Intravesical Instillations of Hyaluronic Acid as First-Line Treatment in Patients with Interstitial Cystitis/Bladder Pain Syndrome: Use, Efficacy and Effects on Quality of Life.

The efficacy of hyaluronic acid instillations as therapy for patients with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) has been demonstrated in some clinical studies, with response rates up to 70%. The aim of the study is to investigate the change in symptoms and quality of life in female patients with IC/BPS after intravesical instillations of hyaluronic acid used as first-line treatment. A retrospective single-center cohort study was conducted. Female patients, whose symptoms were compatible with the diagnosis of IC/BPS as defined by the International Continence Society, were treated with a variable number of intravesical instillations of a hyaluronic acid-based drug. Three validated questionnaires were administered by telephone to all patients, before the beginning of the treatment and 6 months after the last administration of the drug. A total of 50 patients with symptoms compatible with the diagnosis of IC/BPS were included in the study. The median number of instillations performed is 4. For all questionnaires, the median value was significantly reduced following treatment with intravesical instillations (p = 0.000). The present study has shown that intravesical hyaluronic acid treatment results in both statistically and clinically significant symptomatic improvement, thereby improving the quality of life of patients with IC/BPS.

The Efficacy of CO2 Vaginal Laser in the Treatment of Recurrent, Post-Coital and Interstitial Cystitis: A Multicentric Prospective Study.

Background: This multicentric prospective study was carried out at Fondazione Policlinico Universitario Campus Bio Medico and Ospedale di Stato of St. Marino Republic. Between 1 January 2019, and 31 December 2022, all pre- and post-menopausal women diagnosed with recurrent, post-coital, and interstitial cystitis at both centers were included in the study. The main aim of the study was to assess the effectiveness of vaginal CO2 laser treatment, alone or combined with intravesical hyaluronic acid instillations, in managing cystitis symptoms, such as dysuria, pollakiuria, and urgency, across the entire patient cohort. The secondary objective was to investigate the reduction in number of annual cystitis episodes post-treatment. Methods: Each woman underwent three to four sessions of micro-ablative CO2 vaginal laser treatment. A follow-up examination was conducted 12 months after the final laser session (up to December 2023), during which a post-treatment VAS assessment evaluated dysuria, daily pollakiuria, and urgency. The enrolled patients recorded the number of cystitis episodes experienced during the 12-month pre- and post-treatment period. Results: Results indicated the laser's efficacy in reducing the total number of cystitis episodes per year and an improvement in symptoms up to one year post-treatment. Greater efficacy of the CO2 laser treatment, particularly when combined with intravesical hyaluronic acid instillation, was observed in both pre- and post- menopausal women. Conclusions: Fractional CO2 laser therapy represents a safe and efficacious, non-hormonal approach for pre- and post-menopausal women diagnosed with recurrent, post-coital, and interstitial cystitis.

The Role of TAP/RS Block in Minor Gynecologic Laparoscopic Surgery: A Randomized Clinical Trial.

