Side effects and complications of sonohysterosalpingography

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1 FERTILITY AND STERILITY VOL. 80, NO. 3, SEPTEMBER 2003 Copyright 2003 American Society for Reproductive Medicine Published by Elsevier Inc. Printed on acid-free paper in U.S.A. Side effects and complications of sonohysterosalpingography Salvatore Dessole, M.D., a Mario Farina, M.D., a Giovanni Rubattu, M.D., a Erich Cosmi, M.D., a Guido Ambrosini, M.D., b and Giovanni Battista Nardelli, M.D. b University of Sassari, Sassari, and University of Padua, Padua, Italy Objective: To evaluate the side effects and complications of, difficulties with, and possible solutions to the problems associated with sonohysterosalpingography. Design: Prospective study. Setting: University hospital. Patient(s): One thousand, one hundred fifty-three patients who underwent sonohysterosalpingography to investigate abnormal uterine bleeding, infertility, thick endometrium at transvaginal ultrasonography, müllerian abnormalities, or the Asherman syndrome. Main Outcome Measure(s): Side effects and complications of and difficulties related to the procedure. Tolerance was assessed by using a pain-rating scale. Result(s): Ninety-three percent (1,074 of 1,153) procedures were performed correctly. Investigation was not completed in 79 (7%) ; a second attempt was successful in 60 of these patients. Side effects, such as moderate or severe pelvic pain, vasovagal symptoms, nausea, and vomiting, occurred in 102 (8.8%). Such complications as fever and peritonitis occurred in 0.95% of patients. Conclusion(s): Sonohysterosalpingography is a simple, safe, and well-tolerated technique that has a low rate of side effects and rare complications. (Fertil Steril 2003;80: by American Society for Reproductive Medicine.) Key Words: Sonohysterosalpingography, side effects, complications, difficulties Received October 14, 2002; revised and accepted February 19, Reprint requests: Salvatore Dessole, M.D., Department of Pharmacology, Gynecology and Obstetrics, Viale San Pietro 12, Sassari, Italy (FAX: ; E- mail: dessole@uniss.it). a Department of Pharmacology, Gynecology and Obstetrics, University of Sassari. b Department of Gynecology and Obstetrics, University of Padua /03/$30.00 doi: /s (03) X Sonohysterography consists of transvaginal sonography with concomitant instillation of contrast medium into the uterine cavity by using a catheter inserted through the cervical os. Several studies have shown that sonohysterosalpingography has high sensitivity and specificity for study of the uterine cavity (1 5) and determination of tubal patency (6, 7); results concord well with those of hysteroscopy (3, 4) and hysterosalpingography (7, 8). However, compared with these latter techniques, sonohysterosalpingography provides more information on the location and size of endometrial polyps and submucous myomas (9). Furthermore, it allows simultaneous visualization of the uterine cavity and endometrium, as well as the entire corpus uteri and tubes (10, 11). Therefore, sonohysterosalpingography is performed in many hospitals as a first-line diagnostic procedure for abnormal uterine bleeding (11 14) and müllerian abnormalities (15, 16), to investigate infertile patients undergoing IVF (5, 10), and to program endoscopic surgery (17 19). Sonohysterosalpingography has recently been used to evaluate the endometrium in with a history of breast cancer who were receiving tamoxifen (20, 21), to investigate asymptomatic entering menopause who have not yet started hormone replacement therapy (22), and to detect trophoblastic tissue retention in the uterine cavity (23). We sought to prospectively assess the side effects and complications of and difficulties with sonohysterosalpingography, to ascertain safety and patient tolerance of the procedure, and to identify factors that are implicated in frequent complications. Possible solutions to technique-related difficulties are also discussed. MATERIALS AND METHODS From June 1997 to November 2001, 1,210 patients at our clinic underwent sonohystero- 620

