Satisfaction and tolerance with office hysteroscopic tubal sterilization

TECHNIQUES AND INSTRUMENTATION Satisfaction and tolerance with office hysteroscopic tubal sterilization Jose E. Arjona, M.D., Ph.D., a Monica Mi~no, M.D., Ph.D., a Javier Cordon, M.D., Ph.D., a Balbino Povedano, M.D., Ph.D., a Blas Pelegrin, M.D., a and Camil Castelo-Branco, M.D., Ph.D. b a Hysteroscopy Unit, Department of Gynecology and Obstetrics, Reina Sofıa University Hospital, Cordoba; and b Institut Clinic of Gynecology, Obstetrics and Neonatology, Faculty of Medicine University of Barcelona, Hospital Clinic Institut d Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Barcelona, Spain Objective: To evaluate women s satisfaction and tolerance of hysteroscopic sterilization. Design: Prospective analysis of case series. Setting: Gynecology department in a teaching hospital. Patient(s): A total of 1,630 women who underwent hysteroscopic sterilization by placement of Essure microinserts (Conceptus, Inc., Mountain View, CA) from January 2003 to June 2006. Intervention(s): Transvaginal ultrasound examination, pelvic x-ray examination, and hysterosalpingography 3 months after sterilization with Essure microinserts. Satisfaction was assessed by a visual analog scale. Adverse effects and tolerance also were recorded. Main Outcome Measure(s): Transvaginal ultrasound and pelvic x-ray confirmation of correct localization of microinserts and patient s satisfaction and tolerance after a 3-month follow-up. Result(s): The rate of successful insertion was 99%. Most of women returned to their daily activities on the same day of insertion, and 86.5% considered the procedure painless or scarcely painful. All the patients were highly satisfied after hysteroscopic sterilization: 91% of subjects by visual analog scale (on a 0 to 10 scale) rated the method at 10 (high satisfaction degree), and none of the subjects rated it under 8. For patients, the most valuable aspects of the procedure were absence of surgery room (52.7%), method s quickness and comfort (19.9%), and permanent sterilization (18.2%). More than 97% of the patients said that they would recommend the procedure to others. Conclusion(s): This study provides evidence that Essure microinserts can be placed in a usual gynecologic consultation room in standard conditions without any type of anesthesia or sedation and are associated with great overall patient satisfaction. Women also have high tolerance for the procedure and describe minor postoperative pain. (Fertil Steril Ò 2008;90:1182 6. Ó2008 by American Society for Reproductive Medicine.) Key Words: Essure, hysteroscopic tubal occlusion, outpatient setting, hysteroscopy, tubal sterilization The Essure microinsert system (Conceptus, Inc., Mountain View, CA) is a modern device used in a recently proposed technique for female sterilization. The microinsert is made of an inner stainless steel coil surrounded by an outer nickel titanium alloy coil. The inner coil attaches to a guidewire used for placement and is extended into the fallopian tube. The inner coil is surrounded by white polyethylene terephthalate fibers, which generate benign local ingrowth when in contact with tissue (1, 2). Over a 3- month period, the tubal lumen is occluded by tissue growth stimulated by the polyethylene terephthalate fibers about the inner coil. Nowadays, most current methods of female permanent birth control (e.g., tubal ligation) require general anesthesia, Received May 18, 2007; revised August 2, 2007; accepted August 3, 2007. Reprint requests: Camil Castelo-Branco Flores, M.D., Ph.D., Institut Clinic of Gynecology, Obstetrics and Neonatology, Hospital Clinic, Villarroel 170, 08036-Barcelona, Spain (FAX: 39-93-227-93-25; E-mail: castelobranco@ub.edu). exposing the patient to the intrinsic risks of a surgical procedure and needing a period of postoperative recovery. Laparoscopic sterilization requires abdominal wall skin incisions followed by the introduction of a laparoscopic trocar and cannula through these incisions. As well as the small risk associated with general anesthesia, laparoscopic sterilization has specific complications such as those related to perforation or damage to small and large bowel and to major abdominal wall vessels (3, 4). In contrast, the Essure system is placed transcervically in an office setting. Placement is achieved via catheterization by hysteroscopy. Therefore, with no hospitalization and in a few minutes, irreversible sterilization is achieved (5). Because of its minimally invasive method of placement and its high degree of effectiveness, the Essure device has a high satisfaction rate as a form of permanent female birth control, and for these reasons one could expect that the popularity of the device may increase rapidly in the near future (5). 1182 Fertility and Sterility â Vol. 90, No. 4, October 2008 0015-0282/08/$34.00 Copyright ª2008 American Society for Reproductive Medicine, Published by Elsevier Inc. doi:10.1016/j.fertnstert.2007.08.007

