Cecile A. Unger

Evaluation and management of complications from synthetic mesh after pelvic reconstructive surgery: a multicenter study.

OBJECTIVE The purpose of this study was to describe the evaluation and management of synthetic mesh-related complications after surgery for stress urinary incontinence (SUI) and/or pelvic organ prolapse (POP). STUDY DESIGN We conducted a multicenter, retrospective analysis of women who attended 4 US tertiary referral centers for evaluation of mesh-related complications after surgery for SUI and/or POP from January 2006 to December 2010. Demographic, clinical, and surgical data were abstracted from the medical record, and complications were classified according to the Expanded Accordion Severity Classification. RESULTS Three hundred forty-seven patients sought management of synthetic mesh-related complications over the study period. Index surgeries were performed for the following indications: SUI (sling only), 49.9%; POP (transvaginal mesh [TVM] or sacrocolpopexy only), 25.6%; and SUI + POP (sling + TVM or sacrocolpopexy), 24.2%. Median time to evaluation was 5.8 months (range, 0-65.2). Thirty percent of the patients had dyspareunia; 42.7% of the patients had mesh erosion; and 34.6% of the patients had pelvic pain. Seventy-seven percent of the patients had a grade 3 or 4 (severe) complication. Patients with TVM or sacrocolpopexy were more likely to have mesh erosion and vaginal symptoms compared with sling only. The median number of treatments for mesh complications was 2 (range, 1-9); 60% of the women required ≥2 interventions. Initial treatment intervention was surgical for 49% of subjects. Of those treatments that initially were managed nonsurgically, 59.3% went on to surgical intervention. CONCLUSION Most of the women who seek management of synthetic mesh complication after POP or SUI surgery have severe complications that require surgical intervention; a significant proportion require >1 surgical procedure. The pattern of complaints differs by index procedure.

Perioperative adverse events after minimally invasive abdominal sacrocolpopexy

OBJECTIVE Our first objective was to compare peri- and postoperative adverse events between robotic-assisted laparoscopic sacrocolpopexy (RSC) and conventional laparoscopic sacrocolpopexy (LSC) in a cohort of women who underwent these procedures at a tertiary care center. Our second objective was to explore whether hysterectomy and rectopexy at the time of sacrocolpopexy were associated with these adverse events. STUDY DESIGN This was a retrospective cohort study of women who underwent either RSC or LSC with or without concomitant hysterectomy and/or rectopexy from 2006-2012. Once patients were identified as either having undergone RSC or LSC, the electronic medical record was queried for demographic, peri-, and postoperative data. RESULTS Four hundred six women met study inclusion criteria. Mean age and body mass index of all the women were 58 ± 10 years and 27.9 ± 4.9 kg/m(2). The women who underwent RSC were older (60 ± 9 vs 57 ± 10 years, respectively; P = .009) and more likely to be postmenopausal (90.9% vs 79.1%, respectively; P = .05). RSC cases were associated with a higher intraoperative bladder injury rate (3.3% vs 0.4%, respectively; P = .04), a higher rate of estimated blood loss of ≥500 mL (2.5% vs 0, respectively; P = .01), and reoperation rate for pelvic organ prolapse (4.9% vs 1.1%, respectively; P = .02) compared with LSC. Concomitant rectopexy was associated with a higher risk of transfusion (2.8% vs 0.3%, respectively; P = .04), pelvic/abdominal abscess formation (11.1% vs 0.8%, respectively; P < .001), and osteomyelitis (5.6% vs 0, respectively; P < .001). The mesh erosion rate for all the women was 2.7% and was not statistically different between LSC and RSC and for patients who underwent concomitant hysterectomy and those who did not. CONCLUSION Peri- and postoperative outcomes after RSC and LSC are favorable, with few adverse outcomes. RSC is associated with a higher rate of bladder injury, estimated blood loss ≥500 mL, and reoperation for recurrent pelvic organ prolapse; otherwise, the rate of adverse events is similar between the 2 modalities. Concomitant rectopexy is associated with a higher rate of postoperative abscess and osteomyelitis complications.

