Patient experience when self‐introducing gel into the vagina for assessment of deep endometriosis: A pilot study

When scanning for deep endometriosis a 20 mL syringe is used to insert gel into the vagina for a gel sonovaginography (SVG) examination. This is invasive and can cause discomfort. The aim of this study is to compare participant experience with the self‐administration of 20 mL of gel total using a 10 mL syringe versus 20 mL syringe for participants undergoing a gel SVG ultrasound to assess for any participant discomfort.


| INTRODUCTION
Endometriosis is a common gynaecologic condition affecting 1 in 10 individuals assigned female at birth. 1,2It is the implantation of endometrial glands and stroma in anatomical positions outside of the uterine cavity and can be categorised into superficial and deep endometriosis. 2 Superficial endometriosis is defined by ectopic endometrial like glands extending 5 mm under the peritoneal pelvic surface and/or serosa of the pelvic viscera. 3Superficial endometriosis requires different patient preparation and scanning techniques including bowel evacuation and/or uterine saline infusion termed 'sonoPODography' with detailed examination of the pelvic peritoneum compartments. 3 such, superficial endometriosis will not be discussed further in this work.DE infiltrates the ovaries, pelvic peritoneum, pouch of Douglas (POD), rectum, rectosigmoid, rectovaginal septum, uterosacral ligaments, vagina and urinary bladder. 2,6Patients with DE have reduced quality of life as common manifestations include chronic pelvic pain, dysmenorrhoea and infertility. 1,2Transvaginal ultrasound (TVUS) is currently the first-line imaging technique for diagnosing DE as it is low in cost, accessible and is well tolerated with high diagnostic accuracy.7][8][9] Accurate diagnosis and location of DE in the posterior compartment is important for pre surgical planning and counselling, thus, improvements to methods for detecting DE are important to enhance patient outcomes.
To create an acoustic window between the transvaginal probe and surrounding structures and improve the detection of DE in the posterior compartment, sterile saline solution was introduced into the vagina. 4The saline solution did enhance the visualisation of the posterior compartment to demonstrate more clearly DE lesions, however, there was leakage of the saline from the vagina so saline was replaced by ultrasound gel. 4 A total of 20 mL of gel was introduced into a plastic syringe prior to performing the TVUS, with care taken not to include excessive air bubbles. 10The plastic syringe with gel is then inserted into the posterior fornix of the vagina by the sonographer. 8,10As the sonographer must manually guide the syringe into the patient's vagina, this technique is invasive and a 20 mL syringe may be uncomfortable and painful for the participant.It is our practice to allow gel insertion by the participants, inserting the gel syringes themselves rather than the sonographer, improving participant autonomy, control and potentially comfort.It was hypothesised that the use of a 10 mL syringe may be better tolerated by the patient due to the reduced diameter compared to a 20 mL syringe.
The aim of this study was to assess patient experience when inserting 20 mL of gel in total into the vagina using two different syringe sizes, a 10 and 20 mL syringe, comparing the reported level of discomfort.

| METHOD
This was a pilot study designed to assess participant reported experience.Prior to the commencement of the study, ethics approval was obtained from an institutional Human Research Ethics Committee (Institutional ethics approval number: 2022-059).The research project was conducted between August 2022 and May 2023 and funded by an imaging centre.
Participants were recruited into the study if they presented for gel sonovaginography (SVG) examination and were over 18 years of age.
After completing a routine pelvic history questionnaire, (standard procedure) the researcher and the participant reviewed the questionnaire and participant information sheet (PIS) in private to determine study eligibility.Eligible participants included participants over 18, who were presented for a gel SVG and were able to provide consent.If eligible, the researcher explained the standard SVG examination procedure which includes patient use of two 10 mL syringes and the research study procedure of one 10 mL syringe and one 20 mL syringe.Both methods resulted in the use 20 mL of gel total.Terumo ® brand luer slip tip syringes (Terumo Australia Pty Limited, Terumo Corporation Japan) were used as per the method published by Sibal in 2016 which included the use of 20 mL of gel. 10 Prior to consent, participants were also provided a sample of the different syringes to assess the size.The SVG examination was explained with the amended procedure and the opportunity to ask questions or obtain further clarification was offered and subsequently provided if needed.
Participants with vaginismus or other vaginal complications, persons who could not provide informed consent, persons without a vagina and persons with female genital cutting were excluded.If the participant declined to participate, the standard SVG examination protocol, using two 10 mL syringes was followed.

