Validation of the Simulated Vaginal Hysterectomy Trainer.

STUDY OBJECTIVE: To establish construct validity of the simulated vaginal hysterectomy trainer (SimVaHT). DESIGN: A cross-sectional validation study (Canadian Task Force classification II-2). SETTING: A single academic medical center in the United States. SUBJECTS: Fourteen residents in obstetrics and gynecology (4 postgraduate year [PGY] 1, 4 PGY-2, 3 PGY-3 and 3 PGY-4). PGY-1 and PGY-2 residents were grouped to form the "junior level" cohort, whereas PGY-3 and PGY-4 residents comprised the "senior level" cohort. INTERVENTIONS: Each participant underwent surgical skill simulation by performing a simulated vaginal hysterectomy on a practical, inexpensive vaginal hysterectomy trainer. MEASUREMENTS AND MAIN RESULTS: The primary outcome was resident surgical skill as assessed by the Objective Structured Assessment of Technical Skills Global Rating Scale (GRS). All obstetrics and gynecology residents were videotaped performing a simulated vaginal hysterectomy on the SimVaHT. The tapes were reviewed independently by 2 blinded urogynecology experts, each of whom provided a GRS score. The primary outcome was overall GRS scores. The secondary outcome was time to complete the exercise. GRS scores were compared between junior- and senior-level residents. Senior-level residents scored significantly higher on the GRS overall compared with junior-level residents (p = .008). CONCLUSION: Construct validity was demonstrated for the SimVaHT. The SimVaHT is a practical and inexpensive tool that may improve resident vaginal surgical skills before their first case in the operating room.

Intraoperative cervix location and apical support stiffness in women with and without pelvic organ prolapse.

BACKGROUND: It is unknown how initial cervix location and cervical support resistance to traction, which we term "apical support stiffness," compare in women with different patterns of pelvic organ support. Defining a normal range of apical support stiffness is important to better understand the pathophysiology of apical support loss. OBJECTIVE: The aims of our study were to determine whether: (1) women with normal apical support on clinic Pelvic Organ Prolapse Quantification, but with vaginal wall prolapse (cystocele and/or rectocele), have the same intraoperative cervix location and apical support stiffness as women with normal pelvic support; and (2) all women with apical prolapse have abnormal intraoperative cervix location and apical support stiffness. A third objective was to identify clinical and biomechanical factors independently associated with clinic Pelvic Organ Prolapse Quantification point C. STUDY DESIGN: We conducted an observational study of women with a full spectrum of pelvic organ support scheduled to undergo gynecologic surgery. All women underwent a preoperative clinic examination, including Pelvic Organ Prolapse Quantification. Cervix starting location and the resistance (stiffness) of its supports to being moved steadily in the direction of a traction force that increased from 0-18 N was measured intraoperatively using a computer-controlled servoactuator device. Women were divided into 3 groups for analysis according to their pelvic support as classified using the clinic Pelvic Organ Prolapse Quantification: (1) "normal/normal" was women with normal apical (C < -5 cm) and vaginal (Ba and Bp < 0 cm) support; (2) normal/prolapse had normal apical support (C < -5 cm) but prolapse of the anterior or posterior vaginal walls (Ba and/or Bp ≥ 0 cm); and (3) prolapse/prolapse had both apical and vaginal wall prolapse (C > -5 cm and Ba and/or Bp ≥ 0 cm). Demographics, intraoperative cervix locations, and apical support stiffness values were then compared. Normal range of cervix location during clinic examination and operative testing was defined by the total range of values observed in the normal/normal group. The proportion of women in each group with cervix locations within and outside the normal range was determined. Linear regression was performed to identify variables independently associated with clinic Pelvic Organ Prolapse Quantification point C. RESULTS: In all, 52 women were included: 14 in the normal/normal group, 11 in the normal/prolapse group, and 27 in the prolapse/prolapse group. At 1 N of traction force in the operating room, 50% of women in the normal/prolapse group had cervix locations outside the normal range while 10% had apical support stiffness outside the normal range. Of women in the prolapse/prolapse group, 81% had cervix locations outside the normal range and 8% had apical support stiffness outside the normal range. Similar results for cervix locations were observed at 18 N of traction force; however the proportion of women with apical support stiffness outside the normal range increased to 50% in the normal/prolapse group and 59% in the prolapse/prolapse group. The prolapse/prolapse group had statistically lower apical support stiffness compared to the normal/normal group with increased traction from 1-18 N (0.47 ± 0.18 N/mm vs 0.63 ± 0.20 N/mm, P = .006), but all other comparisons were nonsignificant. After controlling for age, parity, body mass index, and apical support stiffness, cervix location at 1 N traction force remained an independent predictor of clinic Pelvic Organ Prolapse Quantification point C, but only in the prolapse/prolapse group. CONCLUSION: Approximately 50% of women with cystocele and/or rectocele but normal apical support in the clinic had cervix locations outside the normal range under intraoperative traction, while 19% of women with uterine prolapse had normal apical support. Identifying women whose apical support falls outside a defined normal range may be a more accurate way to identify those who truly need a hysterectomy and/or an apical support procedure and to spare those who do not.

