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Introduction/BackgroundCervical intraepithelial neoplasia (CIN) commonly occurs in women of reproductive age. Conservative management of CIN1 is widely established, as is excisional treatment for CIN3; however, management of CIN2 remains debatable.Our objective was to evaluate the utility of human papilloma virus (HPV) genotyping and the previous cytology in the management of patients with CIN2 lesions.MethodologyPatients newly diagnosed with CIN2 cervical biopsy, older than 16 years old, who agreed to follow up every 6 months for at least 2 years, were prospectively recruited. Unsatisfactory colposcopy and endocervical CIN2 were considered exclusion criteria.Total regression was defined as two consecutives negative cytologies and no evidence of colposcopic lesions, partial regression if final biopsy showed CIN1, persistence when biopsy showed CIN2, and progression if a CIN3 biopsy was detected during follow-up.ResultsThe mean age of 300 patients included was 30 years, 50% were smokers, 76% nulliparous, 9% were vaccinated, 6% were pregnant at moment of diagnosis and 37% affected by HPV16. Overall, the rate of spontaneous total regression at 2 years of follow-up was 59.7%, 20.9% presented partial regression, 13.1% had persistent disease, while 6.3% progressed.HPV16 infection [OR 4.7 (95% CI 1.6 to 13.7)] and previous HSIL cytology [OR 4.4 (95% CI 1.5 to 12.8)], were statistically associated with progression. Age or smoking were no statistically associated.None of vaccinated patients neither HPV-HR negative lesions progressed in 24 months.ConclusionThe high regression rate of CIN2 supports clinical observation and conservative management in selected patients.Patients with CIN2 lesions HPV16 positive and HSIL previous cytology are more likely to progress to CIN3, so tight control is crucial. In contrast, vaccinated patients and HPV-HR negative lesions regress spontaneously.Study of predictive factors of CIN2 evolution, as HPV16 or previous cytology, would have a great clinical value to reduce unnecessary cone excision and tailored treatment.DisclosureThe authors declare no conflicts of interest. None received grant support for the study neither for other clinical or research activity, except for the inscription to the current congress, for three of the authors, that was funded by VIFOR Pharma (non related to the study we present).

Introduction/BackgroundThe survival rates improvement of oncogynecologic surgeries and adjuvant therapies has led to focus on their long-term effects. Lower tract urinary symptoms (LTUS), sexual dysfunction (SD) and impaired quality of life (QoL) have been described as common complications in survivors. Disruption of paracervical autonomic fibers during hysterectomy and radiation cystitis could be main LTUS causes; while psycho-affective deterioration may play great role on SD.Our aim was to assess changes on these aspects after oncogynecological radical treatment.MethodologyThis prospective cohort study included oncogynecological patients (endometrial, cervical and ovarian) undergoing radical-intent treatment in our unit, March2017-June2018, classified according the received therapy. ERAS protocol (Enhanced Recovery after Surgery) was performed.Baseline features as age, surgical-obstetric history, comorbidities, emotional traits and relationship stability were considered. All patients were surveyed before and 6 months after treatment, using validated questionnaires: ICIQ-UI-SF (International-Consultation-Incontinence-Questionnaire) evaluating LTUS impact on QoL, CACV (‘Cuestionario-de-Autoevaluación-de-Control-Vesical’) for detrusor dysfunction, ISFS (Index-of-Feminine-Sexual-Function) measuring SD risk, and SF-12 providing QoL profile.Results67 patients were finally included, without finding differences in baseline characteristics among the 46 ones completing both surveys and analysed. Pre-treatment, 50.7% patients reported urinary incontinence (UI), 74.6% no sexual activity and all high QoL scores. In the follow-up, an UI worsening tendency with advanced age was found independently of treatment modality, not reaching statistical significance. Mental QoL score in SF-12 reduced ∼2.5 points if undergoing radiotherapy. SD did not differ from pre-treatment status.ConclusionUrinary and sexual function, as global QoL, remained stable 6 months after oncogynecological treatment. Although LTUS is difficult to assess being common in gynecological patients baseline, special attention is recommended in older women to avoid UI worsening. Those receiving radiotherapy may benefit from mental QoL support.Further research with larger populations is needed to accurately assess the impact of radical oncogynecological treatments; probably leading to develop patient-targeted recovery programs.DisclosureThe authors declare no conflicts of interest. None received grant support for this study neither for other clinical or research activity, except for the inscription to the current congress for 3 authors that was funded by VIFOR Pharma (non related to the study we present).

