Retrospective study of combined pelvic exenteration in the treatment of primary and recurrent pelvic malignant tumors.

Background: Pelvic malignant tumors often originate in the rectum, bladder, uterus, and other organs. In patients with locally advanced tumours in the presence of direct invasion of one or more organs, negative tumor resection margin (R0) resection can be very beneficial to patient survival if it can be performed. As a multidisciplinary and high-risk surgical method, the pelvic exenteration (PE) procedure has only been reported in a few medical centres internationally. We retrospectively analyzed the clinical data of patients who had undergone PE surgery in our hospital, in order to provide ideas for the best treatment of patients with pelvic malignant tumors. Methods: A retrospective analysis was conducted of 59 patients with pelvic malignant tumors admitted to the Affiliated Cancer Hospital of Zhengzhou University from January 2015 to July 2021, all of whom received PE surgery. They were divided into two groups according to the location of the disease: the rectal cancer group (n=40) and the cervical cancer group (n=19). Statistical analysis was performed on the baseline and follow-up data of the two groups of patients. Results: (I) Patient baseline data. Compared to the rectal cancer group, more patients in the cervical cancer group received preoperative radiotherapy and chemotherapy (P=0.013), and had a lower R0 resection rate (P=0.037). Postoperative complications in patients with rectal cancer and cervical cancer were 27.5% and 47.3%, respectively. (II) Patient survival analysis after PE surgery. The 5-year survival rate was 36.6% in the rectal cancer group and 25.3% in the cervical cancer group. In the rectal cancer group, for the primary tumor, if there was no lymph node metastasis or no postoperative complications in the postoperative pathology, the patient had a good survival prognosis. Univariate analysis showed that recurrent rectal cancer, postoperative lymph node metastasis, postoperative complications, and microsatellite stability (MSS) were significant predictors of poor survival outcomes. Multivariate analysis showed that lymph node metastasis and postoperative complications were independent prognostic factors for patient survival. Conclusions: PE is a viable option for pelvic malignancies; aggressive radical resection of lesions and reduced postoperative complications can effectively improve patient outcomes.

Identification of Tissue-Resident Natural Killer and T Lymphocytes with Anti-Tumor Properties in Ascites of Ovarian Cancer Patients.

Women with ovarian cancer have limited therapy options, with immunotherapy being unsatisfactory for a large group of patients. Tumor cells spread from the ovary or the fallopian tube into the abdominal cavity, which is commonly accompanied with massive ascites production. The ascites represents a unique peritoneal liquid tumor microenvironment with the presence of both tumor and immune cells, including cytotoxic lymphocytes. We characterized lymphocytes in ascites from patients with high-grade serous ovarian cancer. Our data reveal the presence of NK and CD8+ T lymphocytes expressing CD103 and CD49a, which are markers of tissue residency. Moreover, these cells express high levels of the inhibitory NKG2A receptor, with the highest expression level detected on tissue-resident NK cells. Lymphocytes with these features were also present at the primary tumor site. Functional assays showed that tissue-resident NK cells in ascites are highly responsive towards ovarian tumor cells. Similar results were observed in an in vivo mouse model, in which tissue-resident NK and CD8+ T cells were detected in the peritoneal fluid upon tumor growth. Together, our data reveal the presence of highly functional lymphocyte populations that may be targeted to improve immunotherapy for patients with ovarian cancer.

Factors influencing surgical outcomes of laparoscopic myomectomy. A propensity-score matched analysis.

