Three-year comparison of thermal balloon and rollerball ablation in treatment of menorrhagia.

STUDY OBJECTIVE: To compare uterine balloon therapy and hysteroscopic rollerball endometrial ablation with respect to efficacy and safety in treatment of menorrhagia. DESIGN: Multicenter, prospective, randomized study (Canadian Task Force classification I). SETTING: Fourteen North American university and private practice sites. PATIENTS: Women undergoing endometrial ablation for menorrhagia. INTERVENTION: Rollerball endometrial ablation or uterine balloon therapy. MEASUREMENTS AND MAIN RESULTS: Of 275 women randomized to one of these procedures, 255 were treated under the protocol and 214 were followed for 3 years. Results of uterine balloon therapy and rollerball endometrial ablation remained similar, with little difference at 3 years compared with results at 1 year. We noted a suggestion of an increase in hysterectomies in the rollerball group (14) compared with the uterine balloon therapy group (8) at 3 years. CONCLUSION: Endometrial ablation with the ThermaChoice uterine balloon or rollerball continues at 3 years to be a successful method for treating menorrhagia, avoiding hysterectomy, decreasing dysmenorrhea and premenstrual symptoms, and improving quality of life. (J Am Assoc Gynecol Laparosc 8(1):48-54, 2001)

Preliminary experience with the VersaPoint bipolar resectoscope using a vaporizing electrode in a saline distending medium.

OBJECTIVE: To evaluate a new bipolar resectoscope that uses physiologic saline as a distending medium. DESIGN: Clinic-based, prospective, non-randomized study (Canadian Task Force classification II-2). SETTING: A free-standing ambulatory surgical facility. Patients. Eleven women with menorrhagia or menometrorrhagia and four with menorrhagia and infertility. INTERVENTION: Hysteroscopic removal of submucosal myomas with concomitant endometrial ablation in seven patients. MEASUREMENTS AND MAIN RESULTS: Complete removal of the submucosal myoma was achieved in all 15 patients. Eight patients had a European Society of Gynecologic Endoscopy type II myoma, five had a type I, and two had a type zero. Five patients had multiple myomas. There were no complications. CONCLUSIONS: The bipolar resectoscope is effective in the removal of submucosal myomas and in this series allowed completion of several cases that probably could not have been done with a traditional monopolar resectoscope.

Cycle control with oral contraceptives containing 20 micrograms of ethinyl estradiol. A multicenter, randomized comparison of levonorgestrel/ethinyl estradiol (100 micrograms/20 micrograms) and norethindrone/ethinyl estradiol (1000 micrograms/20 micrograms).

A randomized, open-label, multicenter study was undertaken to compare the effects of oral contraceptives (OC) containing 100 micrograms levonorgestrel (LNG)/20 micrograms ethinyl estradiol (EE) (Aless/Loette) and 1000 micrograms norethindrone acetate (NETA)/20 micrograms EE (Loestrin Fe 1/20) on menstrual cycle control over four cycles of use. A total of 84 evaluable women provided 274 cycles of exposure in the LNG/EE group, and 89 women provided 289 cycles of exposure in the NETA/EE group. Overall, the LNG/EE group achieved a consistently higher percentage of normal menstrual cycles as well as a lower rate of intermenstrual bleeding and amenorrhea than the NETA/EE group. In cycle 4, 63.8% of cycles were normal in the LNG/EE group compared with 41.9% in the NETA/EE group (p < 0.005). Of the total cycles in the NETA/EE group, 10% were amenorrheic, compared with 1.1% in the LNG/EE group. The occurrence of bleeding and/or spotting was significantly lower in cycles 2 and 3 in the LNG/EE group (41.7% and 34.8%, respectively) compared with the NETA/EE group (62.3% and 56.3%; p < 0.05). Other cycle variables were generally similar between groups, as was the incidence of adverse events. These results demonstrate that good cycle control was achieved with an OC containing 20 micrograms EE and that 100 micrograms LNG/20 micrograms EE produces better cycle control than 1000 micrograms NETA/20 micrograms EE.

Thermal balloon and rollerball ablation to treat menorrhagia: a multicenter comparison.

OBJECTIVE: To compare the clinical efficacy and safety of a thermal uterine balloon system with hysteroscopic rollerball ablation in the treatment of dysfunctional uterine bleeding. METHODS: Two hundred fifty-five premenopausal women were treated in a randomized multicenter study comparing thermal uterine balloon therapy with hysteroscopic rollerball ablation for the treatment of menorrhagia. Preprocedural and postprocedural menstrual diary scores and quality-of-life questionnaires were obtained. Twelve-month follow-up data are presented on 239 women. RESULTS: Twelve-month results indicated that both techniques significantly reduced menstrual blood flow with no clinically significant difference between the two groups as reflected by return to normal bleeding or less (balloon 80.2% and rollerball ablation 84.3%). Multiple quality-of-life questionnaire results were also similar, including percent of patients highly satisfied with their results (balloon 85.6% compared with rollerball 86.7%). A 90% decrease in diary scores was seen in more than 60% of patients in both groups. Procedural time was reduced significantly in the uterine balloon therapy group. Intraoperative complications occurred in 3.2% of the hysteroscopic rollerball patients, whereas no intraoperative complications occurred in the thermal balloon group. CONCLUSION: In the treatment of dysfunctional uterine bleeding, uterine balloon therapy is as efficacious as hysteroscopic rollerball ablation and may be safer.

