Levator ani muscle volume and architecture in normal vs. muscle damage patients using 3D endovaginal ultrasound: a pilot study.

INTRODUCTION AND HYPOTHESIS: This study aimed to compare the difference in levator ani muscle (LAM) volumes between 'normal' and those with sonographically visualized LAM defects. We hypothesized that the 'muscle damage' group would have a significantly lower muscle volume. METHODS: The study included patients who had undergone a 3D endovaginal ultrasound. The normal (NM) and damage (DM) muscle groups' architectural changes were evaluated based on anterior-posterior (AP), left-right (LR) diameter, and minimal levator hiatus (MLH) area. The puboanalis-puboperinealis (PA), puborectalis (PR), and pubococcygeus-iliococcygeus (PC) were manually segmented using 2.5 vs. 1.0 mm to find the optimal sequence and to compare the volumes between NM and DM groups. POPQs were compared between the NM and DM groups. RESULTS: The 1.0-mm segmentation volumes created superior volume analysis. Comparing NM to the DM group showed no significant difference in LAM volume. Respectively, the mean total LAM volumes were 17.27 cm3 (SD = 3.97) and 17.04 cm3 (SD = 4.32), p = 0.79. The mean MLH measurements for both groups respectively were 10.06 cm2 (SD = 2.93) and 12.18 cm2 (SD = 2.93), indicating a significant difference (p = 0.01). POPQ analysis demonstrated statistically significant differences at Ba and Bp parameters suggesting that the DM group had worse prolapse (p = 0.05, 0.01, respectively). CONCLUSIONS: While LAM volumes are similar, there is a significant difference in the physical architecture of the LAM and the POPQ parameters in muscle-damaged patients compared to the normal group.

The Correlation Between the Sonographic Course of Transobturator Slings and Sling-Related Pain.

OBJECTIVES: To determine whether transobturator slings follow a consistent path and whether there is an association between ultrasonographically visualized sling pattern or position with sling-related pain. METHODS: This was a cross-sectional retrospective pilot study. We evaluated women who were presented to our clinic for pain or other urogynecologic symptoms following transobturator sling placement between 2009 and 2014. Patients had undergone a 3-dimensional endovaginal pelvic floor ultrasound, assessing minimal levator hiatus, antero-posterior diameter, left-right diameter, and the hiatal shape. The mesh patterns were categorized as seagull patterns (normal), lopsided, flat, and convoluted. RESULTS: A total of 68 cases were reviewed. Fifty patients reported pain, and 18 did not. There were wide variations in the course of the slings. The sling center- minimal levator hiatus position ranged 14.8 mm below and 17.9 mm above the minimal levator hiatus. The lateral arm insertion points ranged between 17.1 mm below and 16.6 mm above the minimal levator hiatus. The right arm insertion points ranged between 9.6 mm below and 18.8 mm above the minimal levator hiatus. Thirty-five of 68 (70%) patients with pain and 13 of 18 (72.2%) without had abnormal sling patterns. The abnormal sling shape was not correlated with pain (P = 1). The levator shape trended toward a statistical significant correlation with sling shape abnormality (P = .084). CONCLUSIONS: This population of women with transobturator sling complications demonstrated wide variations in anatomic paths. Neither the abnormal sling shape nor the distance of the center of the tape from the minimal levator hiatus level were correlated with pain.

Does aging affect the elastic properties of the bladder and the urethra in nulliparous women: An ultrasound shear-wave elastography study.

