The Adiana® Procedure in the Office Setting Compared With the Operating Room

EASE Trial Investigator
Physician and Head of Clinical Research, Minnesota Gynecology & Surgery, Edina, Minnesota

EASE Trial Investigator
Clinical Professor in Gynaecology, University of New South Wales, Director, Women’s Health and Research Institute of Australia, Randwick, Australia

DISCLOSURES
Dr. James B. Presthus is a paid consultant for Hologic, Inc. and an active speaker, preceptor, and investigator. He is also a consultant and investigator with stock ownership for Interlace Medical, and a consultant and speaker for American Medical Systems and Olympus/Gyrus/ACMI.

Dr. Thierry G. Vancaillie is a paid consultant and investigator for Hologic, Inc.

Industry support for this study was provided by Hologic, Inc., Malborough, MA. Editorial support was sponsored by Hologic, Inc., and provided by Ed Shifflett, PhD, and Amanda McGeary, MS, at AlphaBioCom.

ABSTRACT

Objective: To evaluate whether Adiana^® Permanent Contraception is functionally different when used in-office versus a hospital operating-room setting.

Methods: All data were collected during the EASE (Evaluation of the Adiana System for Transcervical Sterilization Using Electrothermal Energy) clinical study. Here, we evaluated women aged 18 to 45 who underwent the Adiana procedure either in office (“OFFICE”) or in a hospital or surgical center (“OR”). Procedure duration, percentage of procedure attempts, device reliance, pain, and recovery and return-to-work times were recorded.

Results: Procedure duration was slightly longer for the OFFICE group (12.8 minutes vs 11.2 minutes; p=.02). The percentage of procedure attempts (OFFICE, 87.3% vs OR, 85.5%; p=.56) were not signifi-cantly different. Device reliance was not significantly different at 3 months (OFFICE, 89.0% vs OR, 91.0%; p=.09) or at 6 months (91.2% vs 94.4%; p=.49).

For pain assessment, the OFFICE group had a significantly lower value during matrix placement (3.8 +/- 11.7 vs 8.8 +/- 18.1; p <.001). The OFFICE group also displayed significantly shorter recovery time (0.8 +/- 1.2 hours vs 1.2 +/- 1.3 hours; p=.02) and return-to-work time (0–2 days [median, 0] absent vs 0–7 days [median, 1] absent; p < .001).

Conclusion: Adiana in-office performance is functionally the same as in the operating room. Improvements were seen in the OFFICE group compared with the OR group for pain assessment, recovery time, and return-to-work time.

INTRODUCTION

Nearly all women aged 15 to 44 years who have had sexual intercourse have used at least one form of birth control in their lifetime (98%).¹ Female sterilization is the second most common form of contraception in this age group with more than 10.3 million women currently relying on this contraceptive method.¹ In 2001, there were 3.1 million unintended pregnancies in the United States, half of which were related to contraceptive failures.² One factor that may contribute to contraception failure is the high rate of discontinuation of temporary birth control in the first year, estimated to range from 10% to 70%.³

With the approval of transcervical sterilization, permanent female sterilization is now a less invasive hysteroscopic procedure. Some of the advantages of transcervical sterilization over tubal ligation include a decreased potential for complications, greater patient convenience, and minimal anesthesia. There are no incisions required with transcervical sterilization; therefore, women generally have less discomfort and a shorter recovery time. Women with certain medical conditions, such as heart disease or obesity, can undergo this procedure. Additionally, as transcervical sterilization often requires minimal anesthesia, it can be safely performed in an office setting as an alternative to the operating room.

In 2009, the US Food and Drug Administration approved a new form of female sterilization, Adiana^® Permanent Contraception (Hologic^™, Inc., Marlborough, Mass.)(Figure 1), which involves surgical implantation of a polymer matrix into the fallopian tubes (Figure 2). The Adiana procedure does not require any incision and can be performed either in-office or in an operating room (hospital or surgical center) under local anesthesia.

The EASE (Evaluation of the Adiana System for Transcervical Sterilization Using Electrothermal Energy) clinical study was the pivotal trial to evaluate the efficacy and safety of the Adiana procedure. In this clinical investigation, no uterine or tubal perforations, expulsions, injuries related to matrix placement, excessive pain, or bleeding occurred. One report of hyponatremia was reported and resolved without complication. Adiana Permanent Contraception demonstrated a 98.4% efficacy rate for 3-year pregnancy prevention.

