Polyhexamethylene Biguanide Reduces High-Risk Human Papilloma Virus Viral Load in Cervical Cell Samples Derived from ThinPrep Pap Test.

Human papilloma virus (HPV) infection and its progression still represent a great medical challenge worldwide. Clinical evidence has demonstrated the beneficial effects of polyhexamethylene biguanide (PHMB) on HPV clinical manifestations; however, evidence of the effect of this molecule on HPV viral load is still lacking. In this in vitro study, 13 ThinPrep Papanicolaou (Pap) tests were treated with a PHMB solution (0.10 g/100 mL) for 2 h. We observed no cytological changes but a significant reduction in the viral load of high-risk (HR) HPV after PHMB treatment, also revealing a dose-dependent antiviral effect. In addition, by stratifying the obtained results according to HR-HPV genotype, we observed a significant reduction in the viral load of HPV 16, P2 (56, 59, 66), 31, and P3 (35, 39, 68) and a strong decrease in the viral load of HPV 45, 52, and P1 (33, 58). Overall, 85% of the analyzed cervical cell samples exhibited an improvement in HPV viral load after PHMB exposure, while only 15% remain unchanged. For the first time, the data from this pilot study support the activity of PHMB on a specific phase of the HPV viral lifecycle, the one regarding the newly generated virions, reducing viral load and thus blocking the infection of other cervical cells.

[Introduction of a centralised system (Service) for collecting clinical data in cancer screening programmes in Piedmont (Northern Italy): a pre-post assessment of a hub&spoke model]. / L'introduzione di un sistema centralizzato (Service) per la raccolta dei dati clinici negli screening oncologici in Piemonte: valutazione pre-post di un modello hub&spoke.

OBJECTIVES: evaluation of a centralised collection of clinical data (Service) within cancer screening programmes in Piedmont based on a hub&spoke model and its impact on process indicators. DESIGN: assessment of an organisational intervention, through a non-controlled pre-post design. SETTING AND PARTICIPANTS: organised screening programmes within the Piedmont Region, divided into 9 departments. MAIN OUTCOME MEASURES: clinical data (extracted from medical charts for mammography screening and from excision histology reports for cervical screening) obtained through the Service were quantified and their completeness was assessed. The Service impact on the detection rate (DR) was evaluated, comparing the DR pre- (2005-2008) and post-Service (2009- 2012) within breast screening; the DR was computed through histological diagnosis made during colposcopy (pre-Service method) or through the worst diagnosis between the latter and that reported from excision histology (post-Service method) within cervical screening (data available for department 1, year 2013). Some hints on human resources employed in pre- and post-Service periods were reported. RESULTS: within mammography screening, the Service obtained 53.1% of extra-department medical charts and 45.8% of extra-region ones; the percentage of missing diagnoses changed from 5.5% (pre- Service) to 3.7% (post-Service). The age standardised DR for malignant tumours in the post-Service period is 1.3 times the DR of the pre-Service period per 1,000 screening tests. Within cervical screening, 51.7% of histological reports was recorded. Crude DR for high-grade lesions changed from 3.9 (pre-Service) to 4.7 (post-Service) per 1,000 screened women. The system centralisation did not imply an increase in the dedicated personnel. CONCLUSION: the Service is an operational core which coordinates the collection of clinical data, impacting on process indicators without an increase in human resources at departmental level.

Counteracting HPV Cervical and Anal Infection through Dietary Supplementation of EGCG, Folic Acid, Vitamin B12 and Hyaluronic Acid: Clinical Case Reports.

