Determining the best catheter for sonohysterography

FERTILITY AND STERILITY威 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 best catheter for sonohysterography Salvatore Dessole, M.D.,a Mario Farina, M.D.,a Giampiero Capobianco, M.D.,a Giovanni Battista Nardelli, M.D.,b Guido Ambrosini, M.D.,b and Giovanni Battista Meloni, M.D.c University of Sassari, Sassari, and University of Padua, Padua, Italy

Received December 8, 2000; revised and accepted February 28, 2001. Reprint requests: Salvatore Dessole, M.D., Departments of Pharmacology, and Gynecology and Obstetrics, 07100 Viale San Pietro 12, Sassari, Italy (FAX: ⫹39 079 228 265; E-mail: [email protected]). a Departments of Pharmacology, Gynecology and Obstetrics, University of Sassari. b Department of Gynecology and Obstetrics, University of Padua. c Department of Radiology, University of Sassari. 0015-0282/01/$20.00 PII S0015-0282(01)01941-0

Objective: To compare the characteristics of six different catheters for performing sonohysterography (SHG) to identify those that offer the best compromise between reliability, tolerability, and cost. Design: Prospective study. Setting: University hospital. Patient(s): Six hundred ten women undergoing SHG. Intervention(s): We performed SHG with six different types of catheters: Foleycath (Wembley Rubber Products, Sepang, Malaysia), Hysca Hysterosalpingography Catheter (GTA International Medical Devices S.A., La Caleta D.N., Dominican Republic), H/S Catheter Set (Ackrad Laboratories, Cranford, NJ), PBN Balloon Hystero-Salpingography Catheter (PBN Medicals, Stenloese, Denmark), ZUI-2.0 Catheter (Zinnanti Uterine Injection; BEI Medical System International, Gembloux, Belgium), and Goldstein Catheter (Cook, Spencer, IN). Main Outcome Measure(s): We assessed the reliability, the physician’s ease of use, the time requested for the insertion of the catheter, the volume of contrast medium used, the tolerability for the patients, and the cost of the catheters. Result(s): In 568 (93%) correctly performed procedures, no statistically significant differences were found among the catheters. The Foleycath was the most difficult for the physician to use and required significantly more time to position correctly. The Goldstein catheter was the best tolerated by the patients. The Foleycath was the cheapest whereas the PBN Balloon was the most expensive. Conclusion(s): The choice of the catheter must be targeted to achieving a good balance between tolerability for the patients, efficacy, cost, and the personal preference of the operator. (Fertil Steril威 2001;76:605–9. ©2001 by American Society for Reproductive Medicine.) Key Words: Sonohysterography (SHG), catheters, comparison

Sonohysterography (SHG) has recently become a widely used method for studying both the uterine cavity and tubal patency. It consists of transvaginal sonography (TVS) with concomitant instillation of an echogenic contrast medium into the uterine cavity by means of a catheter inserted in the uterine cavity through the cervical os. Several recent studies have shown that SHG has a very high rate of sensitivity and specificity for the study of the uterine cavity and tubal patency, and has a high concordance with hysteroscopy (1) and hysterosalpingography (2). In comparison with other techniques, SHG has been shown to be easier and faster to perform, and safer and less expensive; it is well tolerated by patients, and has fewer adverse

effects (1–2). Because of these features, SHG is performed in many centers as a first-line diagnostic procedure for the study of abnormal uterine bleeding and mullerian abnormalities, for the investigation of infertile patients undergoing in vitro fertilization treatment, and for programming endoscopic surgery. For the last 7 years, the MEDLINE database of the U.S. National Library of Medicine lists more than 80 papers discussing the SHG technique. However, to our knowledge few papers have focused on the type of catheter (3– 4); the existing studies evaluated only one or two catheters and enrolled no large series. Our study in a large series of patients evaluated the six types of catheters we use most frequently, including balloon and nonballoon catheters; we com605

FIGURE 1 (A), Foleycath (Wembley Rubber Products; Sepang, Malaysia; (B), Hysca Hysterosalpinography Catheter (GTA International Medical Devices S.A., La Caleta D.N., Dominican Republic); (C), H/S Catheter Set (Ackrad Laboratories, NJ); (D), PBN Balloon Hystero-Salpingrography Catheter (PBN Medicals, Stenloese, Denmark); (E), ZUI-2.0 Catheter (Zinnanti Uterine Injection, BEI Medical System International, Gembloux, Belgium); (F), Goldstein Catheter (Cook, Spencer, IN).