OBJECTIVE: To investigate how aging and menopausal status in absence of pregnancy and childbirth affect the elasticity of the bladder and urethra. STUDY DESIGN: A single-center prospective observational study including nulliparous 10 pre- and 12 postmenopausal women. Data collection included baseline characteristics, physical examination data, questionnaire scores, PDFI and the Pelvic Floor Impact Questionnaire, and pelvic floor sonographic measurements as well as elastography measurements. The shear wave elastography (SWE) of tissue was measured using Kilopascal (kPa). The elastography measurements were taken over the rhabdosphincter, the suburethra smooth muscle, and the trigonal areas. RESULTS: A total of 22 nulliparous subjects were enrolled in the study. The cohort's mean age was 43.5 years, the mean body mass index (BMI) was 26.8, and 86% were of Caucasian ethnicity. The postmenopausal group was older and with higher BMI (p < 0.001 and p = 0.05). They also had higher scores in all the questionnaires (p < 0.05 for all) and did not demonstrate prolapse in any compartments. The SWE results for the whole group were 35.2 kPa in the rhabdosphincter measuring point, 40.2 kPa in the sub-urethra point, and 20.6 kPa in the trigone point. Comparing the premenopause and postmenopause groups, we found lower measurements in the rhabdosphincter area and equivocal measurements for the suburethral zone. No statistically significant differences were found between the groups CONCLUSIONS: The elastic properties of the different bladder components and the urethra change with age and menopause. Using elastic properties of the tissues, we can further explore both stress urinary incontinence and overactive bladder.

Correlation between pelvic floor ultrasound parameters and vaginal pressures in nulliparous women: a subanalysis of the SUM-AN study.

INTRODUCTION AND HYPOTHESIS: Pelvic floor ultrasound is used as a validated technique for measuring levator ani dimensions. Vaginal manometry has been used in the past as a method to assess levator ani muscle (LAM) strength. Whether the combination of both methods can contribute to our understanding of pelvic floor pathophysiology has not yet been described. We hypothesized that as female pelvic floor muscular hiatus increases, the vaginal pressure and strength decrease. METHODS: We recruited 20 asymptomatic nulliparous women ages 18-85 years. Minimal levator hiatus (MLH) area, anteroposterior/left-right (AP/LR) diameter ratio, the distance between levator plate and the pubic symphysis (LP-PS) while at rest and squeeze were measured using endovaginal ultrasound (US). Vaginal pressure at rest, squeeze (Kegel) and Valsalva were measured using 3D manometry. Logistic and linear regression analysis was performed to assess correlations. RESULTS: MLH area was negatively correlated with the sum of all the squeeze pressures produced on the four walls of the vagina (p = 0.049, R2 = 0.197). There was also a borderline negative correlation between MLH and the sum of rest pressures (p = 0.09, R2 = 0.15). AP/LR ratio was negatively correlated with the sum of squeeze pressures (p = 0.056, R2 = 0.197). LP-PS distances, both while at rest and during squeeze, were negatively correlated with the vaginal squeeze pressure (p = 0.046, R2 = 0.21; p = 0.011, R2 = 0.31, respectively). LP-V distance, both at rest and during squeeze, was negatively correlated with the sum of squeeze pressures on four vaginal walls (p = 0.02, R2 = 0.25; p = 0.005, R2 = 0.36, respectively). CONCLUSIONS: Stronger levator ani muscles, smaller MLH area and a more oval shape of pelvic floor hiatus as assessed by pelvic floor ultrasound are associated with higher squeeze vaginal pressures as assessed by 3D manometry.

The Fresh Frozen Cadaveric Study of Direct Pouch of Douglas Laparoscopic and Robotic Trocar Insertion for Vaginal Natural Orifice Transluminal Endoscopic Surgery.