Botulism is a severe neuroparalytic disorder that can be potentially life-threatening. In Barcelona, Spain, no outbreaks had been reported in the past 25 years. However, in September 2011, two outbreaks occurred involving two different families. A rare case of Clostridium baratii which produced a neurotoxin F outbreak was detected in five family members who had shared lunch, and several days before that another family was affected by C. botulinum toxin A which was probably present in homemade pâté.

Purpose The role of the radioguided occult lesion localisation (ROLL) technique in breast cancer has been increasing in recent years. One of the important drawbacks of such a technique is radiotracer spillage within the mammary gland that makes the precise lesion resection difficult, and this requires the use of a hook-wire collocation to reach the lesion. The possibility of obtaining an intraoperative image of the specimen could help to confirm whether the lesion is correctly removed. Some types of portable gamma cameras have been designed, but up to now, intraoperative use has been confined to surgery of parathyroid adenomas and sentinel lymph node location. The aim of the study was to value the usefulness of an intraoperative gamma camera to assess the resection of non-palpable breast lesions. Materials and methods The study involved 42 women diagnosed with non-palpable early breast cancer. Lymphoscintigraphy was performed on the day before surgery by injection of 99m Tc-labelled nanocolloid. During surgery a gamma probe was used to guide the surgeon, and afterwards images of the surgical bed and the tumoral specimen were acquired by means of a portable gamma camera, fitted with a pinhole collimator. A 99m Tc pointer was used to draw an outline image around the specimen. Results On lymphoscintigraphy, radiotracer was concentrated in 31 cases. During surgery, all lesions were removed. In the images acquired by the portable gamma camera, the lesion was centred inside the surgical specimen in 23 of 42 cases, non-centred in 15 and in contact in 4 cases. Congruence of 60% was found between the intraoperative images and the histopathological results. The posterior margin was the most frequently involved. The whole acquisition time for the tumoral specimen with its margins was 5 min at most. Conclusion The use of portable gamma cameras in theatre is in an early phase. The short period of time required during the surgical procedure will allow the surgical team to improve this technique until it can replace hand-held probes. The intraoperative acquisition of such images can predict the involvement of surgical margins, avoiding future surgical procedures.

Background: Women with spinal cord injuries usually suffer from sexual dysfunction, such as alterations during arousal and an increase in the time to reach orgasm. However, little evidence has been found on its physiotherapeutic approach, as well as poor adherence to the latter. The aim of this study is to determine the effectiveness of two interventions to improve sexual dysfunction: the application of genital vibration and transcutaneous tibial nerve stimulation. Methods: This is a randomized clinical trial that will recruit 54 women who, one year after a spinal cord injury, suffer from sexual dysfunction associated with the latter. The participants will be randomized to three groups: (a) intervention group 1 treated with transcutaneous tibial nerve electrostimulation (n = 18), (b) intervention group 2 treated with genital vibration (n = 18), and (c) a control group (n = 18). The treatment time will be 12 weeks. Adherence to the treatment will be evaluated, as well as the effectiveness of the treatment, through the Female Sexual Function Index, the Sexual Quality of Life-Female questionnaire, quantitative sensory tests, and the improvement reported by the patient in terms of arousal and orgasm. The evaluations will be carried out before the treatment, at the end of the treatment and 3, 6 and 12 months after the end of the treatment.