2 salpingography. Inclusion criteria for the procedure were one or more episodes of abnormal uterine bleeding, female sterility, thick endometrium ( 5 mm in postmenopausal or 12 mm in premenopausal ) (24), suspected müllerian abnormalities on transvaginal sonography, and clinical suspicion of the Asherman syndrome. Exclusion criteria for the examination were symptoms or signs of active pelvic infection, vulvovaginal infections, abnormal cytologic smear tests, risk of conception in the menstrual cycle during which the procedure was undertaken, and presence of risk factors for endometrial cancer in postmenopausal with abnormal uterine bleeding. Risk factors for endometrial cancer were obesity, nulliparity, and late menopause. Fifty-seven patients with incomplete data were also excluded; the remaining 1,153 patients were included. First-line transvaginal sonography and sonohysterosalpingography were performed throughout the proliferative phase of the menstrual cycle in with sterility; thick, irregular endometrium; suspected Asherman syndrome; or uterine abnormalities. These procedures were done regardless of the phase of the cycle in premenopausal with abnormal uterine bleeding (25). Postmenopausal underwent these procedures upon referral to our center. Our institutional review board approved the study. All patients gave informed consent. Sonohysterography was performed as follows. Bimanual examination of the pelvis was performed with the patient in the dorsal lithotomic position. An initial transvaginal ultrasonographic scan was obtained by using a Siemens SL 1 machine (Siemens, Erlangen, Germany) machine equipped with a 5- to 7.5-MHz transducer. The morphology and the size of the uterus, features and thickness of endometrium, and the adnexa were assessed by obtaining sagittal and transverse scans. The ultrasonographic probe was removed, and an open-sided vaginal speculum was inserted. The cervix and vagina were cleansed with a solution of 10% povidone-iodine and 1% free iodine. A balloon catheter was the first-choice catheter used during the procedure. Other catheters were used in case of procedure-related difficulties according to our experience (26). The catheter was flushed with the saline solution and then placed into the cervical os under direct visualization. The speculum was removed, and a 20-mL plastic syringe containing sterile saline solution (0.9% NaCl) was attached to the catheter. The ultrasonographic probe was then reintroduced, and the saline solution was infused into the uterus while uterine distention was monitored. Usually, 5 to 20 ml of fluid were required for uterine distention. Simultaneously the uterine cavity was reevaluated by sagittal and coronal views, and selected images were obtained by using an image printer. The procedure lasted no more than 15 minutes. Neither pain drugs nor antibiotics were administered for at least 1 week before or during the procedure. All procedures were performed by two gynecologists who were skilled in transvaginal sonography. To assess pain during the procedure, we used an 11-point (0 to 10) numerical rating scale on which 0 corresponded to no pain at all and 10 indicated very severe pain (27). The patients were familiarized with the scale before the procedure was performed. Pelvic pain was classified as mild when pain was rated as 1 to 4, moderate from 5 to 7, and severe from 8 to 10. Moderate and severe pain were considered to be side effects of the procedure. After the examination, a nurse monitored each patient for at least 1 hour. At the end of each examination, the operator recorded whether the procedure was correctly performed, the pain score provided by the patient, and side effects observed during the procedure. Side effects were vagal symptoms such as lipothymia, hypotension, and severe sweating; vomiting; and severe nausea. To assess complications related to the