A new bipolar system for performing operative hysteroscopy in normal saline.

We evaluated the efficacy and safety of the VersaPoint bipolar vaporization system during hysteroscopic treatment of 10 women with symptomatic submucous leiomyomata, endometrial polyps, uterine septa, and synechiae in a prospective, uncontrolled pilot study at two Canadian university-affiliated teaching hospitals. Patients were two women with recurrent pregnancy loss associated with a diagnosis of uterine septa, one with infertility, one with recurrent pregnancy loss and synechiae, and six with menorrhagia associated with either leiomyomata or endometrial polyps. Electrodes were inserted through a 5F operating channel of a 15F cystoscope, and a 17 or 21F hysteroscope. Three electrodes were used: ball, twizzle, and spring. Power settings ranged from 50 W (desiccation mode) to 200 W (vapor cut mode). Normal saline was used as the distention medium in all cases. Either general anesthesia or intravenous sedation with paracervical block was used. There were no major complications such as uterine perforation, excessive bleeding, fluid overload, or thermal injury. The amount of normal saline used varied considerably from 0.5 to 20 L. The maximum amount of saline absorbed was 900 ml in a case involving resection of 4.5- and 2.0-cm leiomyomata that lasted 115 minutes. Mild cramping, vaginal bleeding, and discharge in the first 2 to 3 days were relieved by nonsteroidal antiinflammatory agents. No patients were readmitted up to 6 weeks after the procedure. Preliminary results of this pilot study support the safety of the VersaPoint bipolar vaporization system, although its long-term efficacy remains to be determined. It appears to be well tolerated by some women using conscious sedation and paracervical block. Therefore, it can potentially be used in an office setting as well as in symptomatic patients who are at risk from a general anesthetic. (J Am Assoc Gynecol Laparosc 6(3):331-336, 1999)

Modern treatments of menorrhagia attributable to dysfunctional uterine bleeding.

Menorrhagia (excessive uterine bleeding) affects some 20 percent of the women of reproductive age worldwide. The following review describes known and theorized etiologies of the disorder, followed by a discussion of treatment options that are currently in use as well as those on the horizon. There is much interest internationally in decreasing hysterectomy rates, particularly for those women with abnormal bleeding and anatomically normal uteri. It is these women who are the focus of this paper. Pharmacotherapy and surgery are the mainstay treatments for such patients with menorrhagia secondary to dysfunctional uterine bleeding. Most commonly, hormonal and nonhormonal medications are followed by dilatation and curettage, and ultimately, in many cases, hysterectomy. Endometrial ablation techniques have been evolving since the 1980s in response to the need for an efficacious, safer, and more cost-effective alternatives to hysterectomy. Hysteroscopic ablation achieves these goals but is difficult technically and requires significant additional training even for otherwise skilled and experienced gynecologists. The current decade has seen the development of many innovative approaches to performing endometrial ablation. These methods are intended to be much simpler to perform with less risk than electrosurgical or laser endometrial ablation. The final section of this article presents the published data to date on these new technologies, which should (in their refined state) revolutionize the treatment of menorrhagia secondary to dysfunctional uterine bleeding.

Measurement of serosal temperatures and depth of thermal injury generated by thermal balloon endometrial ablation in ex vivo and in vivo models.

OBJECTIVE: To evaluate the safety profile of endometrial ablation performed with a thermal balloon as defined by serosal temperature elevation and depth of injury. DESIGN: Observational study with histopathologic correlation conducted in ex vivo and in vivo phases. SETTING: Academic medical center. PATIENT(S): Twenty patients undergoing total abdominal hysterectomy. INTERVENTION(S): Endometrial ablation with a thermal balloon. MAIN OUTCOME MEASURE(S): Serosal temperature elevation and histologic depth of injury. RESULT(S): Ex vivo phase results revealed serosal temperatures remained within a safe physiologic range (<45 degrees C). Greatest depth of myometrial injury in the premenopausal uteri was 5.8 mm over the anterior lower uterine segment. In postmenopausal uterus. the greatest depth of myometrial injury was 3.8 mm in the anterior midline. In vivo phase results revealed mean (+/- SD) peak serosal temperatures of 36.1 +/- 1.6 degrees C. As with the ex vivo phase. histologic examination revealed deep endometrial and superficial myometrial damage to all areas. The greatest depth of myometrial injury occurred in the midfundus at 3.4 mm. CONCLUSION(S): No patients experienced complications or adverse events secondary to treatment. Results showed that transuterine thermal injury is a highly unlikely scenario. In both phases of this study, histologic examination revealed that temperatures exposed to the endometrial layer were sufficient to cause tissue damage.

