Sexual abuse and chronic pelvic pain in a gynecology outpatient clinic. A pilot study.

INTRODUCTION AND HYPOTHESIS: Almost 20% of women will suffer from sexual abuse at some point in their lives. This is a known risk factor for developing chronic pelvic pain (CPP), which is a major health problem worldwide. We conducted a pilot study in a Gynecology Outpatient Clinic to find the correlation between these two clinical entities and provide better evidence for their diagnosis and treatment. METHODS: A semi-structured interview for the evaluation of sexual violence in women (EVS) was used as a screening tool and a complement to routine gynecological examination to identify patients suffering from sexual abuse. Patients included were also assessed for comorbidities, including CPP, and other coexisting mental health problems. RESULTS: Of the 61 patients screened, 33 (54.1%) had pelvic pain. Also, 11 patients (18%) had suffered sexual abuse at some point in their lives, which was only disclosed when the specific interview was performed. Ten patients (90.8%) out of 11 that had been sexually abused also had pelvic pain. This was found to be statistically significant in this sample (p = 0.008) with a more than 11-fold greater risk of having pelvic pain (OR, 11.7; 95% CI, 1.4-98.7). Most patients did not have psychological violence (77%) but those that did (23%) had a seven-fold greater risk of having pelvic pain (OR, 7.4; 95% CI, 1.5-36.9). CONCLUSION: Specific tools should intentionally be used for evaluating sexual abuse and chronic pelvic pain, since a strong correlation exists between these two entities and they are seldom reported by patients.

Post-Ablation Cavity Evaluation: A Prospective Multicenter Observational Clinical Study to Evaluate Hysteroscopic Access to the Uterine Cavity 4 Years after Water Vapor Endometrial Ablation for the Treatment of Heavy Menstrual Bleeding.

STUDY OBJECTIVE: Patients who have undergone endometrial ablation may present a diagnostic challenge when they subsequently develop vaginal bleeding, pelvic pain, or postmenopausal bleeding. Extensive scarring of the uterine cavity often precludes evaluation and/or conservative treatment. For further research on this topic, we performed hysteroscopic examination in study subjects a mean duration of 4 years after they had undergone water vapor endometrial ablation. DESIGN: Prospective, multicenter, observational clinical study. SETTING: Eight private practice or outpatient sites in the United States and Mexico. PATIENTS: Seventy subjects who had completed their 36-month follow-up in the AEGEA Pivotal Trial. INTERVENTIONS: Diagnostic hysteroscopy. MEASUREMENTS AND MAIN RESULTS: The subjects were screened for general health and infection and underwent diagnostic hysteroscopy. Menstrual bleeding status was recorded. The video of the hysteroscopic examination was analyzed by an independent reviewer, who assessed uterine cavity access and visualization of the cornua and tubal ostia as well as characterized adhesions on the basis of the criteria by March et al. An independent reviewer also subjectively assessed whether Pipelle endometrial biopsy or intrauterine device placement would be feasible. Uterine cavity access was achieved in 90% (63/70) of subjects. Among subjects with cavity access, the cornua and ostia were visualized in 79% (50/63) and adhesions were absent in 75% (47/63), with only 2 women having severe adhesions (3%, 2/63). Biopsy was projected to be feasible in 86% (62/70) and intrauterine device placement in 60% (42/70) of all subjects. The subjects' bleeding statuses were not correlated with uterine cavity access. The results were consistent for subjects with large uterine cavities and International Federation of Gynecologic and Obstetrics type II to VI myomas ≤4 cm. CONCLUSION: Water vapor endometrial ablation preserved an accessible uterine cavity and visualization of the ostia in most subjects, with minimal incidence of severe adhesions, a mean of 4 years after the ablation procedure.

Pilot Study of the Mirabilis System Prototype for Rapid Noninvasive Uterine Myoma Treatment Using an Ultrasound-Guided Volumetric Shell Ablation Technique.