procedure, patients were invited to contact our institution in the event of any disturbance or pain at the level of the genital tract. Moreover, the study group was evaluated with an interview 1 week after the procedure and, depending on the outcome of the interview, underwent a clinical or sonographic evaluation. RESULTS The age of the patients ranged from 23 to 64 years (mean [ SD], years). Five hundred eighty-five patients had had from one or more episodes of abnormal uterine bleeding. Of these patients, 345 were premenopausal and 240 were postmenopausal. Three hundred thirteen patients had sterility, and 188 had a thick endometrium on transvaginal sonography (124 postmenopausal and 64 premenopausal ) (24). Müllerian abnormalities were suspected on the basis of transvaginal ultrasonograpy in 45 patients, and Asherman syndrome was clinically suspected in 22 patients. Ninety-three percent of the procedures (1,074 of 1,153) were performed correctly. Investigation was not completed in 79 (7%) (Table 1). Causes of incomplete procedures were the presence of a stenotic cervix that did not allow insertion of the intrauterine catheter in 36 patients (of whom 20 were nulliparous and 16 were menopausal); an insufficient cervical seal causing vaginal back-flow of the contrast medium in 12 patients (of whom 8 were pluriparous); and difficulty in distending the uterine cavity because of myomas, which resulted in unsatisfactory ultrasonographic images in 11 patients. Pelvic pain occurred during distention of the uterine cavity in 11 patients. In 9 patients, symptoms related to vagal stimulation that occurred during insertion of the catheter or inflation of its balloon resulted in interruption of the proce- FERTILITY & STERILITY 621

3 TABLE 1 Causes of failed sonohysterography in 1,153 patients. TABLE 3 Side effects of sonohysterography. Cause nulliparous pluriparous postmenopausal All (%) Side effect nulliparous pluriparous postmenopausal All (%) Severe cervical (3.12) stenosis Insufficient (1.04) cervical seal Uterine myomas (0.95) Pelvic pain (0.95) Vagal symptoms (0.78) Total (6.85) dure. Most failed procedures occurred in nulliparous and postmenopausal. The 79 in whom examination was incomplete were scheduled to undergo another procedure within 45 days. The second attempt was successful in all patients and lacked complications in 60 (75.9%) patients. The operator took particular care to overcome the previous difficulties. Table 2 shows the difficulties encountered and the techniques the operator used to obviate them. Table 3 shows information on side effects, which occurred in 102 (8.8%) of 1,153. The most frequent side effects were moderate and severe pelvic pain (44 patients [3.8%]), but the examination was stopped for this reason in only 11 (0.95%). Forty patients (3.5%) had vagal symptoms such as severe sweating and hypotension, and 6 (0.52%) had lipothymia, which resulted in the interruption of the examination. Side effects were higher in nulliparous and post-menopause. Technique-related complications were as follows. Postprocedural fever occurred within 5 days of the examination Moderate or (3.81) severe pelvic pain Vagal symptoms (3.47) Lipothymia (0.52) Hypotension (1.30) Sweating (1.65) Nausea (1.04) Vomiting (0.52) Total (8.84) in nine patients (0.78%). Four of these patients (0.34%) experienced spontaneous resolution within 24 hours, whereas five (0.43%) required antibiotic therapy. Two patients (0.17%) experienced severe infective complications and underwent surgery for peritonitis. One patient of these patients underwent surgery 3 days after sonohysterography to treat peritonitis caused by salpingitis, and the other patient underwent surgery 4 days after the procedure to treat pelvic inflammatory disease with pelvic abscess. Technique-related complications occurred exclusively in young with sterility. DISCUSSION Several studies have demonstrated the usefulness of sonohysterosalpingography in the study of the uterine cavity