Background: Human papilloma virus (HPV) infection and the management of its persistence is still a great medical challenge. Recently, scientific evidence has supported the potential therapeutic effects of four combined natural molecules-epigallocatechin gallate (EGCG), folic acid, vitamin B12 and hyaluronic acid (HA)-in counteracting HPV DNA positivity and related cytological lesions. Methods: Each patient of these five clinical cases had persistent HPV positivity in the anogenital site and assumed a dietary supplement based on a combination of 200 mg of EGCG, 50 mg of HA, 1 mg of vitamin B12 and 400 mcg of folic acid (Pervistop®, Farmares s.r.l., Rome, Italy) at a dosage of 1 or 2 caps/day for 6 or 3 months, respectively, depending on clinical history. Results: After treatment, all the patients reported a negative HPV DNA test and improved cytological lesions, thus demonstrating the ability of these combined molecules to counteract both anal and cervical HPV infection and related manifestations. Conclusions: Overall, these data corroborate previous evidence about the effectiveness of such natural molecules in the management of HPV infection and its persistence. Naturally, further studies with a larger population and long-term follow-up will contribute to reinforce the positive effects of this dietary supplement in counteracting HPV infection.

A bitter pill to swallow: adjustments to oral contraceptive pill use in polycystic ovary syndrome.

INTRODUCTION: This Special Report aims to highlight the importance of tailored therapies in women with Polycystic Ovary Syndrome (PCOS), avoiding prescribing generalized or unsuitable therapies based on oral contraceptive pills (OCPs). AREAS COVERED: This article discusses the benefits and risks of OCP-based therapy, highlighting the possible undesirable effects, especially in those patients exhibiting risk factors as women with PCOS, and the importance of carefully evaluated tailored therapeutic approaches. Literature searches were performed with the use of PubMed, Google Scholar, and Web of Science between January and February 2024. EXPERT OPINION: Considering the recent re-analysis of PCOS Rotterdam Criteria by the Expert Group on Inositol in Basic and Clinical Research, and on PCOS (EGOI-PCOS), the traditional Rotterdam phenotypes can be reclassified to achieve more efficacious therapy choices. Using personalized therapies that consider the specific clinical characteristics of the patient allows to improve the management of the syndrome, thus avoiding the generalized use of OCPs, which risk treating only symptoms of PCOS rather than the underlying cause. In cases when contraceptive purpose is desired, patients may benefit from combined therapy with diet or insulin-sensitizer agents, as inositol, to rebalance the metabolic profile, thus reducing the risk of developing future complications.

Minimally Invasive Treatment of Stress Urinary Incontinence in Women: A Prospective Comparative Analysis between Bulking Agent and Single-Incision Sling.

INTRODUCTION: The study aims to compare the efficacy and safety of bulking agents and single-incision slings in the treatment of urinary incontinence in 159 patients during a 29-month follow-up period. MATERIAL AND METHODS: Of the 159 patients suffering from stress urinary incontinence, 64 were treated with bulking agents (PAHG Bulkamid®) and 75 with a single-incision sling (Altis®). The ICIQ-UI-SF (Incontinence Questionnaire-Urine Incontinence-Short Form), PISQ-12 (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaires short form), FSFI (Female Sexual Function Index), FSDS (Female Sexual Distress Scale), and PGI-I (Patient Global Improvement Index) were used to assess efficiency and quality of life. RESULTS: The bulking agents showed high efficacy and safety during the 29-month follow-up. Post-operative complications were recorded in both groups, with only two significant differences. The Bulkamid group experienced no pain, while 10.8% of the ALTIS group experienced groin pain and 5% experienced de novo urgency. Furthermore, patients treated with bulking agents experienced reduced nicturia (0.78 vs. 0.92 in patients treated with single-incision slings.). In both groups, we noticed a significant improvement in QoL (quality of life), with a halved ICIQ-UI-SF (International Consultation on Incontinence Questionnaire-Urine Incontinence-Short Form) score which was completed to assess the impact of urine symptoms. After 24 months of therapy, the Bulkamid group saw a decrease from 14.58 ± 5.11 at baseline to 5.67 ± 1.90 (p < 0.0001), whereas the ALTIS group experience a decrease from 13.75 ± 5.89 to 5.83 ± 1.78. Similarly, we observed an improvement in sexual function, with the number of sexually active patients increasing from 29 to 44 (56.4%) in the Bulkamid group (p = 0.041) and from 31 to 51 (61.7%) in the ALTIS group (p = 0.034). According to the most recent statistics, the PISQ-12, FSFI, and FSDS scores all demonstrated an improvement in women's sexual function. CONCLUSIONS: In terms of efficacy and safety, bulking agents had notable results over the 29-month follow-up period. Furthermore, the patients treated with bulking agents reported a lower incidence of postoperative complications and a no discernible difference in terms of quality of life and sexual activity compared to the ones treated with single-incision slings. Bulking agents can be considered a very reliable therapeutic option based on accurate patient selection.

