Long-Term Outcomes of Tension-Free Vaginal Tape Obturator: Efficacy and Safety at Long-Term Follow-Up.

Background/Objectives: The use of tension-free vaginal tape obturator (TVT-O) for the treatment of stress urinary incontinence (SUI) has been widely debated over the last decade due to the lack of evidence on its long-term outcomes. The aim of this prospective study is to assess, for the first time in the available literature, the efficacy and safety of TVT-O implantation in women with pure SUI over a 17-year follow-up period. Methods: We included all women who complained of pure SUI symptoms (confirmed urodynamically) and underwent the TVT-O procedure. An objective cure was defined as the absence of urine leakage during the stress test, while subjective outcomes were assessed by means of the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), the Patient Global Impression of Improvement (PGI-I) scale, and a Visual Analogue Scale (VAS). Results: A total of 70 patients who met the inclusion criteria underwent the TVT-O procedure. During the study period, no patients were lost to follow-up, and all women completed the last evaluation at the 17-year mark. At the 17-year mark of follow-up, 62 out of 70 patients (81.4%) were subjectively cured, and 56 out of 70 (80%) patients were objectively cured. These data do not reveal any significant variation in the surgical outcomes over the follow-up period. We recorded seven (10%) tape exposure (three occurred after 10 years and four after 17 years). Among these, one woman was symptomatic for dyspareunia and "hispareunia". All patients with mesh exposure were treated with partial removal and re-suture of the vagina, but only one developed the recurrence of SUI that required a second treatment with a urethral bulking agent (UBA). In all other cases, women reported a complete resolution of symptoms without any worsening of the urinary continence. No significant bladder or urethral erosion was recorded. Conclusions: The 17-year evaluation of the TVT-O procedure has shown that it is a highly effective and safe option for the treatment of female SUI. Although there was an increased risk of tape exposure 17 years after implantation, no serious complications were reported, and no patient required the total removal of the sling.

Macroplastique Is a Safe and Effective Long-term Surgical Treatment for Stress Urinary Incontinence: Prospective Study with 10-Year Follow-up.

BACKGROUND AND OBJECTIVE: Until a few years ago, a midurethral sling was considered the gold standard for the treatment of female stress urinary incontinence (SUI) after failure of conservative therapies. However, criticisms regarding the rate of mesh exposure and lack of long-term efficacy have led to reconsideration of other surgical procedures. Our aim was to investigate long-term subjective and objective outcomes after injection of Macroplastique, a urethral bulking agent. METHODS: We prospectively enrolled all consecutive women complaining of pure SUI symptoms with urodynamically proven SUI who received a Macroplastique injection. We investigated patient-reported subjective outcomes using International Consultation on Incontinence Questionnaire-Short Form, Urogenital Distress Inventory, Patient Global Impression of Improvement, and Visual Analog Scale (VAS) questionnaires, and the cough stress test to assess objective outcomes. Adverse events were recorded during follow-up. KEY FINDINGS AND LIMITATIONS: At 10 yr after Macroplastique injection, the objective cure rate was 56% and 71% of patients reported that they were satisfied. Long-term data revealed no significant decline in subjective or objective cure rates. No serious complications were reported. Study limitations include the small sample size and the lack of pad tests and bladder diaries for postoperative evaluations. CONCLUSIONS AND CLINICAL IMPLICATIONS: Our study shows that Macroplastique injection can be an effective and safe option for the treatment of female SUI in the long term, even when used in the first-line setting. PATIENT SUMMARY: We evaluated outcomes for women with stress urinary incontinence (SUI) who were treated with an injection of Macroplastique gel into the wall of the urethra to prevent leakage of urine. We found that this is a safe option for treatment of female SUI that is effective in the long term.

A switchable light-responsive azopolymer conjugating protein micropatterns with topography for mechanobiological studies.

