Comparison of Sonography, Sonohysterography, and Hysteroscopy for Evaluation of Abnormal Uterine Bleeding Mo H. Saidi, MD, R. Kent Sadler, MD, Vernon D. Theis, MD, Bruce D. Akright, MD, Scott A. Farhart, MD, Gil R. Villanueva, MD We compared transvaginal sonography, sanahysterography, and diagnostic hysteroscopy in the evaluation of abnormal uterine bleeding. Sixtyeight women 40 or older with abnormal uterine bleeding were assigned to undergo either transvaginal sonography or sonohysterography. All subjects then had diagnostic hysteroscopy and endometrial biopsy. Patients with abnormal findings underwent operative hysteroscopy or definitive therapy. Transvaginal sonography, sonohys- terography, and diagnostic hysteroscopy revealed a sensitivity of 95%, 90%, and 78%, and a specificity of 65%, 83%, and 54%, respectively. The average cost for transvaginal sonography or sonohysterography was $195 and the cost for diagnostic hysteroscopy was $675. Transvaginal sonography and sonohysterography are cost-effective alternatives and more sensitive diagnostic tests than office diagnostic hysteroscopy. KEY WORDS: Bleeding, uterine; Transvaginal sonography; Sonohysterography. T he management of abnormal uterine bleeding in women over the age of 40 years requires prompt diagnosis. Invasive and costly diagnostic procedures, such as diagnostic hysteroscopy and dilatation and curettage, are common initial steps in evaluating abnormal uterine bleeding. ABBREVIATIONS TVS, Transvaginal sonography; SHG, Sonohysterography Received February 11, 1997, from the San Antonio Gynecologic Endoscopy Facility. Department of Obstetrics and Gynecology, The University of Texas Health Science Center at San Antonio (M.H.S.), and the Northeast OB/GYN Associates IM.HS., R.KS., V.D.T., B. D.A., S.A.F., G.R.V.), San Antonio, Texas. Revised manuscript accepted for publication May 25, 1997. Address correspondence and reprint requests to Mo H. Saidi, MD, Northeast OB/GYN Associates, 8500 Village Drive, Suite 10], San Antonio, TX 78217-4606. Pelvic ultrasonography has enhanced our ability to evaluate the pathologic endometrial, myometrial, or pelvic cavity conditions that may contribute to abnormal uterine bleeding. TVS is effective in identifying or excluding intrauterine and endometrial abnormali ties. Hysteroscopy may allow visualization of intrauterine cavity lesions, although TVS is more precise in revealing and measuring submucous, intra mural, and subserous uterine myomas. However, it frequently fails to differentiate endometrial hyperplasia, polyps, and submucous myomas. 1 The introduction of sterile fluid into the uterine cav ity during TVS has been reported as a diagnostic tool to ascertain intrauterine abnormalities.l~ Diagnostic hysteroscopy has become an acceptable tool to visual ize the uterine cavity and perform biopsy on the suspected abnormalities. However, this examination is an invasive procedure and requires a more complicated setup at higher expense than sonography. Recent published reports have suggested that sonography could be used in lieu of this costly procedure.s..to In this study, we compared the efficacy, accuracy, and cost-effectiveness of TVS, SHG, and office diagnostic hysteroscopy in the evaluation of women 40 years or older with abnormal uterine bleeding. 1997 by the American Institute of Ultrasound in Medicine J Ultrasound Med 16:587-591, 1997 0278-4297/97/$3.50
588 ABNORMAL UTERINE BLEEDlNG MATERIAL AND METHODS In a prospective, unblinded, randomized study of women who complained of abnormal uterine bleeding, 68 consecutive cases were evaluated from September 1, 1994, to June 30, 1995. The patients' ages ranged from 40 to 89 years. Patients were entered into the study if they manifested abnormal uterine bleeding, such as menorrhagia, metrorrhagia, polymenorrhea, hypermenorrhea, or abnormal postmenopausal bleeding. The patients were numbered consecutively and divided into two groups. Group A patients (odd numbers) underwent SHG; group B (even numbers) underwent TVS. All patients then had office diagnostic hysteroscopy and endometrial biopsy. Patients with intracavitary lesions, such as endometrial hyperplasia, endometrial polyps, submucous myomas, or intrauterine septa, underwent operative hysteroscopy with polypectomy, resection of the submucous myomas, or septal resection. A 5 MHz pulsed vaginal transducer (Ultramark-4; Advanced Technology Laboratories, Bothell, WA) was used for both TVS and SHG. The sonographic examinations were performed by the authors. The transducer was placed in a condom containing transducer coupling gel. TVS was performed with an empty bladder. SHG was performed using the conventional technique described elswhere.l.