{"paper_id":"8e7b815e-4cbf-4919-bf76-5dade326176a","body_text":"TECHNIQUES AND INSTRUMENTA TION\nHysterosalpingo-foam sonography (HyFoSy) using two different\nballoon catheters: a randomized trial\nDominique Van Schoubroeck& Thierry Van den Bosch &\nLieveke Ameye & Thomas D’Hooghe & Dirk Timmerman\nReceived: 31 July 2014 / Accepted: 14 October 2014 / Published online: 28 October 2014\n# Springer-V erlag Berlin Heidelberg 2014\nAbstract The purposes of this study were to evaluate and\ncompare the technical feasibility and the patients’ pain during\nhysterosalpingo-foam sonography (HyFoSy) using two differ-\nent 2-mm balloon catheters. Randomized trial in 46 consecu-\ntive women referred for tubal patency testing by HyFoSy at\nthe Leuven University Hospital. Six women refused to partic-\nipate. Forty women were randomized and blinded as to the\ncatheter used. The patients underwent first a transvaginal\nultrasound examination to assess the uterus and the ovaries\nand to exclude the hydrosalpinx, and subsequently, a HyFoSy\nwas performed using an uVue catheter (Cook Medical,\nBloomington, IN, USA) or a pediatric Foley ’sc a t h e t e rw i t h\nstylet (Pediatric Folysil, Coloplast A/S; Humlebaek, Den-\nmark) according to randomization. If the catheter could not\nbe inserted smoothly into the uterine cavity at first attempt,\ntransabdominal ultrasound guidance was performed. After the\nprocedure, the patients were asked to fill in a questionnaire\nincluding a visual analog scale (V AS) score for the pain at\ninitial ultrasound examination (V AS\nUS), used as baseline\nscore, and at HyFoSy (V AS HyFoSy). The pain related to the\nHyFoSy procedure was reported as (V AS HyFoSy−VA SUS)/\nVA SUS. Catheter insertion failed in one patient of the uVue\ngroup (5 % failure rate) and in none of the Foley group.\nUltrasound guidance during catheter insertion was performed\nin 68 % of the uVue group and 20 % of the Foley group. The\nmedian ratio (V AS\nHyFoSy−VA SUS)/V ASUS for the uVue and\nthe Foley group was 1.82 and 0.54, respectively (p=0.00 5). A\npediatric Foley catheter was easier to insert as compared to an\nuVue catheter, and HyFoSy using a pediatric Foley catheter\nwas reported by the women to be the least painful.\nKeywords Ultrasonography . Infertility . Female . Fallopian\ntube patency tests . Microbubbles\nBackground\nHysterosalpingo-contrast-sonography (HyCoSy) is as accu-\nrate as hysterosalpingography (HSG) in the evaluation of\nFallopian tube patency and is to be preferred as it does not\nexpose the patient nor the examiner to radiation [ 1–3]. More-\nover, HyCoSy is reportedly less painful and better tolerated by\nt h ep a t i e n t sa sc o m p a r e dt oH S G .H y s t e r o s a l p i n g o - f o a ms o -\nnography (HyFoSy) is a novel variant of HyCoSy using gel\nfoam, a mechanically mixing of water, gel, and air, as a\npositive contrast agent [4–8].\nThis study aims to evaluate and compare the technical\nfeasibility and the patients ’ pain during HyFoSy using two\ndifferent 2-mm balloon catheters.\nMethods\nWe performed a randomized trial in 46 consecutive women\nreferred for tubal patency testing by HyFoSy at the Leuven\nUniversity Hospital. The study had been approved by the local\nethics committee, and informed consent was obtained in all\npatients. Six women refused to participate. Forty women were\nrandomized (Fig.1) using a random number generator (https://\nwww.random.org/). The random assignments were placed in\n40 numbered, opaque, and sealed envelopes. The envelope\nwas opened after consent was given and just prior to the\nHyFoSy procedure. The patients were blinded as to the\ncatheter used, but for obvious reasons, the clinician was not\nblinded. The patients underwent first a transvaginal ultrasound\nexamination to assess the uterus and the ovaries and to\nexclude the hydrosalpinx, and immediately thereafter, a\nD. V an Schoubroeck (*) : T. V an den Bosch: L. Ameye :\nT. D’Hooghe : D. Timmerman\nKU Leuven Department of Development and Regeneration,\nUniversity Hospital Leuven, Herestraat 49, 3000 Leuven, Belgium\ne-mail: Dominique.vanschoubroeck@uzleuven.be\nGynecol Surg (2015) 12:41–44\nDOI 10.1007/s10397-014-0867-z\n\nHyFoSy was performed using a 2-mm uVue catheter (Cook\nMedical, Bloomington, IN, USA) or a 2-mm pediatric Foley’s\ncatheter with stylet (Pediatric Folysil, Coloplast A/S;\nHumlebaek, Denmark) accordi ng to randomization. The\nHyFoSy procedure was performed as outlined elsewhere [ 5].