This study was designed to evaluate women s satisfaction with and tolerance of this novel office sterilization procedure and to analyze the rate of success of insertion and related complications. MATERIALS AND METHODS After Institutional Review Board approval, a total of 1,630 women were asked to participate in this prospective study between January 2003 and June 2006. Before obtaining written consent, irreversibility and the very high, but not infallible, efficacy were emphasized. Continuous oral contraceptives at least 1 month before the procedure were indicated to induce endometrial atrophy, and 1 hour before the insertion patients were given pretreatment with ibuprofen 600 mg and benzodiazepine 10 mg. All Essure procedures were carried out at Reina Sofıa University Hospital (Cordoba, Spain) in a dedicated outpatient facility by a gynecologist. The microinserts were placed through the 5F working channel of a 5-mm, continuousflow, 30 hysteroscope (Karl Storz Endoscopia, Barcelona, Spain) with use of a saline distention medium. Essure microinsert hysteroscopic sterilization involves the bilateral placement of a coiled microinsert into the proximal section of the fallopian tube, under hysteroscopic visualization. The device then induces an inflammatory process, which leads to occlusion of the fallopian tubes. Placement was performed according to the manufacturer s instructions (6). Optimal placement was considered to be three to eight coils remaining visible in the uterine cavity. Immediately after insertion women were asked about their sensation of pain, and after the procedure most patients left the consulting room with no recovery time. As a postprocedure indication, women were advised to use an alternative contraceptive method until a simple pelvic x-ray examination was performed, at least 3 months after the insertion. Hysterosalpingography or ultrasonography was performed when the placement was not satisfactory (more than 10 or fewer than three coils remaining visible by hysteroscopy, insertion only in one tube, unclear radiologic results). At the 3-month follow-up visit adequate positioning was confirmed, and patients were advised to rely on the Essure system for contraception. All women who underwent Essure placement were discharged home on the same day as the procedure. As part of this study design all patients completed a self-assessment diary and were contacted by the study team after discharge. The primary outcome, patient tolerance and satisfaction, was judged by patients completing questionnaires on days 1 and 90. The patient diary recorded satisfaction with the sterilization decision, speed of recovery after the procedure, and overall satisfaction with the procedure chosen. Patients satisfaction was evaluated with use of a visual analog scale (VAS; 100-mm line with end anchors) rating from 0 (absolutely dissatisfied) to 10 (highly satisfied) and by a verbal rating scale as follows: very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, and very dissatisfied. In addition, patients were asked if they would recommend the procedure to others. Patient tolerance and discomfort were also measured with use of an ordinal Likert-style scale and determined while patients were in the recovery room. All patients were required to rate their tolerance as follows: poor, fair, good, very good, and excellent. Women were then asked to describe the discomfort they experienced during the procedure. The following pain rating categories were used to record this information: none, mild, moderate, and severe. Secondary outcome measures include successful completion of procedure, procedure time, and postoperative adverse events. Adverse events (unintended injuries or complications as a result of the sterilization) were recorded at the following time points: recovery room, day of procedure, and 90 days after the procedure. Finally, the follow-up was expanded up to the present time to detect late complications and further pregnancies. RESULTS A total