The INTEGRITY Trial: Preservation of Uterine-Wall Integrity 12 Months After Transcervical Fibroid Ablation with the Sonata System.

Objective: The 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). Materials and Methods: 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). TFA was performed on up to 5 fibroids per subject ranging from 1-5 cm in diameter as determined by magnetic resonance imaging (MRI). All measurements and comparisons, including uterine-wall thicknesses were derived from baseline and 12-month MRI scans by an independent core MRI center. Scans were analyzed to assess preservation of uterine-wall integrity and reviewed for uterine-wall anomalies after TFA with the Sonata system. Results: Twenty-nine patients had baseline and 12-month MRI with contrast enhancement. Minimum uterine-wall thicknesses in all visible slices were >2.5 mm in diameter. No areas on MRI indicated any loss of uterine-wall integrity, compared with baseline imaging; comparison of baseline and postablation uterine-wall thicknesses revealed no significant changes. Conclusion: Transcervical fibroid ablation with the Sonata system was associated with preservation of uterine-wall integrity in this patient cohort.

Long-Term Clinical Outcomes of Transcervical Radiofrequency Ablation of Uterine Fibroids: The VITALITY Study.

Objective: The aim of this research was to learn the long-term (> 5 years) clinical outcomes of transcervical radiofrequency ablation of uterine fibroids. Materials and Methods: 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. Symptoms were assessed using the Uterine Fibroid Symptom and Quality-of-Life's Symptom Severity Score (SSS) and Health-Related Quality of Life (HRQoL) subscales. Patients were queried regarding pregnancy and surgical reinterventions. Results: Seventeen women (73.9%) provided long-term follow-up information, with a mean of 64.4 months ±4.5 months (range: 57-73 months). From baseline, mean SSS decreased significantly from 64.9 ± 16.9 to 27.6 ± 36.1, and mean HRQoL improved significantly from 27.2 ± 22.4 to 76.0 ± 32.6 (p = 0.002, and p = 0.0001, respectively). There were no surgical reinterventions through the first 3.5 years post-treatment. There was an 11.8% incidence of surgical reinterventions over 5.4 years of average follow-up, with 2 hysterectomies occurring after 3.5 and 4 years postablation, respectively (event rate: 2.2% per year; 95% confidence interval; 0.3%, 7.9%). Freedom from surgical reintervention at 1, 2, and 3 years was 100%, and, at 4 and 5 years, was 88.2% ± 7.8%. There was a single pregnancy occurring within the first year of treatment leading to a normal-term delivery by elective repeat cesarean section. Conclusions: Transcervical radiofrequency ablation with the Sonata System produced substantial durable clinical benefits beyond 5 years with a low reintervention rate.

Ultrasound-Guided Transcervical Ablation of Uterine Leiomyomas.

OBJECTIVE: 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. Coprimary endpoints assessed at 12 months were reduction in menstrual blood loss and absence of surgical reintervention. Additional assessments included symptom severity, quality of life, patient satisfaction, reductions in uterine and leiomyoma volumes, and safety. RESULTS: One hundred forty-seven patients were enrolled and treated in the United States and Mexico. The study met its coprimary endpoints at 12 months (N=143; full analysis set), because 64.8% of patients (95% CI 56.3-72.6%) experienced 50% or greater reduction in menstrual bleeding and 99.3% of patients (95% CI 95.1-99.9%) were free from surgical reintervention. The mean pictorial blood loss assessment chart score decreased by 38.9%, 48.4%, and 51.1% at 3, 6, and 12 months, respectively (P<.001), and 95.1% of patients experienced a reduction in menstrual bleeding at 12 months. There were significant mean improvements in symptom severity and health-related quality of life of 32.1 points and 43.7 points, respectively, at 12 months (all P<.001). Mean maximal leiomyoma volume reduction per patient was 62.4% (P<.001). More than half of patients returned to normal activity within 1 day, 96.3% of patients reported symptom improvement at 12 months, and 97% expressed satisfaction with the treatment at 12 months. There were no device-related adverse events. CONCLUSION: Transcervical ablation was associated with a significant reduction in leiomyoma symptoms with no device-related adverse events and a low surgical reintervention rate through 12 months, demonstrating its potential to safely and effectively treat all nonpedunculated leiomyoma types through a uterus-conserving, incisionless approach. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02228174. FUNDING SOURCE: Supported by Gynesonics, Inc.

The FAST-EU trial: 12-month clinical outcomes of women after intrauterine sonography-guided transcervical radiofrequency ablation of uterine fibroids.