-1 The maximal endometrial thickness was measured in the longitudinal view of the uterus with the endometrial surface perpendicular to the angle of the insonation. In normal images the total of both layers was used as the thickness. The endometrial thickness was considered abnormal if it was more than 12 mm in the perimenopausal period or 5 mm in the postmenopausal period. Sonographic findings were recorded on the data base sheet. Except for two cases, all diagnostic hysteroscopy procedures were performed in the office using local anesthesia, consisting of approximately 10 ml of 2% lidocaine intracervically and paracervicauy. These procedures were performed immediately after either SHG (group A), or TVS (group B). Cervical dilation to the diameter of a No. 5 Hegar dilator was performed routinely prior to hysteroscopy. A 5 mm hysteroscope (Karl Storz, Tuttlingen, Germany) was used. The uterine cavity was distended with C02 using a hysterosufflator (Karl Storz). The video camera was connected to the hysteroscope and operative findings were described and recorded. At the end of the diagnostic hysteroscopy procedure, an endometrial biopsy using an endometrial biopsy catheter or a small serrated curette was performed. J Ultrasound Med 16:587-591, 1997 The final diagnosis in patients with abnormal results was made by the following procedures: operative hysteroscopy with resection and excision of the lesions, 39 cases; vaginal hysterectomy, four cases; abdominal hysterectomy, three cases; laparoscopicauy assisted vaginal hysterectomy, two cases; and dilatation and curettage, two cases. Abnormal results included inconclusive examinations and intracavitary lesions, such as endometrial polyps, submucous myomas, endometrial hyperplasia, and intrauterine septa. Operative hysteroscopy was performed as an outpatient procedure in the ambulatory surgical center under regional or general anesthesia. An operative 10 mm hysteroscope with loop and roller ball (Karl Storz) was used. The distention medium was 1.5% glycine. In every case the volume of the distention medium used during surgery was measured and recorded. No cases of pulmonary edema or water intoxication were encountered. The mean and the standard deviation for demographic data were calculated for groups A and B and compared by the unpaired statistical Student's t-test. Specificity, sensitivity, positive predictive value, and negative predictive value for TVS, SHG, and diagnostic hysteroscopy were calculated with the z test (Arcus, Medical Computer, Aughton, England) using a 95% confidence interval and P < 0.05. RESULTS Table 1 shows characteristics of the 68 study subjects (group A, n 34; group B, n = 34). No significant differences were observed in age, weight, gravidity, or parity. TVS and SHG were well tolerated by all patients. One TVS, one SHG, and six diagnostic hysteroscopy examinations were inconclusive. Posttest diagnoses after SHG, TVS, and diagnostic hysteroscopy and the final diagnosis of all study subjects are included in Table 2. Nineteen of 68 patients (28~ ) had no organic causes for the abnormal uterine bleeding and were diagnosed as having dysfunctional uterine bleeding. The next most common causes for abnormal uterine bleeding were submucous myomas and endometrial polyps (Table 3). Comparison between the SHG group (group A) and the final diagnosis revealed a sensitivity of 90% and specificity of 83% (Table 4). In the TVS group (group B), sensitivity was 95% and specificity was 65%. For diagnostic hysteroscopy, the sensitivity was 78% and specificity was 54%. Although the sensitivity of TVS and SHG appears to be higher than that for diagnostic hysteroscopy, only TVS shows statisti cal significance. The differences in specificity, positive
