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.
View Article and Find Full Text PDFThe aim of this research was to evaluate uterine-wall integrity 12 months after transcervical fibroid ablation (TFA) of uterine fibroids with the Sonata system (Gynesonics Inc., Redwood City, CA). INTEGRITY is a secondary analysis of the FAST-EU clinical trial, a prospective, longitudinal, multicenter single-armed trial involving women with heavy menstrual bleeding secondary to fibroids who were treated at 7 academic and community hospitals in the United Kingdom, the Netherlands, and Mexico with transcervical, intrauterine, ultrasound-guided radiofrequency ablation (the Sonata system).
View Article and Find Full Text PDFStudy 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.
View Article and Find Full Text PDFThe aim of this research was to learn the long-term (> 5 years) clinical outcomes of transcervical radiofrequency ablation of uterine fibroids. For this retrospective, single-arm, long-term data-collection study, 23 women with heavy menstrual bleeding secondary to fibroids were treated with transcervical radiofrequency ablation guided by integrated intrauterine sonography (using the Sonata System, Gynesonics, Redwood City, CA). This study was within the 12-month Fibroid Ablation Study-EU clinical trial in Mexico.
View Article and Find Full Text PDFObjective: To evaluate the 12-month safety and effectiveness of transcervical ablation for the treatment of symptomatic uterine leiomyomas.
Methods: In this prospective, multicenter, single-arm interventional trial, transcervical ablation was performed on 1-10 leiomyomas per patient with leiomyoma diameters ranging from 1 to 5 cm. Treated leiomyomas included all nonpedunculated types.
J Minim Invasive Gynecol
December 2017
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).
The FAST-EU Trial was designed to establish the effectiveness and confirm the safety of transcervical intrauterine sonography-guided radiofrequency ablation with the VizAblate™ System in the treatment of symptomatic uterine fibroids. This was a multicenter, prospective, single-arm trial involving academic and community hospitals in the United Kingdom, the Netherlands, and Mexico. Women with qualifying uterine fibroids and heavy menstrual bleeding underwent intrauterine sonography-guided transcervical radiofrequency ablation (RFA) with the VizAblate System; anesthesia was individualized.
View Article and Find Full Text PDFObjective: 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.
This was a prospective, longitudinal, multicenter, single-arm controlled trial, using independent core laboratory validation of MRI results, to establish the effectiveness and confirm the safety of the VizAblate® System in the treatment of symptomatic uterine fibroids. The VizAblate System is a transcervical device that ablates fibroids with radiofrequency energy, guided by a built-in intrauterine ultrasound probe. Fifty consecutive women with symptomatic uterine fibroids received treatment with the VizAblate System.
View Article and Find Full Text PDFStudy Objective: To analyze the clinical success of radiofrequency volumetric thermal ablation (RFVTA) at 3-year follow-up in terms of subject responses to validated questionnaires and surgical repeat intervention to treat myomas.
Design: Prospective follow-up of patients for 36 months after treatment in a multicenter international trial of outpatient, laparoscopic ultrasound-guided RFVTA of symptomatic uterine myomas (Canadian Task Force classification II-1).
Setting: University hospitals and private surgical centers.
Thirty-one women aged 28 to 51 years with symptomatic uterine leiomyomas who desired uterine preservation underwent outpatient laparoscopic, ultrasound-guided, radiofrequency volumetric thermal ablation using the Halt 2000 System. Postoperative follow-up occurred at 3, 6, and 12 months. The primary outcome measures were patient safety, frequency of adverse events, repeat intervention rate because of symptoms of myoma, symptom severity, and health-related quality-of-life scores from the validated Uterine Fibroid Symptom and Quality-of-Life Questionnaire.
View Article and Find Full Text PDFObjective: To evaluate and compare the effectiveness of oral and vaginal misoprostol versus placebo to facilitate office hysteroscopy without anesthesia during infertile diagnostic evaluation.
Design: Randomized, prospective trial.
Setting: Patients scheduled for diagnostic office hysteroscopy at a university hospital.
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.
Study Objective: To compare the safety and effectiveness of the NovaSure impedance-controlled endometrial ablation system with hysteroscopic wire loop resection plus rollerball ablation for treatment of excessive uterine bleeding in premenopausal women.
Design: Randomized, multicenter, double-arm study (Canadian Task Force classification I).
Setting: Nine academic medical centers and private offices.