OBJECTIVES: The aim of the study was to compare, in patients undergoing minor gynecological laparoscopic procedures, the effects of ultrasound (US)-guided transversus abdominis plane (TAP) + rectus sheath (RS) block versus no TAP/RS block in terms of post-surgical pain control using the numeric pain rating scale (NRS) and the degree of patient satisfaction, according to the main goals of Early Recovery After Surgery (ERAS) programs. The primary outcome is to value the postoperative abdominal pain using NRS in both groups. Secondary outcomes are to evaluate blood values, presence of postoperative nausea and vomiting (PONV), postoperative ileus, level of patient expected satisfaction, time of discharge, length of stay (LOS), and the amounts of additional analgesics required. DESIGN: In this prospective randomized controlled trial, patients were randomly assigned to loco-regional anesthesia (LRA) group, who received TAP and RS block under US guidance, or no loco-regional anesthesia (N-LRA) group. Enrolled patients were randomized 1:1 to either receive bilateral TAP/RS block with ropivacaine or sham treatment (patches were applied on the abdominal wall of the patients under general anesthesia). PARTICIPANTS: All patients aged between 18 and 75 years, with ASA (American Society of Anesthesiologists) physical status 1-2, undergoing laparoscopic minor gynecological surgery, were enrolled. SETTING: The study was conducted to the University of Campus Bio-Medico Hospital of Rome. METHODS: Half an hour before surgery, all patients received gabapentin 300 mg per os. Once the patient underwent general anesthesia, US-guided bilateral TAP/RS block was performed by the anesthesiology team, while the uterine manipulator was positioned by a gynecology resident (not involved in the study). In the operative room, all patients received the same standardized anesthetic regimen. Postoperative abdominal pain was assessed at rest, after palpation, during movement, and after a cough by evaluating the patient at 6, 12, 18, 24, 36, 48, and 72 h after surgery, using the NRS from 0 to 10 in both groups. The amount of drug used for analgesia in the first 48 h after surgery was recorded. Moreover, hemoglobin, white blood cells, and c-reactive protein levels were recorded at 24, 48, and 72 h. The presence of PONV and the postoperative ileus was recorded throughout convalescence. The expected level of patient satisfaction at discharge and finally the LOS were assessed. LIMITATIONS: The major weakness of this study is that 60 mL of 0.5% ropivacaine was administered to each patient, without considering weight differences, yet contemporary literature rarely suggests volume/dose titration in fascial blocks. RESULTS: A total of 104 women, undergoing gynecological minor laparoscopic surgery, were enrolled and assigned to LRA group (53 pts) and N-LRA group (51 pts). Postoperative pain was significantly reduced in patients who received TAP/RS block. A reduction in the intake of non-steroidal anti-inflammatory drugs after surgery was registered in LRA group (p < 0.01). Moreover, a significant reduction of LOS (45.97 ± 9.87 vs. 65.08 ± 17.32 h; p < 0.01) and PONV was observed in the LRA group, as well as a better level of patient satisfaction at discharge (9.43 ± 0.94 vs. 8.26 ± 1.19; p < 0.01), compared to the N-LRA group. CONCLUSIONS: US-guided TAP and RS block significantly reduces postoperative pain after minor gynecologic laparoscopic surgery and improves patients' post-operative recovery.

Impact of COVID-19 Pandemic on the Diagnostic and Therapeutic Management of Endometrial Cancer: A Monocentric Retrospective Comparative Study.

Endometrial cancer represents an ideal target to evaluate the impact of COVID-19 being the most frequent gynecological malignancy in Italy, generally detected at early stages and correlated with favorable oncological outcomes. The present comparative retrospective study carried out at Campus Bio-medico University Foundation in Rome aims to evaluate the impact of the COVID-19 pandemic on the presentation, diagnosis and treatment of EC. All women with a histological diagnosis of non-endometrioid and endometrioid endometrial cancer between 1 March 2018 and 31 October 2022 were included. The number of cases was higher in period 2 (95 vs. 64 cases). Time to diagnosis did not show statistically significant differences but in period 2, 92.06% of the diagnoses were made following abnormal uterine bleeding, while in period 1, only 67.02% were. The waiting time for the intervention was significantly shorter in period 2. Definitive histology, FIGO staging, surgical technique and adjuvant therapy did not show significant differences between the two periods. The study demonstrates that the impact of the COVID-19 pandemic did not have a direct effect on the diagnostic delay, tumor staging and type of therapy but rather on the presentation pattern of endometrial cancer.

The use of sealing hemostat patch (HEMOPATCH®) in laparotomic myomectomy: a prospective case-control study.

PURPOSE: Uterine myomas are the most common gynecological disease. In these cases, a myomectomy is performed traditionally laparotomically. However, alternatives have been widely used, including laparoscopic, endoscopic, and robotic surgery. During these techniques, diffuse parenchymatous bleeding remains one of the main intraoperative and postoperative complications and sometimes requires unplanned hysterectomies. Recently, hemostatic agents and sealants have been used to prevent excessive blood loss during surgical repair. METHODS: We propose a prospective case-control study on the use of a sealing hemostat patch (HEMOPATCH®) on uterine sutures in laparotomic myomectomy. In the period between July 2016 and April 2017, 46 patients with symptomatic uterine fibromatosis underwent surgery. They were divided into two groups of 23 patients, with different treatments in the hemostatic phase of oozing bleeding. HEMOPATCH® is applied in group A, and spray electrocoagulation is applied in group B. RESULTS: In group A, we achieve faster hemostasis (p < 0.05), than in group B. We report a significantly lower C-reactive protein value on the second and third days after surgery for group A compared to group B. CONCLUSIONS: HEMOPATCH®, during laparotomic myomectomy, is a valid alternative solution for obtaining rapid hemostasis and consequently intraoperative and postoperative bleeding. Furthermore, we suggest that a lower inflammatory peritoneal state is probably correlated with the barrier effect of the patch on the suture.