and tubal patency (1 19). However, no study has prospectively evaluated side effects and complications during and after the procedure. TABLE 2 Procedure-related difficulties, and suggestions for their solution. Difficulty Cause Solution Catheter introduction Severe angulation of the cervix Traction of the cervix by the use of a single-tooth tenaculum; appropriate use of the speculum Cervical stenosis Use of Hegar dilatators and/or a suitable catheter Uterine cavity distention Cervical incompetence with saline solution reflux Use of a catheter with a balloon inflated in the internal os Uterine myomas Low tolerance of procedure Low pain threshold Use of paracervical block analgesia (rare) Endometriosis Use of a catheter without balloon Chronic pelvic pain syndrome Aspiration of saline solution after the procedure Fear of the examination NSAIDs Patient counseling Note: NSAID non-steroidal anti-inflammatory drug. 622 Dessole et al. Side effects and complications of sonohysterography Vol. 80, No. 3, September 2003

4 The risk of intrauterine infection and spread of malignant endometrial cells into the peritoneal cavity at the time of saline instillation were considered to be disadvantages of the sonohysterosalpingography (28). In our series, infective complications that required surgical resolution developed in only two patients (0.17%). Similar risks are reported with diagnostic and operative hysteroscopy (29 33); the incidence of this risk is higher (2.5% to 4%) during hysterosalpingography (34, 35). At our center, we do not routinely perform bacterial culture or antibiotic prophylaxis in patients undergoing sonohysterosalpingography. The small number of infective complications that occurred in our study group does not, in our opinion, justify the use of routine antibiotic prophylaxis. In theory, there is a risk that a substantial number of malignant cells may enter the peritoneal cavity. Nevertheless, only small volumes of saline under low pressure are used. Valenzano et al. (36) assessed the role of sonohysterosalpingography in the diagnosis and staging of endometrial carcinoma and found appropriate evaluation of myometrial infiltration in 89.4% of cases. In contrast, Alcazar et al. (37) assessed the risk of malignant cell diffusion in 14 patients with endometrial cancer during sonohysterosalpingography and concluded that a small but real risk exists in these patients. Malignant cell diffusion in with presumed endometrial cancer was reported with use of fluid or gas hysteroscopy (38 40). However, other studies provide different results (41), and no well-designed prospective trials have been published on this risk. We excluded with risk factors for endometrial cancer (obesity, nulliparity and late menopause). However, we agree that peritoneal implantation of malignant disseminated cells during sonohysterosalpingography is controversial. Further research is needed to define this risk. Many difficulties may arise during sonohysterosalpingography. Most of these problems can be overcome by using specific techniques. For example, in the case of severe cervix angulation, introduction of the catheter may be problematic. The operator can angle the speculum appropriately and reduce cervical angulation by exerting traction on the cervix with a single-tooth tenaculum, thus permitting introduction of the catheter. For a stenotic cervix, the operator may use Hegar dilatators or a suitable catheter, such as the Goldstein variety (26). Saline solution reflux may occur during the procedure because of cervical incompetence. Reflux renders the procedure difficult to perform because uterine cavity distention is not achieved. In this case, the operator should use a catheter with a balloon to ensure a good seal at the level of the internal os or the cervix (26). Sonohysterosalpingography is usually well tolerated, causing no pain in most patients and mild pain in a few. In patients with low tolerance, use of a catheter without a balloon is more