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. Patients were required to have up to five fibroids from 1 to 5 cm in diameter. The primary trial endpoint was the percentage change in perfused fibroid volume, as assessed by contrast-enhanced MRI at 3 months by an independent core laboratory. Secondary endpoints, evaluated at 6 and 12 months, included safety, percentage reductions in the Menstrual Pictogram (MP) score, and the Symptom Severity Score (SSS) subscale of the Uterine Fibroid Symptom-Quality of Life (UFS-QOL) questionnaire, along with the rate of surgical reintervention for abnormal uterine bleeding and the mean number of days to return to normal activity. Additional assessments included the Health-Related Quality of Life (HRQOL) subscale of the UFS-QOL, nonsurgical reintervention for abnormal uterine bleeding, anesthesia regimen, patient satisfaction, and pain during the recovery period. An additional MRI study was performed at 12 months on a subgroup of patients. Fifty patients (89 fibroids) underwent transcervical radiofrequency ablation with the VizAblate System. At 3 and 12 months, perfused fibroid volumes were reduced from baseline by an average of 68.1 ± 28.6 and 67.4 ± 31.9 %, respectively, while total fibroid volumes were reduced from baseline by an average of 54.7 ± 37.4 and 66.6 ± 32.1 %, respectively (all P < .001 compared with baseline; Wilcoxon signed-rank test). At 12 months, mean MP score and SSS decreased by 53.8 ± 50.5 and 55.1 ± 41.0 %, respectively; the mean HRQOL score increased by 277 ± 483 %. There were four surgical reinterventions (8 %) within 12 months. This is the first report of the 12-month follow-up for patients in the FAST-EU Trial. In concert with previously reported 3- and 6-month endpoint data, the 12-month results of the FAST-EU Trial suggest that in addition to substantially reducing the perfused and total volume of targeted uterine fibroids, the VizAblate System is safe and effective through 12 months in providing relief of abnormal uterine bleeding associated with submucous, intramural, and transmural fibroids.

Transcervical, intrauterine ultrasound-guided radiofrequency ablation of uterine fibroids with the VizAblate® System: three- and six-month endpoint results from the FAST-EU study.

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. Patients had a minimum Menstrual Pictogram score of 120, no desire for fertility, and met additional inclusion and exclusion criteria. The VizAblate System was inserted transcervically and individual fibroids were ablated with radiofrequency energy. An integrated intrauterine ultrasound probe was used for fibroid imaging and targeting. Anesthesia was at the discretion of each investigator. The primary study endpoint was the percentage change in perfused fibroid volume, as assessed by contrast-enhanced MRI at 3 months. Secondary endpoints, reached at 6 months, included safety, percentage reductions in the Menstrual Pictogram (MP) score and the Symptom Severity Score (SSS) subscale of the Uterine Fibroid Symptom-Quality of Life questionnaire (UFS-QOL), along with the rate of surgical reintervention for abnormal uterine bleeding and the mean number of days to return to normal activity. Additional assessments included the Health-Related Quality of Life (HRQOL) subscale of the UFS-QOL, medical reintervention for abnormal uterine bleeding, and procedure times. Fifty patients were treated, representing 92 fibroids. Perfused fibroid volumes were reduced at 3 months by an average of 68.8 ± 27.8 % (P < 0.0001; Wilcoxon signed-rank test). At 6 months, mean MP and SSS scores decreased by 60.8 ± 38.2 and 59.7 ± 30.4 %, respectively; the mean HRQOL score increased by 263 ± 468 %. There were two serious adverse events (overnight admissions for abdominal pain and bradycardia, respectively) and no surgical reinterventions. These 6-month results suggest that the VizAblate System is safe and effective in providing relief of abnormal uterine bleeding associated with fibroids, with appropriate safety and a low reintervention rate.

Three-year outcome of the Halt trial: a prospective analysis of radiofrequency volumetric thermal ablation of myomas.

STUDY 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. PATIENTS: One hundred thirty-five premenopausal women (mean [SD] age, 42.5 [4.6] years; body mass index, 30.5 [6.1]) with symptomatic uterine myomas and objectively confirmed heavy menstrual bleeding (≥ 160 to ≤ 500 mL). INTERVENTIONS: Laparoscopic ultrasound-guided RFVTA. MEASUREMENTS AND MAIN RESULTS: One hundred four participants were followed prospectively for 36 months after treatment of myomas via RFVTA. For 104 evaluable participants with 36-month data, change in mean (SD) symptom severity from baseline (60.2 [18.8]) to 36 months was -32.6 (95% confidence interval, -37.5 to -27.8; p < .001). Health-related quality of life also was improved, from the baseline value of 39.2 (19.2) to 38.6 (95% confidence interval, 33.3 to 43.9; p < .001) at 36 months. Patient-reported Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire subscores demonstrated statistically significant improvement from baseline to 36 months in all categories (Concern, Activities, Energy/Mood, Control, Self-consciousness, and Sexual Function) (p < .001). For the 104 participants with 36-month data, mean state of health scores (EuroQOL-5D Health State Index) improved from a baseline value of 71.0 (19.3) to 86.2 (11.7) at 36 months. The cumulative repeat intervention rate of 11% (14 of 135 participants) at 36 months was well below the possible 25% maximum expected at the beginning of the trial. CONCLUSION: RFVTA of uterine myomas resulted in sustained relief from myoma symptoms and continued improvement in health-related quality of life through 36 months after ablation. The low repeat intervention data through 36 months is a positive outcome for patient well-being.