J Ultrasound Med 16:587-591, 1997 SAIDI ET AL 589 Table 1: Classification of SHG, TVS, Diagnostic Hysteroscopic Findings, and Final Diagnoses Diagnoses Group A Group B Diagnostic Hysteroscopy Final Diagnosis (SHG) (TVS) (Groups A+B) (Groups A+B) No. % No. Normal cavity 12 35.3 8 Abnormal: 22 64.7 26 1. Abnormal 4 11.7 9 endometrium 2. Intrauterine cavity 15 44.1 16 structure 3. Uterine septum 2 5.9 0 4. Blood dot 0 0 0 5. Inconclusive 1 3 1 Tctnl 34 100 34 % No. % No. o/~ 23.5 23 (12+11) 33.08 23 (12+11) 33.8 76.5 45 (22+23) 66.2 45 (22+23) 66.2 26.5 11 (5+6) 16.2 6 (4+2) 8.8 47 0 0 3 100 27 (13+14) 39.7 36 (16+20) 53 1 (1+0) 1.5 1 (1+0) 1.5 0 0 2 (1+1) 2.9 6 (3+3) 8.8 0 0 68 (34+34) 100 68 (34+34) 100 predictive value, and negative predictive value were higher for SHG than for diagnostic hysteroscopy, but these differences did not show any statistical significance (Table 4). Uterine cavity lesions, such as submucous myomas (Figs. 1, 2) and polyps (Figs. 3, 4) were correctly delineated by SHG in 14 of 15 cases (93.3%), by TVS in 14 of 16 cases (87.5%), and by diagnostic hysteroscopy in 26 of 36 cases (72.2%) (Table 4). Table 2: Selected Characteristics of Group A and Group B Cases Characteristic Group A Group B (n "' 34) (n = 34) Age Mean 49.35 53.2 Median 44.5 50.5 Range 49 (40-89) 34 (40-74) Standard deviation 10.8009 10.16004 Weight Mean 161.35 152.38 Median 157.5 150 Range 110 (115-225) 144 (117-261) Standard deviation 26.73198 26.29784 Grnvidity Mean 2.44 1.97 Median 2 2 Range 6 (0-6) 4 (0-4) Standard deviation 1.283725 0.968763 Pnrity Mean 1.97 l.f(} Median 2 2 Range 4 (0-4) 4 (0-4) Standard error 1.114241 0.938387 No significant differences at P= 0.05 by unpaired Student's t test for all demographic data (group A versus group B). During the sonographic evaluation, 12 cases had normal endometrium and uterine cavity but other pathologic lesions were found. These included intramural myomas, two cases; abnormal ovarian cysts, two cases; adenomyosis, six cases; and endometriosis, two cases. The average cost of TVS and SHG in groups A and B was $195. The average cost in our study for diagnostic hysteroscopy performed at the office was $650. For two patients who had diagnostic hysteroscopy in the ambulatory surgical center the average cost was $1500. The average cost for all cases in this study was $675. DISCUSSION TVS, SHG, and diagnostic hysteroscopy with endometrial biopsy were used as a triage for the management of abnormal uterine bleeding Table 3: Final Diagnosis of Patients in This Study"' Diagnosis Group A Group B Total Dysfunctional uterine bleeding 8 11 19 Submucous myoma 9 6 15 Endometrial polyps 5 9 14 Endometrial hyperplasia 4 1 5 Atrophic endometrium 4 1 5 Hyperplasia and polyps 2 1 3 Intramural myoma 1 2 3 Submucous myoma and polyps 1 1 2 Endometrial or uterine 0 2 2 carcinoma Hyperplasia + submucous myoma 0 1 1 Hematometra 0 1 1 ~some patients had more than one diagnosis.
J Ultrasound Med 16:587-591, 1997 ABNORMAL UTERINE BLEEDING Table 4; Comparison Among SHG, TVS, and Diagnostic Hysteroscopy with Final Diagnosis E)!amination Sensitivity Specificity SHG 90.9% (0.789-1.029) 83.3% (0.622- L044) 63.6% {0.352-0.920) TVS Diagnostic hysteroscopy 95.7% (0.874-1.040) 82.2 % (0.7\D-0.934) Neg.1tive Predictive Value 65.2~ (0.457-0.847) in women 40 years of age or older. In our study population, 72% of patients had one or more patho logic conditions and only 28% had dysfunctional uterine bleeding. TVS has become a valuable tool in the clinical evaluation of pathologic pelvic conditions. The uterus and ovaries can be visualized dearly and their pathologic lesions identified. In the presence of abnormal endometrium or intrauterine cavity lesions, the addition of saline solution to expand the cavity and separate the endometrial surfaces may reveal submucous myomas or pedunculated polyps. The differentiation of endometrial hyperplasia from polyps and myomas can be achieved with this approach. We found that more than 70% of patients with abnormal uterine bleeding may not require diagnostic hysteroscopy. These were cases with dysfunctional uterine bleeding, submucous myomas, and endometrial polyps. All of these conditions may be diagnosed with TVS or SHG. Diagnosis of cancer was made in two patients after discovery of abnormal endometrium in the TVS group with endometrial biopsy using a Pipelle catheter. Diagnostic Figure 1 S.1gittal view of uterus during SHG shows a large endometrial polyp. 