When a balloon catheter or tenaculum is required for cervical traction during hysterosalpingography

Abstract The aim of this study was to define the actual rate of the traction needed and the balloon catheter or tenaculum requirement for hysterosalpingography (HSG) examinations, and to investigate the correlation between pain scores with the type of traction, operator, parity or the type of infertility. 788 patients undergoing HSG participated in the trial. The HSG examinations were completed in 58% of the patients (458) without any traction. Traction was needed in 42% of patients, those with the balloon catheter in 26.9%, and those with the tenaculum only at 15%. Patients with balloon catheter traction had similar pain scores to those using tenaculum traction. The pain scores changed according to the operator. HSG examinations should be performed step-by-step and the need for traction evaluated during the procedure. IMPACT STATEMENT What is already known on this subject? HSG is a technique to evaluate fallopian tube patency and other potential intrauterine pathology in infertile women. What do the results of this study add? Traction was not needed in more than half of the HSG examinations. The pain due to the balloon catheter and tenaculum is similar. What the implications are of these findings for clinical practice and/or further research? HSG examinations should be performed step-by-step by checking the need for traction. Traction with the balloon catheter prevents the uterine spasm, infection and bleeding complications during or after the HSG.


Introduction
Despite the technological improvement in imaging technology, hysterosalpingography (HSG) is still a gold standard technique for the investigation of infertility in everyday practice.
An ante or retro version of the uterus should be corrected to obtain an en-face image of the cavity.The reasons for pain in HSG are clutching the cervix by single-tooth tenaculum for fixation and traction, expansion of the cavity due to liquid (ICA) and liquid flow via the tuba uterina into the peritoneum (Gulec et al. 2014;Chauhan et al. 2013).
The pain does not necessitate anaesthesia commonly, however, might cause the procedure uncomfortable according to the tolerability of the patient (Chauhan et al. 2013).
Other side effects of tenaculum use are uterine spasm, which can cause suboptimal imaging, along with complications of infection and bleeding during or after the procedure.
The aim of the present study was to define the actual rate of the traction needed and the balloon catheter or tenaculum requirement for HSG examinations, and to investigate the correlation of pain scores with the type of traction, operator, parity or the type of infertility.

Material and methods
The written informed consent of the patients and the ethical approval of the hospital committee were obtained (14.04.2022À 8/3).
788 patients, who underwent the HSG between January 2021 and March 2022 in the tertiary care centre participated in the trial.The lower third of the informed consent was filled in by the operators after the procedure, which informs about the traction required and type, the amount of iodinated contrast agent (ICA), and the VAS pain score.

HSG technique
Initially, the position of the uterus was assessed by injecting a few millilitres of water-soluble iodinated contrast agent (ICA) after a spasmolytic agent, Hyoscine butyl-bromide.If traction was needed, a flexible catheter with an insufflated balloon was applied to pull backwards of the uterus.The position of the uterus was verified once again after the ICA and when the traction with a balloon catheter was inadequate, a tenaculum was used.In the final step of the exam, the catheter balloon was deflated to visualise the lower portion of the uterus and cervix.

Imaging equipment and examination team
HSG examinations in the study were obtained using simple X-ray equipment through the hospital facilities.Informed consent and images from exams have been transferred to the picture archiving and communication system (PACS) (Sectra AB, Teknikringen 20, SE-583 30 Link€ ooping, Sweden).The examination team consisted of two nurses and one x-ray technician, who has over 7 years of experience.

Features of the catheter
The catheter was the same one used in HSG and saline infusion sonography.It was 5 F, 30 cm, as flexible as other usual catheters but with a netted surface of the balloon, 11.5 mm in diameter, and double-separated lumen for the ICA and balloon sufflation.

The evaluation of the HSG exams
HSG examinations were evaluated by the authors of the study retrospectively through the PACS about the en-face view of the cavity, and optimal 788 exams were determined.The traction necessity and technique, VAS scores and other demographic data were recorded for statistical analysis.

Statistical analysis
Data were recorded and analysed by using SPSS 23 for Windows.Continuous variables were expressed as mean, median, minimum, and maximum, whereas categorical variables were expressed as percentages and frequencies.The Shapiro-Wilk test was used to assess the equality of variance of the data.When appropriate, and according to data distribution, analysis of variance was used for demographic comparison, the Kruskal-Wallis test was used for continuous data, the v 2 test was used for categorical data, and Fisher's exact test was used for small samples.Post-hoc analysis for multiple comparisons was performed by using the Bonferroni test.A pvalue of <0.05 was considered statistically significant.