of 1,630 women with one or more previous pregnancies (mean pregnancy rate: 2.4 1.2), 32 to 41 years old (mean age 36.6 5.7 years), who asked for permanent sterilization, were included. Of them, 92% were former or present users of oral contraceptives. Fifteen women (<1%) dropped out because of a failure in the procedure (insertion success rate >99%). Thus, of the entire sample, 1,615 were considered evaluable for tolerance and satisfaction. The procedure was well tolerated, inasmuch as 1,398 (86.5%) of the 1,615 women with Essure microinserts inserted considered it excellent or very good, 10.2% (166) felt pain similar to normal menstruation (good), and only 3.1% felt more pain than with menstruation (fair or poor). There were no major complications during the procedures, and only vasovagal syncopes resolved without medication were recorded in 16 women (1%). A total of 1,612 women (99.8%) completed the 3-month follow-up. Most of them (83.9%) returned to their daily activity at the same day of insertion, 239 (14.8%) the day after, and only 20 (1.2%) required more than 1 day. One hundred thirteen women (7%) needed oral analgesic for 1 or 2 days after the procedure. Ninety-four percent of the subjects (1,516 women) expressed themselves very satisfied with the procedure and 6% (96) somewhat satisfied. No women reported dissatisfaction of any type. Of the 1,612 women who were contacted at the end of follow-up, 722 were surveyed with additional questionnaires on satisfaction and tolerance. When this subset was interrogated on satisfaction with the procedure, 91% of women (n ¼ 658) referred a satisfaction degree of 10, and the lowest rating referred was 8 (in a 10-point VAS). The most positive aspect of the procedure was the avoidance of an operating room (52.7%) followed by the perception of quick and comfortable procedure (19.9%). Other Fertility and Sterility â 1183

aspects considered positive by subjects included in the study are given in Figure 1. More than half of the women (55.8%) said there was nothing unpleasant about the procedure. Figure 2 provides the reported negative aspects related to the procedure. A majority of women, 97.5% (n ¼ 704) have already recommended the procedure to others. Three pregnancies were diagnosed during the first 90 days after the procedure, two in women using oral contraceptives and one in a woman who chose not to use contraception after the procedure. Pregnancy rates and complications accumulated until June 2007 are given in Tables 1 and 2. FIGURE 2 Patient report of the negative aspects of the Essure procedure (n ¼ 722). More than half of the women did not find anything unpleasant, and the main related complaints were the need for use of oral contraceptives during the study follow-up, the discomfort during and after procedure, and the need to wait 3 months to consider the procedure as definitive. DISCUSSION This was a case-series study to assess the satisfaction with and tolerance of hysteroscopic tubal sterilization performed in the office. Our results show that the insertion of the Essure microinserts may be carried out in an outpatient office without hospital admission in all cases. To provide evidence that this new method of permanent birth control confers an advantage, in terms of patient satisfaction, over the traditional method of laparoscopic sterilization a comparative study would be the best option. However, there are several limitations with this type of study. First, it is a comparison of two methods of sterilization with clearly different surgical approaches. Second, the procedures are carried out in different subjects who also may have different perceptions of tolerance and satisfaction. Finally, and more important, it is also investigating the environment in which the procedures are carried out (hospital admission and general anesthesia vs. outpatient FIGURE 1 Patient report of the positive aspects of the Essure procedure (n ¼ 722). The most valued aspect was the absence of an operating room followed by the perception of quick, comfortable, and definitive procedure and the fast return to normal life. office and no anesthesia). Moreover, it is clear that the pros and cons of office outpatient versus hospital admission procedures are linked to patient satisfaction with the procedure itself (7, 8). As with all novel techniques, insertion of the Essure system depicts a learning curve. An improved experience is TABLE 1 Life table analysis of pregnancy rates accumulated over 42 months. Months of follow-up No. Pregnancies a 42 177 0 36 435 0 30 270 0 24 367 0 18 170 0 15 196 0 Total 1,615 0 Note: No pregnancies were diagnosed among the 1,419 women who have R18 months of follow-up. a Excluded three cases diagnosed in the first 90 days after procedure. 1184 Arjona et al. Sterilization in office without anesthesia or sedation Vol. 90, No. 4, October 2008