Introduction: To evaluate factors influencing surgical choice in performing uterine myomectomy by comparing laparoscopic and open approach surgery. Material and methods: We analyzed women undergoing uterine myomectomy in our hospital. Patients were divided into two groups: patients who underwent laparoscopic myomectomy (group A) and patients who underwent laparotomic myomectomy (group B). We matched 1 : 1 women in these two groups to compare the effects of the procedures on each outcome according to a propensity-matched score analysis. Results: 460 myomectomies were performed in the study period: 361 cases by laparoscopy (group A) and 99 cases by laparotomy (group B). We found lower estimated intraoperative blood loss (200 ml group A vs. 300 ml group B, < 0.0001) and a smaller decrease in hemoglobin value on the first postoperative day (1.7 g/dl group A vs. 2.2 g/dl group B, < 0.0001) with the laparoscopic approach. The propensity score matching estimated that to obtain an equivalent outcome, we required an average of 2 myomas and an average diameter of 8 cm in laparoscopy and 10 cm in laparotomy. Moreover, the variables mostly associated with a laparotomic conversion were the presence of a myoma > 8 cm and association with the presence of more than 2 myomas. Conclusions: Despite some proposals from previous studies, there are no specific guidelines regarding the best surgical procedure for myomectomy. Our data confirm that the choice of surgical technique should consider the patient characteristics and the surgeon experience to reduce longer operating times and more significant blood loss.

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.

Survival outcomes after surgical management of endometrial cancer: Analysis after the first 10-year experience of robotic surgery in a single center.

OBJECTIVES: To report the 5-year survival rates of patients undergone surgery for endometrial cancer, within a 10-year study. METHODS: Single institution series with a minimum 2-year follow-up. The 5-year survival outcomes of patients managed by robotics, laparoscopy and open surgery during the same period were compared. Multivariable analyses were performed to identify prognostic factors. RESULTS: Three hundred and sixty-three consecutive patients were analysed. Open surgery showed a higher rate of abdominal recurrences (17.2% vs. 3.3%; p < 0.001); no differences were recorded in terms of vaginal, nodal or distant recurrences between open and minimally invasive surgery. At multivariable analyses, type II histology, peritoneal cytology and lympho-vascular space invasion were independent predictors for survival. Based on each FIGO (The International Federation of Gynecology and Obstetrics) stage, no differences were found in terms of 5-year disease-free survival and overall survival between the approaches. CONCLUSIONS: The surgical route does not affect the 5-year survival in patients with endometrial cancer. Both robotics and laparoscopy are confirmed as viable options.

Survival outcomes of robotic radical hysterectomy for early stage cervical cancer: A 9-year study.

BACKGROUND: Recently, the results of a RCT have raised concerns on the management of cervical cancer through a minimally invasive approach. This study reports on the outcomes of patients with early stage cervical cancer submitted to robotics. METHODS: Retrospective review of a consecutive series of patients with an early cervical cancer treated with robotics at a single Institution over a 9-year period. RESULTS: A total of 91 women were managed; 39 (41.1%) had cervical adenocarcinoma. One (1.1%) conversion to laparotomy and one (1.1%) intraoperative complication occurred. Five (5.5%) patients experienced postoperative (>G2) complications; 24 (26.4%) patients required further adjuvant therapies. After a median follow-up of 40.7 (3.8-96.6) months, the DFS and OS were 90.4 (95%CI 85.3-95.6)% and 94.5 (95%CI 91.8-97.2)%, respectively. CONCLUSIONS: According to the available literature, the survival outcomes of this series of RRH for ECC are not inferior to what recorded in the past by an open approach.

Primary Debulking Surgery Versus Neoadjuvant Chemotherapy in Advanced Epithelial Ovarian Cancer: A Propensity-matched Analysis.

AIMS: To compare the surgical and survival outcomes of patients undergoing primary debulking surgery (PDS) versus neoadjuvant chemotherapy (NACT) plus interval debulking surgery (IDS) for advanced epithelial ovarian cancer (EOC). MATERIALS AND METHODS: Consecutive patients managed for advanced EOC since 2009 were matched through a propensity score analysis, defined as the probability of a woman having PDS or NACT plus IDS. RESULTS: The study group consisted of 100 propensity-matched women receiving PDS or NACT plus IDS. Groups resulted homogeneous in terms of baseline characteristics and pathologic findings. Patients undergoing PDS had longer operative time (P=0.032) and more blood loss (P=0.011) than the counterpart receiving NACT. No differences were found in terms of residual disease (P=0.11), as well as in terms of hospitalization, intraoperative, and postoperative complications. The mean progression-free survival was 23.0 and 27.7 months (P=0.67), whereas the overall survival (OS) was 44.5 and 43.2 months (P=0.48) for the PDS and NACT plus IDS group, respectively. Residual disease (P<0.0001) was the only independent predictor of progression-free and OS at multivariate analysis. CONCLUSIONS: PDS and NACT plus IDS achieved comparable results in terms of progression-free and OS in patients with advanced EOC.