STUDY OBJECTIVE: To determine the distances and angles that assure a safe entry into the pouch of Douglas (POD) during blind laparoscopic and robotic trocar entry. DESIGN: Trocars were inserted into the POD of 4 intact fresh frozen female pelves. Cadaveric dissection was performed, and the distance from the POD to the sacrum at rest and with maximal pressure to POD with the trocar was measured. In addition, the optimal angle for trocar insertion and entry was evaluated. SETTING: Inova Advanced Simulation and Technology Evaluation Center. PATIENTS: Fresh frozen cadavers with intact reproductive organs. INTERVENTIONS: Vaginal POD trocar insertion. MEASUREMENTS AND MAIN RESULTS: Measurements were recorded from the sacrum to the POD at rest and from the sacrum to the hymen with trocar pressure. The dissection demonstrated correct trocar placement in the POD of human cadaveric specimens. The mean distances from the sacrum to the hymen, the sacrum to the POD, and the sacrum to the POD with pressure were 18.75 cm, 9.75 cm, and 7.25 cm, respectively. After the deployment of the trocar, the tip was observed to be 2 cm below the cervix in the POD. The mean trocar angle to clear the sacral promontory and the neurovascular structures without injury to the uterus was 25° to 40° from the horizontal plane and 15° to 30° from the coronal plane. CONCLUSION: A direct trocar entry into the POD has been found to be feasible in fresh frozen cadaveric specimens. This study provided valuable information for the angle of entry into the POD to facilitate vaginal and robotic trocar entry for minimally invasive gynecologic procedures.

Ultrasongraphic age-related changes of the pelvic floor muscles in nulliparous women and their association with pelvic floor symptoms: A pilot study.

OBJECTIVE: To assess age-related changes in the pelvic floor muscular hiatus and their association with symptoms of pelvic organ prolapse, urinary and fecal incontinence, and sexual function. METHODS: In this pilot study we performed 3D endovaginal ultrasonography in two age groups of nulliparous women: 18 to 40 years and 52 to 85 years. Anterior-posterior (AP) diameter, left-right (LR) diameter, and the Minimal Levator Hiatus area were measured. The AP/LR ratio was calculated to compare the shape of the pelvic floor muscles between participants (oval vs circular). Other measurements included length of the urethra, and levator plate lift. Participants were assessed for (1) distress symptoms of pelvic floor prolapse, urinary, and fecal symptoms by the Pelvic Floor Distress Inventory-20, (2) quality of life via the pelvic floor impact inventory-7, and (3) sexual function by the female sexual function inventory (FSFI-19). RESULTS: A total of 12 women into the younger group and 10 to the older group were recruited. Older women had higher AP/LR ratio and longer distance levator plate lift while performing the squeeze maneuver ( P = 0.017 and 0.038, respectively). Older women had worse urinary and pelvic organ prolapse symptoms ( P = 0.002 and 0.004, respectively). Fewer women in the older group were sexually active (60% vs 92%) and their quality of sexual life was lower based on their FSFI-19 results. CONCLUSION: Levator ani muscle hiatus changes to a more oval form in older nulliparous postmenopausal women and this change in shape is associated with increased pelvic floor symptoms.

Twelve years' experience with fascia lata autograft to replace complicated anterior vaginal mesh.

OBJECTIVES: To report 12-year experience with replacing transvaginal mesh (TVM) with fascia lata autograft. METHODS: This was a chart review of TVM removal and replacement with a fascia lata autograft placement by a single surgeon between 2005 and 2017. The Pelvic Organ Prolapse Quantification (POP-Q) system before and 1 year following the procedure, patient-reported recurrence of symptoms, changes in the POP-Q examination and complication rates are analyzed. RESULTS: Twenty-four patients were included. Mean age was 57.2 (95% CI 53.2-61.2) years. Mean number of days to Foley catheter removal was 3.2 days (95% CI 1.6-4.9) and mean number of days to drain removal was 10.9 days (95% CI 9.9-12.0). Following the surgery, no leg seroma, infection or numbness was reported. UTI occurred in four (16.7%) of the participants postoperatively. At 3-month follow-up, mild urinary symptoms were reported in five participants (20.8%). At 1-year follow-up, one participant was symptomatic of pelvic organ prolapse. Paired t-test analysis revealed statistically significant retraction of Aa and Ba vaginal points (p < 0.001). C, GH and PB points were also statistically significantly retracted. CONCLUSION: Fascia lata autograft for anterior compartment reconstruction due to TVM complications is associated with high safety and efficacy rates.

Methotrexate success rates in progressing ectopic pregnancies: a reappraisal.