TABLE 2 Complications during the procedure and the expanded follow-up (up to 42 months). Complication No. Percentage Uterus perforation 0 0 Pelvic inflammatory disease 0 0 Vasovagal syncope 16 1 Migration to abdominal cavity 3 0.18 Expulsion of one microinsert 12 0.73 Intramyometrial placement 2 0.12 of the devices Nickel allergy 1 0.6 Pregnancy 3 0.18 Total 33 2.45 Note: Several subjects presented more than one complication. linked to a better rate of success in insertion and comfort. Our present success rate for insertion is one of the best published to date, 99%, reflecting our own learning curve: 3.6% failure in the 110 first cases (9), 1.4% in the next 755 patients (10), and 1% in the present series. Other authors have reported similar results (11, 12). In our study, the expulsion of one microinsert was observed in 12 of 1,630 women. In all cases, a new device was placed in the free tube without further problems. In two additional women an intramyometrial placement of the devices was observed after hysterosalpingography. The low rate of expulsion of microinserts may be due to a failure in its aperture mechanism inside the tube (10). One of the advantages of Essure microinserts is that adverse events are infrequent. Herein we report only 1% of patients experiencing vasovagal syncope, all of which instances were resolved with no medication; this is similar to published data (13). Some authors have reported other minor complications such as cervical bleeding (14) or cramping (5). Although some physicians routinely use a paracervical block, IV sedation, or both (12), it has already been demonstrated that the use of local anesthesia does not alter the tolerance related to the procedure (15, 16), and most of the physicians only use it when medically indicated (14). Premedication with spasmolytics, analgesics, or both has been related to a better rate of insertion and a lower procedural time (5, 17). In our study, 1 hour before the procedure patients were given 10 mg diazepam, because the relaxation that it induces improves toleration of the procedure (5, 13). Satisfaction is a very subjective concept but greatly desirable in the practice of medicine. In our previous report on the Essure microinserts success rate and patient satisfaction, we found 94% of subjects very satisfied (10). In the present series, nine out of 10 women who had chosen Essure microinserts felt very satisfied with the method, and the others graded the procedure eight or nine points out of 10. There are many aspects related to satisfaction; among them, the more valued by the women were the absence of a surgery room and the quickness and good toleration of the procedure. It should be emphasized that only 3 of each 100 women felt some pain during insertion greater than that felt during a normal menses, 80 out of 100 resumed normal activity the same day of insertion, and only 7 of each 100 required analgesics after the procedure. These results are quite similar to those observed in our first cutoff with 875 women (10). This lack of interference with normal activity is distinctive of the Essure procedure. Satisfaction with the Essure procedure has been suggested to be superior to that with other permanent birth control procedures (13, 18); in a comparative study versus laparoscopic sterilization (14) satisfaction at 90 days after the procedure was 100% for Essure and only 80% for the laparoscopic sterilization group. The contraceptive efficacy of the microinserts, the excellent tolerance, and the high grade of personal satisfaction with the procedure are the real clues of the procedure s acceptance and what persuades women to recommend it to their friends and relatives. In addition, for the same reasons and for the balanced cost efficacy ratio (19) its widespread use should be warranted. Finally, although hysteroscopic sterilization with the use of the Essure microinsert must be considered as definitive, a recent report of two cases suggests that the uterine presence of the microinserts may be compatible with successful pregnancy outcomes after IVF and ET procedures (20). In conclusion, because of the high rate of