Evaluating the Efficacy of Pervistop®, a New Combination Based on EGCG, Folic Acid, Vitamin B12 and Hyaluronic Acid on Patients with Human Papilloma Virus (HPV) Persistent Infections and Cervical Lesions: A Pilot Study.

BACKGROUND: The persistence of the HPV infection is a risk factor in the integration of viral DNA in the host genome, leading to transforming events. The lack of therapies for HPV-persistent infections determine an unmet medical need. METHODS: We enrolled forty patients with persistent HPV infections and cervical lesions and divided them into two groups. The women in the treated group received 200 mg epigallocatechin gallate (EGCG), 400 µg folic acid (FA), 1 mg vitamin B12, and 50 mg hyaluronic acid (HA) for 12 weeks. The control group received no treatment. RESULTS: 40 patients completed the study. Fifteen out of 20 women in the control group still had an LSIL at the end of the study. One woman had a decrease in the DNA load, while six had no change and eight had an increase in DNA content. In the treatment group, 17 out of 20 women achieved a full viral clearance. These women showed no cytological or histological evidence of lesions following the treatment. CONCLUSIONS: Our data highlight the possible effect of such combination on LSIL. Therefore, the evidence reported here supports the potential to carry out further randomized placebo-controlled studies with an adequate number of patients to verify our results.

Italian multicenter mid-term analysis of laparoscopic lateral suspension in women with pelvic organ prolapse: clinical, sexual and Quality of Life assessment after surgical intervention.

BACKGROUND: The aim of this study was to evaluate effectiveness and safety of laparoscopic lateral suspension in women affected by high grade uterine prolapse associated to anterior defect. The secondary endpoint is to evaluate mid-term impact on Quality of Life and sexual function. METHODS: A multicenter retrospective study on women undergoing laparoscopic lateral suspension for uterine prolapse ≥III stage was performed. We included 174 women, but due to exclusion criteria, 134 patients were enrolled for this study. Preoperative evaluation consisted of an urogynecological interview, clinical exam, 3-day voiding diary and urodynamic testing; the prolapse Quality of Life Questionnaire was used to quantify the impact of prolapse symptoms on Quality of Life and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form, the Female Sexual Function Index and the Female Sexual Distress Scale were administered to evaluate sexual function before surgical intervention and at median follow-up of 3.8 years. RESULTS: We included 134 women with uterine prolapse ≥III stage. All patients underwent laparoscopic lateral suspension, 8 also posterior colporrhaphy and 5 also transobturator tape insertion. POP-Q classification score for anterior and apical compartment showed a significant average decrease. The surveys administered to patients showed an improvement in Quality of Life, an increase in the number of monthly intercourses and a significant improvement in sexual life after surgery. CONCLUSIONS: Laparoscopic lateral suspension for pelvic organ prolapse correction is a safe and effective technique for uterine and anterior associated defect. Quality of Life and sexual function significantly improved after surgery.

Post radical hysterectomy urinary incontinence: a prospective study of transurethral bulking agents injection.