Dessole. Best catheter for sonohysterography. Feril Steril 2001.

pared their features to verify which had the best properties such as reliability, tolerability, and affordable cost.

MATERIALS AND METHODS The study was approved by our institutional review board. From June 1997 to June 2000, 860 patients underwent SHG. All of them gave both their oral and written informed consent to participate in this study. We excluded 250 patients for incomplete data; the other 610 were included in this prospective survey. The age of the included patients ranged from 23 to 64 years (42 ⫾ 12.3; means ⫾ SD). Among these patients, 357 suffered from one or more episodes of metrorrhagia; 206 were of fertile age, and 151 were in menopause. In addition, 171 suffered from sterility, and 82 had a thick endometrium on TVS: 54 women had endometrium thicker than 5 mm, and 28 women of fertile age had endometrium thicker than 12 mm. First-line TVS and SHG were performed throughout the proliferative phase of the menstrual cycle in the women suffering from sterility or thick endometrium. The procedures were performed regardless of the phase of the cycle for fertile women with abnormal uterine bleeding (5). Women in menopause underwent these procedures as a result of counseling. 606

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Best catheter for sonohysterography

Exclusion criteria were symptoms or signs of active pelvic infection, vulvovaginal infections, abnormal cytologic smear tests, and any risk of conception during the menstrual cycle when the procedure was to be performed. The procedure was performed as reported elsewhere (1) and lasted no more than 15 minutes. Neither premedication drugs nor prophylactic antibiotics were administered. All procedures were performed by two sonologists who were skilled in TVS.

Catheters We used six different types of catheter (Fig. 1): 1. Foleycath (Wembley Rubber Products, Sepang, Malaysia). A two-way standard, natural rubber latex, 30-cm long, 8 Ch with a diameter corresponding to 2.7 mm, with a balloon close to the tip which can be filled 3 to 5 mL. 2. Hysca Hysterosalpingography Catheter (GTA International Medical Devices S.A., La Caleta D.N., Dominican Republic). A two-way standard, radiopaque, polyvinylchloride, 30-cm long, 5-Fr catheter with a balloon close to the tip. The tip is spherical in shape with a lateral hole. The balloon is connected to a tube with a stopcock at the end, which may be attached to a 3-mL syringe. The catheter is also supplied with an introducer. 3. H/S Catheter Set (Ackrad Laboratories, Cranford, NJ). A

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two-way, polyurethane, 30-cm long, 5-Fr catheter with a Kraton balloon close to the tip, which is closed with a lateral hole. The catheter has two extensions: one is attached to a 1.5-mL syringe by a stopcock used to inflate the balloon; the other is attached to a syringe used for the injection of the contrast medium. The catheter is supplied with a polypropylene introducer that is used for the positioning of the catheter into the cervix. 4. PBN Balloon Hystero-Salpingography Catheter (PBN Medicals, Stenloese, Denmark). A 40-cm long, 5-Fr catheter consisting of radiopaque Pebax with a latex balloon at the tip which has a capacity of 3 mL. It has two directions of flow: one used to inflate the balloon and the other to inject the contrast medium, both equipped with a one-way stopcock. The tube is transparent to visualize air bubbles. The catheter is supplied with a sheath, which has a round tip, used to facilitate the positioning of the catheter. A 5-mL syringe is equipped with a Luer lock connected to the lumen of inflation. A hole, equipped laterally on the reservoir, avoids the excessive inflation of the balloon. 5. ZUI-2.0 Catheter (Zinnanti Uterine Injection, BEI Medical System International, Gembloux, Belgium). A two-way standard catheter, 23-cm long, with a diameter of 2 mm. The handle is curve-shaped to allow easy visualization of the external cervical os and to facilitate use in the case of both antiversion and retroversion of the uterus. The ZUI-2.0 catheter has a balloon close to the tip and includes a movable stopper that is V-shaped for better visualization of the cervical os. The balloon and stopper are attached to the internal and external os of the uterus, respectively, to fix the catheter in place. The balloon is connected to a tube with a stopcock at the end, which is attached to a 3-mL syringe. 6. Goldstein Catheter (Cook, Spencer, IN). A one-way standard catheter of TFE, 26-cm long, 5-Fr, that uses no balloon. It is equipped with a movable stopper which is fixed to the external os of the uterus.