OBJECTIVE: The purpose of this study was to determine the success rates of methotrexate in progressing ectopic pregnancies and to correlate them with beta-human chorionic gonadotropin (ß-hCG) levels. STUDY DESIGN: This retrospective cohort study that was carried out in a tertiary university-affiliated medical center included women who had been diagnosed with ectopic pregnancies between January 2001 and June 2013. Daily ß-hCG follow-up examinations were performed to determine the progression of the ectopic pregnancy. Women with hemodynamically stable progressing ectopic pregnancies received methotrexate (50 mg/m(2) of body surface). We measured the success and failure rates for methotrexate treatment in correlation to ß-hCG level. RESULTS: One thousand eighty-three women were candidates for "watchful waiting" (ß-hCG follow up). Spontaneous resolution and decline of ß-hCG levels occurred in 674 patients (39.5%); 409 women (24.0%) had stable or increasing ß-hCG levels and were treated with methotrexate. In 356 women (87.0%), the treatment was successful; 53 women (13.0%) required laparoscopic salpingectomy. Compared with prompt administration of methotrexate, our protocol resulted in lower overall success rates for all levels of ß-hCG in women with progressing ectopic pregnancies: 75% in women with ß-hCG levels of 2500-3500 mIU/mL, and 65% in women with ß-hCG levels >4500 mIU/mL. A mathematic model was found describing the failure rates for methotrexate in correlation with ß-hCG levels. CONCLUSION: The success rates for methotrexate treatment in progressing ectopic pregnancies after daily follow-up evaluation of ß-hCG levels are lower than previously reported. This reflects redundant administration of methotrexate in cases in which the ectopic pregnancy eventually will resolve spontaneously.

[Anti mullerian hormone (AMH)--is it a new reliable marker of the ovarian reserve? Its role in predicting the ovarian response in assisted reproductive technology (ART)].

Anti-Müllerian hormone (AMH) is predominantly known for its important role in the differentiation of the male and female sexual system during the early embryonic period. Recently, many animal and human researches have been studying the role of the AMH in the postnatal ovarian function. In the female, AMH is produced by the granulosa cells of early developing follicles. It plays a major role in the folliculogenesis and seems to be able to inhibit the initiation of the growth of primordial follicles and FSH-induced follicles. As AMH is expressed throughout the folliculogenesis, from the primary follicular stage to the antral stage, the serum levels of AMH may represent both the quantity and the quality of ovarian follicles. Thus, the AMH levels may be useful as a new potential marker of the ovarian reserve. As compared to other ovarian reserve tests, the AMH has unique characteristics which make it a favorable marker. The measurement of AMH levels may be useful in the prediction of poor response and cycle cancellation as well as hyper-response and the ovarian hyperstimulation syndrome in assisted reproductive technology (ART). We assume that the measurement of AMH Levels may play a role in the individualization of treatment strategies among patients who are treated by ART. However, the AMH cannot predict the qualitative ovarian response in ART. In men, the AMH was not found to have satisfactory clinical utility as a single marker of spermatogenesis.

Vaginal ultrasound-guided Pouch of Douglas robotic entry in a live ovine model and human female cadaveric specimens.

We aimed to determine whether intraoperative ultrasound is a feasible tool for visualization of the pouch of Douglas (POD) to facilitate a safe vaginal entry for direct robotic vaginal trocar insertion for pelvic floor surgery. Endovaginal ultrasound-guided needle insertion of a trocar into the POD was performed in six fresh frozen female cadavers and a live sheep animal model. Using an endovaginal probe the POD was identified as a fluid-filled space clear of bowel or adhesions, then a Veress needle was also used to confirm POD localization. Access to the POD was achieved using a robotic trocar designed for this purpose. The animal study was approved by the Ethics Committee of Asaf-Harofe hospital. Direct visualization during laparoscopy in cadavers and open cadaveric dissections confirmed safe POD entry and accurate trocar placement. This method was found feasible in the development of a safe vaginal entry in both the animal and cadaveric model, possibly negating the need for laparoscopic umbilical observation.

