Results of a Community-based Survey Evaluating Pregnancy Prevention With Adiana® Permanent Contraception

Clinical Associate Professor of Obstetrics and Gynecology, Northeastern Ohio Universities College of Medicine, Physician, Stark County Women’s Clinic, Canton, Ohio

DISCLOSURES AND ACKNOWLEDGEMENTS
Dr. Randall S. Starcher participates as a consultant and advisor for Hologic, Inc.

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

ABSTRACT

Objective To obtain a better understanding of physicians’ current opinions of Adiana^® Permanent Contraception, and how the procedure compares with another transcervical sterilization procedure.

Methods Survey invitations were sent to all Adiana-trained physicians in the United States (US) and all US EASE pivotal trial investigators. The survey was designed to evaluate physician experience with Adiana’s clinical performance characteristics, including anesthesia, compliance with hysterosalpingogram (HSG), and the observed rate of tubal occlusion.

Results Survey invitations were sent to 337 physicians (168 physicians began the survey; 156 completed it). Physician responses represent experience with approximately 1,500 patients. Physicians who responded to the survey reported that the majority of hysteroscopic sterilizations (55%) are performed in-office, and the majority of respondents perform 10 to 25 hysteroscopic sterilizations annually. Physicians (59.1%) reported that more than 95% of patients return for the 3-month HSG; 79.8% (126) estimated that over 85% are bilaterally occluded. A large majority (93.7%) agreed or strongly agreed that the Adiana device can be easily deployed, and 86.7% agreed or strongly agreed that the procedure is compatible in the office setting. Among physicians surveyed, 97.5% agreed or strongly agreed that patients are generally satisfied with the Adiana procedure and that patient satisfaction is similar or better compared with another transcervical sterilization product (83.5%).

Conclusions The Adiana procedure provides a reliable method of permanent contraception, which is well-accepted by patients and physicians. Physicians responding to this survey recognized the value of a hysteroscopic sterilization procedure that can be performed in either a hospital or office setting.

INTRODUCTION

In the United States (US), there were 75.2 million women of reproductive age (15–49 years) in 2008. This number is expected to reach 76 million in 2015.¹ Age, sexual activity, number of partners, desire to have children, and family history of certain diseases can influence a woman’s contraceptive choice.²

As of 2002, 10.3 million US women relied on female sterilization.³ In the US, female sterilization is the most common form of contraception for women aged 35 to 44 years and the second most common choice for women aged 15 to 44 years.³ Annually, 684,000 women undergo sterilization procedures.⁴

Compared with tubal ligation, transcervical sterilization offers several advantages, including decreased potential for complications and greater convenience for patients. Incisions are not required, and patients typically experience less discomfort and shorter recovery time. Transcervical sterilization may be performed in a hospital or office setting. It is possible that this option may result in more women electing to undergo the procedure in-office, as many women may be more comfortable being in their regular doctor’s office rather than a less familiar hospital setting.

Adiana^® Permanent Contraception (Hologic^™, Inc., Marlborough, Mass.) is a transcervical sterilization system indicated for women who desire permanent birth control by occlusion of the fallopian tubes. Here, the findings from a US community-based survey evaluating physicians’ experiences with Adiana are presented. The survey was designed to collect information on baseline characteristics of commercial use of Adiana to gauge physician response to the training and performance characteristics of the product.

METHODS

Physicians were invited by email to participate in the Web-based survey, including all those trained to use Adiana since its approval in the US and all US EASE (Evaluation of the Adiana System for Transcervical Sterilization Using Electrothermal Energy) trial investigators. Participants who completed the survey were offered compensation. The survey was available online for 30 days (August–September 2010). After the survey was open for approximately 14 days, email reminders were sent to unresponsive physicians. One week prior to the close of the survey, additional email reminders were sent to physicians who had begun but not completed the survey. The 29 multiple-choice–question survey was designed to evaluate several areas of practice specific to Adiana. Questions focused on: 1) experiences with permanent sterilization; 2) preferences when performing the Adiana procedure; 3) hysterosalpingogram (HSG) evaluations; 4) efficacy trends (commercial use); 5) ease-of-use; and 6) opinions on Adiana compared with another transcervical sterilization product.

