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New transcervical sterilization procedure: optimal epithelial ablation∗
Conclusions: The results of this study indicate that the Adiana procedure is able to prevent pregnancy in rabbits and resulted in space-filling, occlusive ingrowth.
Continuous Administration of 100 g Levonorgestrel and 20 g Ethinyl Estradiol for Elimination of Menses: A Randomized Trial Leslie Miller, MD University of Washington, Seattle, WA
New Transcervical Sterilization Procedure: Optimal Epithelial Ablation* Brett S. Bowman, MS Adiana, Inc., Redwood City, CA
Victoria E. Carr-Brendel, PhD, Vijay K. Dhaka, Douglas C. Harrington, and Thierry Vancaillie, MD Objective: A novel transcervical method to achieve permanent fallopian tube occlusion has been developed. The Adiana procedure applies radio frequency (RF) energy to ablate the tubal epithelium and then deposits an ingrowable, synthetic implant into the lesion area of the fallopian tube. The quality of the ingrowth—and therefore the blockage of the tube—is hypothesized to be dependent on the character of the ablation. The objectives of this study are to test this hypothesis—and, if it is true, to determine the optimal ablation characteristics in a rabbit model. Methods: Forty-four New Zealand white rabbits were treated with the procedure, using various levels of RF energy. Temperature and time were used to control the intensity of the ablation, with a minimum ablation of 52°C for 60 seconds and a maximum ablation of 95°C for 60 seconds. The intensity was also quantified using an Arrhenius cellular damage score. Upon explant, histologic sections of the implant and surrounding tissue were taken and were analyzed using a qualitative ingrowth scoring system. Results: Ingrowth scores demonstrated a bell-shaped curve with respect to ablation intensity. Complete tubal occlusion occurred in ablations between 58°C and 70°C. Below this range the ingrowth was dominated by epithelial cells, whereas above this range the ingrowth was primarily necrotic; in both of these cases the tubal lumen was not completely blocked. Conclusion: The ability of the Adiana procedure to block the tubal lumen of the rabbit is dependent on the intensity of the ablation. The maximum ingrowth score occurred at moderate ablation parameters.
* This document includes a discussion of use of a product that is unapproved by the U.S. Food and Drug Administration.
16S Monday Posters
Objective: To evaluate the efficacy and safety of continuous 20-g oral contraceptive pill use, compared with cyclic use of the same pill, for the elimination of menses as measured by daily menstrual bleeding diaries. Methods: This was an open-label prospective randomized trial to compare 28-day– cycle monthly arm (MA) subjects with continuous arm (CA) subjects. Outcomes measured are bleeding and spotting, pill-taking compliance, method satisfaction, estrogen symptoms, and hemoglobin. Endometrial histology and ultrasonographic measurements are being collected on a subset of subjects at randomization and after nine study cycles are completed. Results: Beginning February 2000, 94 subjects enrolled for a ‘wash-in‘ cycle. Eighty subjects were then randomized either to MA or CA study assignment. The ongoing study has 75 continuing subjects, with 57 women on their fourth or subsequent pill cycle in the study. Reasons for study discontinuation among MA subjects have included irregular bleeding and weight gain, and some were lost to follow-up; among CA subjects, reasons for study discontinuation have been a desire to conceive and bloating. Conclusion: This randomized trial will compare the experience of women taking continuous low-estrogen oral contraceptives with the experience of women undergoing a monthly hormonal withdrawal period. We will present detailed bleeding and spotting profiles for women during their first 6 months of continuous oral contraceptive use. Rates of amenorrhea, infrequent bleeding, and irregular bleeding will be reported to confirm the efficacy and acceptability of menstrual suppression.
Laparoscopic Pomeroy: A Comparison with Tubal Cauterization in a Teaching Hospital Dale C. Robinson, MD Louisiana State University, Baton Rouge, LA
Staci K. Stewart, MD, Richard S. Gist, MD, and Glenn N. Jones, PhD Objective: To compare laparoscopic Pomeroy tubal ligation to standard bipolar tubal cauterization for the outcome measures of failure rate, complication rate, and procedure duration.
