The popularity of office hysteroscopy is steadily increasing. Hysteroscopy is often considered to be the first-line method of investigation for abnormal uterine bleeding and other pathological conditions involving the uterine cavity. Office hysteroscopy has distinct advantages over inpatient hysteroscopy under general anesthesia, including reduced anesthetic risks, enhanced time–cost-effectiveness, and patient preference. However, the main limitation to the widespread use of this valuable diagnostic procedure is pain and low patient tolerance. Sources of pain during traditional diagnostic hysteroscopy include insertion of the speculum, application of the tenaculum to the cervix, its traction, and the introduction of the hysteroscope through the cervical canal. Local anesthesia is used by many hysteroscopists.
In 1997, Bettocchi and Selvaggi,1 advocated the vaginoscopic approach for diagnostic hysteroscopy. The hysteroscope was inserted to the vagina, which was distended by flowing saline. The hysteroscope was further advanced into the uterine cavity through the cervical canal. Avoiding the introduction of the speculum and the application of the tenaculum to the cervix seemed to reduce patient discomfort.
In the present prospective randomized study, we compared the traditional hysteroscopic technique using intracervical local anesthesia with the vaginoscopic approach without anesthesia in terms of patient pain and satisfaction.
MATERIALS AND METHODS
A prospective, randomized, treatment-controlled study was conducted at the outpatient clinic, Maccabi Health Services in Tel Aviv, Israel. The trial was approved by the local Institutional Review Board. All participants received a detailed explanation about the study and signed an informed-consent form. Patients were encouraged to observe images of their procedure on the screen.
One hundred and thirty consecutive women referred to our center were enrolled in the study (Fig. 1). The patients were randomized by using a computer-generated randomization list into two groups, with the ratio of 2:1 in favor of the vaginoscopic method. This ratio was selected because it was our a priori clinical impression that vaginoscopy was more comfortable for the patient.
The study group included 83 women who underwent vaginoscopic hysteroscopy without analgesia or anesthesia. The patient was placed in dorsolithotomy position, and the vagina was cleansed with a noniodide disinfectant using a small swab positioned on a thin Collins forceps. The hysteroscope was then inserted into the vagina, while distending it by the flowing saline, obviating the need to assist the introduction of the scope into the cervix using a tenaculum. The anatomy could be followed by gentle movements of the hands that correctly drove the hysteroscope into the cervix and through the internal cervical os.
The control group consisted of 47 women who underwent the traditional hysteroscopic technique 2–3 minutes after an intracervical injection of 10 mL mepivacaine 3% solution. The solution was injected with a 22-gauge spinal needle on two sites (at 3:00 and 9:00 positions). In premenopausal women, all procedures were performed during the early proliferative phase of the menstrual cycle. Endometrial sampling was performed using a Pipelle de Cornier device whenever indicated. However, in such cases, a visual analog scale (VAS) score was assessed before performing the biopsy. All the procedures were performed with a rigid 3.7-mm hysteroscope in a medium of 0.9% saline, and the video image was transmitted to a screen visible to the patient
A VAS score on a 10-cm line was used to assess the intensity of pain experienced during and after the procedure (0=no pain to 10=worst pain). The patients were asked to quantify pain twice, immediately after the procedure (VAS1) and 15 minutes later (VAS2). Overall satisfaction rate was assessed during and immediately after the procedure, and the assessment was repeated 15 minutes later and 3 days later, with scores ranging from 1 to 3 (1=minimal to 3=full satisfaction).
Samples size was calculated to provide 80% power to detect a true difference, by treatment group, of at least 40% in treatment satisfaction scores, assuming a difference in satisfaction score of 1±1.2, by treatment group, and a two-sided α of 0.05. Using these assumptions and a randomization ratio of 1.5, it was calculated that a total of 134 participants (80 women in the active treatment group, 54 in the placebo group) would provide adequate power.
