Intrauterine fluid instillation to confirm tubal occlusion after transcervical permanent contraception: A pilot study.

OBJECTIVES: To determine if women with tubal patency experience more fluid loss compared to those with bilateral tubal occlusion following intrauterine instillation of fluid via a balloon catheter. STUDY DESIGN: In this prospective cohort pilot study, we enrolled women with prior Essure® procedures and healthy controls from September 2016 to July 2017. We excluded women using an implant or intrauterine device, or with a prior cesarean delivery or permanent contraception procedures other than Essure®. An infusion pump delivered saline via balloon catheter under continuous pressure monitoring. After one minute, we withdrew the fluid and recorded volumes in and out. Subjects then underwent hysterosalpingogram for evaluation of tubal patency. We conducted crude analyses with t-tests and sensitivity analyses. RESULTS: We recruited 23 participants; ten provided analyzable data in each group. Hysterosalpingogram confirmed patency in all control and occlusion in all post-Essure® subjects in the analysis group. We found the median volume of saline lost among control subjects [7.8 mL (7.4, 8.4)] larger than post-Essure® participants [2.2 mL (2.0, 3.8), p < 0.01]. While 50% of control subjects tolerated the full 10 mL of fluid instillation, none of the post-Essure® subjects tolerated this volume (p = 0.03). A combination of saline loss ≤4 mL and participant intolerance of the full 10 mL volume yielded sensitivity of 0.80 (95% CI: 0.57, 1.00) and specificity of 1.00 for bilateral tubal occlusion. CONCLUSION: Instillation of a fixed volume into the uterus may discriminate between women with tubal patency and occlusion following permanent contraception procedures with high specificity and adequate sensitivity. These findings should be validated in larger, more diverse study populations. IMPLICATIONS: Confirmation of tubal occlusion following permanent contraception with an office-based approach could improve acceptability of transcervical approaches. The recent removal of Essure® from the U.S. market increases the need for novel transcervical procedures and occlusion verification methods.

Comparing 3-Dimensional Ultrasound to 3-Dimensional Magnetic Resonance Imaging in the Detection of Levator Ani Defects.

OBJECTIVE: The aim of this study was to compare the detection of levator ani defects (LAD) between 3-dimensional (3D) ultrasound (US) and 3D magnetic resonance imaging (MRI). METHODS: This is a secondary analysis of the Pelvic Floor Nerve Injury Following Childbirth Study. Nulliparous women underwent a standardized protocol of pelvic floor evaluations between January 2008 and December 2013, prior to pregnancy (V1) and at 2 points postpartum: 6 weeks (V2) and 6 months (V3). Those women who underwent a high-resolution 3D MRI pelvic floor sequence were selected. Comparisons were made to concomitantly acquired 3D perineal US. Eight tomographic slices were examined in the axial plane, each side independently scored with 0 (no defect) or 1 (defect). A similar tomographic approach was applied to the MRI. For both MRI and US, the right and left sides were each scored. A total score of 0 to 8 was given to each side. A dichotomous variable "complete LAD" was defined. Cohen κ was used as a measurement of agreement of complete LAD between MRI and US. Kendall τ b was used to correlate total scores. RESULTS: On the right side, 80 (90%) of 89 pairs were in agreement (concordant in the diagnosis or not of a "defect"). On the left side, 72 (81%) of 89 pairs were in agreement. Correlations (Cohen κ) of complete LAD were 0.65 (P < 0.001) on the right and 0.37 (P < 0.001) on the left. Correlations of total scores were 0.47 (P < 0.001) on the right and 0.41 (P < 0.001) on the left. CONCLUSIONS: Moderate agreement was found between 3D US and 3D MRI LAD detection. More LADs and discordance were seen on the left.

Pressure dynamics in the non-gravid uterus: intrauterine pressure cannot confirm tubal occlusion after non-surgical permanent contraception.

OBJECTIVE: The objective was to determine if intrauterine pressure can distinguish bilateral tubal occlusion (BTO) from unilateral or bilateral tubal patency (TP) in women following a permanent contraception procedure. STUDY DESIGN: We used a small inline pressure sensor to continuously monitor intrauterine pressure during hysterosalpingogram (HSG) in a cross-sectional study that enrolled women having HSGs for any indication. The primary outcome was the peak intrauterine pressure compared between women with BTO and TP as verified by HSG. RESULTS: We enrolled 150 subjects, of which 111 (74.0%) provided usable pressure readings. Of these, 98/111 (88.3%) had TP, and 13 (11.7%) had BTO. There was no difference in peak intrauterine pressure for subjects with TP (mean 293.8±58.7 mmHg) compared to those with BTO (292.7±71.3 mmHg, p=.95). Among parous women, peak intrauterine pressure in subjects with BTO (311.9±78.0 mmHg) was higher but not significantly different from subjects with TP (282.7±49.2 mmHg, p=.20). In linear regression analysis, peak intrauterine pressure was not associated with age, body mass index, gravidity or having at least one prior live birth. CONCLUSIONS: Measurement of peak intrauterine pressure does not distinguish between women with patent and blocked fallopian tubes. This approach would not be clinically useful to verify occlusion following permanent contraception. IMPLICATIONS: Peak intrauterine pressure does not differ between women with patent and occluded fallopian tubes and cannot be used to confirm tubal occlusion after nonsurgical permanent contraception.