C-reactive protein "at first sight": Standard postoperative trend in gynecological surgery and a comparative analysis with white blood cell levels.

OBJECTIVE: There is a lack of information about the normal trend of C-reactive protein (CRP) blood levels in the postoperative days after gynecological benign surgery. We investigated the impact of different surgical techniques on CRP trend. We performed a comparative analysis between a CRP and white blood cell (WBC) trend in postoperative monitoring. METHODS: We studied 207 surgical patients for benign gynecological pathology. We analyzed CRP and WBC levels after surgery in the total number of women and separately by approaches. RESULTS: CRP mean log scores showed a typical behavior. Moreover, results from chi-square test underline that the proportion of women with this result is independent from the type of surgery they underwent. Log score mean values of CPR differed between all groups and between times. No difference in the mean number of white cells between the second and the third day was found, as observed for CRP. CONCLUSIONS: Our study shows a trend reference model in postoperative monitoring of patients with benign gynecological surgery. The comparative analysis between the CRP and WBC trend in the postoperative days provided us data demonstrating the superiority of CRP in postsurgical patient outcomes monitoring.

Role of Protopine and Nuciferine in the Management of Nocturia, Urgency, and Dysuria in Pre- and Postmenopausal Women: A Prospective Pilot Study.

OBJECTIVES: Nocturia was commonly treated with drugs burdened with high costs and numerous side effects; in fact, more than 70% of patients drop out of long-term treatment. Protopine and nuciferine are two alkaloids that have different effects on the neurotransmitter receptors involved in the regulation mechanism of the onset of urinary stimuli. The aim of the study was to evaluate the efficacy in controlling primarily nocturia and secondarily urgency and dysuria after 3 months of treatment with combination therapy of protopine and nuciferine syrup. DESIGN: This is a prospective cohort study in which all patients were diagnosed with overactive bladder syndrome (OAB) and the presence of the following symptoms: nocturia, urgency, and dysuria. Thirty patients were administered 10 mL/die (16.6 mg of nuciferine, 0.09 mg of protopine) of syrup for 3 months. Patients were evaluated at baseline (T0) with the International Consultation on Incontinence Questionnaire (ICIQ), Visual Analogue Scale (VAS) for the evaluation of dysuria, Patient Perception of Intensity of Urgency Scale (PPIUS) and at 3 months (T1) with the Patients' Global Impression of Change (PGI-C) scale, PPIUS, VAS, and ICIQ. PARTICIPANTS: Women with diagnosis of OAB; the presence of nocturia, urgency, and dysuria symptoms agreeing to undergo treatment and compiling informed consent; and the absence of contraindications to the use of active ingredients were included in the study. SETTING: Patients were recruited at T0 during the visit to the Uro-Gynecology clinic of the University of "Campus Bio-Medico" and visited again 3 months (T1) after the initiation of therapy. METHODS: We explored survey data by descriptive statistics: in particular, continuous values (i.e., ICIQ) have been summarized by mean and standard deviation of discrete ordinal values (i.e., VAS, PPIUS, and bladder diary parameters at T0 and T1) by median, minimum, and maximum reported scores. Where we could assume normality in distribution, assessed by the Shapiro-Wilk test and the evaluation of the QQ plot, we compared the observation of T0 and T1 with the paired Student's t test; otherwise, we tested differences in distribution with the paired Mann-Whitney U test. RESULTS: Thirty patients completed a 3-month therapy. The ICIQ and VAS questionnaires for the assessment of dysuria, both, reported an improvement in dysuria at T1 (p < 0.001). The PPIUS questionnaire reported an improvement in urinary urgency at T1 (p < 0.001). The PGI-C scale in T1 indicated an improvement in symptoms: 93% for nocturia, 70% for urinary urgency, and 63% for dysuria. LIMITATIONS: The weaknesses of this study are the small number of patients; as a pilot study, the study design was not randomized with a placebo and without blinding; and the short follow-up. CONCLUSIONS: Protopine and nuciferine can be an interesting alternative to primarily treat and reduce nocturia episodes, in addition to improving OAB-related urgency and dysuria.