Symptomatic endometriosis of the posterior cul-de-sac is associated with impaired sleep quality, excessive daytime sleepiness and insomnia: a case-control study.

OBJECTIVE: To assess the impact of endometriosis of the posterior cul-de-sac on quality of sleep, average daytime sleepiness and insomnia. STUDY DESIGN: This age-matched case-control study was conducted in a tertiary referral centre for the diagnosis and treatment of endometriosis between May 2012 and December 2013. It included 145 women with endometriosis of the posterior cul-de-sac (cases; group E) and 145 patients referred to our Institution because of routine gynaecologic consultations (controls; group C). This study investigated whether sleep is impaired in patients with endometriosis of the posterior cul-de-sac. Sleep quality, daytime sleepiness and insomnia were assessed using the following self-administered questionnaires: the Pittsburgh Sleep Quality Index, the Epworth sleepiness scale and the Insomnia Severity Index, respectively. The primary objective of the study was to evaluate sleep quality in the two study groups. Secondary outcomes of the study were to assess average daytime sleepiness and insomnia in the two study groups. RESULTS: The prevalence of poor sleep quality was significantly higher in group E (64.8%) than in group C (15.1%; p<0.001). The prevalence of excessive daytime sleepiness was significantly higher in group E (23.4%) than in group C (12.9%; p=0.033). Patients of group E experienced subthreshold insomnia (29.0%) and moderate clinical insomnia (16.6%) significantly more frequently than patients in group C (24.4% and 5.0%; p=0.002). CONCLUSION: A substantial proportion of women with endometriosis of the posterior cul-de-sac experiences poor sleep quality, excessive daytime sleepiness and insomnia.

Robotic Surgery in Patients With Locally Advanced Cervical Cancer After Neoadjuvant Chemotherapy: Survival Outcomes.

AIM: To evaluate the survival outcomes of consecutive patients with locally advanced cervical cancer (LACC) who underwent comprehensive robotic surgery after neoadjuvant chemotherapy (NACT). MATERIALS AND METHODS: Since 2009, patients with LACC (FIGO [International Federation of Gynecology and Obstetrics] stages IB2-IIB) were submitted to robotic surgical staging after 3 cycles of NACT. Clinical objective tumor response was assessed according to the Response Evaluation Criteria in Solid Tumors, whereas pathologic responses were defined according to the criteria of the European study SNAP01. Univariable and multivariable analyses were performed to assess potential clinicopathologic prognostic factors affecting progression-free survival and overall survival (OS). RESULTS: During the study period, 32 patients meeting the inclusion criteria were managed. The median (range) age and body mass index were 47.3 (8.6-75.5) years and 22.7 (17.5-37.1) kg/m(2), respectively. Overall, 28.0 (range, 12-58) lymph nodes were retrieved. According to the final pathologic examination, 6 (18.8%) women had positive pelvic lymph nodes, whereas 16 (50.0%) patients achieved an optimal pathological response. After a median follow-up of 36.3 (range, 5.2-71.1) months, 6 (18.8%) patients had a recurrence and subsequently died of disease.Positive nodal status was the only independent predictor of both progression-free survival (12.5 [2.3-69.1]; P < 0.0001) and OS (12.0 [2.0-60.4]; P < 0.0001) at multivariable analysis. CONCLUSIONS: Nodal status represents the strongest predictor of survival in women with LACC. Similarly, NACT including 3 agents (TIP [paclitaxel 175 mg/m(2) + ifosfamide 5 g/m(2) + cisplatin 75 mg/m(2)] and TEP [paclitaxel 175 mg/m(2) + epirubicin 80 mg/m(2) + cisplatin 75 mg/m(2)] regimens) warranted better OS than those achieved by other schedules.

Sentinel Node Mapping Using Indocyanine Green and Near-infrared Fluorescence Imaging Technology for Uterine Malignancies: Preliminary Experience With the Da Vinci Xi System.