Analysis of data were carried out with SPSS 9.0 (SPSS Inc, Chicago, IL). For continuous variables, descriptive statistics were calculated and are reported as mean±standard deviation. Categorical variables were described using frequency distribution. Distributions of continuous variables were tested for normality using the Kolmogorov-Smirnov test. Normally distributed continuous data were compared by group using the t test for independent samples. Variables with distributions differing significantly from normal were compared by treatment assignment using the Mann Whitney U. Chi-square test (exact when necessary) was used to detect differences in categorical variables by treatment assignment. General linear modeling repeated measures was used to examine satisfaction and, separately, VAS over time. Spearman ρ correlation coefficients were calculated to describe associations between VAS scores and, independently, satisfaction scores, with hemodynamic parameters. All tests were considered significant at P< .05.
Characteristics of study participants are described in Table 1. As can be seen, patients were similar by treatment assignment.
The indications for hysteroscopy did not differ between the two groups (Table 2). No complications occurred in any of the patients in either group.
All 130 hysteroscopies were carried out successfully. Two procedures in the vaginoscopy group were unsuccessful because of cervical stenosis and were performed successfully using a traditional method. Nevertheless, these patients were analyzed in their originally assigned treatment group.
Visual analog scale scores are shown in Table 3. During the procedure, a total of 11 biopsies were performed, as indicated by a finding of postmenopausal bleeding or menometrorrhagia, five in the vaginoscopy group and six in the traditional method group. In these cases, VAS was assessed before performance of the biopsy. The general linear modeling repeated measures analysis of VAS indicates that VAS differed overall by group. Pain perception was significantly more intense in the traditional hysteroscopy group. As noted, VAS1 and VAS2 were both significantly higher in this group than in the vaginoscopic hysteroscopy group (VAS1: 3.8±2.7 versus 5.34±3.23, P=.01; VAS2: 3.02±2.50 versus 4.57±3.30, P=.008, respectively), indicating that women in the vaginoscopic hysteroscopy group experienced significantly less pain than women in the traditional hysteroscopy group.
Participants were stratified by menopausal status. Premenopausal women in the traditional hysteroscopy group reported significantly higher VAS scores than premenopausal women in the vaginoscopy group (VAS1: 5.21±3.35 versus 3.36±2.53, P=.005; VAS2: 4.18±3.25 versus 2.75±2.45, P=.024, respectively). When further stratifying these patients by parity, multiparous premenopausal women in traditional hysteroscopy group reported significantly higher VAS1 and VAS2 than those in the vaginoscopic hysteroscopy group (VAS1: 4.77±3.17 versus 3.06±2.53, P=.015; VAS2: 3.96±3.41 versus 2.40 ±2.32, P=.026, respectively). In nulliparous premenopausal women, no significant differences in VAS1 and VAS2 were observed. In postmenopausal patients, no significant differences in VAS1 or VAS2 were detected by treatment assignment.
Satisfaction scores are shown in Table 4. General linear modeling repeated measures analysis indicated no significant by-group differences in patient satisfaction immediately after the procedure, 15 minute later, or 3 days posthysteroscopy. On the other hand, VAS scores at time 1 and time 2 were significantly inversely associated with satisfaction scores at time 3 in both patient groups and overall (VAS1 and satisfaction at day 3, r=−0.38, P<.0001; VAS2 and satisfaction at day 3, r=−0.36, P<.001).
The modern continuous-flow hysteroscopic technique was introduced by various authors between the end of the 1970s and the beginning of the 1980s.2–7 Since then, hysteroscopy has proved to be a powerful diagnostic tool for visualizing the cervical canal and the uterine cavity. Recently, office hysteroscopy, together with endometrial biopsy, has become increasingly used as the gold standard for the investigation of abnormal uterine bleeding and other conditions involving the uterine cavity.8–10 Hysteroscopy has been shown to be highly accurate in the diagnosis of intrauterine pathology in several studies.11–14 The main limitation to its widespread use is pain and low patient tolerance. Therefore, many hysteroscopies are still performed under general anesthesia.15 However, outpatient hysteroscopy reduces risks associated with general anesthesia. Outpatient hysteroscopy is easy to perform, takes less time, and is cost-efficient, making it a convenient office procedure using local anesthesia.16 Various methods of local anesthesia have been tested to reduce the discomfort associated with hysteroscopy, but results have been controversial.17–28
Using the “traditional technique” of diagnostic hysteroscopy, patients may experience pain during speculum insertion into the vagina, grasping and traction of the cervix by the tenaculum, passage of the hysteroscope through the cervical canal, and distention of the uterine cavity with the distention medium (usually physiological solution). Bettocchi and Selvaggi,29,30 reported their experience with more than 11,000 hysteroscopic procedures performed using the vaginoscopic technique eliminating the use of speculum and a tenaculum. They found that as many as 99.1% of the patients reported no discomfort related to the procedure. In our study, pain perception was statistically significantly lower in patients who underwent the vaginoscopic hysteroscopy than in those who underwent the traditional procedure, despite application of intracervical anesthesia in the latter group.