Early Mini-Invasive Treatment of Persistent Cervical Dysplasia: Clinical Outcome and Psycho-Relational Impact.

Introduction: After the diagnosis of L-SIL, 77. 3% had a persistent infection and anomalous Pap Test results. Many of these patients had highlighted psychological consequences such as anxiety, hypochondria, fear of cancer, and sexual problems. Several studies suggested that the clearance of HR-HPV infection could be accelerated by cervical excisional procedures, especially in L-SIL. In consideration of the psychological implications for HPV infection and related dysplasia in patients with CIN1 at PAP-smear and HR-HPV positivity at least for 6 months, we decided to plan a prospective study where we tried to anticipate excisional cervical using a minimally invasive treatment: thin loop electrosurgical excision procedure (t-LEEP). This study aims to analyze the clearance of HR-HPV after 6 and 12 months, clinical outcomes related to t-LEEP, and the psycho-relational impact at 12 months after t-LEEP. Materials and Methods: We enrolled patients with the diagnosis of L-SIL at PAP-smear and HR-HPV positivity with a persistent CIN 1 (at least for 6 months), confirmed by cervical biopsy. All enrolled patients underwent t-LEEP. We followed prospectively and performed for all patients the HPV DNA test at 6 (T1) and 12 months (T2) and STAI-Y and FSFI scores at T0 and T2. Results: We prospectively enrolled 158 patients, 22 are excluded for the established criteria. Patients with HR-HPV and CIN 1 lesions treated with t-LEEP had an overall clearance of 83.8% at T2. In subgroups analysis at T2, we had a regression: in smoker 71.8%, in contraceptive users 69.5%, in patients aged <25 years 100%, aged 25-30 years 85%, aged 30-35 years 94.4%, aged 35-40 years 92%, and aged ≥40 years 89.1%, in HPV-16 96.4%, in HPV-53 89.5%, in HPV-18 87.5%, in HPV-31 86.6%, and in coinfected 3.5%. STAI-Y and FSFI after t-LEEP (T2) were statistically significant, reducing anxiety status and improving sexual function. Conclusion: Based on these results, the use of t-LEEP in patients with persistent CIN 1 and HPV-HR at least for 6 months could be useful for accelerating HPV-HR clearance, in particular, for a subpopulation patient with an increased risk of progression and/or patients with psychological and sexual consequences of carrying an HR-HPV infection.

Role of BRCA Mutation and HE4 in Predicting Chemotherapy Response in Ovarian Cancer: A Retrospective Pilot Study.

Even though 80% of patients with High-Grade Serous Ovarian Cancer respond to standard first-line chemotherapy, a majority of them could relapse in the following five years due to a resistance to platinum. Human Epididymis protein 4 (HE4) is one of the most promising markers in predicting platinum therapy response. This pilot study aims to evaluate the potential role of HE4 value in predicting chemotherapy response in BRCA mutated patients and in BRCA wild-type (non-mutated) ones. We selected 69 patients, affected by High-Grade Serous Ovarian Cancer, and optimally debulked and submitted to standard chemotherapy protocols. HE4 was dosed during every chemotherapy course. Patients were classified as platinum-resistant and platinum-sensitive. According to BRCA mutation test, patients were further divided into BRCA wild-type (53 patients), and BRCA mutated (16 patients). 35 patients out of 69 (52%) were platinum-sensitive (recurrence > 12 months), while 33 patients (48%) were platinum-resistant (recurrence < 12 months). Thus, in the total population, HE4 performed as a marker of chemosensitivity with a sensibility of 79% and a specificity of 97%. In the BRCA WT group, 23 patients out of 53 (43%) were platinum-sensitive, while 30 patients out of 53 (57%) were platinum-resistant. In the BRCA WT group, HE4 performed as a predictive marker of chemosensitivity with a sensibility of 80% and a specificity of 100%. In the BRCA mutated group, 13 patients out of 16 (82%) were platinum-sensitive, while 3 patients (18%) were platinum-resistant. In the BRCA mutated group, HE4 performed as a predictive marker of chemosensitivity in all patients. The ability to detect platinum-resistant patients before tumor relapse probably could open new therapeutic scenarios.