\nAn open-sided Collin speculum was inserted, the cervix\ndisinfected with a water-based Dakin solution, and the cathe-\nter was inserted into the uterine cavity. If the catheter could not\nbe inserted smoothly at first attempt, transabdominal ultra-\nsound guidance was performed. Catheter insertion was per-\nformed without the use of a cervical tenaculum or a dilator.\nThe balloon was slowly inflated with 0.5 to 1.0 ml of saline in\nthe lower part of the uterine cavity till the patient reported a\nvague pressure in the lower abdomen indicating perceptible\nintrauterine pressure. The speculum was removed, and the\nvaginal ultrasound probe was reinserted. The size of the\nballoon was measured in three perpendicular diameters, and\nthe gel foam was slowly injected under direct ultrasound\ncontrol. Tubal patency was defined as a sustained and fast\nforward flow of the gel foam through the entire Fallopian tube.\nAfter the procedure, the patients were asked to fill in a\nquestionnaire including a visual analog scale (V AS) score for\nthe pain at initial ultrasound examination (V AS\nUS), used as\nbaseline score, and at HyFoSy (V ASHyFoSy). The pain related\nto the HyFoSy procedure was calculated as the median ratio\n(V ASHyFoSy−VA SUS)/V ASUS.\nThe patients were asked also to describe the\npain/discomfort during HyFoSy (as “neutral,”“ unpleasant,”\n“painful but bearable,” or “really painful”) and to compare the\npain/discomfort during HyFoSy with two common minor\nprocedures (i.e., blood sampling and cervical cytology smear)\nas ‘less,”“ equally,” or “more painful/causing discomfort.”\nThe Fisher’s exact test was used to assess the differences in\ncategorical variables, t test and Wilcoxon test were used to\nassess differences in continuous variables. SAS 9.4 (SAS\nInstitute Inc., Cary, NC, USA) was used for the statistical\nanalyses.\n46\nConsecu/g415ve women\nreferred for HyFoSy\n40 women\nrandomized\nuVue\nN =  20\n19 analysed\nIn 1 pa/g415ent the uVue\ninser/g415on failed\n(a Foley was inserted)\nFoley\nN = 20\n20 analysed\n6 women refused to\npar/g415cipate\nFig. 1 Study design\nTa bl e 1 Patients’ characteristics\nuVue (n=19)a Foley (n=20 )\nMean age 31 29\nPrimary subfertility 13 12\nSecondary subfertility 6 8\nP≥14 5\nUnilateral block at HyFoSy 1 3\nBilateral block at HyFoSy 1 0\nP parity (all nine cases had a parity of 1)\na In one patient randomized in the “uVue” arm, a Foley was used after\nuVue insertion failed\nTa bl e 2 Reported pain/discomfort during HyFoSy\nuVue Foley\nN % N %\nNeutral 1 5.3 2 10.0\nUnpleasant 6 31.6 8 40.0\nPainful but bearable 7 36.8 8 40.0\nReally painful* 5 26.3 2 10.0\nTotal 19 20\n*p value 0.24\nTa bl e 3 Compared to\nblood sampling\n*p value 0.48\nuVue Foley\nN % N %\nLess 0 0.0 2 10.0\nEqual 4 21.1 5 25.0\nMore* 15 78.9 13 65.0\nTotal 19 20\nTa bl e 4 Compared to\ncervical cytology smear\n*p value 0.33\na One patient randomized\nto the Foley arm did not\nanswer this question\nuVue Foley\nN % Na %\nLess 1 5.3 2 10.5\nEqual 5 26.3 7 24.1\nMore* 13 68.4 10 52.6\nTotal 19 19\n42 Gynecol Surg (2015) 12:41–44\n\nFindings\nThe patients ’ characteristics (age, parity, primary/secondary\nsubfertility) and tubal patency for both subgroups were\ncomparable (Table 1).\nCatheter insertion failed in one patient of the uVue group\n(5 % failure rate) and in none of the Foley group. In the patient\nwith failed uVue catheter insertion, a Foley was inserted\nsuccessfully during the same session. Ultrasound guidance\nfor catheter insertion was performed in 68 % of the uVue\ngroup and 20 % of the Foley group ( p=0.00 4). The mean\nballoon diameter in the uVue group and the Foley group was\n8.7 and 9.3 mm, respectively (p=0.22). Five women (26 %) of\nthe uVue group reported the procedure to be really painful\nversus two (10 %) in the Foley group ( p=0.24) (Table 2).\nIn the uVue group and in the Foley group, 79 and 65 %,\nrespectively, found HyFoSy to be more painful than blood\nsampling (p=0.48) (Table 3), and 68 and 53 %, respectively,\nfound HyFoSy more painful than a cervical cytology smear\n(p=0.33) (Table 4).\nThe median V AS\nUS in the uVue and in the Foley group was\n1.5 (0.1–4.7) and 1.9 (0–6.5), respectively (p=0.14), while the\nmedian V ASHyFoSy was 4.8 (0.6–8.5) and 3.5 (0–7.1), respec-\ntively ( p=0.10). The median ratio (V AS HyFoSy − VA SUS)/\nVA SUS for the uVue and the Foley group was 1.82 and 0.54,\nrespectively (p=0.005) (Fig. 2).\nConclusions\nA 2-mm pediatric Foley catheter was easier to insert compared\nto an uVue catheter, and HyFoSy using a pediatric Foley\ncatheter was reported by the women to be the least painful too.