OBJECTIVE(S): The aim of the present study is to prospectively investigate the efficacy and complications of macroplastique transurethral implantation in cervical cancer patients affected by stress urinary incontinence (SUI) after radical hysterectomy (RH). METHODS: Patients affected by de novo SUI post type 3 RH were considered for eligibility in this study. Preoperative and postoperative assessment included a standardized urogynecological history, urogynecological and neurological physical examination, evaluation of severity of SUI symptoms, a 3-day voiding diary, urine culture and urodynamic assessment. All patients underwent transurethral implantation using Macroplastique Implantation System (MIS). Patient follow-up was performed 6 and 12 months after surgery. RESULTS: A total of 24 consecutive patients were enrolled. At the 12 month follow up SUI cure rate was 42% (10 of 24 patients), the improvement rate was 42% (10 of 24) and the failure rate was 16% (4 of 24). The overall success rate was 84% (10 patients cured and 10 improved). No intraoperative or postoperative early complications were found. The 4 patients in whom treatment was not a success had preoperative urethral hypermobility. Subjective patient perception of SUI symptom severity showed significant improvement (mean severity of urinary loss perception 6.6+/-1.8 vs 2.3+/-3.3, p<0.05). The frequency of incontinence on the 3-day voiding diary was significantly reduced at the follow up (14.5+/-5.8 vs 4.3+/-7.9 episodes per 3 days, p<0.05). CONCLUSION(S): Bulking agents urethral injection could be a valid option having no surgical complications. This therapeutic strategy is able to treat SUI and improve well being of cervical cancer patients after radical surgery.

Three-day topotecan schedule in heavily pretreated recurrent ovarian cancer patients.

OBJECTIVE: To evaluate the clinical benefit of a 3-day topotecan schedule in heavily pretreated recurrent ovarian cancer patients scheduled for palliative treatment. METHODS: Eligibility criteria were 2 or more prior chemotherapy regimens, Eastern Cooperative Oncology Group performance status of 2 or less; adequate organ function, assessable disease by serum CA-125 measurement before each cycle; and 1 or more cycle of topotecan (1.5 mg/m per day) on 3 consecutive days of a 28-day treatment cycle. Toxicity was graded according to the National Cancer Institute Common Toxicity Criteria version 3. Tumor response, stable disease, and progression were evaluated on the basis of CA-125 levels. RESULTS: A total of 68 patients were considered eligible for the study. Median age was 58 years (range, 40-77 years), and the median number of prior chemotherapy regimens was 2 (range, 2-6). A total of 272 cycles of topotecan were administered, with a median of 4 cycles per patient (range, 1-8). No treatment delays or dose reduction was recorded. Major toxicities were grade 3/4 (18%) neutropenia, neutropenic fever (6%), grade 4 thrombocytopenia (3%), requirements for blood (5%), and platelet transfusions (3%). Thirty-five (54%) of the 64 evaluable patients showed a clinical benefit. Of these, 11 patients (17%) had a partial response, and 24 (37%) had stable disease with a median time to progression of 7.5 months (range, 6-10 months) and 4 months (range, 2-6 months), respectively. CONCLUSION: More than half of heavily pretreated ovarian cancer patients may benefit from 3-day topotecan.

Effects of myo-inositol plus alpha-lactalbumin in myo-inositol-resistant PCOS women.

BACKGROUND: Myo-inositol (MI), successfully used in polycystic ovary syndrome (PCOS), was administered with α-LA to exploit its action of favouring the passage of other molecules through biological barriers, and also considering its anti-inflammatory effect. METHODS: PCOS patients, according to the Rotterdam ESHRE-ASRM criteria, with anovulation and infertility > 1 year, were included in this open and prospective study. The preliminary phase was aimed at determining a set of MI-resistant PCOS patients. This treatment involved 2 g MI, taken twice per day by oral route, for three months. The Homeostasis Model Assessment (HOMA) index and MI plasma levels were measured. In the main phase, previously selected MI-resistant patients received the same daily amount of MI plus 50 mg α-LA twice a day, for a further three months. Ovulation was assessed using ultrasound examination on days 12, 14 and 20 of the cycle. The HOMA index, lipid, hormone and MI plasma levels were detected at baseline and at the end of this phase. RESULTS: Thirty-seven anovulatory PCOS subjects were included in the study. Following MI treatment, 23 of the 37 women (62%) ovulated, while 14 (38%) were resistant and did not ovulate. In the latter group, MI plasma levels did not increase. These MI-resistant patients underwent treatment in the main phase of the study, receiving MI and α-LA. After this combined treatment, 12 (86%) of them ovulated. Their MI plasma levels were found to be significantly higher than at baseline; also, a hormone and lipid profile improvement was recorded. CONCLUSION: The combination of MI with α-LA allowed us to obtain significant progress in the treatment of PCOS MI-resistant patients. Therefore, this new formulation was able to re-establish ovulation, greatly increasing the chances of desired pregnancy. TRIAL REGISTRATION: Clinical trial registration number: NCT03422289 ( ClinicalTrials.gov registry).