A GE Voluson e10 (GE Medical Systems, Austria GmbH & Co OG)
with a RIC5-9-D probe was used to perform the examination.All participants were required to empty their bladder prior to the SVG.After consent was obtained, one 20 mL and one 10 mL syringe were prepared using an aseptic hand washing and gloving technique.A sterile drape was then placed on a bench.The 10 mL syringe was held, by one gloved hand, half open within its package and the plunger removed from the syringe and placed on the sterile drape, using the opposite hand.Ensuring the minimal introduction of air, the sterile gel (Durex K-Y Jelly: Reckitt Benckiser Health) was squeezed from its tube directly into the syringe, (Figure 1A,B).A small amount of gel was released into the packet when the plunger was returned to the syringe and engaged (Figure 1C).This expelled air from the luer slip tip of the syringe and released gel around the syringe tip, acting as a lubricant for insertion.The same process was repeated for the 20 mL syringe.
The packaged and prepared syringes were given to the participant (Figure 1D) to insert into their vagina in privacy.
Participants were instructed to insert the gel syringes one at a time in a similar fashion to a tampon, at their own pace in a comfortable position (Figure 2).Participants then lay in a supine position on the bed with their buttocks placed on the bed protector to absorb gel leakage.
The order of which syringe to insert first into their vagina, to introduce the gel, was chosen by the participants and random.The TV probe was placed initially at the introitus, and the SVG was performed.
Following the SVG scan, the participant received a Qualtrics survey link (Qualtrics International Inc, Washington USA) questionnaire by phone or email.Participants were asked six closed-ended questions and two five-point Likert scale questions.The six closed ended questions asked whether the syringes were easy to insert and which syringe they preferred.The Likert scales assessed participant comfort for each syringe from no discomfort to unbearable.All data were recorded anonymously, reported as number (percentage) and analysed using Excel ® Version 16.54 with results displayed in graph and tabulation form.
A total of 31 participants took part in the study, with 100% agreeing that the instructions for the gel insertion were easy to follow.Of the 31 participants, 25 (80.6%)stated both syringes were easy to insert.The remaining six (19.4%) stated that one of the syringes was harder to insert with 50% stating the smaller syringe was more difficult to insert and expel the gel and 50% reported the larger syringe was more difficult.
In terms of the 20 mL syringe and reported level of comfort, all participants (n = 31) had no to mild discomfort (Table 1).The same number of participants reported no to mild discomfort using the 10 mL syringe, although more (22/31 (71%)) had no discomfort, (Table 1).Finally, the majority 20/31 (67%) of participants preferred to use one 20 mL syringe compared to two 10 mL syringes (Figure 3).