\nThe strength of this study is its strict randomized design,\nthe blinding of the patients, and the fact that the study was\nperformed by the same group in the same center, precluding\nan operators’ bias. The weaknesses are the relatively small\nsample size and the impossible operators’ blinding.\nBoth catheters have the same diameter (2 mm) and have a\nsimilar balloon at the tip. The main difference is the devices ’\nrigidity, the uVue being stiffer. The latter has the advantage to\nallow insertion without the need of a swab forceps. Moreover,\nin case of severe ante- or retroversion of the endocervical\ncanal, it can be bent before insertion to match/fit the shape\nof the canal. However, in case of a tortuous or S-shaped\nendocervical canal, this may prove to be a disadvantage, since\nthe catheter will keep its pre-bended shape, the tip may\n“scrape” the more distal part of the canal, thus causing pain.\nThe more difficult insertion is reflected by the significantly\nhigher proportion of patients in the uVue group necessitating\nultrasound guidance. Moreover, the catheter ’s stiffness may\ncause discomfort when inserting the vaginal ultrasound probe\nand makes the uterus more rigid during ultrasound examina-\ntion. The Foley’s catheter does not have the above-mentioned\ndisadvantages, because it has a much less rigid and removable\nstylet to facilitate insertion, and once the stylet has been\nremoved, the catheter is supple.\nThe results of our study favor the use of the Foley’sc a t h e t e r\nover the uVue catheter in term of patients ’ tolerance and\noperators’ technical preference.\nConflict of interest Dominique V an Schoubroeck, Thierry V an den\nBosch, Lieveke Ameye, Thomas D ’Hooghe, and Dirk Timmerman de-\nclare that they have no conflict of interest.\nThe author’s role in the study can be summarized as follows:\nD. V an Schoubroeck—participation in study design, execution, anal-\nysis, manuscript drafting, and critical discussion; corresponding author\nT. V an den Bosch—participation in study design, execution, analysis,\nmanuscript drafting, and critical discussion\nL. Ameye, study design and analysis\nT. D’Hooghe—critical discussion\nD. Timmerman—critical discussion\nInformed consent All procedures followed were in accordance with\nthe ethical standards of the responsible committee on human experimen-\ntation (institutional and national) and with the Helsinki Declaration of\n1975, as revised in 2000 (5). Informed consent was obtained from all\npatients for being included in the study.\nReferences\n1. Campbell S, Bourne TH, Tan SL, Collins WP (1994) Hysterosalpingo\ncontrast sonography (HyCoSy) and its future role within the investi-\ngation of infertility in Europe. Ultrasound Obstet Gynecol 4:245–253\n2. Strandell A, Bourne T, Bergh C, Granberg S, Thorburn J, Hamberger L\n(2000) A simplified ultrasound based infertility investigation protocol\n0\n2\n4\n6\n8\n10\nVAS US VAS HyFoSY\nuVue\n0\n2\n4\n6\n8\n10\nVAS US VAS HyFoSY\nFOLEY\nFig. 2 Pain related to the\nHyFoSy procedure; for each\npatient, the reported pain during\nultrasound examination (V AS\nUS)\nand during the HyFoSy procedure\n(V AS\nHyFoSy) is presented\nGynecol Surg (2015) 12:41–44 43\n\nand its implications for patient management. J Assist Reprod Genet 17:\n87–92\n3. Lim CP , Hasafa Z, Bhattacharya S, Maheshwari A (2011) Should a\nhysterosalpingogram be a first-line investigation to diagnose female tubal\nsubfertility in the modern subfertility workup? Hum Reprod 26:967–971\n4. Exalto N, Stappers C, van Raamsdonk LA, Emanuel MH (2007) Gel\ninstillation sonohysterography: first experience with a new technique.\nFertil Steril 87:152–155\n5. Emanuel MH, Exalto N (2011) Hysterosalpingo-foam sonography\n(HyFoSy): a new technique to visualize tubal patency. Ultrasound\nObstet Gynecol 37:497–499\n6. Emanuel MH, van Vliet M, Weber M, Exalto N (2012) First experi-\nences with hysterosalpingo-foam sonography (HyFoSy) for office\ntubal patency testing. Hum Reprod 27:114–117\n7. V an Schoubroeck D, V an den Bosch T, Meuleman C, Tomassetti\nC, D ’Hooghe T, Timmerman D (2013) The use of a new gel foam\nfor the evaluation of tubal patency. Gynecol Obstet Investig 75:\n152–156\n8. V an Schoubroeck D, V an den Bosch T, Ameye L, Boes AS, D’Hooghe\nT, Timmerman D (2014) Pain during Fallopian tube patency testing by\nhysterosalpingo-foam-sonogra phy (HyFoSy). Ultrasound Obstet\nGynecol. doi:10.1002/uog.14646\n44 Gynecol Surg (2015) 12:41–44","source_license":"CC0","license_restricted":false}