STUDY OBJECTIVE: The primary objective of this pilot study was to evaluate the safety and acute tissue ablation efficacy of a transabdominal high-intensity focused ultrasound (HIFU) prototype device that uses ultrasound imaging guidance for rapid noninvasive ablation of uterine myomas. The secondary objective was to assess preliminary myoma-related symptom improvement and myoma volume reduction at 3 to 6 months post-treatment in subsets of patients. DESIGN: Multicenter prospective single-arm pilot study (Canadian Task Force classification II-2). SETTING: University-affiliated teaching hospital and private community hospital. PATIENTS: Women with a diagnosis of symptomatic uterine myomas planning to undergo hysterectomy. INTERVENTIONS: Seventy-three women underwent transabdominal ultrasound-guided HIFU treatment using a volumetric ablation technique referred to as "shell ablation," in which the HIFU energy is deposited in patterns that partially encapsulate the peripheral region of the targeted myoma(s). Patients were divided into 2 sequential cohorts, the development cohort (the first 37 patients treated) and the validation cohort (the final 36 patients treated). Development cohort treatments were performed for dose-ranging purposes to identify the optimum HIFU treatment parameters, whereas the validation cohort treatments were performed to validate these final settings. Sixty-five patients (89.0%) received only prophylactic oral, sublingual, or intramuscular analgesia before treatment, sometimes with oral anxiolytics. The remaining 8 patients (11.0%) were anesthetized before treatment. Sixty-seven patients (91.8%) then had scheduled hysterectomies between 0 and 179 days after treatment completion. Adverse events were monitored until study exit, which ranged from 10 to 191 days post-treatment. MEASUREMENTS AND MAIN RESULTS: The primary efficacy endpoint measured in all 73 patients was the nonperfused volume (NPV) of tissue produced, which was assessed between 0 and 7 days post-treatment either by tissue sectioning after hysterectomy or by gadolinium-enhanced magnetic resonance imaging. Secondary efficacy endpoints were also measured in subsets of patients who were prospectively scheduled for delayed hysterectomies: Changes in menstrual blood loss (MBL), symptom severity (SS), and quality of life (QOL) scores were assessed using validated techniques at 3 months post-treatment in 10 patients and changes in treated myoma volume were assessed using magnetic resonance imaging at 3 to 6 months post-treatment in 14 patients. In all 73 patients, there were no reports of any serious adverse device effects, including no damage to any extrauterine collateral tissues or the abdominal skin. In the development cohort, a mean NPV of 17.9 ± 24.9 cm3 (range, 0-123.0) was produced in a mean total treatment time of 4.9 ± 2.4 minutes (range, 1.1-11.3). These metrics improved in the validation cohort, where a mean NPV of 44.9 ± 58.5 cm3 (range, 0-284.7) was produced in a mean total treatment time of 3.6 ± 2.1 minutes (range, 1.5-9.5). In the subsets of patients with data available, there was a significant improvement in QOL score (median, 16.5 point increase; p = .011), an improving trend in SS score (median, 13.5 point decrease; p = .254), and a significant improvement in treated myoma volume (mean, 24.0% decrease; p = .013). In 8 patients who had above-average MBL scores at baseline and regular menstrual cycle lengths during follow-up, there was also a significant improvement in MBL score (median, 40.8% decrease; p = .035). CONCLUSION: Ultrasound-guided HIFU ablation with the prototype device demonstrated an excellent safety profile and produced clinically relevant NPVs in a mean total treatment time of under 4 minutes using the final validated treatment settings. Short-term clinical efficacy metrics assessed in subsets of patients were encouraging, and larger studies should be conducted to confirm these results (ClinicalTrials.gov, NCT01946178).

Reproductive Outcomes in Women Following Radiofrequency Volumetric Thermal Ablation of Symptomatic Fibroids. A Retrospective Case Series Analysis.

OBJECTIVE: To report reproductive outcomes in women who underwent radiofrequency volumetric thermal ablation (RFVTA) of symptomatic uterine fibroids. STUDY DESIGN: Retrospective analysis of fibroid characteristics, treatment parameters, and pregnancy outcomes of 6 subjects in 3 prospective trials of laparoscopic ultrasound-guided RFVTA. RESULTS: Despite the requirement that women enrolled in the RFVTA studies did not desire current or future childbearing and were to continue contraception, 6 subjects conceived at between 3.5 and 15 months postreatment. The number of fibroids treated per patient ranged from 1 to 7, measured between 1.0 cm and 7.6 cm at the greatest diameter, and included multiple types (submucosal, intramural, transmural, and subserosal). Five patients (5/6, 83%) delivered full-term healthy infants: 1 by vaginal delivery and 4 by cesarean section. One patient (1/6, 17%) had a spontaneous miscarriage in the first trimester. CONCLUSION: Viable, full-term pregnancies are possible after RFVTA. Further, in-depth study of pregnancy outcomes following laparoscopic ultrasound-guided radiofrequency, volumetric ablation of fibroids is warranted.