Transcervical sterilization can be completed in the office and may offer greater patient benefits compared with completing the procedure in the operating room. We sought to evaluate the functionality of the Adiana procedure both in the office and in the operating room based on the EASE study. Our objective was to determine whether Adiana Permanent Contraception is functionally different when used in an office than in an operating room.

METHODS

The EASE trial enrolled 770 women aged 18 to 45 years. Procedures were performed in-office (“OFFICE” group) or in the operating room (“OR” group). We evaluated and compared procedure duration, percentage of procedure attempts, device reliance, pain, and recovery and return-to-work times in those women who had the procedure completed in an office setting versus an operating room setting.

RESULTS

The majority of the study population was Caucasian (OFFICE, 88.2% vs OR, 68.1%); the average age at enrollment was 33.2 years for the OFFICE group and 31.2 years for the OR group (Table 1). There were no differences in the percentage of procedure attempts (OFFICE, 87.3% vs OR, 85.5%; p=.56). The reliability of the Adiana device was not signifi-cantly different at 3 months (OFFICE, 89.0% vs OR, 91.0%; p=.09) or at 6 months (OFFICE, 91.2% vs OR, 94.4%; p=.49).

Patient demographics

The average duration of the procedure for the OFFICE group was slightly longer than for the OR group (12.8 minutes vs 11.2 minutes; p=.02; Table 2). Yet, women in the OFFICE group experienced a significantly shorter recovery time compared with the OR group (0.8 +/- 1.2 hours vs 1.2 +/- 1.3 hours; p=.02). Correspondingly, the women in the OFFICE group had a shorter return-to-work time than the OR group (0–2 days [median, 0] vs 0–7 days [median, 1]; p < .001) (Table 3 and Table 4). We also observed a lower pain value during matrix placement for the OFFICE group than for the OR group (3.8 +/- 11.7 vs 8.8 +/- 18.1; p < .001) (Table 5).

Procedure duration

Recovery time

Time to return-to-work

Pain Assessment

DISCUSSION

Transcervical sterilization provides women with an alternative permanent method of birth control. Because the procedure is relatively simple and is often performed with local anesthesia, it may be completed in the office. We evaluated data from the EASE study and found that the performance of Adiana Permanent Contraception is functionally equivalent for both office and operating room settings. We also assessed the potential benefits of performing the procedure in-office compared with the operating room. We determined that, although the average duration of the procedure was slightly longer for the OFFICE group (12.8 minutes) compared with the OR group (11.2 minutes), there were potential benefits for the patient, including shorter recovery time, shorter return-to-work time, and a lower pain value.

Although benefits such as these are often not accounted for in cost-benefit analyses, they are equally important. Patient preference is a major factor in a woman’s decision to select a method of pregnancy prevention. Interventions that have minimal or no impact on their activities of daily living and quality of life, including disruptions in mood, are utilized more frequently and with better adherence rates. Again, we found that performing transcervical sterilization in the office resulted in a shorter recovery time and allowed women to return to work earlier after the procedure. It is possible that these patient benefits would make transcervical sterilization more appealing to the patient, particularly when performed in an office setting.

Medical care is constantly facing challenges. One of the challenges faced by the medical practitioner is providing the best care for the patient in a cost-effective manner, while maintaining efficacy and safety. ObGyns have traditionally performed tubal ligation for permanent contraception. Transcervical sterilization is a new option to tubal ligation that can provide similar efficacy, yet with a more favorable safety profile. In addition to the potential benefits discussed already, transcervical sterilization may be more cost-effective for the health care system. Performing the procedure in-office eliminates the need for a full preoperative examination the day before the procedure, and the overnight stay in the hospital for recovery, and lowers anesthesia costs. Although when performed in-office, transcervical sterilization may have slightly higher upfront costs for the health care system, it has a favorable cost profile over time compared with temporary birth control methods.^4,5

In conclusion, we demonstrate that transcervical sterilization with Adiana Permanent Contraception is functionally equivalent when performed in-office compared with the operating room. We observed improvements in the OFFICE group compared with the OR group for pain assessment, recovery times, and return-to-work times. These outcomes, in conjunction with patient preference and physician judgment, provide additional considerations when selecting the method and determining the setting for transcervical sterilization.

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