Stem cell shape and mechanical properties in vitro can be directed by geometrically defined micropatterned adhesion substrates. However, conventional methods are limited by the fixed micropattern design, which cannot recapitulate the dynamic changes of the natural cell microenvironment. Current methods to fabricate dynamic platforms usually rely on complex chemical strategies or require specialized apparatuses. Also, with these methods, the integration of dynamic signals acting on different length scales is not straightforward, whereas, in some applications, it might be beneficial to act on both a microscale level, that is, cell shape, and a nanoscale level, that is, cell adhesions. Here, we exploited a confocal laser-based technique on a light-responsive azopolymer displaying micropatterns of adhesive islands. The laser light promotes a directed mass migration and the formation of submicrometric topographic relieves. Also, by changing the surface chemistry, the surfacing topography affects cell spreading and shape. This method enabled us to monitor in a non-invasive manner the dynamic changes in focal adhesions, cytoskeleton structures, and nucleus conformation that followed the changes in the adhesive characteristic of the substrate. Focal adhesions reconfigured after the surfacing of the topography, and the actin filaments reoriented to coalign with the newly formed adhesive island. Changes in cell morphology also affected nucleus shape, chromatin conformation, and cell mechanics with different timescales. The reported strategy can be used to investigate mechanotransduction-related events dynamically by controlling cell adhesion at cell shape and focal adhesion levels. The integrated technique enables achieving a submicrometric resolution in a facile and cost-effective manner.

Up-to-Date Procedures in Female Stress Urinary Incontinence Surgery: A Concise Review on Bulking Agents Procedures.

To avoid complications related to mid-urethral slings (MUS), alternative procedures to treat stress urinary incontinence (SUI), such as urethral bulking agents (UBAs) have been adopted. The aim of this review is to narratively report the efficacy and safety of UBAs for SUI treatment. For this review, research from PubMed and EMBASE was performed to evaluate relevant studies that were undertaken from January 2012 to January 2022. Nineteen prospective studies were included. Several definitions of subjective and objective success were adopted. At a follow-up of <24 months, significant improvement was widely observed, even if with a heterogeneous rate of success between 32.7−90%, and a reinjection rate of 8.3−77.3%. Compared with other procedures, MUS resulted as significantly superior to UBAs but was balanced by a higher complication rate. Acute urinary retention, urinary tract infection and de novo urgency, and other complications, such as injection site rupture, urethral erosion and particle migration have been described after UBAs. SUI after UBAs treatment resulted in improvements in all studies and can be considered a safe and effective option to treat SUI. However, homogenous and longer-term data lack, limiting general recommendations. Thus, larger RCTs evaluating long-term effects are required.

Vaginal Laser Therapy for Female Stress Urinary Incontinence: New Solutions for a Well-Known Issue-A Concise Review.

Background and Objectives: Insufficient connective urethra and bladder support related to childbirth and menopausal estrogen decrease leads to stress urinary incontinence (SUI). The aim of this review is to narratively report the efficacy and safety of new mini-invasive solutions for SUI treatment as laser energy devices, in particular, the microablative fractional carbon dioxide laser and the non-ablative Erbium-YAG laser. Materials and Methods: For this narrative review, a search of literature from PubMed and EMBASE was performed to evaluate the relevant studies and was limited to English language articles, published from January 2015 to February 2022. Results: A significant subjective improvement, assessed by the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-UI-SF) was reported at the 6-month follow up, with a cure rate ranged from 21% to 38%. A reduction of effect was evidenced between 6 and 24-36 months. Additionally, the 1-h pad weight test evidence a significant objective improvement at the 2-6-month follow up. Conclusions: SUI after vaginal laser therapy resulted statistically improved in almost all studies at short-term follow up, resulting a safe and feasible option in mild SUI. However, cure rates were low, longer-term data actually lacks and the high heterogeneity of methods limits the general recommendations. Larger RCTs evaluating long-term effects are required.

Characteristics and patterns of care of endometrial cancer before and during COVID-19 pandemic.