Unexplained infertility is a relevant indication for controlled ovarian stimulation associated to intrauterine insemination. The \"step-up\" and \"step-down\" gonadotropin-based protocols were designed to reduce multiple pregnancy and ovarian hyperstimulation syndrome in polycystic ovary syndrome patients, but there is no related evidence in normoovulatory women undergoing intrauterine insemination. Our aim was to compare the efficacy and safety of both protocols with intrauterine insemination in unexplained infertility patients. Randomized clinical trial including 145 women with unexplained infertility randomly following the step-up (n=73) or step-down (n=72) protocol. In the step-up group, patients started on day 3 of a spontaneous cycle administrating recombinant FSH 75IU sc/day, increasing it to 150IU if no response after 7 days. In the step-down, patients started administrating 150IU sc/day, constantly decreasing it to 75IU after 5 days. Recombinant hCG was administered when a follicle reached ≥18mm diameter. Clinical pregnancy rate was higher in the step-up group than in the step-down (20.5% vs . 8.3%; p =0.037). Significant differences between step-up and step-down protocols were found regarding days of rFSH administration (8.83±4.01% vs . 7.42±2.18%; p =0.001) and cancellation rate due to hyper response (8.21% vs . 25%; p =0.05). No differences were detected in miscarriage rates, multiple pregnancy rates/cycle and hyper stimulation syndrome incidence. The step-up protocol is longer-lasting but more effective obtaining pregnancies than the step-down in patients with unexplained infertility undergoing intrauterine insemination. This effect could be explained by lower cancellation rates due to ovarian hyper response than the step-down protocol, with no differences in ovarian hyper stimulation syndrome incidence.

Background We previously reported that the RTS,S/AS02A vaccine had an acceptable safety profile, was immunogenic, and demonstrated efficacy against Plasmodium falciparum malaria disease for 21 months. Methods We conducted a randomized, controlled, phase 2b trial of RTS,S/AS02A in 2022 Mozambican children aged 1–4 years. We now report safety results for all randomized subjects and vaccine efficacy (VE) findings for children in the Manhiça area over the 45-month surveillance period. Results During the surveillance period, the VE(2.5–45) (VE over months 2.5–45 of surveillance) against a first or only episode of clinical malaria disease was 30.5% (95% confidence interval [CI], 18.9%–40.4%; P <.001 ), and the VE(2.5–45) against all episodes was 25.6% (95% CI, 11.9%–37.1%; P <.001). When the same period was considered, the VE(2.5–45) for subjects protected against severe malaria was 38.3% (95% CI, 3.4%–61.3%; P = .045). At study month 45, the prevalence of P. falciparum was 34% lower in the RTS,S/AS02A group than in the control group (66 [12.2%] of 541 patients vs 101 [18.5%] of 547 patients) (P = .004). Conclusion These results show evidence that RTS,S/AS02A maintained protection during the 45-month surveillance period, and they highlight the feasibility of developing an effective vaccine against malaria. In combination with other malaria-control measures, such a vaccine could greatly contribute to reducing the intolerable global burden of this disease. Trial registration ClinicalTrials.gov identifiers NCT00197041 and NCT00323622.

Children with hemiplegia have lower spontaneous use and quality of movement in the affected upper limb. The modified constraint-induced movement therapy (mCIMT) is applied to improve the affected upper limb function. The objective of this study was to study the efficacy of unaffected hand containment to obtain changes in the function of the affected upper limb after applying two unimanual therapies. A randomized controlled pilot study was performed with 16 children diagnosed with congenital infantile hemiplegia, with eight children randomized in each group (average age: 5.54 years; SD: 1.55). mCIMT and unimanual therapy without containment (UTWC) were applied, with a total of 50 h distributed in five weeks (two h/per day). Two assessments were performed (pre- and post-treatment) to evaluate the affected upper limb spontaneous use, measured with the Shiners Hospital Upper Extremity Evaluation (SHUEE), and the quality of movement, measured with the Quality of Upper Extremity Skills Test (QUEST scale). The progression of the variables was different in both groups. The results are expressed in the median of the improvement percent and interquartile range (IQR). The spontaneous use analysis showed an improvement percent of 31.65 (IQR: 2.33, 110.42) in the mCIMT group with respect to 0.00 (IQR: 0.00, 0.00) in the UTWC group. The quality of movement increased in the mCIMT and UTWC groups, 24.21 (IQR: 13.44, 50.39), 1.34 (IQR: 0.00, 4.75), respectively and the greatest increase was obtained in the grasp variable for both groups. The use of unaffected hand containment in mCIMT would produce improvements in the affected upper limb functionality in children with hemiplegia (4–8 years old) compared to the same protocol without containment (UTWC).