Complications of fluid overload from resectoscopic surgery.

Excess absorption of liquid distending media is one of the most frequent complications of operative hysteroscopy. Although most women recover uneventfully, we are seeing cases of permanent morbidity or death resulting from this complication.

A multicenter, randomized comparative trial of the clinical effects on cycle control of two 21-day regimens of oral contraceptives containing 20 µg EE.

Purpose: This multicenter, randomized, open-label comparative study was designed to evaluate the effects on cycle control of the only two oral contraceptives (OCs) containing 20 µg ethinyl estradiol (EE) that are available in North America.Methods: Women of childbearing age who desired OCs for birth control were eligible to enroll in this study. Sixty-two subjects were randomly assigned to receive Alesse (levonorgestrel 0.1 mg and EE 20 µg) or Loestrin Fe 1/20(R) (norethindrone acetate 1.0 mg and EE 20 µg).Results: At the time of the interim analysis data cut-off 32 subjects had completed 3 cycles of Alesse and 30 had completed 3 cycles of Loestrin Fe 1/20. The groups were similar with regard to age, weight, height, race, and prior OC usage. A total of 22% of the subjects in the levonorgestrel group and 27% of those subjects in the norethindrone group had never used OCs. The remainder had not used OCs for at least 3 months before entering the trial. During the third cycle of use, the percentage of normal cycles was significantly greater in the levonorgestrel group (P <.05). Moreover, the rate of intermenstrual bleeding (breakthrough bleeding and/or spotting) in the norethindrone group (62.9%) was more than double that in the levonoregestrel group (29.0%). Cumulatively, from cycles 1 to 3, there was a higher incidence of absence of withdrawal bleeding with norethindrone when compared with levonorgestrel (27.7% vs 5.3%).Conclusion: The results of this study demonstrate that good cycle control can be achieved with an OC containing 20 µg EE. The superior cycle control of Alesse compared with Loestrin Fe 1/20 is consistent with that found in comparative studies of the cycle control of levonorgestrel, norethindrone, and norethindrone acetate containing OCs that had a higher dose of EE.

Complications of hysteroscopy-their cause, prevention, and correction.

Complications of hysteroscopy occur more frequently in operative than in diagnostic cases. Problems related to uterine distention are common, usually preventable, and potentially extremely serious. Perforation of the uterus may occur during hysteroscopy but do not always cause significant problems. In procedures of high risk for perforation the use of mechanical energy is safer than either laser or electrical energy. Laparoscopy and ultrasonography have some limited use in facilitating operative hysteroscopic procedures. Most complications occur during the hysteroscopic surgical procedure. However, some problems may not be apparent until the post operative period.

Contraindications and complications of hysteroscopy.

If the contraindications to hysteroscopy are observed, complications should be small. The risks of fluid overload, especially in operative cases, is the most common critical problem, so that accurate recording of fluid use and collection are essential. The inexperienced, unsupervised surgeon is most likely to encounter significant complications.

Endometrial ablation and resection.

Many hysterectomies for abnormal uterine bleeding can be avoided by the use of endometrial ablation or resection. Their role in older and postmenopausal patients has recently been emphasized. Complications, although infrequent, relate primarily to fluid intravasation or the inexperience of the surgeon. This cost-effective technique should be offered to all appropriate patients.

Removal of large symptomatic intrauterine growths by the hysteroscopic resectoscope.

Fifty-three patients underwent 55 procedures with a resectoscope for the removal of large symptomatic intrauterine growths. The presenting complaint was menorrhagia, menometrorrhagia, or heavy postmenopausal bleeding in 38 patients; excessive menses plus infertility in 13 patients; and infertility alone in two patients. Forty-three patients had pedunculated or sessile submucous myomas and ten patients had large endometrial polyps. The long-term results are based on 45 patients followed for longer than 1 year. Excessive bleeding was controlled in 40 of the 43 women (93%). Failure to control abnormal bleeding was apparent within the first year. Seven of the 12 infertility patients (58%) delivered live-born infants. Five patients have undergone subsequent hysterectomies (9%). Two patients had repeat resectoscopic removal of myomas and two had subsequent non-resectoscope myomectomies. No major complications were encountered.