STUDY OBJECTIVE: Sentinel lymph node (SLN) mapping has emerged as the new frontier for the surgical staging of apparently early-stage cervical and endometrial cancer. Different colorimetric and radioactive tracers, alone and in combination, have been proposed with encouraging results. Fluorometric mapping using indocyanine green (ICG) appears to be a suitable and attractive alternative to provide reliable staging [1-4]. DESIGN: In this video, we present the technique of SLN mapping in 2 cases (1 endometrial and 1 cervical cancer, respectively) using ICG and the near-infrared technology provided by the newest Da Vinci Xi robotic system (Intuitive Surgical Inc., Sunnyvale, CA). Together we report the results of our preliminary experience on the first 20 cases performed. The new robotic Da Vinci Xi system was available at our institution since May 2015. INTERVENTION: Upon institutional review board/ethical committee approval, all consecutive patients with early-stage endometrial and cervical cancer who were judged suitable for robotic surgery have been enrolled for SLN mapping with ICG. We adopted the Memorial Sloan Kettering Cancer Center SLN algorithm; the tracer was delivered into the cervix in all cases. Four milliliters (1.25 mg/mL) of ICG was injected divided into the 3- and 9-o'clock positions of the cervix alone, with 1 mL deep into the stroma and 1 mL submucosally at the skin incision. Sentinel lymph nodes were examined with a protocol including both ultrastaging with immunohistochemistry [3] and 1-step nucleic acid amplification assay [5,6] under a parallel protocol of study. During the study period, 20 cases were managed; 14 and 6 patients had endometrial and cervical cancer, respectively. SLN was detected in all cases (20/20, 100%). Bilateral SLNs were detected in 17 of 20 (85.0%) cases. Based on preoperative and intraoperative findings, 13 (65.0%) patients received systematic pelvic lymphadenectomy after SLN mapping. Three (15.0%) patients had microscopic nodal metastases on SLN. No patients had positive regional nodes other than SLN. No perioperative complications were recorded. CONCLUSION: SLN mapping has been acknowledged by the National Comprehensive Cancer Network guidelines as a viable option for the management of selected uterine malignancies [7,8]. Currently, the near-infrared technology built in the Da Vinci Xi system provides an enhanced real-time imaging system that improves the advantages given by ICG. Together with our experience, these conditions indicate that SLN mapping is an effective and safe procedure with high overall detection and low false-negative rates.

The role of pelvic and aortic lymphadenectomy at second look surgery in apparent early stage ovarian cancer after inadequate surgical staging followed by adjuvant chemotherapy.

BACKGROUND: Systematic aortic and pelvic lymphadenectomy (SAPL) is a milestone procedure in the treatment of early stage ovarian cancer. It defines staging and prognosis and helps in tailoring adjuvant chemotherapy. Only limited data are available about SAPL at second look surgery in patients with apparent early stage ovarian cancer who underwent inadequate surgical staging and adjuvant platinum based chemotherapy. METHODS: From January 1991 through January 2013, 66 patients with International Federation of Gynecology and Obstetrics (FIGO) stage IA-IIA epithelial ovarian carcinoma suboptimally surgically staged and treated with adjuvant chemotherapy, were referred to our center and underwent second look surgery including SAPL. RESULTS: Twenty-two women underwent bilateral and 44 unilateral SAPL. A total of 2168 nodes were removed and analyzed. The median number of lymph nodes dissected was 29 (range 14-73); in particular it was 29 (range 14-60) in case of unilateral and 37 (range 17-73) in case of bilateral SAPL. Only one woman had nodal metastasis (1.5%). After a median follow-up of 78 months, 10 women (15.2%) relapsed and 5 (7.6%) died of progressive disease. The 5-year disease-free survival and overall survival are 91.7% and 96%. CONCLUSION: The risk of nodal metastases in stage I-IIA unstaged ovarian cancer after adjuvant chemotherapy is negligible. Our study suggests that SAPL at second look is not indicated in this subset of women.

Robotic radical hysterectomy following neoadjuvant chemotherapy in FIGO stage IIIB cervical cancer: a case report.