appropriate, because inflation of the balloon stimulates the nervous fibers of the uterine cervix and thus causes pelvic pain and vasovagal symptoms (26). In our experience, aspiration of saline solution soon after the procedure reduces pain. Each patient should be appropriately counseled before the procedure, as such discussion reduces fear and increases pain tolerance. Paracervical blockade may be necessary in rare cases of dilatation of the cervical canal. In addition, administration of nonsteroidal anti-inflammatory drugs 30 to 90 minutes before the procedure may be helpful in patients who remain fearful of the examination. In conclusion, sonohysterosalpingography is a simple, safe, and well-tolerated technique that has a low rate of side effects and rare complications. References 1. Goldstein SR. Saline infusion sonohysterography. Clin Obstet Gynecol 1996;39: Gucer F, Hausler MC, Arikan MG, Pieber D. Contrast sonography for inconclusive findings on routine sonography. Int J Gynecol Obstet 1996;54: Widrich T, Bradley LD, Mitchinson AR, Collins RL. Comparison of saline infusion sonography with office hysteroscopy for the evaluation of the endometrium. Am J Obstet Gynecol 1996;174: Schwarzler P, Concin H, Bosch H, Berlinger A, Wohlgenannt K, Collins WP, et al. An evaluation of sonohysterography and diagnostic hysteroscopy for the assessment of intrauterine pathology. Ultrasound Obstet Gynecol 1998;11: Hamilton JA, Larson AJ, Lower AM, Hasnain S, Grudzinskas JG. Routine use of saline hysterosonography in 500 consecutive, unselected, infertile. Hum Reprod 1998;13: Inki P, Palo P, Anttila L. Vaginal sonosalpingography in the evaluation of tubal patency. Acta Obstet Gynecol Scand 1998;77: Spalding H, Perala J, Martikainen H, Tekai A, Jouppila P. Assessing tubal patency with transvaginal salpingosonography after the reversal of tubal ligation for female sterilization. Hum Reprod 1998;13: Goldberg JM, Falcone T, Attaran M. Sonohysterographic evaluation of uterine abnormalities noted on hysterosalpingography. Hum Reprod 1997;12: Turner RT, Berman AM, Topel HC. Improved demonstration of endometrial polyps and submucous myomas using saline-enhanced vaginal sonohysterography. J Am Assoc Gynecol Laparosc 1995;2: Kim AH, McKay H, Keltz MD, Preston Nelson H, Adamson GD. Sonohysterographic screening before in vitro fertilization. Fertil Steril 1998;69: Lev-Toaff AS, Lev-Toaff ME, Liu JB, Merton DA, Goldberg BB. Value of sonohysterography in the diagnosis and management of abnormal uterine bleeding. Radiology 1996;201: Saidi MH, Sadler RK, Theis VD, Akright BD, Farhart SA, Villanueva GR. Comparison of sonography, sonohysterography, and hysteroscopy for evaluation of abnormal uterine bleeding. J Ultrasound Med 1997; 16: Goldstein SR. Use of ultrasonohysterography for triage of perimenopausal patients with unexplained uterine bleeding. Am J Obstet Gynecol 1994;170: Goldstein SR, Zeltser I, Horan CK, Snyder JR, Schwartz LB. Ultrasonography-based triage for perimenopausal patients with abnormal uterine bleeding. Am J Obstet Gynecol 1997;177: Salle B, Sergeant P, Gaucherand P, Guimont I, de Saint Hilaire P, Rudigoz RC. Transvaginal hysterosonographic evaluation of septate uteri: a preliminary report. Hum Reprod 1996;11: Alatas C, Aksoy E, Akarsu C, Yakin K, Aksoy S, Hayran M. Evaluation of intrauterine abnormalities in infertile patients by sonohysterography. Hum Reprod 1997;12: Cohen LS, Valle RF. Role of vaginal sonography and hysterosonography in the endoscopic treatment of uterine myomas. Fertil Steril 2000; 73: FERTILITY & STERILITY 623