[The effect of MTHFR polymorphisms, pregnancy and first intercourse on cervical cancer in a population from the Northeastern Mexico]. / Interacciones entre polimorfismos del gen MTHFR, gestaciones e inicio de vida sexual modifican el riesgo para cáncer cérvico-uterino en una población del noreste de México.

OBJECTIVE: To investigate the possible association among MTHFR polymorfhisms, environmental factors and cervical cancer (CC) in the Mexican population. METHODS: Seventy patients with CC and 89 control women were questioned about clinical data and their 677 and 1298 genotypes of MTHFR gene were analized. RESULTS: Multipregnancies (0-2 vs. > or = 3, OR 2.1), an early age of first intercourse (IVS) (17 < or = vs. > or = 18 years, OR 4.3) or both factors (OR 3.5) were significantly associated with CC. MTHFR 677, 1298 polymorphisms and their combinations were not different between cases and controls. However, a significant association between pregnancies, IVS and MTHFR polymorphisms (presence of 1298C allele or 677TT genotype) was observed. The 1298C allele plus multipregnancies and IVS < or = 17 years, or both factors, increased 4.3, 5.3, and 11.8 times the risk for CC, respectively, while 677TT genotype changed the risk 2.0, 1.9, and 4.2 times, respectively. CONCLUSION: The 1298C allele increases the risk of CC strongly in women with multipregnancies and early age of IVS, while 677TT genotype has a lower risk without becoming a protection factor.

Interacciones entre polimorfismos del gen MTHFR, gestaciones e inicio de vida sexual modifican el riesgo para cáncer cérvico-uterino en una población del noreste de México / The effect of MTHFR polymorphisms, pregnancy and first intercourse on cervical cancer in a population from the Northeastern Mexico

Objective. To investigate the possible association among MTHFR polymorfhisms, environmental factors and cervical cancer (CC) in the Mexican population. Methods. Seventy patients with CC and 89 control women were questioned about clinical data and their 677 and 1298 genotypes of MTHFR gene were analized. Results. Multipregnancies (0-2 vs. > 3, OR 2.1), an early age of first intercourse (IVS) (17 < vs. > 18 years, OR 4.3) or both factors (OR 3.5) were significantly associated with CC. MTHFR 677, 1298 polymorphisms and their combinations were not different between cases and controls. However, a significant association between pregnancies, TVS and MTHFR polymorphisms (presence of 1298C allele or 677TT genotype) was observed. The 1298C allele plus multipregnancies and IVS < 17 years, or both factors, increased 4.3, 5.3, and 11.8 times the risk for CC, respectively, while 677TT genotype changed the risk 2.0, 1.9, and 4.2 times, respectively. Conclusion. The 1298C allele increases the risk of CC strongly in women with multipregnancies and early age of IVS, while 677TT genotype has a lower risk without becoming a protection factor.

Objetivo. Buscar la asociación entre polimorfismos de la enzima metilentetrahidrofolato reductasa (MTHFR), factores ambientales y cáncer cérvico-uterino (CaCU) en mujeres del noreste de México. Métodos. Setenta pacientes con CaCU y 89 mujeres controles se sometieron a un interrogatorio clínico y a genotipificación de los polimorfismos 677C -> T y 1298A -> C del gen MTHFR. Resultados. La multigestación (0-2 vs.> 3, OR 2.1), un temprano inicio de vida sexual (IVS) (17 < vs. > 18 años, OR 4.3) o la combinación de ambos factores (OR 3.5), estuvieron asociados significativamente al CaCU. Los polimorfismos de MTHFR 677, 1298 y sus combinaciones no fueron diferentes entre casos y controles. Sin embargo, se observó una interacción significativa entre las gestaciones, el IVS y los polimorfismos de MTHFR (presencia del alelo 1298C o del genotipo 677TT). El alelo 1298C combinado con multigestación, con un IVS < 17 años, o con ambos factores, incrementó el riesgo para CaCU en 4.3, 5.3 y 11.8 veces, respectivamente, en tanto que el genotipo 677TT modificó este riesgo a 2.0, 1.9, y 4.2 veces, respectivamente. Conclusión. El alelo 1298C incrementa considerablemente el riesgo para CaCU en mujeres multigestas y con un IVS temprano, en tanto que el genotipo 677TT disminuye este riesgo, pero sin llegar a convertirse en un factor protector.