BACKGROUND: The management of advanced cervical cancer is challenging. The administration of neoadjuvant chemotherapy (NACT) followed by radical hysterectomy has proved to be safe in selected cases. Nevertheless, data on the use of minimally invasive surgery is lacking with this clinical application. METHODS: A 31 year-old woman was diagnosed with a FIGO stage IIIB squamous cell cervical carcinoma. During multidisciplinary consultation it was decided that she should receive NACT, followed by robotic hysterectomy. RESULTS: After three cycles of TIP (paclitaxel, ifosfamide and cisplatin), the patient achieved a complete clinical and radiological response. She underwent robotic type III/C2 radical hysterectomy with bilateral salpingo-oophorectomy and bilateral systematic pelvic lymphadenectomy. No complications were recorded. The complete response was confirmed at pathological examination. Two additional cycles of adjuvant chemotherapy were administered, and the patient is currently without evidence of disease at 18 months of follow-up. CONCLUSIONS: In selected patients, robotics is a viable option to accomplish radical hysterectomy, including cases of advanced cervical cancer. Further experiences are needed to confirm our findings.

Robotic surgery for deep endometriosis: a paradigm shift.

BACKGROUND: Minimally invasive surgery represents the gold standard for the management of deep infiltrating endometriosis (DIE). This study aimed to evaluate the feasibility of robotic surgery for the management of DIE. METHODS: A 5-year retrospective cohort study was made of robotic procedures including: segmental bowel resections, removal of nodules from the rectovaginal septum (RVS) with or without rectal shaving and partial bladder resection. RESULTS: Overall, 19 bowel resections, 23 removals of RVS nodules and five bladder resections were performed, alone or in combination. Associated posterior vaginal resections were performed in 12 cases. Neither intra-operative complications, nor conversion to laparotomy occurred. One anastomotic leakage was recorded. CONCLUSION: This series of robotic procedures for DIE represents the largest currently available and it helps to promote robotics as a safe and attractive alternative to accomplish a comprehensive surgical treatment of DIE, especially when bowel or bladder resections are needed.

Solifenacin in women with de novo overactive bladder after tension-free obturator vaginal tape--is it effective?

PURPOSE: To our knowledge no group has evaluated antimuscarinic efficacy in patients with de novo overactive bladder after mid urethral sling placement. We assessed solifenacin efficacy in women with de novo overactive bladder after obturator tension-free vaginal tape placement compared to a control group. MATERIALS AND METHODS: We prospectively considered all women with de novo overactive bladder symptoms at a 3-month followup visit after placement of obturator tension-free vaginal tape. Patients with overactive bladder preoperatively and those with obstructive symptoms or signs were excluded from analysis. Women who satisfied inclusion and exclusion criteria (group 1) were compared with a series of consecutive naïve patients with overactive bladder symptoms without a previous surgical procedure for stress urinary incontinence (group 2). We prescribed 12-week antimuscarinic therapy with oral solifenacin 5 mg once daily. Objective outcomes included changes from baseline in 3-day voiding diary data. Subjective efficacy was evaluated using the Overactive Bladder Questionnaire Short Form, Urgency Severity Scale and Patient Global Impression of Improvement questionnaires. RESULTS: A total of 110 patients with de novo overactive bladder after obturator tension-free vaginal tape placement completed solifenacin treatment and were included in group 1. They were compared with 120 consecutive naïve women with overactive bladder (group 2). Group 1 presented at the 3-month followup visit with significantly less benefit in the mean decrease in urgency and urgency urinary incontinence episodes daily (-1.1 vs -2.3 and -0.2 vs -1.1, respectively, each p <0.0001). In group 1 we also found a lower subjective solifenacin effect. Previous obturator tension-free vaginal tape placement was an independent predictor of failed solifenacin treatment. CONCLUSIONS: Antimuscarinic treatment with solifenacin had significantly lower efficacy in women with de novo overactive bladder after mid urethral sling placement than in controls.

Risk factors for the failure of antimuscarinic treatment with solifenacin in women with overactive bladder.