Tubal patency during the menstrual cycle and during treatment with hormonal contraceptives: a pilot study in women.

Background Hysterosalpingram (HSG) evaluation of tubal patency is typically performed in the follicular phase, but data to support this timing are lacking. Purpose To determine whether menstrual cycle phase or hormonal treatments affect observation of tubal patency during HSG. Material and Methods Ten participants underwent repeated HSG examinations: during the follicular and luteal phase of a natural menstrual cycle; 30 days following continuous administration of a combined oral contraceptive (COC); and 30 days after an intramuscular injection of depo medroxyprogesterone (DMPA) acetate. Participants with tubal blockade following DMPA had a fifth HSG 30 days following a second course of COCs. The primary outcome was tubal patency. Results All 10 participants demonstrated bilateral tubal patency (BTP) on at least one HSG examination during the study. One participant showed bilateral functional occlusion (FO) during the follicular phase examination, but BTP with the luteal phase, COC cycle, and DMPA exams. One participant with BTP discontinued participation and nine completed the COC HSG exam with BTP in seven, and one each with bilateral or unilateral FO. Seven participants completed the DMPA HSG with BTP in six and unilateral FO in one; BTP was seen in the final HSG after restarting the COC. Conclusion This pilot study supports the luteal phase of natural cycles as the optimum time for evaluation of tubal patency. The occurrence of functional occlusion of the fallopian tube on HSG examination performed during the follicular phase and following contraceptive steroid treatment supports a role of hormonal action on the utero-tubal junction.

The history and current status of fallopian tube pressures - developing alternate methods for confirmation of tubal occlusion.

Permanent contraception with hysteroscopic tubal ligation is an increasingly popular choice for women around the world. However, inconveniences associated with the required confirmation test for tubal occlusion can be prohibitive. As new methods of permanent contraception are being investigated, ways of making all aspects of the procedure more accessible and comfortable for women should be considered. Means of examining tubal patency in the infertility population, such as tubal perfusion pressures measured at the time of hysterosalpingogram (HSG), provide inspiration for alternative methods of tubal occlusion confirmation after contraception. Evaluation of intrauterine pressures measured by a manometer attached to an intrauterine balloon catheter could serve as a preliminary tool for verification of tubal occlusion; higher pressures would indicate tubal occlusion and lower pressures would indicate the need for confirmatory HSG. The development and validation of this technique is ongoing and could reduce overall costs and patient burdens associated with the current tubal occlusion confirmation procedure.

Pelvic floor levator hiatus measurements: MRI versus ultrasound.

OBJECTIVE: The objective of this study is to compare levator hiatus measurements between pelvic magnetic resonance imaging (MRI) and pelvic ultrasound (US) imaging modalities. METHODS: We performed pelvic MRI and 3-dimensional US in 37 asymptomatic nulliparous women. For the MRI protocols, we performed axial and sagittal sequences at rest. We then obtained sagittal sequences during Kegel squeeze and Valsalva maneuvers. Blinded to the findings of the MRI, we obtained 3-dimensional pelvic US images using a perineal approach at rest, Kegel and Valsalva maneuvers. Finally, we measured the levator hiatus in both sagittal and axial planes. RESULTS: For the resting sagittal measurements, the mean levator hiatus measurement using MRI (5.0 cm; SD, 0.8) is significantly greater than that using US (4.4 cm; SD, 0.6; P < 0.05). Although the absolute mean levator measurements between the 2 modalities are significantly different, this difference is not influenced by the magnitude of the measurements as noted in Bland-Altman plots of the limits of agreement. CONCLUSIONS: We found that the MRI measurements obtained from the sagittal images were consistently greater than the corresponding US images. In contrast, there was not the same consistency of difference between MRI and US for the axial images. This suggests possible variation in acquisition planes for axial images or interpretation of landmarks for the sagittal images.

Fallopian tube catheterization.

Fallopian tube catheterization is used for treatment of infertility caused by proximal tubal occlusion, and has replaced surgical treatment for this condition. More recently, fallopian tube catheterization has been used for tubal sterilization. Interventional radiologists tested numerous methods for tubal occlusion using the rabbit as an animal model. As a result, a tubal device has recently been Food and Drug Administration approved for permanent sterilization using hysteroscopic guidance; it can also be placed fluoroscopically by fallopian tube catheterization as an "off-label" procedure. This is a 5-year continuation and update on a procedure that has been done by interventional radiologists for 25 years; history of the development of fallopian tube catheterization in women has been published in detail in this journal. Highlighted in this article will be description of the basic components needed for fallopian tube catheterization.