The choice of catheter we used for the examination depended on the availability of the catheter during that period in our university hospital. Usually at least two or three types of catheter were simultaneously available. The type of catheter was assigned randomly by drawing a sealed envelope in which the name of an available catheter had been written. The catheters used were compared with regard to the reliability, the physician’s ease of use, the time required for catheter positioning, the volume of contrast medium used, the tolerability for the patients, and cost. Reliability was assessed on the basis of the number of the procedures carried out correctly that allowed satisfactory distention and complete visualization of the uterine cavity. To evaluate the physician’s ease of use for each catheter, we asked the operators to rate their experiences by category using a 1 to 10 scale, where 1 denoted maximal discomfort and 10 maximal ease while performing the procedure. The time requested for the introduction and the positioning of the catheter was measured with a chronometer by a nurse who was not informed about the study. FERTILITY & STERILITY威

During each procedure, the volume of the contrast medium injected into the uterus was registered by a senior resident who assisted the operator. To assess the degree of pain that the patient experienced during the procedure, we used a rating scale with 10 categories, where 1 denoted no pain at all and 10 denoted very severe pain. The patients were familiarized with the scale before the procedure was performed. At the end of each exam, the operator noted whether the procedure had or had not been correctly performed and recorded the following parameters: the score for the physician’s ease of use, the amount of time needed for the introduction and the positioning of the catheter, the volume of saline solution used, and the score for the patient’s degree of pain. We obtained the cost of each type of catheter (updated in May 1999) from the pharmaceutical suppliers of our hospital.

Statistical Analysis The data were recorded and analyzed using Microsoft Excel Pop tools. One-way analysis of variance (ANOVA) was performed to verify mean differences. The differences in proportion were studied using the ␹2 test with continuity correction. The significance level was fixed at P⬍.05.

RESULTS The characteristics of the patients are summarized in Table 1. The groups had no statistically significant differences in age, gravidity and parity, or in number of postmenopausal women. The results of the comparison of the different types of catheter used for the performance of SHGs are shown in Table 2. Overall, no statistically significant differences emerged for the groups of women, with the 568 out of 610 (93%) procedures that were correctly performed. The investigation was not completed in 42 out of 610 (7%) women: 19 women with a stenotic cervix that did not allow the insertion of the intrauterine catheter (among these latter 10 were nulliparous, 9 in menopause); 11 women who experienced pelvic pain and symptoms related to vagal stimulation during the passing of the catheter or inflating of its balloon, requiring the suspension of the exam; and 12 women in whom an insufficient cervical seal resulted in the vaginal backflow of the contrast medium. Although the percentage of failures was higher in the group of women who underwent SHG with the use of the Foleycath, the differences among the several types of catheter were not statistically significant. When compared with the other types of catheter, physicians rated the Foleycath as being more difficult to use (P⬍.05); it required significantly more time for its insertion and positioning (P⬍.05). The Goldstein catheter required a significantly higher volume of contrast medium (P⬍.05). 607

TABLE 1 Characteristics of the patients. Characteristics No. of patients Nulliparous Pluriparous Fertile age Postmenopausal Age (y)

Foleycath

Hyska HSG

H/S

PBN Balloon

ZUI-2.0

Goldstein

140

105

94

91

87

93

60 80 95 45 42 ⫾ 12.3

48 57 67 38 41.5 ⫾ 13.6

40 54 66 28 40.4 ⫾ 14.5

44 47 63 28 43 ⫾ 16

36 51 56 31 43.5 ⫾ 12.5

35 58 58 35 45 ⫾ 15

Dessole. Best catheter for sonohysterography. Fertil Steril 2001.

With regard to the patient’s pain, there were statistically significant differences (P⬍.05) found when comparing the Goldstein catheter to the other types of catheter: patients rated the Goldstein catheter as being better tolerated. We did not observe any significant difference with regard to these parameters in the evaluation of the Hysca, H/S, PBN Balloon, and ZUI-2.0 catheters.

loon-tip catheter in the performance of SHG; these results suggested higher patient tolerance for the nonballoon catheter. Platt et al. (4) proposed the use of chorionic villus biopsy catheters for SHG in women with cervical stenosis. According to our experience, almost all catheters permitted the recovery of good quality images in more than 90% of patients, allowing an accurate diagnosis.

With regard to the cost of the catheters, the Foleycath was the cheapest, and the PBN Balloon the most expensive.