Tailoring parametrectomy for early cervical cancer (Stage IA-IIA FIGO): a review on surgical, oncologic outcome and sexual function.

INTRODUCTION: Cervical cancer is currently one of the most common cancers afflicting the female population worldwide and in industrialized countries the presence of screening and a specific diagnostic and therapeutic process has favored early diagnosis of cervical cancer. In literature have found that reducing the radicality on the parametria in early cervical cancer (ECC), reduces complications without impacting oncological outcomes, but the data in the literature are not yet clear. EVIDENCE ACQUISITION: Searching on PubMed, we included 1473 articles from January 1974 to 2020. We identified all the studies that compared different type of radical hysterectomy in the primary surgical treatment of ECC. 16 articles were elected for the review. EVIDENCE SYNTHESIS: Modified radical hysterectomy (Piver II/Querleu-Morrow Type B) in ECC, if compared to CRH (Piver III/Querleu-Morrow Type C2), is not associated with worse cancer outcome and patient survival, but it is associated with a minor operating time, lower blood loss and minor bladder dysfunction. Nerve sparing radical hysterectomy approach (NSRH/Querleu-Morrow Type C1) compared to CRH (Piver III/Type C2) in the ECC, with our data we can confirm a non-inferiority regarding the oncological outcome. CONCLUSIONS: Reduced radicality on the parametrium offers positive effects on the quality of life (sexual life and bladder function) of patients without impacting on survival, oncological outcome.

Sentinel lymph node in cervical cancer: a literature review on the use of conservative surgery techniques.

INTRODUCTION: Sentinel lymph node detection is a surgical procedure that allow to avoid systematic lymphadenectomy in those tumors in early stage where lymph node spread is not sure. If the sentinel lymph node is not involved by tumor in 98-99% of case other lymph nodes are clean. The reason why less radical surgery is chosen is linked to the lower postoperative morbidity rate, the risk of lower limb lymphedema decreases. The aim of this review was to summarize what is the state of art of using the sentinel lymph node dissection (SLD) technique and what are the future goals to improve the safety and the reliability. EVIDENCE ACQUISITION: We have conducted a review of the literature of the past 10 years to understand the attitudes of oncologist gynecologists in the world to the conservative treatment of cervical cancer. We only selected articles from 2010 onwards, which meet the inclusion criteria. EVIDENCE SYNTHESIS: The detection rate varies from 83% to 100%. The bilateral detection rate, on the other hand, varies from 42% to 100%. The false negative rate ranges from 4% to 12%. Sensitivity varies from 20.7% (considering the frozen section) to 100%. CONCLUSIONS: Indocyanine green is the most reliable and performing tracer for the search of the sentinel lymph node; that the false intraoperative negative rate is too high to be sure not to subject the patient to an incorrect therapeutic procedure; data concerning the safety and survival of conservative lymphadenectomy (SLND) compared to systematic lymphadenectomy are still lacking in the literature and therefore we are awaiting the results of the two ongoing randomized clinical trials that will allow us to have more significant scientific data.

Laparoscopic Ethanol Sclerotherapy for Ovarian Endometriomas: Preliminary Results.