Uterine thermal balloon therapy for the treatment of menorrhagia: the first 300 patients from a multi-centre study. International Collaborative Uterine Thermal Balloon Working Group.

OBJECTIVE: To evaluate the safety and efficacy of thermal balloon therapy for menorrhagia. DESIGN: Prospective, observational study. SETTING: Fifteen centres in Canada and Europe. POPULATION: Two hundred and ninety-six eligible women for whom follow up data were available for three months or more. Eligible women included those for whom further fertility was not a concern, were not postmenopausal, suffered from intractable menorrhagia, had a normal uterine cavity, and who were fully informed regarding the investigational nature of uterine thermal balloon therapy. METHODS: Three hundred and twenty-one procedures of balloon endometrial ablation were performed using the same protocol between June 1994 and August 1996. Exclusion criteria included structural uterine abnormality or (pre) malignant lesions. Treatment entailed controlled heating of fluid in an intrauterine balloon. General anaesthesia was employed in the 61% of procedures while local anaesthesia with or without sedation was used in 39% of cases. ANALYSIS: Follow up data at 3 and/or 6, and/or 12 months were required for inclusion in the analysis. A paired t test, Wilcoxon signed-ranks test, and multiple and logistic regression analyses were used to evaluate the changes in bleeding and dysmenorrhoea patterns, and possible confounding variables, respectively. Success was defined as the subjective reduction of menses to eumenorrhoea or less. RESULTS: No intra-operative complications occurred, and post-operative morbidity was minimal. Success of the procedure was constant over the year (range 88%-91%). Treatment led to a significant decrease in the duration of menstrual flow and severity of pain (P < 0.0001). Increasing age, higher balloon pressure, smaller uterine cavity, and a lesser degree of pre-procedure menorrhagia were associated with significantly improved results. Pre-treatment with gonadotrophin releasing hormone agonists increased amenorrhoea and spotting rates (P = 0.03), but was only used in 5% of cases. CONCLUSION: Thermal balloon endometrial ablation appears to be safe, as well as effective in properly selected women with menorrhagia and is potentially an outpatient procedure.

Clinical trial of the uterine thermal balloon for treatment of menorrhagia.

STUDY OBJECTIVES: To evaluate the safety and efficacy of thermal balloon endometrial ablation in women with menorrhagia, and to identify factors influencing outcome. DESIGN: Prospective, observational study (Canadian Task Force classification II-2). SETTING: Three Canadian university-affiliated teaching hospitals. PATIENTS: One hundred twenty-one women suffering from menorrhagia serious enough to make them candidates for endometrial ablation or hysterectomy. Patients without obvious structural or (pre)malignant abnormalities were included if their uterine cavities sounded to less than 12 cm, they were in good health, and had undergone hysteroscopy or pelvic ultrasound and endometrial biopsy within 6 months and had a normal Papanicolaou smear within 1 year. INTERVENTIONS: A balloon catheter was placed through the cervix and after inflation in the endometrial cavity with 5% dextrose in water, was heated to 87 +/- 5 degrees C. Two-thirds of patients avoided general anesthesia and very few required cervical dilatation to admit the 4.5-mm diameter catheter. Balloon pressures were 90 to 140 mm Hg in 13 patients; pressures between 140 and 190 mm Hg were well tolerated by the rest. Nineteen women underwent 12 minutes of therapy, and the rest had 8-minute sessions. MEASUREMENTS AND MAIN RESULTS: No intraoperative complications occurred, and minor postoperative morbidity occurred in 4% of patients. Preoperative and postoperative bleeding was assessed by pad counts and patient self-reports. The degree of dysmenorrhea was recorded similarly. A paired t test was used to compare pretreatment with posttreatment pad counts. A Wilcoxon signed rank test was employed to evaluate the effect of treatment on dysmenorrhea. The effects on outcome of several independent variables were analyzed by multiple and logistic regression. Success of the procedure was constant over the year (range 86-90%). Treatment led to significant decreases in menstrual flow, duration, and pain (p <0.0001). No significant effects of parity, uterine position or cavity depth, timing, or various endometrial-thinning regimens were found. Increasing age was significantly associated with increased odds of success (p < 0.05). Excluding the 19 women who underwent 12 minutes of therapy did not change statistical results, whereas excluding the 13 treated with balloon pressures less than 140 mm Hg improved the results. Conclusion. The facts that bleeding and dysmenorrhea were significantly reduced by thermal balloon endometrial ablation, that no intraoperative complication occurred, and that postoperative morbidity was minimal, lead us to conclude that this is potentially a safe and effective technique. Larger studies and longer follow-up are required to substantiate this impression.