The study has a few limitations, however. For example, neither the treating physician nor patients were blinded to treatment assignment. However, the primary endpoint of the present study was patient-rated pain. None of the participating patients had prior experience with either vaginoscopy or the traditional approach, so it is unrealistic to presume that patients would be predisposed to report their experience of pain differently by treatment. If, indeed, lack of blinding caused some measurement error, we must assume it is nondifferential, which would bias the results toward the null hypothesis.
Another drawback of the study is the small effect size observed. In absolute terms, this effect size can be estimated at approximately one half of a standard deviation. Effect size “d” is a useful statistic for expressing the magnitude of difference between groups on a continuous outcome variable. The d statistic is calculated as the difference between the group means divided by the standard deviation of the control group. As a general rule, effect size can be categorized as “small effect”= 0.20, “medium effect”=0.50, and “large effect”= 0.80.31 In the present study, the d statistic for VAS1 is 0.14, a small effect, while the d statistic for VAS2 is 0.48, or a medium effect. Nevertheless, this difference is undoubtedly clinically important to the patient undergoing the procedure.
In the subgroup of premenopausal women, our study confirmed that the vaginoscopic approach was statistically significantly more comfortable and less painful. The pain scores were statistically significantly lower in the vaginoscopic hysteroscopy group, even among multiparous women in the analysis stratified for parity. No significant by-treatment group difference in reported pain was observed among nulliparous women, but we believe that this may be attributable to the small sample size of this subgroup. Further, the study was not designed to examine this question, and another study designed specifically to examine the effect of hysteroscopic approach on pain in specific patient subgroups should be designed.
Two cases assigned to the vaginoscopy group were unsuccessful and required conversion to the traditional procedure. One procedure was in a 29-year-old nulligravid woman, and the second procedure was performed in a menopausal woman with cervical stenosis. Both cases were analyzed in their original treatment assignment, preserving the intent-to-treat concept. In their recent randomized controlled study, Sharma et al32 failed to observed any advantage of vaginoscopic hysteroscopy, or “non-touch” hysteroscopy, compared with traditional hysteroscopy. Their findings are not consistent with those of observational studies29,30 or the present study. Three explanations for this discrepancy were proposed by Sharma's group. First, the authors cited small sample size. Second, results can be distorted due to the use of different diameters of the hysteroscopes. Finally, the analysis of their data was intention to treat, which means that the results for the non-touch group include those who required conversion, whereas there was no similar conversion option for the traditional group. On the other hand, use of the intent-to-treat method clearly provides the best estimate of how an intervention “behaves” in a population. Sharma et al32 clearly demonstrated that vaginoscopic hysteroscopy is significantly quicker to perform. Although not statistically significant, our study found a similarly reduced procedure duration time.
In the present study, although we found a statistically significant difference in VAS by treatment, we failed to find a similar difference in satisfaction scores. This apparent contradiction may be explained by noting that factors other than pain are components of a patient's overall sense of satisfaction with treatment. Additionally, the satisfaction score was rated on a three-point scale, and it is possible that this method was inadequately sensitive to detect differences. On the other hand, significant inverse associations were observed between VAS1 and, separately, VAS2 and satisfaction score on day 3 postprocedure in both treatment groups, suggesting that an inverse association between the subjective experience of pain and overall treatment satisfaction did, in fact, exist.
In summary, we found that significantly less pain was experienced with the vaginoscopic approach of diagnostic hysteroscopy without analgesia than in the traditional procedure with analgesia in the overall patient group and, particularly, in multiparous premenopausal women. This technique has permitted complete elimination of any type of premedication, analgesia, or anesthesia, making the procedure faster, more acceptable, and complication-free. These findings support the use of vaginoscopy over the traditional method.
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