Evaluation of the American College of Surgeons National Surgical Quality Improvement Program Risk Calculator to predict outcomes after hysterectomies.

OBJECTIVE: To evaluate the American College of Surgeons (ACS) surgical risk calculator's reliability in predicting outcomes in hysterectomies. METHODS: This is a prospective cohort study at a large community-based hospital. Twenty-one preoperative and postoperative criteria were abstracted from the electronic medical record and entered into the online ACS calculator to determine a risk score. Logistical regression was used to determine the association between risk score and actual outcome. The prediction capability was analyzed with c-statistic, Hosmer-Lemeshow, and Brier score. RESULTS: A total of 634 hysterectomies were performed during the study period from January to April 2019. Patients were predominantly 55 years old, white (53%) and overweight (body mass index 30). Predicted perioperative adverse events were significantly higher than actual adverse events across all domains. In all, 54/634 (8.5%) patients experienced postoperative urinary tract infection. C-statistics for return to operating room, renal failure, and readmission were 0.607 (95% C Statistic index [CI] 0.370-0.845), 0.882 (95% CI 0.802-0.962), 0.637 (95% CI 0.524-0.750), respectively. Brier scores approached one in all categorical domains. CONCLUSION: The ACS surgical risk calculator holds the promise of predicting postoperative complications or length of stay for patients undergoing hysterectomy. Further adjustment to this tool is required before it can be advocated for use in the clinical setting.

Clinical Consensus Statement: Vaginal Energy-Based Devices.

ABSTRACT: This clinical consensus statement on vaginal energy-based devices (EBDs) reflects an update by content experts from the American Urogynecologic Society's EBD writing group. In 2019, the American Urogynecologic Society's EBD writing group used a modified Delphi process to assess statements that were evaluated for consensus after a structured literature search. A total of 40 statements were assessed and divided into 5 categories: (1) patient criteria, (2) health care provider criteria, (3) efficacy, (4) safety, and (5) treatment considerations. Of the 40 statements that were assessed, 28 reached consensus and the remaining 12 did not. Lack of evidence was among the main reasons that vulvovaginal EBD treatment statements did not reach consensus. In March 2022, these statements were reassessed using the interim literature.

Vaginal Energy-Based Devices.

This clinical consensus statement on vaginal energy-based devices (EBDs) reflects statements drafted by content experts from the American Urogynecologic Society's EBD writing group. The American Urogynecologic Society's EBD writing group used a modified Delphi process to assess statements that were evaluated for consensus after a structured literature search. A total of 40 statements were assessed and divided into 5 categories: (1) patient criteria, (2) health care provider criteria, (3) efficacy, (4) safety, and (5) treatment considerations. Of the 40 statements that were assessed, 28 reached consensus and the remaining 12 did not. Lack of evidence was among the main reasons that vulvovaginal EBD treatment statements did not reach consensus.

Haptoglobin genotype and endothelial function in diabetes mellitus: a pilot study.

Endothelial function (EnF) is impaired in patients with diabetes mellitus (DM) due in large part to an increase in oxidative stress. Haptoglobin (Hp) is a potent antioxidant protein which is encoded by two different alleles (1 and 2) with the Hp 1 protein being a superior antioxidant to the Hp 2 protein. We hypothesized that DM individuals with the Hp 2-2 genotype would have greater endothelial dysfunction as compared to DM individuals with the Hp 1-1 genotype. We studied EnF in 16 Hp 2-2, 14 Hp 1-1 DM individuals and 14 healthy subjects. DM patients' groups were matched in terms of age, cardiovascular risk factors and metabolic characteristics. EnF was assessed using post-ischemic reactive hyperemia and strain gauge plethysmography and expressed either as the maximal flow after the ischemic period or as the area under the flow-time curve (AUC). We showed that EnF indices, AUC and maximal flow, were also higher in the healthy and Hp 1-1 groups compared with Hp 2-2 genotype group (615 +/- 60 and 600 +/- 40 vs. 450 +/- 50 ml dl(-1), 29 +/- 2.6 and 25 +/- 3 vs. 14 +/- 1.8 ml min(-1) dl(-1), P < 0.003 and P < 0.05, for AUC and maximal flow, one-way ANOVA, respectively). We concluded that Hp 2-2 diabetic patients had a worse EnF than controls and Hp 1-1 diabetic subjects.

