1 Department of Gynecological Science and Human Reproduction, University of Padua School of Medicine, Via Giustiniani No. 3, 35128 Padua, Italy, 2 Department of Obstetrics and Gynaecology, University Politecnico Belle Marche, Ancona, Italy
3 To whom correspondence should be addressed. E-mail: ecosmi{at}hotmail.com
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Abstract |
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Key words: intratubal device/outpatient hysteroscopy/tubal sterilization
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Introduction |
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Laparoscopic tubal sterilization is safe and effective, albeit invasive, and has potential surgical and anaesthesiological risks and complications such as unintended major surgery, re-hospitalization, febrile morbidity, transfusion and life-threatening events may occur, with an incidence of 0.9% (Jameson et al., 2000). Moreover, fatal complications have been reported to occur in four to 11 patients per 100 000 procedures performed (Hulka et al., 1995
; Intaraprasert et al., 1997
). Furthermore, it has been shown that there is a time-related risk of contraception failure. In fact, it has been reported that after 10 years the pregnancy rate varied from 7.5 to 36.5 per 1000 procedures (Peterson et al., 1996
; 1999
; 2001
).
Since 1970 several investigators have aimed to obtain permanent tubal sterilization by the trancervical approach, although the attempts were not safe and had low effectiveness (Sciarra and Keith, 1995).
Recently, a new micro-device namely the Essure (Essure permanent birth control system; Conceptus Inc., San Carlos, CA, USA) has been developed, which leads to the formation within 3 months of an intratubal fibrosis created by the proliferation of connective tissue (Valle et al., 2001). The Essure device is inserted by hysteroscopy in to the proximal section of the Fallopian tube. The advantage of this technique is the non-invasive approach, the effectiveness and the ability to use it in an outpatient setting.
The aim of the present study was to assess the feasibility, effectiveness and patient procedure compliance of permanent tubal sterilization using the micro-device system in an outpatient setting without anaesthesia.
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Materials and methods |
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Use of the Essure, a nitinol-dacron intratubal device, was suggested to each women asking for tubal sterilization after they were informed about the technique, benefits, failure rate, irreversibility and procedure complications, and the necessity to verify tubal occlusion by the devices after 3 months by hysterosalpingography and to use contraception for the first 3 months after the procedure. After acceptance women were asked to sign an informed consent form.
Exclusion criteria were women with a positive pregnancy test, unsure about their desire to end their fertility, uterine, cervical or adnexal pathologies, uterine or cervical neoplasia, abnormal uterine bleeding, chronic pelvic pain, pelvic infiammatory desease, previous tubal surgery, and monolateral tubal occlusion.
The study group underwent ultrasonography and diagnostic hysteroscopy to exclude anatomic or dysfunctional uterine and adnexal disorders.
All the women received 0.6 ml of atropine and 0.6 ml of diazepam intramuscularly 15 min before hysteroscopic tubal sterilization. The procedure was performed during the proliferative phase of the cycle without anaesthesia using a continuous flow hysteroscope 30° lens (Karl Storz®, Tuttlingen, Germania), with an operative channel of 1.8 mm. Uterine distension was obtained using pumped saline solution.
The procedure was performed by introducing the hysteroscope without the use of vaginal speculum in to the uterine cavity with the Essure devices inserted in the hysteroscope operative channel. After visualization of the proximal tubal ostia the operator placed the Essure devices in the intramural part of the tube. Optimal placement of the Essure device was obtained at the moment the black stop ring of the device wire reached the level of uterine tubal ostia, at which point the wire was removed.
After the procedure, the operating time required for the procedure was recorded and the discomfort experienced by the patient recorded using a visual analogue scale (VAS) using the following rating scale: 0, no discomfort; 100, severe discomfort (Valle et al., 2001). Each woman was familiarized with the scale before the procedure.
Pelvic pain was classified as mild when pain was rated from 0 to 40, moderate from 41 to 70 and severe from 71 to 100. The occurrence of moderate or severe pain were considered limits of the procedure in office setting.
At the end of the procedure, an assistant monitored each patient for at least 1 h and recorded the pain score provided by the patient and the presence of any side-effects.
Three months after the procedure, all patients underwent a hysterosalpingography to evaluate tubal occlusion and diagnostic hysteroscopy to assess the number of coils in the uterine cavity and detect the migration of the micro-device from the intramural portion of the tube.
The effectiveness of pregnancy prevention, complications and patients satisfaction (assessed by asking each woman whether they would undergo the same procedure if they had the chance to choose again) were recorded by a telephone interview. Statistical analyses has been performed using the Chi-Square analyses. A P < .05 has been considered statistically significant.
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Results |
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Bilateral micro-insert placement was successfully performed in 32 patients (88.9%), 31 (96.9%) of whom were obtained in a single session; in one (3.1%) two procedures were performed. One patient (2.8%) with monolateral insertion of the device asked for laparoscopic approach, refusing to proceed with further hysteroscopy. In three (8.3%) women (two nulliparous and one pluriparous) the procedure was not successful and women refused further approaches.
Mean operating time was 8.6 ± 5.3 min (range 420). Mean VAS was 36.1 ± 23.9 (range 085). Twenty-three (64%) patients experienced a VAS <40; 11 (30.5%) a VAS of 4170; and two (5.5%) a VAS of 71100.