In vivo properties of uterine suspensory tissue in pelvic organ prolapse.

The uterine suspensory tissue (UST), which includes the cardinal (CL) and uterosacral ligaments (USL), plays an important role in resisting pelvic organ prolapse (POP). We describe a technique for quantifying the in vivo time-dependent force-displacement behavior of the UST, demonstrate its feasibility, compare data from POP patients to normal subjects previously reported, and use the results to identify the properties of the CL and USL via biomechanical modeling. Fourteen women with prolapse, without prior surgeries, who were scheduled for surgery, were selected from an ongoing study on POP. We developed a computer-controlled linear servo actuator, which applied a continuous force and simultaneously recorded cervical displacement. Immediately prior to surgery, the apparatus was used to apply three "ramp and hold" trials. After a 1.1 N preload was applied to remove slack in the UST, a ramp rate of 4 mm/s was used up to a maximum force of 17.8 N. Each trial was analyzed and compared with the tissue stiffness and energy absorbed during the ramp phase and normalized final force during the hold phase. A simplified four-cable model was used to analyze the material behavior of each ligament. The mean ± SD stiffnesses of the UST were 0.49 ± 0.13, 0.61 ± 0.22, and 0.59 ± 0.2 N/mm from trial 1 to 3, with the latter two values differing significantly from the first. The energy absorbed significantly decreased from trial 1 (0.27 ± 0.07) to 2 (0.23 ± 0.08) and 3 (0.22 ± 0.08 J) but not from trial 2 to 3. The normalized final relaxation force increased significantly with trial 1. Modeling results for trial 1 showed that the stiffnesses of CL and USL were 0.20 ± 0.06 and 0.12 ± 0.04 N/mm, respectively. Under the maximum load applied in this study, the strain in the CL and USL approached about 100%. In the relaxation phase, the peak force decreased by 44 ± 4% after 60 s. A servo actuator apparatus and intraoperative testing strategy proved successful in obtaining in vivo time-dependent material properties data in representative sample of POP. The UST exhibited visco-hyperelastic behavior. Unlike a knee ligament, the length of UST could stretch to twice their initial length under the maximum force applied in this study.

Post-reduction stress urinary incontinence rates in posterior versus anterior pelvic organ prolapse: a secondary analysis.

INTRODUCTION/HYPOTHESIS: Stress incontinence with vaginal prolapse reduction is less common in women with posterior-predominant prolapse (rectocele) compared with those with anterior-predominant prolapse (cystocele). METHODS: This was a secondary analysis of a cohort of prospectively enrolled women with symptomatic pelvic organ prolapse at or beyond the hymen and prolapse-reduced stress urinary incontinence (SUI) testing. Subjects were included if they had anterior- or posterior-predominant prolapse with at least a 1 cm difference in pelvic organ prolapse quantification (POP-Q) points Ba and Bp (N = 214). We evaluated the prevalence and risk factors of post-reduction SUI between the two groups. RESULTS: Comparing posterior (n = 45) and anterior (n = 169) prolapse groups, we identified similar rates of post-reduction SUI (posterior: 6/45, 13.3 %; anterior:18/169, 10.7 %; p = 0.52) and SUI without reduction (posterior:4.4 %; anterior:11.2 %; p = 0.26). Maximum prolapse size was slightly larger in anterior than in posterior patients (+3.1 vs +2.0 cm beyond the hymen, p = 0.001), while a higher proportion of posterior subjects reported a prior hysterectomy (p = 0.04). Among posterior subjects, lower maximum urethral closure pressure values (MUCP; p = 0.02) were associated with post-reduction SUI. In contrast, among anterior-predominant prolapse, larger prolapse measured at POP-Q point Ba (p = 0.003) and maximum POP-Q measurement (p = 0.006) were each associated with higher rates of post-reduction SUI and were highly correlated with each other (R = 0.90). CONCLUSIONS: We observed similar rates of post-reduction SUI in women with anterior- and posterior-predominant pelvic organ prolapse. Factors affecting the anterior and posterior prolapse groups differed, suggesting different mechanisms of continence protection. These findings suggest that reduction incontinence testing for operative planning would be as relevant to posterior-predominant prolapses as it is to anterior prolapse.