RESULTS

Respondents

In total, 337 physicians were invited to participate in the survey; 168 physicians began the survey, and 156 completed it. Physician responses represent experience with approximately 1,500 patients and cases. There was good geographic and practice-type representation (Table 1). Almost half of physician-respondents work in private practice obstetrics and gynecology (ObGyn) offices in suburban US areas.

Demographic make-up of respondents

Procedural Information

Physicians who responded to the survey reported that almost 55% of hysteroscopic sterilizations are performed in-office, 27% in-hospital; the remaining 19%, at other sites (e.g., ambulatory surgical center)(Table 2). The number of hysteroscopic sterilizations performed annually varied greatly. The majority of physicians (50.3%) perform 10 to 25 hysteroscopic sterilizations annually; a small percentage (3.1%) perform more than 100 hysteroscopic sterilizations. In the previous year, 49.1% of physicians performed 5 to 10 Adiana procedures; 8.1% of physicians performed more than 25 Adiana procedures. However, respondents predict their number of procedures will increase; 38 physicians (23.5%) expect to perform more than 25 Adiana procedures next year (Figure 1).

Fifty physicians (30%) reported using a paracervical block as anesthesia during in-office hysteroscopic sterilization procedures. In contrast, when performing hysteroscopic sterilization procedures in-hospital, 20 physicians (12.4%) use paracervical block and 106 physicians (65.8%) use general anesthesia. Approximately 43% of physicians prefer to perform the Adiana procedure during the early to mid-follicular phase of the menstrual cycle, while the rest of the procedures appear distributed throughout the cycle. Fifty-nine physicians (36.6%) reported that cycle timing is irrelevant because patients are prescribed cycle-suppressing medication. The preferred distention media for the Adiana procedure is glycine (54.4%); others report using sorbitol (22.5%), mannitol (13.1%), a mannitol-sorbitol mix (8.8%), or other (1.3%).

Experience with permanent sterilization

POST-PROCEDURE FOLLOW-UP

Overall, 85 physicians (53.1%) reported that more than 95% of patients comply with contraception use during the waiting period following the procedure. Ninety-four physicians (59.1%) reported that over 95% of patients return for the 3-month HSG evaluation; 49 (30.8%) reported that 75% to 95% of patients return for the evaluation. Physicians (43.1%) prefer to perform the HSG during the early to mid-follicular phase of the menstrual cycle. The majority of HSGs are conducted by the gynecologist/a partner (46.3%). Whereas 46.3% of respondents always review the confirmatory HSG film, 25.6% never review the film. The ability to rely on Adiana after the film has been reviewed is most often conveyed to the patient by the gynecologist (74.4%). Most participants (126; 79.8%) estimated that more than 85% of patients are bilaterally occluded at 3 months. The majority of physicians (96; 60.8%) estimated that more than 95% of patients are bilaterally occluded at the 3-month HSG and can rely on Adiana. Of those who reported a rate of less than 95% bilateral occlusion, 30 physicians (19%) estimated a bilateral occlusion rate of 86% to 95%; 17 (10.8%) estimated a rate of 76% to 85%; 15 (9.5%) estimated a rate lower than 75% (Figure 2).