OBJECTIVE: To evaluate the outcomes of women treated with Solifenacin 5 mg once a day for overactive bladder (OAB) to identify the factors associated with the risk of treatment failure. METHODS: Women with OAB symptoms for at least 3 months were considered for this study. At visit 0, patients received a 3-day voiding diary. Eligibility was determined at visit 1, 2 weeks later, on the basis of the results recorded in the 3-day voiding diary. To be included, patients had to have experienced at least 3 episodes of urgency during the 3-day voiding diary period. Eligible women received a 12-week antimuscarinic therapy with oral Solifenacin 5 mg once a day. At the follow-up examination, objective outcomes included changes from baseline in the 3-day voiding diary data. Subjective efficacy was evaluated using the Overactive Bladder Questionnaire Short Form (OABq-SF), the Indevus urgency severity scale (USS) questionnaire, and the Patient Global Impression of Improvement. RESULTS: A total of 675 (69.3%) women met the inclusion criteria and were directed to Solifenacin therapy. After a 12-week treatment, 632 (93.6%) women were assessed for office evaluation, and 101 (16%) patients were considered as nonresponders. The antimuscarinics were effective both in terms of improvement of questionnaires scores and in terms of reduction of episodes of urgency/24 hour (P <.0001). In multivariable analysis, the number of episodes of urgency/24 hour, baseline OABq-SF symptom severity score, and baseline USS were independent predictors of Solifenacin failure. CONCLUSION: Some markers of OAB severity, such as the higher number of episodes of urgency/24 hour and the higher OABq-SF symptom severity score and USS at baseline, were associated with a lower therapeutic efficacy of Solifenacin.

Robotic surgical staging for endometrial and cervical cancers in medically ill patients.

OBJECTIVES: Patients with high anesthesiological risk due to old age, obesity and severe co-morbidities alone or in combination are considered as poor candidates for extensive surgical staging procedures, especially if through minimally invasive approach. We aimed to evaluate the feasibility and safety of robotic surgical staging of endometrial and cervical cancers in the medically ill patient. METHODS: Between 07-2007 and 12-2012, consecutive patients scheduled for staging for endometrial or cervical cancer were directed towards robotic staging and divided into two groups according to their starting score in the American Society for Anaesthesiologists (ASA): Group 1 (ASA 1-2) and Group 2 (ASA ≥3). RESULTS: Overall, 169 (71.9%) patients had ASA 1-2 whereas 66 (28.1%) had ASA ≥3. ASA ≥3 were older (p<0.0001) with a greater proportion of co-morbidities (p<0.0001), as well as of Class II (4.7% vs 19.7%; p=0.0007) and Class III obesity (2.4% vs 31.8%; p<0.0001). No differences were found between groups in terms of operative time, blood loss, intra- and post-operative complications, conversion rate and hospitalization. No differences were recorded either in terms of staging procedures performed or in terms of number of pelvic (p=0.72) and para-aortic (p=0.86) lymph nodes retrieved. CONCLUSIONS: Despite theoretical concerns about the performance of robotic surgery in patients with high anesthesiological risk, our experience showed that robotics is a feasible, safe and viable option for the management of endometrial and cervical cancers also in this more vulnerable group of patients.

Urodynamic evaluation: can it prevent the need for surgical intervention in women with apparent pure stress urinary incontinence?

OBJECTIVES: To identify how many patients with symptoms of pure stress urinary incontinence (SUI) do not require any surgical treatment on the basis of urodynamics (UDS) and how many patients still do not require surgery 1 year after UDS. To assess the outcomes of these patients at 12-month follow-up. PATIENTS AND METHODS: Women with pure SUI received UDS and were prospectively divided into four groups, comprising women with: urodynamic stress incontinence (USI); detrusor overactivity (DO); USI + DO; and inconclusive UDS. Women with USI underwent a Tension Free Vaginal Tape (Obturator) (TVT-O) procedure (Gynecare; Ethicon Inc., Somerville, NJ, USA), whereas women with DO ±/- USI were recommended 24-week antimuscarinic therapy. Follow-up was scheduled at 3 and 12 months. To define subjective outcomes, all patients completed the International Consultation on Incontinence Questionnaire - short form, the Patient Global Impression - Improvement and the Urinary Distress Inventory. Patients were considered cured if they presented a negative stress test, a score reduction of at least 80% on the Urinary Distress Inventory and a response of 'much better' or 'very much better' on the Patient Global Impression - Improvement. RESULTS: Of the 263 women with pure SUI, 74.5% had a urodynamic diagnosis of USI, 10.6% had DO, 8% had USI + DO and 6.8% had inconclusive UDS. At 12-month follow-up, 165/181 (91.6%) women in group 1 were considered cured post-TVT-O; in the other groups, 33/67 (49.2%) patients were considered cured simply as a result of taking antimuscarinics; 13 of these 67 patients required TVT-O. CONCLUSIONS: UDS is able to show that several patients with symptoms of pure SUI present an underlying DO and do not require surgery, even 1 year after UDS. In these patients, antimuscarinic treatment appears to ensure a good rate of cure; thus, UDS could lead to the avoidance of several surgical procedures.