Obstetrics & Gynecology
Continuous Administration of 100 g Levonorgestrel and 20 g Ethinyl Estradiol for Elimination of Menses: A Randomized Trial Leslie Miller, MD University of Washington, Seattle, WA
New Transcervical Sterilization Procedure: Optimal Epithelial Ablation* Brett S. Bowman, MS Adiana, Inc., Redwood City, CA
Victoria E. Carr-Brendel, PhD, Vijay K. Dhaka, Douglas C. Harrington, and Thierry Vancaillie, MD Objective: A novel transcervical method to achieve permanent fallopian tube occlusion has been developed. The Adiana procedure applies radio frequency (RF) energy to ablate the tubal epithelium and then deposits an ingrowable, synthetic implant into the lesion area of the fallopian tube. The quality of the ingrowth—and therefore the blockage of the tube—is hypothesized to be dependent on the character of the ablation. The objectives of this study are to test this hypothesis—and, if it is true, to determine the optimal ablation characteristics in a rabbit model. Methods: Forty-four New Zealand white rabbits were treated with the procedure, using various levels of RF energy. Temperature and time were used to control the intensity of the ablation, with a minimum ablation of 52°C for 60 seconds and a maximum ablation of 95°C for 60 seconds. The intensity was also quantified using an Arrhenius cellular damage score. Upon explant, histologic sections of the implant and surrounding tissue were taken and were analyzed using a qualitative ingrowth scoring system. Results: Ingrowth scores demonstrated a bell-shaped curve with respect to ablation intensity. Complete tubal occlusion occurred in ablations between 58°C and 70°C. Below this range the ingrowth was dominated by epithelial cells, whereas above this range the ingrowth was primarily necrotic; in both of these cases the tubal lumen was not completely blocked. Conclusion: The ability of the Adiana procedure to block the tubal lumen of the rabbit is dependent on the intensity of the ablation. The maximum ingrowth score occurred at moderate ablation parameters.
* This document includes a discussion of use of a product that is unapproved by the U.S. Food and Drug Administration.
16S Monday Posters
Objective: To evaluate the efficacy and safety of continuous 20-g oral contraceptive pill use, compared with cyclic use of the same pill, for the elimination of menses as measured by daily menstrual bleeding diaries. Methods: This was an open-label prospective randomized trial to compare 28-day– cycle monthly arm (MA) subjects with continuous arm (CA) subjects. Outcomes measured are bleeding and spotting, pill-taking compliance, method satisfaction, estrogen symptoms, and hemoglobin. Endometrial histology and ultrasonographic measurements are being collected on a subset of subjects at randomization and after nine study cycles are completed. Results: Beginning February 2000, 94 subjects enrolled for a ‘wash-in‘ cycle. Eighty subjects were then randomized either to MA or CA study assignment. The ongoing study has 75 continuing subjects, with 57 women on their fourth or subsequent pill cycle in the study. Reasons for study discontinuation among MA subjects have included irregular bleeding and weight gain, and some were lost to follow-up; among CA subjects, reasons for study discontinuation have been a desire to conceive and bloating. Conclusion: This randomized trial will compare the experience of women taking continuous low-estrogen oral contraceptives with the experience of women undergoing a monthly hormonal withdrawal period. We will present detailed bleeding and spotting profiles for women during their first 6 months of continuous oral contraceptive use. Rates of amenorrhea, infrequent bleeding, and irregular bleeding will be reported to confirm the efficacy and acceptability of menstrual suppression.
Laparoscopic Pomeroy: A Comparison with Tubal Cauterization in a Teaching Hospital Dale C. Robinson, MD Louisiana State University, Baton Rouge, LA
Staci K. Stewart, MD, Richard S. Gist, MD, and Glenn N. Jones, PhD Objective: To compare laparoscopic Pomeroy tubal ligation to standard bipolar tubal cauterization for the outcome measures of failure rate, complication rate, and procedure duration.
Obstetrics & Gynecology