STUDY OBJECTIVE: The purpose of this study was to evaluate the laparoscopic aspiration of endometriomas through 95% ethanol sclerotherapy. DESIGN: A single-center, retrospective study. SETTING: Endometriosis outpatient clinic of a tertiary university hospital, gynecology department of Agostino Gemelli University Foundation Polyclinic IRCCS, Rome, Italy. PATIENTS: Fifty-three women with 64 identified endometriomas measuring 4 to 10 cm with no suspected malignancy. INTERVENTIONS: Laparoscopic aspiration and 95% ethanol sclerotherapy of endometriomas were completed in the patients between September 2013 and September 2017. MEASUREMENTS AND MAIN RESULTS: Using standard laparoscopy, the ovarian endometriomas were aspirated and washed to remove all cystic material. A 95% ethanol solution was instilled in the cysts and left for 15 minutes, then removed. The patients were followed by ultrasound at 3, 6, 9, and 12 months, and then annually to identify recurrence. All patients were administered postoperative hormone therapy, suspended only in those desiring pregnancy or experiencing adverse effects. The mean age was 32 years (range 19-40 years), and the mean cyst diameter was 6 cm (range 4-10 cm). Thirteen of the 53 patients (25%) had had previous surgery for endometriomas. Forty-one patients (77%) had associated deep endometriosis, treated during the same laparoscopic procedure. No major ethanol-related complications were recorded. The mean length of follow-up was 31 months. Recurrence of endometriomas was observed in 5 patients (9%). Overall, pregnancy occurred in 16 of 28 patients (57%) desiring pregnancy. CONCLUSION: Laparoscopic aspiration and ethanol sclerotherapy as treatment for endometriomas, even in patients with bilateral endometriomas or with associated deep endometriosis, resulted in <10% recurrence and no major complications.

Role of human epididymis protein 4 (HE4) in detecting recurrence in CA125 negative ovarian cancer patients.

OBJECTIVE: There are no current guidelines regarding evaluation of patients with normal CA125 at initial diagnosis during routine surveillance after completion of treatment. Thus, the purpose of this study was to evaluate the role of human epididymis protein 4 (HE4) in the detection of recurrence in patients with ovarian cancer and a negative CA125 at diagnosis. METHODS: All patients with ovarian cancer with a negative CA125 referred to the Division of Gynecologic Oncology of the University Campus Bio-Medico of Rome were included in the study. Inclusion criteria were: age between 18 and 70 years old, diagnosis of epithelial ovarian cancer, optimal primary surgery (residual tumor <1 cm), and normal CA125 at initial diagnosis. Patients with other malignancies or chronic diseases were excluded from the study. Statistical analysis was based on the calculation of percentages, means, medians, and ranges of the values. RESULTS: A total of eight patients were included in the study. The median age was 53 years (range 40-75). All patients had a normal CA125 at initial diagnosis while seven (87.5%) patients had abnormal HE4 levels at diagnosis. The International Federation of Gynecology and Obstetrics (FIGO) stages at enrollment varied from IC to IIIC (IB (1), IC (3), IIC (1), IIIC (3)). The most common histologic subtype was serous (62.5%). Seven patients recurred and had abnormal HE4 and normal CA125 values. The median HE4 at recurrence was 107 pmol/L. The median disease-free interval was 55 months (range 5-108) and all the patients underwent optimal cytoreductive surgery. CONCLUSIONS: HE4 levels may serve as a marker for recurrence in patients with a normal CA125 at initial diagnosis. Future studies are needed to evaluate the role of HE4 levels in earlier detection of recurrent ovarian cancer.

The role of human epididymis protein 4 as a biomarker in gynecologic malignancies.

INTRODUCTION: The serum levels of glycoprotein human epididymis protein 4 (HE4) have been widely investigated in patients with ovarian cancer as a tumor marker to differentiate benign gynecological tumors from ovarian cancers (OC). A few studies demonstrated the promising role of HE4 in endometrial cancer (EC) too. The aim of this review is to provide an outline of published studies investigating HE4 in the diagnosis of gynecologic malignancies, focusing on its role in OC and EC. EVIDENCE ACQUISITION: We conducted a systematic review of literature from January 1952 to June 2018 on the role of HE4 in OC and EC focusing on the diagnostic power in terms of sensitivity and specificity. EVIDENCE SYNTHESIS: We identified 49 articles with an overall sample size of 12,631 patients in OC group and five studies with an overall sample size of 1221 patients in EC group. We stated that HE4 had a pooled sensitivity of 78% and specificity of 86% in the detection of borderline or malignant OC and a pooled sensitivity of 78.8% and specificity of 100% in EC diagnosis. CONCLUSIONS: This systematic review confirms the importance of HE4 in the diagnosis of epithelial ovarian cancer and its promising role in endometrial cancer (endometrioid histology).