OBJECTIVE: Coronavirus disease 2019 (COVID-19) outbreak has correlated with the disruption of screening activities and diagnostic assessments. Endometrial cancer (EC) is one of the most common gynecological malignancies and it is often detected at an early stage, because it frequently produces symptoms. Here, we aim to investigate the impact of COVID-19 outbreak on patterns of presentation and treatment of EC patients. METHODS: This is a retrospective study involving 54 centers in Italy. We evaluated patterns of presentation and treatment of EC patients before (period 1: March 1, 2019 to February 29, 2020) and during (period 2: April 1, 2020 to March 31, 2021) the COVID-19 outbreak. RESULTS: Medical records of 5,164 EC patients have been retrieved: 2,718 and 2,446 women treated in period 1 and period 2, respectively. Surgery was the mainstay of treatment in both periods (p=0.356). Nodal assessment was omitted in 689 (27.3%) and 484 (21.2%) patients treated in period 1 and 2, respectively (p<0.001). While, the prevalence of patients undergoing sentinel node mapping (with or without backup lymphadenectomy) has increased during the COVID-19 pandemic (46.7% in period 1 vs. 52.8% in period 2; p<0.001). Overall, 1,280 (50.4%) and 1,021 (44.7%) patients had no adjuvant therapy in period 1 and 2, respectively (p<0.001). Adjuvant therapy use has increased during COVID-19 pandemic (p<0.001). CONCLUSION: Our data suggest that the COVID-19 pandemic had a significant impact on the characteristics and patterns of care of EC patients. These findings highlight the need to implement healthcare services during the pandemic.

Factors predicting morbidity in surgically-staged high-risk endometrial cancer patients.

OBJECTIVE: To investigate factors predicting the risk of developing 90-day postoperative complications and lymphatic-specific morbidity in patients undergoing surgical staging for high-risk endometrial cancer. METHODS: This is a multi-institutional retrospective cohort study. Patients affected by apparent early-stage high-risk endometrial cancer (endometrioid FIGO grade 3 with deep myometrial invasion and non-endometrioid endometrial cancer) undergoing surgical staging between 2007 and 2019. Complications were graded according to the Clavien-Dindo classification system. Martin criteria were applied to improve quality of complications reporting. RESULTS: Charts of 279 patients were evaluated. Lymphadenectomy, sentinel node mapping (SNM), and SNM followed by back-up lymphadenectomy were performed in 83 (29.7%), 50 (17.9%), and 146 (52.4%) patients, respectively. The former group of patients included 13 patients who had lymphadenectomy after the failure of the SNM technique. Thirteen (4.6%) patients developed severe postoperative events (grade 3 or worse). At multivariate analysis, body mass index (OR: 1.08 (95%CI: 1.01, 1.17)) and open abdominal surgery (OR: 2.27 (95%CI: 1.02, 5.32)) were the two independent factors predictive of surgery-related morbidity. Seven severe lymphatic complications occurred. The adoption of laparoscopic approach (p < 0.001, log-rank test) and SNM (p = 0.038, log-rank test) correlated with a lower risk of developing surgery-related events. Independently, open abdominal surgery was associated with an increased risk of developing lymphatic morbidity (OR: 37.4 (95%CI: 4.38, 319.5); p = 0.001). CONCLUSION: The adoption of the laparoscopic approach and SNM technique were associated with lower 90-day complication rates than open surgery in high-risk endometrial cancer undergoing staging surgery.

Minilaparoscopy in gynecology: applications, benefits and limitations.

The word "minilaparoscopy" refers to laparoscopic surgical procedures performed using <5-mm trocars, with the exception of the umbilical access. The aim of this review is to explore the feasibility of minilaparoscopy in gynecologic surgery, focusing on instruments, surgical techniques, application and limits of this approach. In this review the authors discussed the positive features and limitation of 3-mm laparoscopy for gynecologic surgery. Using smaller trocars decreases incisional and postoperative pain, and shortens hospitalization, and provides a better cosmetic outcome. Transvaginal specimen extraction can be used to maximize the aesthetic outcomes. A minilaparoscopic surgical procedure is accomplished with lower carbon dioxide pressures, reducing pneumoperitoneum related complications. Accurate patient selection is critical in order to offer the best laparoscopic approach, considering that obesity and endometriosis may represent a challenge for 3-mm surgical tools, which are more flexible and have lower grasping ability. Minilaparoscopy has been shown as a valid alternative to conventional laparoscopy both for diagnostic purpose, major surgical procedures and oncological surgery. Minilaparoscopy in gynecologic surgery represents an option for selected patients, for both benign and malignant indications. The aesthetic outcome represents the main benefit of this approach. Surgeons must be aware of few limitations of this technique such as severe obesity and endometriosis.