M3VR-A multi-stage, multi-resolution, and multi-volumes-of-interest volume registration method applied to 3D endovaginal ultrasound.

Heterogeneity of echo-texture and lack of sharply delineated tissue boundaries in diagnostic ultrasound images make three-dimensional (3D) registration challenging, especially when the volumes to be registered are considerably different due to local changes. We implemented a novel computational method that optimally registers volumetric ultrasound image data containing significant and local anatomical differences. It is A Multi-stage, Multi-resolution, and Multi-volumes-of-interest Volume Registration Method. A single region registration is optimized first for a close initial alignment to avoid convergence to a locally optimal solution. Multiple sub-volumes of interest can then be selected as target alignment regions to achieve confident consistency across the volume. Finally, a multi-resolution rigid registration is performed on these sub-volumes associated with different weights in the cost function. We applied the method on 3D endovaginal ultrasound image data acquired from patients during biopsy procedure of the pelvic floor muscle. Systematic assessment of our proposed method through cross validation demonstrated its accuracy and robustness. The algorithm can also be applied on medical imaging data of other modalities for which the traditional rigid registration methods would fail.

Six-Year Experience in Teaching Pelvic Floor Ultrasonography Using Pelvic Floor Phantoms.

OBJECTIVE: To review our 6-year experience (2009-2015) in teaching three-dimensional pelvic floor ultrasonography workshops that utilized pelvic floor phantoms in the setting of an Objective Structured Assessment of Technical Skills methodology. METHODS: Four-hour Objective Structured Assessment of Technical Skills workshops were given at several society meetings and involved a didactic session, a hands-on session using the pelvic floor phantoms, and a computer station session reviewing pelvic floor pathologies. We analyzed improvement in participants' diagnostic skills using a test with 60 illustrated questions of normal and pathologic findings in live human models. RESULTS: Two hundred forty-three attendees completed the 60-question test before and after attending the workshop. Paired t test showed a significant improvement in attendees' average scores after the workshop in all categories: anatomy, normal, or pathologic endovaginal imaging and normal or pathologic endoanal imaging (P<.001 for all). McNemar test showed a statistically significant increased number of correct answers in 50 of 60 (83%) questions. CONCLUSION: Our Objective Structured Assessment of Technical Skills workshops incorporating pelvic floor phantoms enhanced trainees' pelvic floor ultrasound diagnostic skills.

Anti-oxidative treatment with vitamin E improves peripheral vascular function in patients with diabetes mellitus and Haptoglobin 2-2 genotype: A double-blinded cross-over study.

Vascular dysfunction in both conduit arteries and small vessels is a major contributor to the development of cardiovascular disease (CVD) in diabetes mellitus (DM). In diabetes there is a process of systemic chronic inflammation accompanied by high oxidative stress causing a subsequent decrease in vascular reactivity and negatively affect the metabolic processes responsible for functioning of the microvasculature. Vitamin E is classified as an antioxidant due to its ability to scavenge lipid radicals and terminate oxidative chain reactions. We conducted a double-blinded cross-over study with vitamin E versus placebo in individuals with type 2DM and the Hp2-2 genotype and assessed different aspects of peripheral vascular function in these patients. Twenty patients completed the study with 10 individuals in each study cohort. We were able to show significant improvement of indirect indices of vascular function following 8weeks of treatment with vitamin E. This improvement was consistent for weeks even after stopping the vitamin E treatment. We concluded that a pharmacogenomic rationale utilizing the Hp genotype might potentially provide cardiovascular benefit with vitamin E.