Comparison of the puborectal muscle on MRI in women with POP and levator ani defects with those with normal support and no defect.

INTRODUCTION AND HYPOTHESIS: The objective of this study was to compare puborectal muscle integrity and bulk in women with both major levator ani (LA) defects on MRI and pelvic organ prolapse (POP) to women with normal LA muscle and normal support. METHODS: This is a case-control study comparing 24 cases with known major LA defects and POP to 24 controls with normal LA and normal support. Axial T-2 weighted MRI scans of the pelvis were evaluated for integrity of the puborectal muscle and degree of muscle bulk. RESULTS: There were no significant group differences in age, body mass index, vaginal deliveries, or hysterectomy status. In all 48 subjects, the puborectal muscle was visible and had no disruption noted. There was no difference in muscle bulk between groups (control/case, thin 42% vs. 25%, average 42% vs. 38%, thick-17% vs. 38%; P = 0.47). CONCLUSIONS: Defects and loss of muscle bulk in the puborectal muscle are not seen on MRI in women with major LA defects and POP.

Patient Satisfaction With Nurse-Led Telephone Follow-up in an Ambulatory Setting.

OBJECTIVES: We studied our practice of using nurse telephone follow-up under physician direction to assess symptom improvement and patient satisfaction. METHODS: Women were recruited when their clinical care merited nurse telephone follow-up in the opinion of the attending physician. Women specified a preferred telephone number and completed a symptom questionnaire at the time of enrollment. Nursing telephone follow-up was completed at an interval prescribed by the attending physician to answer specified clinical questions. Approximately 3 months after the initial in-office visit, a satisfaction questionnaire and repeat symptom measure were mailed to the subjects. RESULTS: A convenience sample of 83 women was analyzed. Of those, 91.6% were reached by telephone, and 47.0% returned the follow-up questionnaire. Mean (SD) age was 56.8 (16.6) years (range, 20-89 years). Younger women were less likely to be able to be contacted by telephone (P = 0.02) and less likely to return the questionnaire (P = 0.02). Most common diagnoses were overactive bladder and mixed urinary incontinence. Satisfaction rates were high, and level of convenience for patients was high. Women indicated an ease of speaking over the telephone about their condition and confidence in the treatment plan. Satisfaction with telephone follow-up did not significantly differ based on age or diagnosis. CONCLUSIONS: Patient satisfaction was high for nurse telephone follow-up to replace in-office visits for selected diagnoses. This care strategy deserves further consideration for reimbursement purposes as health care evolves.

Pathologic evaluation of explanted vaginal mesh: interdisciplinary experience from a referral center.

OBJECTIVES: In light of vaginal mesh safety concerns, we reviewed our institutional experience with analytic processes and pathologic findings of explanted vaginal mesh to identify problems and opportunities to facilitate improved documentation and research. METHODS: We reviewed gross and microscopic pathology reports and archival slides of explanted mesh specimens from January 2010 through February 2012. Specimen requisition clinical history, number of mesh specimens per case, and type of examination (gross or histologic) were abstracted from pathology records using the initial search word "mesh". RESULTS: One hundred two cases were reviewed. Explanted mesh specimens included tissue in 97%. Forty-eight percent of these cases were submitted for histopathologic evaluation (as opposed to gross examination only). Specimen requisitions listed clinical history as pain (28.4%), vaginal mesh erosion (24.5%), erosion (17.6%), urinary retention (5.9%), and infection (2.9%). When no history was provided (24.5%), the case was more frequently submitted for histologic examination (74% vs 41%, P = 0.05). In all but 2 cases, the mesh material was polypropylene; no requisition mentioned this information. Gross descriptions of mesh varied significantly; in 18% of the cases, mesh was inaccurately described as "metallic". No cases of neoplasm were diagnosed histologically; all tissue diagnoses described benign reactive processes. CONCLUSIONS: Our experience suggests that either gross or histopathologic examination is appropriate for mesh explants. Documentation of clinical history, mesh product, and material was frequently incomplete and associated with increased submission of tissue for histologic examination and inaccurate gross impression of material type. We recommend improved documentation to aid pathologic examination and enable future pathophysiologic study of mesh complications.