16.7~ (-0.044-0.378) 12.5% (-0.070-0.320) 45.5% (0.161-0.749) Positive Predictive Value 90.9% (0.789-1.029) 84.6% (0.698-0.994) 78.3% (0.615-0.951) hysteroscopy did not provide additional information in these two cases. In 12 patients, gynecologic pathologic lesions outside the uterine cavity were responsible for abnormal uterine bleeding; TVS and SHG were helpful in identifying these pathologic lesions. Diagnostic hysteroscopy could not have produced these diagnoses. Our case series is a small prospective study and produced a small number of samples in groups A and B. The statistical analysis of these results shows a higher sensitivity for TVS and SHG (95.7% and 90.9%, respectively) than for diagnostic hysteroscopy (78.3%). Only the sensitivity of TVS was significantly higher than that of diagnostic hysteroscopy. SHG has higher specificity than either TVS or diagnostic hysteroscopy (Table 4). SHG also allows d ifferentiation of uterine cavity lesions from endometrial hyperplasia. In our study group, the average cost of TVS or SHG was $195, compared to $675 for diagnostic hys~ teroscopy. This is a saving of approximately $480 in each case by avoiding diagnostic hysteroscopy (71 % saving in each case of abnormal uterine bleeding). Figure 2 View of the same patient as in Figure 1 d uring oper ative hysteroscopy using 1.5% glycine medium with gravity pressure shows submucous myoma.
JUltrasound Med 16:587-591, 1997 Figure 3 Sagittal view of uterus during 5HG shows multiple submucous myomas. Finally, TVS and SHG offer a cost-effective alternative to diagnostic hysteroscopy in the evaluation of patients 40 years old or older with abnormal uterine bleeding. Our study suggests that TVS is a more sensitive test than diagnostic hysteroscopy for evaluat~ ing abnormal uterine bleeding. Further studies with a larger number of cases are needed to evaluate the role of SHG and compare its sensitivity, predictability, and accuracy to those of diagnostic hysteroscopy in the management of patients with abnormal uterine bleeding. REFERENCES Fedele L, Bianchi 5, Dorta M, et al: Transvaginal ultra ~ sonography versus hysteroscopy in the diagnosis of utera ine submucous myomas. Obstet Gynecol 77:745, 1991 2. Goldstein SR: Use of ultrasonohysterography for triage of perimenopausal patients with unexplained uterine bleeding. Am J Obstet Gynecol170:565, 1994 3. Parsons AI<,. Lense JJ: Sonohysterography for endometrial abnonnalities: Preliminary results. J Clin Ultrasound 21:87,1993 4. Bonilla-Musoles F, Simon C, Serra V, et al: An assessment of hysterosalpingosonography (HSSG) as a diagnostic tool for uterine cavity defect!:l and tubal patency. J Clin Ultrasound 20:175, 1992 1. SAlOl ET AL Figure 4 View of same patient as in Figure 3 during operative hysteroscopy shows a polyp. 5. Emanuel MH, Verde) MJ, Wamsteker K, et aha prospective comparison of transvaginal ultrasonography and d iagnostic hysteroscopy in the evaluation of patients with abnormal uterine bleeding; Clinical implications. Am J Obstet Gynecol172;547, 1995 6. Cincinelli E, Romano F, Anastasio PS, et at: Transa abdominal sonohysterography, transvaginal sonography, and hysteroscopy in the evaluation of submucous myomas. Obstet Gynecol85:42, 1995 7. Parsons A, Hill A, Spicer 0: Sonohysterographic imaging of the endometrial cavity. Frontier in Bioscience 1:1 (available from www at http:/ /www.baynet.com/bioad ence/1996/v1 / f/parsons/2-2.htm) 8.. Karlsson B, Granberg 5, Hellberg P, et a!: Comparative study of transvaginal sonography and hysteroscopy for the detection of pathologic endometrial lesions in women with postmenopausal bleeding. J Ultrasound Med 13:757, 1994 9. Saidi, MH, Schenken R: 2500 outpatient diagnostic hysteroscopy. Obstet Gynecol88:337, 1996 10, 5aidi MH: Office hysteroscopy versus transvaginal ultrasonography in the evaluation of patients with excessive uterine bleeding (letter to editor). Am J Obstet Gynecol 176:492, 1997