Measuring the levator hiatus with axial MRI sequences: adjusting the angle of acquisition.

AIMS: We aimed to compare MRI measurements of the female levator hiatus and the most caudal "levator ani" muscles between image slices in a plane axial to the body (AxB) and an axial plane parallel to the direction of the puborectalis muscle (AxPRM). METHODS: We performed high-resolution, T2-weighted axial magnetic resonance imaging (in two different planes) on 20 sequentially recruited asymptomatic nulliparous women. Levator hiatus measurements were compared between the two planes. RESULTS: The mean tilt angle of the AxPRM slices relative to the AxB slices was 18.9° (SD 8.5) and the area of the levator hiatus was 10% greater (P=0.04) in the AxPRM plane. CONCLUSIONS: By rotating the acquisition plane to be parallel to the puborectalis muscle (sometimes called the plane of minimal hiatal dimensions), some of the measurements of the distal and medial pelvic floor muscles (and the hiatus defined by them) are altered. This issue is important because both MRI and 3D ultrasound are increasingly being used to evaluate the pelvic floor hiatus, and its relationship to childbirth injury and pelvic floor disorders. To make meaningful comparisons, it is important that both modalities are measuring the same thing.

Reference lines in dynamic magnetic resonance imaging of the pelvic floor.

OBJECTIVE: : To compare the variability in two commonly used reference lines in pelvic magnetic resonance imaging (MRI), the pubococcygeal line (PCL) and the sacrococcygeal to inferior pubis (SCIPP) line, with respect to their distance from pelvic floor points of interest. METHODS: : We obtained pelvic MR images of 20 asymptomatic nulliparous women who are part of an ongoing pelvic floor nerve injury postpartum study. The subjects underwent a high-resolution two-dimensional, T2-weighted sagittal pelvic MRI in the supine position using a GE Signa scanner with a body phased-array coil. We also obtained dynamic T2-weighted sagittal MR images in supine position during Kegel and Valsalva maneuvers. Using the midsagittal image, we measured the length of two reference lines: the PCL and the more cephalad SCIPP line. From each line, we then measured the perpendicular distance to the bladder neck and to the posterior margin of the anorectal angle (M-line). We compared the mean values of all measurements between the two reference lines with paired Student t tests. RESULT: : The SCIPP line (mean [SD], 11.60 [0.91] cm) is longer than the PCL (mean [SD], 10.54 [0.85] cm) at rest (P < 0.001). There is no significant change in length from resting to Kegel maneuver or from resting to Valsalva maneuver in either reference line. Only the resting to Valsalva maneuver for the M-line was significantly different between the 2 reference lines (P = 0.02). The resting to Kegel for the perpendicular distance to the bladder neck and the M-line was not significantly different between the two lines. CONCLUSIONS: : Both reference lines remain stable during pelvic floor maneuvers.

Fallopian tube catheterization.

The delicate fallopian tube is the anatomic pathway to human reproduction. Simple, inexpensive tools and techniques allow radiologists to access this structure for promoting, and preventing pregnancy. Results from centers worldwide have shown that catheter recanalization is possible in ~90% of women with proximal tubal occlusion using basic angiographic techniques familiar to all interventional radiologists. The American Society for Reproductive Medicine has recommended that patients in whom the hysterosalpingogram (HSG) demonstrates proximal tubal occlusion undergo fallopian tube catheterization with selective salpingography prior to more invasive and more costly infertility treatments. The pregnancy rate following fallopian tube recanalization is as high as 60% when the unblocked tubes are found to be normal and there is no history of tubal disease. In a population where the cause of infertility is less well-defined, tubal catheterization may not only help women conceive, but may also help to better define the underlying tubal abnormality. In the prevention of unwanted pregnancy, numerous materials and devices have been tested for blocking fallopian tubes. The ESSURE coil (Conceptus, Inc., Mountain View, CA) was FDA approved in 2002 for tubal sterilization by hysteroscopic placement. In some locales, radiologists are being asked to assist with this procedure or to place the coils fluoroscopically through fallopian tube catheterization.

Imaging of female infertility.

Normal reproduction requires healthy female anatomy. Cervical, uterine, tubal, ovarian, and peritoneal factors can coexist and cause female infertility. Ultrasound, hysterosalpingography, MR imaging, and fallopian tube catheterization are the radiologists' armamentarium for diagnosis. This article illustrates important findings in the infertile woman. An understanding of these entities helps i n accurateand sympathetic treatment.