ratio (OR) =3.43, 95 % confidence interval (CI) 2.1-5.6]. Additionally 30 % of the repeat group underwent urethral bulking postoperatively compared with 8.6 % in the primary group (OR=4.4, 95 % CI 2.5-7.7). Prior incontinence procedures, a positive supine stress test, and transobturator sling were independent risk factors for failure. Among the types of slings placed (transobturator, retropubic, tensioned pubovaginal), pubovaginal slings were most successful (OR=2.7, 95 % CI 1.4-5.2). CONCLUSION: In women with ISD, repeat slings are associated with lower success rates compared with primary slings. Pubovaginal slings resulted in the highest success rate compared with both transobturator and retropubic slings.

Use of three types of synthetic mesh material in sling surgery: a prospective randomized clinical trial evaluating effectiveness and complications.

OBJECTIVE: The aim of this study was to determine the surgical success and complication rates of mixed type of mesh materials compared with Prolene mesh in sling surgery over a 4-year follow-up period. MATERIAL AND METHODS: Between 2005 and 2007, broad-based double-forced sling operations were performed in 144 women with stress incontinence using three different types of mesh material. Group I consisted of 48 patients in whom Vypro® mesh (Ethicon, USA) was used; group II of 48 patients in whom Ultrapro® mesh (Ethicon) and group III of 48 patients in whom Prolene® light mesh (Ethicon) was used. The patients' data and the success of the operation were evaluated based on the 24 h pad test, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) scoring and Korman questionnaire analysis. RESULTS: The ICIQ-SF score, the number of pads used and the results of 24 h pad test were statistically lower in group II at postoperative month 48 (p < 0.05). The rate of postoperative complications was lower in Group II than in the other groups (p < 0.05). The continence rates of groups I, II and III were 84.7%, 91.6% and 85.1%, respectively, in the 48th postoperative month. CONCLUSIONS: Ultrapro mesh can be used in sling surgery owing to its higher success rates, and lower vaginal and urethral extrusion and de novo urgency rates, which have also been shown in clinical studies.

One-year results of a prospective randomized, evaluator-blinded, multicenter study comparing TVT and TVT Secur.

INTRODUCTION AND HYPOTHESIS: The aim of this prospective randomized multicenter study was to compare retropubic tension-free vaginal tape (TVT) with TVT Secur in terms of efficacy and safety. METHODS: We set out to enrol 280 stress urinary incontinent (SUI) women with a half-time interim analysis of short-term cure and adverse events. The short-term results have previously been published. Of the 133 randomized women, 125 underwent surgery, and 121 (TVT n = 61, TVT Secur n = 60) were available for follow-up 1 year postsurgery. RESULTS: No significant differences were found between groups regarding demographics or incontinence grade. One year after surgery, both subjective and objective cure rates were significantly lower for TVT Secur than for TVT (subjective cure: TVT 98 %, TVT Secur 80 %, p = 0.03; objective cure: TVT 94 %, TVT Secur 71 % for cough test, p = 0.01; TVT 76 %, TVT Secur 58 % for pad test, p = 0.05 ). Three major complications occurred in the TVT Secur group: one tape erosion into the urethra, one tape inadvertently placed into the bladder, and one immediate postoperative bleeding due to injury to the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding peroperative bleeding, hospital stay, urge symptoms, residual urinary volume, subjective bladder emptying problems, postoperative urinary tract infections, and minor complications. The TVT Secur group used more antimuscarine medication after surgery than the TVT group (p = 0.03). Median time for surgery was 13 and 22 min for TVT Secur and TVT, respectively (p < 0.0001). CONCLUSION: The TVT Secur procedure had significantly inferior subjective and objective cure rates compared with the retropubic TVT procedure. Three serious adverse events occurred in the TVT Secur group. We therefore discourage further use of TVT Secur.

Single-incision sling compared with transobturator sling for treating stress urinary incontinence: a randomized controlled trial.

INTRODUCTION AND HYPOTHESIS: We tested the hypothesis that the single-incision sling, TVT-Secur (TVT-S), placed in U position is not inferior to transobturator midurethral sling (TVT-O) for treating stress urinary incontinence (SUI). METHODS: This was a noninferiority, prospective, randomized controlled trial in which women with SUI, confirmed by physical and urodynamic evaluation, were randomly assigned to receive either TVT-O (n = 56) or TVT-S (n = 66). Exclusion criteria were voiding dysfunction, detrusor overactivity (DO), and pelvic organ prolapse (POP) beyond the hymen. The primary outcomes were objective and subjective cure rates, which were assessed at the 12-month follow-up visit, defined as negative stress, pad, and urodynamic tests and absence of self-reported SUI symptoms. Secondary outcomes were quality of life (QoL) by King's Health Questionnaire (KHQ) validated for Portuguese language, postoperative pain, and complication rate. The power of the study was 80 % to test the hypothesis that TVT-S is not inferior to TVT-O by >15 %. Statistical significance was fixed at 5 % (p < 0.05). RESULTS: Groups were similar regarding demographic and clinical preoperative parameters. Objective cure rates for TVT-S and TVT-O groups were 84.1 % vs 87 % [90 % confidence interbal (CI) -15 to 9.8], and subjective cure rates were 92.1 % vs 90.7 % (95 % CI -11.4 to 6.7), respectively. TVT-S resulted in less postoperative general and thigh pain (p < 0.001). A few, but not statistically significant different complications, were observed in both groups: vaginal mucosa perforation, urinary retention, urinary infection, tape exposure, and de novo urgency. There was a significant improvement in all KHQ domains in both groups (p < 0.001). CONCLUSION: TVT-S was not inferior to TVT-O for treating SUI at 12-month follow-up.