Descriptive analysis
Age, gravida, parity, history of abortus and curettage, iodinated contrast media amount and VAS pain scores are presented in Table 1.
There was a significant difference between the three groups in terms of pain scores and the amount of contrast material used (p ¼ 0.001, p < 0.001 respectively).Patients with balloon catheter traction had higher pain scores than patients who were not tractioned (p ¼ 0.002).The amount of contrast agent used was similar (p ¼ 0.485).
Patients with balloon catheter traction had similar pain scores to those using tenaculum traction (p ¼ 0.002), however, the amount of ICA used was significantly less (p < 0.001).
Patients with tenaculum traction had higher pain scores than patients without traction (p ¼ 0.004) and the amount of ICA was significantly higher in the tenaculum group (p < 0.001).
The pain scores changed according to the operator.In the present study, the VAS scores were significantly lower in the examinations performed by operator 'E' (p < 0.001), however, the amount of contrast material used was similar (p ¼ 0.093).
The traction pattern changed according to the operator.While operator 'E' preferred less traction in any type, operator 'A' used the balloon catheter more, statistically significant (p < 0.001).
There was no relationship between the mode of delivery and the type of traction used (p ¼ 0.136).
The type of infertility, such as primary or secondary, did not change the type of traction statistically significantly (p ¼ 0.168), however, the VAS pain scores were significantly lower in secondary infertile women (p ¼ 0.025), and the contrast agent used in primary infertile women was significantly less (p < 0.001).

Discussion
Radiologists consider HSG as worthless to investigate due to the modern technological and popular imaging modalities, however, HSG despite a historical procedure, is still the first step and a gold standard technique to evaluate infertility.

Limitations of the study
The manometer to control the intrauterine pressure could not be used or the lack of adequate pressure decision observing the 'pine tree sign' due to the technique.The force of traction by catheter or tenaculum could not be measured.It is planned to get measurements soon with units of kgforce (Newton).The procedures were performed with simple x-ray equipment owing to the hospital facilities.That is why advanced procedures such as selective salpingography or fluoroscopy-guided tubal recanalization had to be planned in another session under DSA in the hospital.
Performing the procedure with simple x-ray equipment was presented above as one of the limitations, however, from a different perspective it might be a positive effect that the patients were exposed to less irradiation considering fluoroscopy.
The pain may be discomforting for some patients and especially for those with previous HSG history may demand the procedure to be performed under general anaesthesia.The most outstanding result of our study was to have VAS pain score found similar in both uterine traction techniques; a balloon catheter and tenaculum.The reason for that result might be the histology of the cervix, in which the innervation is unlike the fundus and the corpus (Goldthwaite et al. 2014).Tractioning the cervix is the shared feature of both techniques and gives rise to a lengthening force, which might be the actual mechanism triggering the pain instead of a puncture of the cervix by a single-tooth tenaculum.
In the present study, 58% of the HSG exams were completed without any uterine traction.The VAS pain scores and the type of traction change according to the operator of HSG.The operator preference of traction type supports the hypothesis above for the pain trigger that operator 'E' has used the tenaculum more, however, the pain scores were lower statistically significant than operator 'A'.
Even though Anserini et al. reported 99% of tenaculum-free examinations (Anserini et al. 2008), in the present study, HSG exams were completed without a tenaculum in 85% of the patients.In the present study comparing the metal cannula with the catheter technique about the traction need was not aimed, since it was thought that the data in our study cannot be achieved using a metal cannula since en-face view imaging is almost impossible without traction with a tenaculum, even for the patients, who do not need uterine traction.
Lindheim et al. state that balloon-type catheters may obliterate the lower uterine segment and prevent further evaluation (Lindheim et al. 2006).However, in the present study, the HSG was performed step-by-step and in the last step balloon of the catheter was deflated and a few millilitres of ICA was administered to visualise the lower segment and cervix of the uterus in all patients.That is why it was thought that balloon-type catheter does not shadow the cavity of the lower uterine segment.
Dessole et al. investigated 6 different catheters including a Foley Cath used for saline-infusion sonography about reliability, tolerability, and cost and found no difference statistically significant.However, Foley Cath was more challenging to use, and time-consuming to position properly but the cheapest if compared with the other types (Dessole et al. 2001).The balloon catheter used in the study has distinctive features compared to the other catheter.The surface of the balloon in the catheter in our study is netted to increase the area and traction force, and the other types of catheters available have smooth surfaces.The traction force comparing the netted and smoothed surface balloons are needed to investigate.
The studies in the literature related to traditional hysterosalpingography are usually about pain or pain relief.de Mello et al. compared balloon catheter, and tenaculum with and without a paracervical block for pain during hysterosalpingography.They found that tenaculum without anaesthesia was the most discomforting technique for pain (de Mello et al. 2006).However, in the present study, the pain during traction either with a balloon catheter or tenaculum without anaesthesia was similar and statistically insignificant.
To the best of our knowledge, the rate of traction needed in HSG was not studied in the literature.HSG is thought to be performed only with uterine traction, which is one of the main sources of pain during HSG.The present study shows that more than half of the uteruses (58%) do not require being imaged en-face in HSG examinations.

Figure 1 .
Figure 1.An HSG exam without any uterine traction, as in 58% of the patients.

Figure 2 .
Figure 2. Traction of the uterus with balloon catheter technique, as in 26.9% of the HSG exams.

Figure 3 .
Figure 3. Traction of the uterus with single-tooth tenaculum technique, as in 15% of HSG exams.

Table 1 .
Descriptive analysis of the patients.