Laparoscopic ultrasound-guided radiofrequency volumetric thermal ablation of symptomatic uterine leiomyomas: feasibility study using the Halt 2000 Ablation System.

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. Secondary outcome measures were uterine volume changes over time. At 3, 6, and 12 months, respectively, mean symptom severity scores improved significantly compared with baseline, by 59.7% (95% confidence interval [CI], 44.8-74.7], 71.7% [95% CI, 55.7%-87.7%], and 82.0% (95% CI, 70.9%-93.1%). The increase in mean health-related quality-of-life scores over time reached statistical significance (p <.001): 60.15 (95% CI, 51.6%-68.7%) at baseline, 87.9 (95% CI, 82.1%-93.7%) at 3 months, 90.8 (95% CI, 82.1%-99.5%) at 6 months, and 97.8 (95% CI, 96.2-99.4) at 12 months. Mean (SD) uterine volume decreased from 194.4 (105.9 cm(3)) at baseline to 159.5 (66.8) at 3 months, 147.2 (73.0 cm(3)) at 6 months, and 113.2 (53.5 cm(3)) at 12 months (p = .006). There were no procedure-related repeat hospitalizations, repeat treatments, or any procedures related to symptoms of myoma after radiofrequency ablation. An anterior abdominal wall vascular injury was discovered in the early postoperative period and resolved after vessel ligation. Volumetric thermal ablation using the Halt 2000 System produced significant reduction in symptoms and improvement in quality of life at 1 year after treatment, with an excellent safety profile. Additional larger multicenter studies are needed to confirm these results.

Effectiveness of misoprostol for office hysteroscopy without anesthesia in infertile patients.

OBJECTIVE: 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. PATIENT(S): Seventy-five infertile patients scheduled for diagnostic office hysteroscopy. INTERVENTION(S): Patients were divided into three groups: group A received oral misoprostol 600 µg; group B, vaginal misoprostol 400 µg; and group C, oral placebo. MAIN OUTCOME MEASURE(S): Pain, evaluated by visual analogue scale, and surgical time were recorded and compared. Statistical analysis was done using Student's t-test. RESULT(S): Pain was low in the vaginal misoprostol group. Mean visual analogue scale in the oral misoprostol group was 6.04 ± 1.5; in the vaginal misoprostol group 2.85 ± 1.2; and in the placebo group 7.50 ± 1.5. Procedural time for office hysteroscopy was shorter in the vaginal misoprostol group (2.7 ± 1.0 minutes) compared with group A (5.5 ± 1.1 minutes) and group C (6.3 ± 3.8 minutes). CONCLUSION(S): Vaginal misoprostol, 400 µg, administered the day before office hysteroscopy considerably reduces pain and the time needed for hysteroscopy. This simple strategy may facilitate office hysteroscopy during an infertility work-up.

A randomized, multicenter trial of safety and efficacy of the NovaSure system in the treatment of menorrhagia.

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. PATIENTS: Two hundred sixty-five premenopausal women with symptomatic menorrhagia. INTERVENTION: Ablation performed with the NovaSure system or wire loop resection and rollerball. MEASUREMENTS AND MAIN RESULTS: Success [pictorial blood loss-assessment chart (PBLAC) score < or =75] was achieved in 88.3% of NovaSure-treated and 81.7% of rollerball-treated patients. One year after treatment 90.9% and 87.8%, respectively, reported normal bleeding or less (PBLAC < or =100) and 41% and 35%, respectively, experienced amenorrhea (PBLAC = 0). Mean procedure time was 4.2 minutes (average 84 sec) in the NovaSure group and 24.2 minutes in the rollerball group. Local and/or intravenous sedation was administered in 73% of NovaSure patients and 18% of rollerball patients. Intraoperative adverse events occurred less frequently with NovaSure (0.6%) than with rollerball (6.7%). Postoperative adverse events occurred in 13% and 25.3% of patients, respectively. CONCLUSION: The NovaSure system was safe and effective in treatment of women with menorrhagia. The procedure is both quick and effective, and eliminates the expense and side effects of endometrial pretreatment.