5 18. Bernard JP, Rizk E, Camatte S, Robin F, Taurelle R, Lecuru F. Saline contrast sonohysterography in the preoperative assessment of benign intrauterine disorders. Ultrasound Obstet Gynecol 2001;17: Krampl E, Bourne T, Hurlen-Solbakken H, Istre O. Transvaginal ultrasonography and operative hysteroscopy for the evaluation of abnormal uterine bleeding. Acta Obstet Gynecol Scand 2001;80: Tepper R, Beyth Y, Altaras MM, Zalel Y, Shapira J, Cordoba M, et al. Value of sonohysterography in asymptomatic postmenopausal tamoxifen-treated patients. Gynecol Oncol 1997;64: Timmerman D, Deprest J, Bourne T, Van den Berghe I, Collins WP, Vergote I. A randomized trial on the use of ultrasonography or office hysteroscopy for endometrial assessment in postmenopausal patients with breast cancer who were treated with tamoxifen. Am J Obstet Gynecol 1998;179: Neele SJ, Marchien Van Baal W, Van Der Mooren MJ, Kessel H, Netelenbos JC, Kenemans P. Ultrasound assessment of the endometrium in healthy, asymptomatic early post-menopausal : saline infusion sonohysterography versus transvaginal ultrasound. Ultrasound Obstet Gynecol 2000;16: Zalel Y, Cohen SB, Oren M, Seidman DS, Zolti M, Achiron R, et al. Sonohysterography for the diagnosis of residual trophoblastic tissue. J Ultrasound Med 2001;20: Granberg A, Wikland M, Karlsson B, Norstrom A, Friberg L. Endometrial thickness as measured by endovaginal ultrasonography for identifying endometrial abnormality. Am J Obstet Gynecol 1991;164: Dessole S, Capobianco G, Ambrosini G. Timing of sonohysterography in menstruating. Gynecol Obstet Invest 2000;50: Dessole S, Farina M, Capobianco G, Nardelli GB, Ambrosini G, Meloni GB. Determining the best catheter for sonohysterography. Fertil Steril 2001;76: Downie WW, Leatham PA, Rhind VM, Wright V, Branco JA, Anderson JA. Studies with pain rating scales. Ann Rheum Dis 1978;37: Spencer CP, Whitehead MI. Endometrial assessment re-visited. Br J Obstet Gynaecol 1999;106: McCausland VM, Fields GA, McCausland AM, Townsend DE. Tuboovarian abscess after operative hysteroscopy. J Reprod Med 1993;38: Garry R, Shelley-Jones D, Mooney P, Phillips G. Six hundred endometrial laser ablations. Obstet Gynecol 1995;85: Loffer FD. Complications of hysteroscopy: their cause, prevention, and correction. J Am Assoc Gynecol Laparosc 1995;3: Bracco PL, Vassallo AM, Armetano G. Infectious complications of diagnostic hysteroscopy. Minerva Ginecol 1996;48: Cooper JM, Brady RM. Intraoperative and early postoperative complications of operative hysteroscopy. Obstet Gynecol Clin North Am 2000;27: Tuveng JM, Vold I, Jerve F, Eng J, Skaug K, Eyolfsson O. Hysterosalpingography: value in estimating tubal function, and risk of infectious complications. Acta Eur Fertil 1985;16: Forsey JP, Caul EO, Paul ID, Hull MG. Chlamydia trachomatis, tubal disease and the incidence of symptomatic and asymptomatic infection following hysterosalpingography. Hum Reprod 1990;5: Valenzano M, Podesta M, Giannesi A, Cotricelli A, Nicoletti L, Costantini S. The role of transvaginal ultrasound and sonohysterography in the diagnosis and staging of endometrial adenocarcinoma. Radiol Med (Torino) 2001;101: Alcazar JL, Errasti T, Zornoza A. Saline infusion sonohysterography in endometrial cancer: assessment of malignant cells dissemination risk. Acta Obstet Gynecol Scand 2000;79: Egarter C, Krestan C, Kurz C. Abdominal dissemination of malignant cells with hysteroscopy. Gynecol Oncol 1996;63: Negele F, Wieser F, Deery A, Hart R, Magos A. Endometrial cells dissemination at diagnostic hysteroscopy: a prospective randomized cross-over comparison of normal saline and carbon dioxide uterine distension. Hum Reprod 1999;14: Zerbe MJ, Zhang J, Bristow RE, Grumbine FC, Abularach S, Montz FJ. Retrograde seeding of malignant cells during hysteroscopy in presumed early endometrial cancer. Gynecol Oncol 2000;79: Kudela M, Pilka R. Is there a real risk in patients with endometrial carcinoma undergoing diagnostic hysteroscopy (HSC)? Eur J Gynaecol Oncol 2001;22: Dessole et al. Side effects and complications of sonohysterography Vol. 80, No. 3, September 2003

Determining the best catheter for sonohysterography

Determining the best catheter for sonohysterography FERTILITY AND STERILITY VOL. 76, NO. 3, SEPTEMBER 2001 Copyright 2001 American Society for Reproductive Medicine Published by Elsevier Science Inc. Printed on acid-free paper in U.S.A. Determining the