EXPERIENCE WITH THE ADIANA DEVICE

A main objective of this survey was to evaluate the ease-of-use of Adiana as an individual device (Table 3A) and compare it with another transcervical sterilization product (Table 3B). When comparing groups, alpha values ranging from 0.7 to 0.8 are considered satisfactory.⁵ In terms of ease and best use, the survey results are reliable (Cronbach’s alpha=0.760). Most physicians (148; 93.7%) agreed or strongly agreed that the device can be easily deployed into the tubal ostia. The majority of physicians (86.7%) agreed or strongly agreed that the Adiana procedure is compatible with an in-office setting. Importantly, 97.5% (154) of physicians agreed or strongly agreed that patients are generally satisfied with the procedure. Results are also reliable (Cronbach’s alpha=0.764) for survey questions comparing Adiana with another transcervical sterilization product. Physicians (131; 82.9%) reported that ease of deployment of the Adiana device is similar or better compared with the other product. Physicians (122; 77.2%) reported that the in-office compatibility of the Adiana system is similar or better than that of another transcervical sterilization product. Additionally, 132 (83.5%) of physicians reported that patient satisfaction with Adiana is similar or better than patient satisfaction with another transcervical sterilization product.

Physician experience with Adiana alone and compared with another transcervical sterilization product

DISCUSSION

The findings of this survey support physician and patient acceptance of Adiana Permanent Contraception since its introduction in July 2009. Physicians (97.5%) surveyed agreed or strongly agreed that their patients were satisfied with the Adiana procedure. For patients, hysteroscopic sterilization offers many benefits over other forms of female sterilization, including a short procedure, local or no anesthesia, no incisions, minimal recovery time, and the convenience of undergoing the procedure in-office. Hysteroscopic sterilization also offers benefits for the physician; 86.7% of respondents agreed or strongly agreed that the Adiana procedure can be performed in-office. In-office procedures decrease physicians’ operating room time, thereby reducing the amount of time spent out of the office.

According to the Adiana Instructions for Use,⁶ physicians should perform an HSG to evaluate and confirm bilateral tubal occlusion 3 months postprocedure. Three-month bilateral occlusion rates are reported as greater than 85% by 79.8% (126) of physicians surveyed. However, less than half of the physicians provided data on 6-month bilateral occlusion rates. The 3-month occlusion rate compares favorably to that found in the EASE trial, where 85.4% (551/645) of intent-to-treat patients were ultimately able to rely on Adiana Permanent Contraception.⁷ Additionally, in EASE, the 6-month bilateral occlusion rate was 88.4% (570/645).⁷ Physicians (119; 74.8%) reported that more than 85% of their patients return for the 3-month HSG. Although this number is encouraging, there is room for improvement. It is important to ensure compliance and patient recall on this important confirmatory step. Only after bilateral occlusion is confirmed should the patient rely on Adiana (Figure 3).⁶ An HSG image demonstrating fill in the proximal tubes is critical to confirming bilateral occlusion (Figure 4).

In its first year of commercial use, Adiana offers a reliable method of permanent contraception. Although a precise pregnancy calculation was not the basis of the survey, the survey did provide important information that allowed for a correlation of pregnancy events between those reported in the survey against those reported to the manufacturer. Using this information, in conjunction with a series of assumptions based on commercial units sold and days of reliance and fertility/fecundity, Herbst and Evantash recently reported an estimated 12-month pregnancy failure rate of 0.57% for Adiana.⁸ * This rate compares favor-ably to the pregnancy failure rate of 1.07% observed in the EASE trial.

Additionally, results demonstrate that physicians believe that Adiana can be easily integrated into office-based practices. Benefits include a device that can be easily deployed, and a procedure that can be performed in-office without general anesthesia and incisions, as well as a lower risk of complications. Results show that the majority of patients are generally satisfied following the procedure. Considering the growing population of reproductive women in the US, it is important that physicians have access to a safe and effective method of hysteroscopic sterilization that can be conveniently performed in a setting that best accommodates physicians and patients.

* The equivalent annual pregnancy rate of 0.57% was calculated using a model that 1) takes the estimated number of Adiana procedures as input; 2) computes the number of women relying on the Adiana procedure each month to give an estimate of the number of patient-relying months; and 3) uses the number of reported pregnancies. The model computes the rate equal to 572,798 patient-relying days, which equates to 1,569 patient-relying years. Assuming all patients had a consistent fecundity rate in the first year of relying, the pregnancy rate at 1-year can be estimated based on the number of reported pregnancies divided by patient-relying years. This estimate represents the period of time between January 2009 and September 2010.

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