All patients were able to return to normal activity within 24 h of the procedure.
The hysterosalpingography performed 3 months after the procedure confirmed tubal occlusion in all 32 women. Diagnostic hysteroscopy performed after 3 months in 32 patients with bilateral mini-device positioning showed a mean upward migration of 3.9 ± 2.2 coils in the right [95% confidence interval (CI) 3.14.8] and of 3.3 ± 2.1 coils in the left tube (95% CI 24.1) (Table II).
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The reduction in the number of coils was statistically significant for both tubal ostia. In four cases in the right and in six cases in the left tube a complete migration of the micro-device was observed. In all cases the number of coils left in the uterine cavity during the procedure was less than six.
Six (16.6%) women required non-steroidal anti-inflammatory drugs (30 mg intavenously) because of severe localized pelvic pain after the procedure (Table III).
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There were neither short- nor long-term severe complications in the study group.
All the women with successful bilateral placement were contacted by means of a telephone interview after a mean follow-up of 11.5 months, and none of the women had had a pregnancy. A total of 31 women (96.8%) answered that they would opt for the same procedure again if they had the chance to choose again.
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Discussion |
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Hysteroscopic tubal sterilization has been developed to avoid the risks associated with the transabdominal approach.
The introduction of the Essure device resulted in a safe and effective procedure for permanent tubal sterilization, and bilateral insertion of the micro-device may achieved in 98% of cases by the use of the new coil catheter delivery system (Kerin et al., 2001; 2003
; Cooper et al., 2003
; Kerin et al., 2004
; Menez and Lopes, 2004
; Ubeda et al., 2004
).
In the present study, successful bilateral insertion was obtained in 88.9% of women using the catheter delivery system. There was only one case of monolateral tubal insertion; the patient refused a second procedure and asked for laparoscopic approach, which was performed after 1 month.
In a phase II study, at second-look hysteroscopy following placement of the device between 4 and 18 months previously, Kerin et al. observed in seven patients that its proximal portion extending from the ostium into the uterine cavity underwent a gradual tissue encapsulation with a decrease in length from 6 to 1.3 mm (Kerin et al., 2003). In the present study, during hysteroscopic follow-up 3 months after insertion, complete migration of the micro-device (i.e. when the number of coils left in the uterine cavity during the procedure was less than six) was observed. According to our data, the optimal placment of the coils is to position the micro-device with at least six coils remaining in the uterine cavity.
The present study highlights that the placement of the Essure system may be performed in an outpatient setting without the need for anaesthesia. This is in agreement with the study performed by Ubeda et al. (2004); in phase I, II and III studies several investigators used sedation in 4166% of cases and paracervical block in 3252% of cases, whilst general anaesthesia has rarely been adopted (Kerin et al., 2001
; 2003
; Cooper et al., 2003
). Kerin et al., in a study adopting a new coil catheter delivery system, performed paracervical block, using sedation in 19% of cases (Kerin et al., 2004
). Menez and Lopes (2004)
performed the procedure always using the paracervical block.
In the present study the procedure was found to be acceptable in terms of patient satisfaction rate, as the mean VAS was 36.1. However, being a small prospective study selection bias cannot be eliminated, which might have affected the VAS scores for the women recruited. Nevertheless, the procedure showed a great satisfaction rate as the VAS experienced was similar to that scored during diagnostic hysteroscopy usually performed with a 3.2 mm hysteroscope (Litta et al., 2003; Shankar et al., 2004
).
Kerin and Ubeda reported good to excellent patient satisfaction rates in 96% of women (Kerin et al., 2003; Ubeda et al., 2004
), with an increase to 99% in the phase III study (Cooper et al., 2003
). In the present study, the satisfaction rate was obtained in 97% of patients after a mean follow-up of 11.5 months.
After 11.5 months of follow-up, none of the women was pregnant, which is in accordance with other studies (Cooper et al., 2003; Litta et al., 2003
; Teoh et al., 2003
; Kerin et al., 2004
; Menez and Lopes, 2004
; Rosen, 2004
; Shankar et al., 2004
; Ubeda et al., 2004
), although long-term follow-up is needed.
Although there were no complications in the present study, which may be due to the small sample size, it should be stressed that several authors have reported a risk of malpositioning and expulsion of the devices, with an incidence ranging from 1.3% (Kerin et al., 2003) to 3.6%, and a risk of uterine perforation ranging from 0.9% to 2.6% (Cooper et al., 2003
; Kerin et al., 2004
). Kerin et al. (2004)
described a perforation rate of 1%.
Our study, although limited by the small sample size, strengthens the evidence of the effectiveness and safety of the Essure device for permanent tubal sterilization.
In conclusion, permanent tubal sterilization using the Essure system is safe and effective, and may be performed in an outpatient setting without use of general anaesthesia. With a low risk and a high patient satisfaction rate, it is a valid alternative to the surgical approach, which has potential risks related to surgery and anaesthetics. It should be borne in mind that this procedure may be performed in women with high surgical and anaesthesiologic risk.
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References |
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Submitted on March 25, 2005; resubmitted on June 7, 2005; accepted on July 4, 2005.
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