The role of macroplastique implantation in the management of occult urinary stress incontinence.

OBJECTIVE: Pelvic floor disorders, in particular pelvic organ prolapse (POP) and stress urinary incontinence (SUI), are common in women. There is a described higher risk to develop postoperative SUI also in preoperatively continent women: this happens because in 30% of women the relief of the urethral obstruction caused by prolapse, unmasks a pre-existing compromised urethral function and thus an "occult" or potential SUI. The aims of this study were to evaluate the role of Macroplastique® implant, TVT-O or surgery alone in the management of occult urinary stress incontinence during prolapse surgery in terms of success rate and adverse events. STUDY DESIGN: We enrolled 47 consecutive patients scheduled to vaginal prolapse surgery who did not report symptoms of stress incontinence. We collected surgical data, success and complication rates. Moreover we compared all the data with retrospective ones regarding surgery plus concomitant TVT-O (39 pts) and surgery alone (41 pts). RESULTS: At 12-months follow-up, we reported a success rate of 87,2% in the "macroplastique group", comparable to the "surgery plus TVT-O group", with a statistically significant difference in comparison to the "surgery alone" group. "Surgery + TVT-O" group reported a higher rate of major complications (p<0,01) in comparison to the other groups. CONCLUSIONS: Postoperative SUI prevention at the time of prolapse repair remains a challenging issue. In selected patients, Macroplastique may play an interesting role having a good success rate and a low complication rate and for these reasons it may be proposed as A concomitant procedure during POP surgery.

Implementing the Risk of Endometrial Malignancy Algorithm (REM) adding obesity as a predictive factor: Results of REM-B in a single-center survey.

OBJECTIVE: In 2013, our group assessed a risk stratification tool of endometrial cancer (EC), called REM (Risk of Endometrial Malignancy). A well known risk factor for EC is body mass index (BMI). In fact, (BMI > 30 and <35 kg/m2) and severe obesity (BMI > 35 kg/m2) were associated with a 2.6-fold and a 4.7-fold increase in EC risk, respectively. Therefore, in the present study we aim to improve the performance of REM, including BMI and developing a new scoring system, called REM-B (Risk of Endometrial Malignancy score associated to BMI), to classify patients into high risk or low risk groups for EC. STUDY DESIGN: Women, between 45 and 80 years, diagnosed with ultrasound endometrial abnormalities and scheduled to have surgery were enrolled on a prospective study at Department of Gynaecologic Oncology of Campus Bio-Medico of Rome. Preoperative clinical, ultrasound and laboratory features were taken into account. RESULTS: A total of 675 patients (88 with EC and 587 with benign endometrial disease) were divided in training set (TS) and verification set (VS). Age, symptom, BMI, HE4 levels and ultrasound endometrial thickness were found statistically significant and included into multivariate logistic regression model in order to determine the probability to have EC. REM-B showed an overall sensitivity of 94.7% (versus 92% of REM) and a specificity of 97.4% (versus 96% of REM). CONCLUSIONS: Our data support the use of REM-B to triage patients into low and high risk of EC, even if an external validation of model is needed.

Assessment of Quality of Life and Urinary and Sexual Function After Radical Hysterectomy in Long-Term Cervical Cancer Survivors.

AIMS: The aim of this study was to evaluate long-term quality of life and urinary and sexual function in long-term cervical cancer survivors previously treated with radical hysterectomy (RH) type C2/type III. METHODS: All patients who presented at Campus Bio-Medico of Rome for RH type C2/type III for cervical cancer were considered eligible for this retrospective study protocol. We included exclusively patients with complete response to primary treatment with at least 36 months of follow up. Included subjects were interviewed with the European Organization for Research and Treatment of Cancer QLQ-CX24 Questionnaire, European Organization for Research and Treatment of Cancer QLQ-C30, and an Incontinence Impact Questionnaire 7. RESULTS: From January 2004 to June 2014, 251 patients affected by locally advanced cervical cancer were treated at Campus Bio-Medico of Rome treated with type C2/type III RH. At time point of March 2017, 90 patients were included with a mean age of 55.6 ± 8.5 years. The questionnaires were administered after a median follow-up of 49 months after the end of therapy. The symptoms of fatigue, nausea and vomiting, appetite loss, pain, insomnia, and dyspnea, as well as a negative financial impact, were reported as not frequent and rarely disabling. On the contrary, patients frequently reported gastrointestinal complaints. Diarrhea was present in 6% of patients and was referred as mild; constipation was present in 75% of women and was reported as mild in 30% of cases, moderate in 30%, and severe in 15%. Concerning sexual activity, data indicated a good level of sexual enjoyment with a slight worsening of sexual activity. Incontinence was reported in 28% of cases and appeared to be mild and rarely disabling (all mean values <2). CONCLUSIONS: Waiting for ongoing randomized controlled trials, this study confirmed that RH may be considered as a useful treatment plan, according to its negligible long-term impact on quality of life, urinary dysfunction, and sexual function.