Slings in surgery of genuine stress incontinence.

PURPOSE: To summarize the available evidence concerning efficacy and safety of standard mid-urethral sling (SMUS) operations for the treatment of stress urinary incontinence (SUI). METHODS AND RESULTS: A non-systematic literature review was carried out in order to collect the available evidence concerning efficacy and safety of SMUS operations for the treatment of SUI. According to the data of our prior meta-analysis, patients receiving SMUS had significantly higher overall and objective cure rates than those receiving Burch colposuspension, although they had a higher risk of bladder perforations. Patients undergoing SMUS and pubovaginal slings had similar cure rates, although the latter were slightly more likely to experience storage lower urinary tract symptoms and had a higher reoperation rate. Patients treated with retropubic SMUS had slightly higher objective cure rates than those treated with transobturator tape (TOT); however, subjective cure rates were similar, and patients treated with TOT had a much lower risk of some complications. Meta-analysis demonstrated similar outcomes for TOTs. With regard to the novel mini-sling, another meta-analysis from Abdel-fattah et al. demonstrated that repeat continence surgery and de novo urgency incontinence were significantly higher in the patients treated with mini-slings. CONCLUSION: Patients treated with retropubic tape (RT) experienced slightly higher continence rates than those treated with Burch colposuspension, but they faced a much higher risk of intraoperative complications. RT and pubovaginal slings were similarly effective. The use of RT was followed by objective cure rates slightly higher than TOT and by higher risk of complications. The novel mini-slings do not seem to be more effective than the SMUS.

What patients think: patient-reported outcomes of retropubic versus trans-obturator mid-urethral slings for urodynamic stress incontinence--a multi-centre randomised controlled trial.

INTRODUCTION AND HYPOTHESIS: The purpose of this study is to determine if the trans-obturator tape (TOT; Monarc, American Medical Systems (AMS)), which has been claimed to have similar or improved outcomes to retropubic mid-urethral slings, was equivalent (but not inferior) to the trans-vaginal tape (TVT; Gynecare) by using patient-reported outcomes for the treatment of urodynamic stress incontinence. METHODS: The primary outcome was the percentage cured of the symptom of stress urinary incontinence at 12 months on the International Consultation on Incontinence Modular Questionnaire-Female Lower Urinary Tract Symptoms question, 'does urine leak when you are physically active, exert yourself, cough or sneeze?'. Secondary outcomes included: quality of life, pain scores, global impression of improvement, patient satisfaction and complications. Objective assessments included cough stress test, urinary diary and pad test. RESULTS: At 12 months, 55 (65.5%) of the TVT group and 59 (63.4%) of the TOT group reported no stress incontinence. TOT was not inferior to TVT. There was less blood loss and pain with TOT than with TVT. There were improvements in quality of life, sexual function and patient satisfaction within groups but not between groups. CONCLUSION: Patient-reported outcomes have shown that TOT is not inferior to TVT, but both produce lower success rates than studies using objective measures.

Can we predict if overactive bladder symptoms will resolve after sling surgery in women with mixed urinary incontinence?

Persistent overactive bladder and urgency urinary incontinence after sling surgery (pubovaginal sling or midurethral sling) in women with mixed urinary incontinence (MUI) is devastating to patients and frustrating to surgeons who perform anti-incontinence surgery. To better predict the outcomes of sling surgery in women with MUI, preoperative parameters need to be examined to accurately predict postsurgical outcomes. In this review article, we will explore recent literature exploring possible preoperative predictors of persistent overactive bladder and urgency urinary incontinence after sling surgery in women with MUI.

Retropubic versus transobturator midurethral synthetic slings: does one sling fit all?

The purpose of this article is to evaluate the recent evidence base for the choice between transobturator and retropubic approaches to midurethral slings used to treat stress urinary incontinence. While the retropubic and transobturator approaches to midurethral sling surgery for stress urinary incontinence demonstrate equivalent efficacy across a number of randomized controlled trials, they do not appear to be equivalent when particular patient populations are considered separately. The retropubic approach appears to be a better option in patients with intrinsic sphincter deficiency and limited urethral mobility.

Clitoral blood flow changes after surgery for stress urinary incontinence: pilot study on TVT Versus TOT procedures.

OBJECTIVES: To study the effects of mini-invasive surgery using the tension-free vaginal tape (TVT) procedure and the transobturator tape (TOT) procedure in modifying clitoral blood flow in women affected by stress urinary incontinence. METHODS: The setting of the prospective open clinical study was the Urogynecologic Service of the Department of Microbiological and Gynecological Science, University of Catania School of Medicine (Catania, Italy). A total of 105 women underwent surgery; 42 (mean age 52.8 years) and 63 (mean age 53.9 years) were treated with TVT and TOT, respectively. Each woman underwent translabial color Doppler ultrasonography to measure the resistance index, pulsatility index, peak systolic velocity, and end-diastolic velocity of the clitoral arteries, before and 6 months postoperatively. RESULTS: In the TVT group, the mean pulsatility index and mean peak systolic velocity were significantly lower and the mean resistance index was significantly greater compared with the pretreatment values (P <0.5). In the TOT group, each color Doppler measurement was similar to that obtained at baseline (P = NS). CONCLUSIONS: The different vaginal approach for these two surgical methods influenced clitoral blood flow. Our data could add new information about sexual behavior after incontinence treatment, particularly the impact of clitoral blood flow changes.