Urologic function and urodynamic evaluation of urinary diversion (Rome pouch) over time in gynecologic cancers patients.

OBJECTIVE: To describe the urologic late complications and urodynamics outcome adopting teniamyotomies technique to create a low-pressure reservoir using the cecum, ascending colon and proximal part of the transverse colon without detubularization (Rome pouch). METHODS: Twenty-eight consecutive patients affected by gynecological cancer and submitted urinary diversion with "Rome pouch" technique were included. After 3 and 12 months from the surgical procedure patients were submitted to urodynamic evaluation of the neobladders. Excretory urography was performed in all patient. Abdominal X-ray, serum electrolytes, creatinine and cultures of the reservoir are obtained during every visit. Long-term urologic complications were recorded. Patient quality of life was assessed using a 10 cm grade visual analog scale (VAS). RESULTS: Urodynamics performed 12 months postoperatively showed that the mean maximum reservoir capacity was 439.9+/-58.9 cm H(2)O. The mean reservoir pressure at maximum capacity was 19.2+/-8.4 cm H(2)O (no contractive wave during the filling in any patient). The mean maximum closure pressure in the efferent tube, at maximum capacity, was 88.8+/-32.3 cm H(2)O. Continence was excellent for 26 (93%) and 23 (92%) patients at 3 and 12 months respectively. A total of 9 (32%) and 6 (24%) patients suffered late complications at 3 and 12 months follow-up respectively. However only one patient with pouch leakage underwent surgical pouch revision. CONCLUSION: Our experience demonstrated that Rome pouch creation with multiple teniamyotomies has good capacity with low internal pressure and good continence with a low rate of late urologic complications. Thus, comparing results to those of other continent pouch models, the Rome pouch technique represents a valid alternative.

Vaginal estrogen therapy and overactive bladder symptoms in postmenopausal patients after a tension-free vaginal tape procedure: a randomized clinical trial.

OBJECTIVE: To evaluate whether the frequency of overactive bladder (OAB) symptoms increases in menopause patients after a tension-free vaginal tape (TVT) procedure, and to determine if topical estrogen therapy can help prevent these symptoms. DESIGN: After undergoing a preoperative assessment, enrolled patients were randomly allocated to receive TVT plus postoperative vaginal estrogen therapy (ET group) or TVT without adjunctive medical treatment (No ET group). The pre- and postoperative assessments included: acquisition of a urogynecologic history with standardized questions regarding urinary function (including a 10-grade visual analogue scale score), urogynecologic clinical examination, and urodynamic assessment. Follow-up assessments were performed at 1, 3, and 6 months after surgery. RESULTS: Fifty-six of 59 patients were evaluable; 28 received topic vaginal estrogen after surgery (ET group) and 28 did not receive adjunctive medical treatment (No ET group). The overall OAB syndrome rate in menopause patients (No ET group) was 7% (2 of 28 patients) at baseline and 32% (9 of 28 patients) 6 months after surgery (P = 0.04). At the 6-month follow-up assessment, the incidence of urinary urgency was 4% (1 of 28 patients) and 29% (8 of 28 patients) in the ET and No ET groups, respectively (P = 0.01). Differences in frequency and nocturia were not statistically significant. Analysis of the visual analogue scale scores revealed that at the 6-month follow-up assessment, urgency significantly improved in the ET group compared with the No ET group (0.23 +/- 1.0 vs 2.30 +/- 3.7, respectively; P = 0.02). CONCLUSIONS: The TVT procedure seems to increase the frequency of OAB syndrome in menopause patients. Vaginal estriol therapy significantly reduces symptoms of urinary urgency, has a high rate of patient satisfaction, and can be used to treat postmenopausal women for at least 6 months after a TVT procedure.