TVT-O for the treatment of pure urodynamic stress incontinence: efficacy, adverse effects, and prognostic factors at 5-year follow-up.

BACKGROUND: Inside-out tension-free vaginal transobturator tape (TVT-O) is currently one of the most effective and popular procedures for the surgical treatment of female stress urinary incontinence (SUI), but data reporting long-term outcomes are scarce. OBJECTIVE: To evaluate the efficacy and safety of TVT-O 5-yr implantation for management of pure SUI in women. DESIGN, SETTING, AND PARTICIPANTS: A prospective observational study was conducted in four tertiary reference centers. Consecutive women presenting with urodynamically proven, pure SUI treated by TVT-O were included. Patients with mixed incontinence and/or anatomic evidence of pelvic organ prolapse were excluded. INTERVENTION: TVT-O implantation without any associated procedure. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Data regarding subjective outcomes (International Consultation on Incontinence-Short Form [ICIQ-SF], Patient Global Impression of Improvement, patient satisfaction scores), objective cure (stress test) rates, and adverse events were collected during follow-up. Multivariable analyses were performed to investigate outcomes. RESULTS AND LIMITATIONS: Of the 191 women included, 21 (11.0%) had previously undergone a failed anti-incontinence surgical procedure. Six (3.1%) patients were lost to follow-up. The 5-yr subjective and objective cure rates were 90.3% and 90.8%, respectively. De novo overactive bladder (OAB) was reported by 24.3% of patients at 5-yr follow-up. Median ICIQ-SF score significantly improved from 17 (interquartile range [IQR]:16-17) preoperatively to 0 (IQR: 0-2) (p<0.0001). Failure of a previous anti-incontinence procedure was the only independent predictor of subjective recurrence of SUI (hazard ratio [HR]: 4.4; p = 0.009) or objective (HR: 3.7; p = 0.02). No predictive factor of de novo OAB was identified. CONCLUSIONS: TVT-O implantation is a highly effective option for the treatment of women with pure SUI, showing a very high cure rate and a low incidence of complications after 5-yr follow-up.

Transobturator vaginal tape for the treatment of stress urinary incontinence in elderly women without concomitant pelvic organ prolapse: is it effective and safe?

OBJECTIVE: To evaluate the efficacy and safety of the transobturator approach (TVT-O) for the surgical management of stress urinary incontinence (SUI) in older women. STUDY DESIGN: Between 2007 and 2010, all consecutive women with SUI undergoing an isolated TVT-O procedure were prospectively enrolled in this study. Patients were divided into two groups by age: older women (≥ 70 years old) were included in group 1, while younger women (< 70 years old) in group 2. Intra- and post-operative outcomes were compared between the groups. RESULTS: During the study period 181 women met the inclusion criteria and were included for final analysis. Among these women, 60 (33.1%) and 121 (66.9%) were included in groups 1 and 2 respectively. After a median follow-up of 26 (IQR 15-41) months for the younger and 25 (IQR 18-40) months for older patients (p>0.99), no differences were observed between the two groups in terms of cure rate (92.5% vs. 88.3%; p=0.40). No differences were observed in terms of voiding dysfunction, vaginal erosion and persistent groin pain, or in terms of onset of de novo overactive bladder (9.0% vs. 13.3%; p=0.44). CONCLUSIONS: TVT-O appears to be a safe and effective procedure for the management of stress urinary incontinence also in elderly population.