success of insertion, excellent tolerance, absence of complications, and the very high grade of satisfaction, the Essure procedure should be one of the first-line options for female permanent sterilization. On the basis of its safety profile it is especially valuable for women at high surgical or anesthetic risk. Acknowledgments: The authors thank Jose Luis Diaz, general manager of our hospital, for his support of the development of this project and the Andalusia Health Service for the acquisition of the microinserts. REFERENCES 1. Haverich A, Maatz W, Stegmann T, Oelert H, Borst HG. Experimental and clinical experiences with double-velour woven Dacron prostheses. Thorac Cardiovasc Surg 1986;34:52 3. 2. Valle RF, Carignan CS, Wright TC. Tissue response to the STOP microcoil transcervical permanent contraceptive device: results from a prehysterectomy study. Fertil Steril 2001;76:974 80. 3. Escobedo LG, Peterson HB, Grubb GS, Franks AL. Case fatality notes for tubal sterilization in US hospitals 1979 to 1980. Am J Obstet Gynecol 1989;160:147 50. 4. Garry R. Towards evidence-based laparoscopic entry techniques: clinical problems and dilemmas. Gynaecol Endosc 1999;8:315 26. 5. Cooper JM, Carignan CS, Cher D, Kerin JF. Selective Tubal Occlusion Procedure 2000 Investigators Group. Microinsert nonincisional hysteroscopic sterilization. Obstet Gynecol 2003;102:59 67. 6. Rogerson L, Hudson H, Duffy S. UK Experience using the ESSURE micro-insert for hysteroscopic sterilisation. Rev Gynaecol Pract 2003; 3:1 4. 7. Kremer C, Duffy S, Moroney M. Patient satisfaction with outpatient hysteroscopy versus day case hysteroscopy: randomised controlled trial. BMJ 2000;320:279 82. Fertility and Sterility â 1185

8. Jack SA, Cooper KG, Seymour J, Graham W, Fitzmaurice A, Perez J. A randomised controlled trial of microwave endometrial ablation without endometrial preparation in the outpatient setting: patient acceptability, treatment outcome and costs. Br J Obstet Gynaecol 2005;112: 1109 16. 9. Arjona JE, Garcıa-Oliveros MC, Mi~no M, Cordon J. Oclusion tubarica en consulta. Proceedings of the XVII FIGO World Congress; 2003 Nov 2 7; Santiago de Chile (Chile): 31. 10. Mi~no M, Arjona JE, Cordon J, Pelegrin B, Povedano B, Chacon E. Success rate and patient satisfaction with the Essure sterilisation in an outpatient setting: a prospective study of 857 women. Br J Obstet Gynaecol 2007;114:763 6. 11. Rosen DM. Learning curve for hysteroscopic sterilization: lesson from first 80 cases. Aust N Z J Obstet Gynaecol 2004;44:62 4. 12. Kerin FJ, Munday DN, Ritossa MG, Pesce A, Rosen D. Essure hysteroscopic sterilization: results based on utilizating a new coil catheter delivery system. J Am Assoc Gynecol Laparosc 2004;11:388 93. 13. Ubeda A, Labastida R, Dexeus S. ESSURE: a new device for hysteroscopic tubal sterilization in an outpatient setting. Fertil Steril 2004;82: 196 9. 14. Duffy S, Marsh F, Rogerson L, Hudson H, Cooper K, Jack S, et al. Female sterilization: a cohort controlled comparative study of ESSURE versus laparoscopic sterilization. Br J Obstet Gynecol 2005;112:1522 8. 15. Ubeda A, Mascaro M. Significative improvement in bilateral placement of Essure. 454 cases, from training phase to routine work. Proceedings of the 13th Annual Congress of the European Society for Gynecological Endoscopy; 2004 Oct 14 17; Cagliari (Italy). Gynecol Surg 2004;1(Suppl 1):s23. 16. Anderson T, Alturi V. A review of the use of Essure outpatient hysteroscopic female sterilization in a provincial hospital in Ireland. Proceedings of the 13th Annual Congress of the European Society for Gynecological Endoscopy; 2004 Oct 14 17; Cagliari (Italy). Gynecol Surg 2004;1(Suppl 1):s13. 17. Chern B, Siow A. Initial Asian experience in hysteroscopic sterilization using the Essure permanent birth control device. Br J Obstet Gynecol 2005;112:1322 7. 18. Kerin JK, Carignan CS, Cher D. The safety and effectiveness of a new hysteroscopic method for permanent birth control: results of the first ESSUREÔ pbc clinical study. Aust N Z J Obstet Gynaecol 2001;41: 364 70. 19. Levie MD, Chudnoff SG. Office hysteroscopic sterilization compared with laparoscopic sterilization: a critical cost analysis. J Min Invasive Gynecol 2005;12:318 22. 20. Kerin JK, Cattanach S. Successful pregnancy outcome with the use of in vitro fertilization after Essureâ hysteroscopic sterilization. Fertil Steril 2007;87:1212.e1 4. 1186 Arjona et al. Sterilization in office without anesthesia or sedation Vol. 90, No. 4, October 2008