| DISCUSSION
This is the first study to investigate the preference of syringe size when participants self-introduce gel into the vagina when sonographically assessing the posterior compartment during a DE scan.2][13] Currently the insertion of a 20 mL syringe filled with gel into the vagina is used as an acoustic window between the transducer F I G U R E 1 (A) Gel filling of the 10 mL syringe, (B) Gel filling of the 20 mL syringe (C) Release of gel into the package, (D) 10 and 20 mL gel filled syringes ready for patient use.and pelvic compartments. 2,8,10Although this method enhances the diagnosis of DE, it is invasive and may be painful for the patient.
Therefore, asking patients which method of gel insertion they prefer is essential to enhancing patient care.Our results demonstrate overall, self-insertion of either size syringes, was successfully completed by participants and well tolerated.Every participant placed the gel in the correct location, as such, extra gel was not needed to successfully perform the SVG.A systematic review demonstrated self-sampling for cervical screening was acceptable to the majority of women 14 and aligns with the results of our work where the majority of women tolerated inserting vaginal gel prior to DE screening.Future research on larger numbers of participants is suggested.
While the majority (71%) reported no discomfort with the 10 mL syringe, most participants preferred inserting one 20 mL syringe instead of two 10 mL syringes.This may be due to the preference to insert a single syringe rather than two separate syringes.The preference for the 20 mL syringe with the larger circumference, may also have been easier to hold, navigate and insert into the vagina to the necessary depth.Furthermore, of the 6/31 participants that found one of the syringes harder to insert, 50% said that the smaller syringe was harder to insert and 50% said that the larger syringe was harder to insert.This variability in results may be because of varying vaginal length, width, and introital size as well as the patient's race, ethnicity, age, parity, and height. 15,16ginal sizes can vary in length and width, varying from 40 to 125 mm and 18 to 65 mm respectively. 15These factors influence the size of speculums used to appropriately accommodate individual anatomical features, 16 which may similarly impact the choice of syringe size.As the 10 mL syringe has a smaller circumference and was reported to have no discomfort, the 10 mL syringe may be beneficial in specific cases with vaginal complications, such as vaginismus.
Laparoscopy is the gold standard for the diagnosis and treatment for DE, however, it is invasive, risky and has multiple complications for the participant. 1,17Pre-surgical planning, using medical imaging is essential for correct diagnosis of nodule location. 18Medical imaging, in particular TVUS and specifically SVG allows for the diagnosis and documentation of the extent and location DE nodules which essentially improves surgical outcomes for patients and allows for team planning and counselling, minimising the risks involved with laparoscopy. 18,19Detection of DE in the posterior compartment has a low sensitivity, thus several studies have improved the TVUS method by using an acoustic standoff, either saline or gel, to increase the distance and enhance the acoustic window between the transvaginal probe and the surrounding structures of the vagina. 5,10Any measures that may improve the patient experience when undergoing SVG examination may lead to improvements in care, and possibly, results.
One technique described in the literature for SVG required an assistant to insert saline into the patient's vagina, which resulted in excessive leakage of the saline.An assistant was required to hold the labia majora closed to prevent this leakage, decreasing patient autonomy. 4Another technique for SVG inserted extra gel into the probe cover of the transvaginal probe which was then inserted into the patient's vagina. 5When inserted into the patient's vagina, air bubbles were introduced, the gel was easily compressed away from the region of interest.This technique reduced the amount of gel available to use as a standoff when imaging a lesion decreasing image quality. 5In contrast, our study did not require an assistant, used a no-touch approach, and had minimal gel leakage.When the participant directly introduced gel into the vagina via the syringes, our experience was that there was no compression of the gel upon introduction of the transvaginal probe, there was enough gel spread around to visualise any endometriotic lesions, and although there were some air bubbles, there was a minimal amount which could be displaced with probe pressure.
Other studies performing SVG examinations have used 40 mL of physician delivered gel of unknown syringe size, noting that the patient did not have any considerable discomfort during the procedure. 2Another SVG study used 20 mL of gel with a 20 mL syringe. 8,10e latter studies did not report patient experience or insertion of gel by the patient themselves.In comparison, our study reported nearly half of the participants experiencing only mild or moderate discomfort with the syringe insertion, in particular, with the 20 mL syringe.Future research comparing participant preference of health professional versus participant gel insertion prior to SVG would be informative.
This research is the first work to assess patient care and the level of comfort for participant administered gel insertion for a SVG examination.A strength of this study is in the design, requiring only a single operator thus reducing the need for a second assistant as the syringes are self-inserted by the participants.This also reduces any risks of harm to the participant that operator-insertion may cause.The risk of the operator's conduct being seen as inappropriate or overly invasive could be reduced, subsequently reducing malpractice claims.Limitations of this study include a small sample size which may result in inaccurate predictions and assumptions.Another limitation is that this study was performed in a single centre which may reduce the generalisability of the results.

| CONCLUSION
The self-administration of gel into the vagina for SVG using a syringe by the participant was well tolerated.Participants found the instructions easy to follow, reducing the need for the researcher to insert the syringe, improving participant autonomy.Despite mixed levels of discomfort experienced using both sizes of the syringe, participants would have preferred to use a single 20 mL syringe over two 10 mL syringes.Future research into the acceptability of self-insertion of gel into the vagina with variable syringe sizes, including larger syringes which allow more gel to be used should be considered in a larger multicultural population.

F I G U R E 2 3
Diagram demonstrating the location of the syringe insertion.Original drawing.Used with permission.T A B L E 1 Numerical tabulation of responses for each category.of 1-5, how comfortable were you while inserting the 20 mL syringe?(Larger syringe) 14 (45.2%) 12 (38.7%) 5 (16.1%) 0 0On a scale of 1-5, how comfortable were you while inserting the 10 mL syringe?(Smaller syringe) Graph of responses for syringe preference.