Bowel preparation for gynecological surgery.

Bowel preparation is an established practice before abdominal surgery. Most surgeons would use both antibiotic prophylaxis and mechanical bowel preparation (MBP) before bowel surgery. In the literature, however, there is no evidence to support the use of MBP before elective colorectal surgery. Some randomized studies and a meta-analysis report a significantly higher incidence of wound infection in patients receiving MBP versus no bowel preparation. As to gynecological surgery, data are scanty, and there is a single randomized study reporting no advantage of MBP over no bowel preparation. Based on these evidences, the routine use of MBP should be reconsidered both in general and gynecological surgery.

Invasive vulvar carcinoma and the question of the surgical margin.

OBJECTIVE: To assess the discrepancy between width of surgical margin measured with the naked eye/ruler by a surgeon before removing an invasive vulvar carcinoma, and width of margin measured under microscope by pathologist after fixation of the resected lesion with formalin. Potential relationships between discrepancy and disease recurrence were also investigated. METHODS: This prospective study was conducted with resected lesions from 86 women who underwent surgery for primary/recurrent invasive vulvar carcinoma. After the surgeon removed the lesions surrounded by 1-2-cm margins, the pathologist determined margin width at the 4 cardinal points of 86 lesions (for a total of 344 margin assessments), first macroscopically and then under the microscope. RESULTS: A safety margin of 0.8 cm on microscopic view was achieved in 83% of cases (112 of 135) when the macroscopic measurement was 1cm, in 91% of cases (58 of 64) when it was 1.5 cm, and 98% of cases (105 of 107) when it was 2 cm. CONCLUSION: There was a small discrepancy between the surgeon's intent and the microscopic margin measurement, mostly related to tissue shrinkage. A 1-cm surgical margin corresponded to a 0.8-cm margin in microscopic view (the "safe margin") in most cases.

Early prolapse of a neovagina created with self-dilatation and treated with sacrospinous ligament suspension in a patient with Mayer-Rokitansky-Küster-Hauser syndrome: a case report.

OBJECTIVE: To report a case of a patient who had an early prolapse of the neovagina, while using Frank's dilators method, that was successfully treated with sacrospinous ligament suspension. DESIGN: Case report. SETTING: Tertiary-care university hospital. PATIENT(S): A 22-year-old woman with Mayer-Rokitansky-Küster-Hauser syndrome. INTERVENTION(S): Frank's vaginal dilators method. MAIN OUTCOME MEASURE(S): Vaginal elongation by self-dilatation. Early prolapse of the neovagina. Surgical repair with vaginal sacrospinous ligament suspension. RESULT(S): A few months after the beginning of the treatment the patient had a prolapse of the neovagina. On pelvic examination, the total vaginal length was 5 cm with eversion of the vaginal apex 3 cm beyond the hymen with strain. Vaginal length was not satisfactory for the patient yet; therefore, the vaginal dilation program was continued to reach the prefixed vaginal length. Two months later the total vaginal length was 8 cm with eversion of the vaginal apex 6 cm beyond the hymen with strain. The patient underwent a sacrospinous ligament suspension. Twenty months after surgery, the patient had no symptoms and was highly satisfied with the result. CONCLUSION(S): Prolapse of a neovagina may occur early after conservative treatment. If the initial prefixed goal of vaginal length has not been reached when prolapse develops, the vaginal dilatation program may be continued. In our case vaginal sacrospinous ligament fixation was successful, with good anatomic and functional results.