We found no statistically significant differences among the catheters with regard to the ease of the physician in performing the exam: all the catheters proved to be practical and easy to handle. In comparison to the others, only the insertion and the positioning of the Foleycath seemed to prove slightly more difficult, perhaps because of the softness of the material with which it is made. The insertion of the catheters supplied by an inflexible guide (Hysca, H/S, and PBN Balloon catheters) was easier. The positioning and fixing of the catheters equipped with a stopper (Goldstein and ZUI-2.0 catheters) were the most successful.

DISCUSSION To our knowledge, this is the first study to compare several of the SHG catheters on the market and to assess the performance of these tools in a large series of patients. Among the available studies, Snyder and Anasti (3), with a group of 23 patients, compared a low-cost, nonballoon-tip catheter to a more expensive balloon-tip catheter in the performance of SHG. The investigators concluded that the nonballoon-tip catheter is a low-cost alternative to the bal-

The Goldstein catheter is without doubt better tolerated

TABLE 2 Comparison of the different types of catheters used for SHG (one-way ANOVA and ␹2 test). Characteristics

Foleycath

No. of patients No. of procedures correctly performed (%) No. of incomplete procedures (%) Physician’s ease Time required for the positioning of the catheter (sec) Volume of contrast medium used (mL) Patient’s pain Cost (Italian liras) a

Hyska HSG

H/S

PBN Balloon

ZUI-2.0

Goldstein

140 125 (89.3)

105 98 (93.4)

94 88 (93.6)

91 85 (93.4)

87 83 (95.4)

93 89 (95.7)

15 (10.7)

7 (6.6)

6 (6.4)

6 (6.6)

4 (4.6)

4 (4.3)

6.7 ⫾ 1.8a 76 ⫾ 35.5a

7.8 ⫾ 1.4 62.3 ⫾ 15.4

8.4 ⫾ 1.2 57 ⫾ 18.5

8.2 ⫾ 1.4 58.2 ⫾ 17.8

7.8 ⫾ 1.1 61.6 ⫾ 19.1

8.2 ⫾ 1.5 59.8 ⫾ 8.2

18.5 ⫾ 5.4

16.0 ⫾ 5.8

16.6 ⫾ 6.0

14.8 ⫾ 6.5

14.5 ⫾ 5.3

27.8 ⫾ 9.2a

5.5 ⫾ 2.3 2800a

4.5 ⫾ 1.8 108000

4.8 ⫾ 2.0 63000

4.6 ⫾ 2.4 116000

4.1 ⫾ 1.7 66000

3.5 ⫾ 1.8a 54000

ANOVA one-way, P ⬍.05.

Dessole. Best catheter for sonohysterography. Fertil Steril 2001.

608

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by patients because it has no balloon. A balloon permits the catheter to be fixed, but its inflation stimulates the nervous fibers of uterine cervix, causing pelvic pain and vasovagal symptoms. Because a balloon catheter can ensure good sealing at the level of the internal os and/or the cervix and prevent the reflux of contrast medium back into the vagina more successfully (in comparison to a nonballoon catheter), it allows higher pressures to be attained within the uterus. Hence, a balloon catheter is preferred for assessing tubal patency, but it may increase the patient’s discomfort and risk of vasovagal reactions. Thus, if only a uterine assessment is required, the Goldstein catheter is probably the most suitable choice. Because of the high backflow into the vagina, this catheter required a largest amount of saline solution. With regard to cost, the catheters we used had a wide range of prices. For example, the cost of the Foleycath (the cheapest) and the PBN Balloon Hystero-Salpingography Catheter (the most expensive) differed remarkably.

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All the catheters we examined permitted good visualization of the uterine cavity in the majority of patients. However, some displayed remarkable characteristics. In clinical practice, the choice of the catheter must be targeted toward achieving a good balance among tolerability for patients, efficacy, cost, and the personal preference of the operator. References 1. 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;174:1327–34. 2. Goldberg JM, Falcone T, Attaran M. Sonohysterographic evaluation of uterine abnormalities noted on hysterosalpingography. Hum Reprod 1997;12:2151–3. 3. Snyder JT, Anasti J. A comparison of two saline infusion sonography catheters. Obstet Gynecol 2000;95(suppl 1):S31. 4. Platt LD, Agarwal SK, Greene N. The use of chorionic villus biopsy catheters for saline infusion sonohysterography. Ultrasound Obstet Gynecol 2000;15:83– 4. 5. Dessole S, Capobianco G, Ambrosini G. Timing of sonohysterography in menstruating women. Gynecol Obstet Invest 2000;50:144.

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