Is urodynamic evaluation able to change and improve the management of women with idiopathic overactive bladder?

BACKGROUND: For women with overactive bladder (OAB), current guidelines recommend the use of urodynamic studies (UDS) only in complicated cases. This study aimed to investigate whether UDS can also be helpful in uncomplicated cases. Specific aims of the study were: 1) to evaluate objective benefit and subjective patient satisfaction with tailored treatment based on the UDS diagnosis compared to the outcomes of the pharmacological treatment only based on the symptoms; 2) to investigate the correlation between symptoms and UDS findings in women with uncomplicated idiopathic OAB symptoms; 3) to assess the ability of UDS to modify management decisions in these patients. METHODS: Women presenting to our clinic with a history of uncomplicated OAB symptoms for the past three months or more, and who completed the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), were considered for this study. We proposed UDS to all participants. In women who accepted UDS (group 1), management decisions were made on the basis of urodynamic findings and post-treatment evaluation was scheduled at three months. The outcomes of treatments in these patients were compared to the results in women who did not accept UDS and who received pharmacological treatment symptoms-based (group 2). Objective outcomes were based on completion of a 3-day micturition diary. Subjective outcomes were captured using the Overactive Bladder Questionnaire Short Form (OABq-SF), the Patient Global Impression of Improvement (PGI-I) scale, and a patient satisfaction scale. RESULTS: A total of 680 women were enrolled in the study; 478 underwent UDS and 202, at the contrary, declined UDS. In 53.6% of cases, UDS led to modification of the proposed management approach. At the 3-month follow-up, the overall patient satisfaction rate in group 1 and group 2 was 77% and 65.8%, respectively (P=0.003). CONCLUSIONS: We showed that OAB management tailored according to the UDS diagnosis results in higher subjective satisfaction if compared with a pharmacological treatment symptoms-based. Our study confirmed a lack of correlation between OAB symptoms and the urodynamically proven diagnosis of detrusor overactivity (DO). It also suggested that UDS can determine the underlying pathophysiology of every woman with OAB syndrome, whether complicated or uncomplicated, allowing treatment to be appropriately tailored with better results.

Spatio-Temporal Control of Cell Adhesion: Toward Programmable Platforms to Manipulate Cell Functions and Fate.

Biophysical and biochemical signals of material surfaces potently regulate cell functions and fate. In particular, micro- and nano-scale patterns of adhesion signals can finely elicit and affect a plethora of signaling pathways ultimately affecting gene expression, in a process known as mechanotransduction. Our fundamental understanding of cell-material signals interaction and reaction is based on static culturing platforms, i.e., substrates exhibiting signals whose configuration is time-invariant. However, cells in-vivo are exposed to arrays of biophysical and biochemical signals that change in time and space and the way cells integrate these might eventually dictate their behavior. Advancements in fabrication technologies and materials engineering, have recently enabled the development of culturing platforms able to display patterns of biochemical and biophysical signals whose features change in time and space in response to external stimuli and according to selected programmes. These dynamic devices proved to be particularly helpful in shedding light on how cells adapt to a dynamic microenvironment or integrate spatio-temporal variations of signals. In this work, we present the most relevant findings in the context of dynamic platforms for controlling cell functions and fate in vitro. We place emphasis on the technological aspects concerning the fabrication of platforms displaying micro- and nano-scale dynamic signals and on the physical-chemical stimuli necessary to actuate the spatio-temporal changes of the signal patterns. In particular, we illustrate strategies to encode material surfaces with dynamic ligands and patterns thereof, topographic relieves and mechanical properties. Additionally, we present the most effective, yet cytocompatible methods to actuate the spatio-temporal changes of the signals. We focus on cell reaction and response to dynamic changes of signal presentation. Finally, potential applications of this new generation of culturing systems for in vitro and in vivo applications, including regenerative medicine and cell conditioning are presented.