Long-term follow-up of bulking agents for stress urinary incontinence in older patients.

OBJECTIVE: Implantation of bulking agents represents a noninvasive procedure for the treatment of stress urinary incontinence (SUI) in all patients where a more invasive procedure may increase perioperative risks. The primary aim of this retrospective study was to evaluate the efficacy over time of bulking agent implantation. As secondary aims, we evaluated long-term (patients' subjective) satisfaction rate, rate of de novo urinary symptoms, and the impact of urinary incontinence on the quality of life. METHODS: All patients who underwent implantation of bulking agents between 1999 and 2013 at Campus Bio-Medico of Rome were retrospectively considered eligible for this study. Patients were interviewed using two standardized questionnaires: International Consultation on Incontinence Questionnaire Short Form and Patient Global Impression of Improvement. Cure rate, improvement rate, failure rate, and the onset of new symptoms were also investigated through specific questions. The original group of patients was then divided into two subgroups according to follow-up time (group A: shorter than median follow-up; group B: longer than median follow-up). RESULTS: Sixty-three patients were enrolled. Mean follow-up was 8.3 ±â€Š3.5 years with a range of 3.5 to 18 years. Fifteen (24%) cured patients (cure rate), 12 (19%) improved patients (improvement rate), 36 (57%) failed treatment (failure rate). We reported an overall success rate of 43%. No differences were reported among groups in terms of overall success rate (42% vs 44% for group A and group B, respectively). CONCLUSIONS: Bulking agent implantation is an effective treatment for people with intrinsic sphincter deficiency (type III SUI) and it is a valid alternative to more invasive surgeries in older patients. Moreover, it shows an overall success rate (43%) that remains high even after many years.

Anterior colporrhaphy plus inside-out tension-free vaginal tape for associated stress urinary incontinence and cystocele: 10-year follow up results.

AIMS: We report the success rate and complications rate of combined ultralateral anterior Colporrhaphy plus Tension-free Vaginal Tape (TVT-O) in a long-term (10 year) follow-up prospective survey. METHODS: Patients previously treated for associated stress urinary incontinence (SUI) and cystocele were subjected to annual follow-up for 10 year with a complete urogynecologic evaluation. Furthermore, an urodynamic assessment and a quality of life questionnaire (ICIQ-UI SF) were recorded at the 5th and 10th year of follow up. RESULTS: Fifty patients treated between June 2004 and May 2006 were included in the analysis. Five patients did not return to 5-yr follow-up: two patients developed a median tape erosion and three patients withdraw. At 10-yr follow-up two more patients withdraw for a total of seven patients lost to follow-up. After 10 years patients objectively cured from cystocele were 41 (95%) while patients objectively cured from SUI were 39 (91%). At 10th year follow-up 38 patients (89%) result cured from both SUI and cystocele, 3 (7%) patients result cured only from prolapse, 1 (2%) patient only from SUI, and 1 (2%) patient result objectively failed for both SUI and cystocele. The ICIQ-UI SF scores at 10th year follow-up was 6.2 ± 3.7. The late complication rate at 10th year follow-up was 32% (OAB symptoms 20%; Mixed incontinence 2%; Bladder outlet obstruction 0%; Dyspareunia 6%; Chronic pelvic pain 0%; Vaginal tape erosion 4%; Detrusor hyperactivity 0%). CONCLUSIONS: The combined procedures shown proved to be an effective and safe procedure to treat concomitant SUI and cystocele.