Care of the transgender patient: the role of the gynecologist

Gender dysphoria refers to distress that is caused by a sense of incongruity between an individuals self-identified gender and natal sex. Diagnosis is made in accordance with the Diagnostic and Statistical Manual of Mental Disorders and treatment first involves psychiatric therapy, which can help determine a patients true goals in regards to achieving gender identity. Patients who wish to transition to the opposite sex must undergo a supervised real-life test and often are treated with hormonal therapy to develop physical characteristics consistent with their gender identity. Sex reassignment surgery is an option for patients who wish to transition completely. Transpatients face many barriers when it comes to basic health needs including education, housing, and health care. This is a result of long-standing marginalization and discrimination against this community. Because of these barriers, many patients do not receive the proper health care that they need. Additionally, because of certain high-risk behaviors as well as long-term hormonal therapy, transpatients have different routine health care needs that should be addressed in the primary care setting. Gynecologists play an important role in caring for transgender patients and should be knowledgeable about the general principles of transgender health.

Gluteal and posterior thigh pain in the postoperative period and the need for intervention after sacrospinous ligament colpopexy.

Introduction Sacrospinous ligament (SSL) colpopexy is a transvaginal surgical option for the treatment of vaginal apex prolapse. The objective of this study was to determine the rate of gluteal and posterior thigh pain after SSL colpopexy using the Capio device in the immediate postoperative period, at the 6-week postoperative visit, and to determine the risk of needing intervention for this type of pain. Methods This was a retrospective cohort study of women who underwent SSL colpopexy with the Capio device for the treatment of vaginal apex prolapse between 2007 and 2012. The electronic inpatient and outpatient medical record was queried for demographic, intraoperative, and immediate and 6-week postoperative data. Results Two hundred forty-two subjects underwent SSL colpopexy with the Capio device for vaginal apex prolapse. Mean age and body mass index were 66 (10) years and 28.7 (5.4) kg/m2, respectively. One hundred thirty-four (55.4%) subjects were found to have immediate gluteal or posterior thigh pain and 36 (15.3%) were found to have persistent pain at 6 weeks. Five (2.1%; 95% confidence interval, 0.8%–4.7%) subjects required intervention: physical therapy (3), trigger point injection (1), both (1), and no patients required reoperation. Concomitant midurethral sling placement was associated with pain at 6 weeks (P = 0.008). Need for intervention was associated with the number of sutures placed (2 or 3 vs 4; P = 0.03). Concomitant hysterectomy and approach to SSL colpopexy were not associated with gluteal or posterior thigh pain. Conclusions The rate of immediate postoperative gluteal and posterior thigh pain is high in patients undergoing SSL colpopexy for vaginal apex prolapse; however, the rate of pain at 6 weeks is much lower, and the need for intervention is even lower.

Neuroanatomy, neurophysiology, and dysfunction of the female lower urinary tract: A review

Abstract The 2 major functions of the lower urinary tract are the storage and emptying of urine. These processes are controlled by complex neurophysiologic mechanisms and are subject to injury and disease. When there is disruption of the neurologic control centers, dysfunction of the lower urinary tract may occur. This is sometimes referred to as the “neurogenic bladder.” The manifestation of dysfunction depends on the level of injury and severity of disruption. Patients with lesions above the spinal cord often have detrusor overactivity with no disruption in detrusor-sphincter coordination. Patients with well-defined suprasacral spinal cord injuries usually present with intact reflex detrusor activity but have detrusor sphincter dyssynergia, whereas injuries to or below the sacral spinal cord usually lead to persistent detrusor areflexia. A complete gynecologic, urologic, and neurologic examination should be performed when evaluating patients with neurologic lower urinary tract dysfunction. In addition, urodynamic studies and neurophysiologic testing can be used in certain circumstances to help establish diagnosis or to achieve better understanding of a patient’s vesicourethral functioning. In the management of neurogenic lower urinary tract dysfunction, the primary goal is improvement of a patient’s quality of life. Second to this is the prevention of chronic damage to the bladder and kidneys, which can lead to worsening impairment and symptoms. Treatment is often multifactorial, including behavioral modifications, bladder training programs, and pharmacotherapy. Surgical procedures are often a last resort option for management. An understanding of the basic neurophysiologic mechanisms of the lower urinary tract can guide providers in their evaluation and treatment of patients who present with lower urinary tract disorders. As neurologic diseases progress, voiding function often changes or worsens, necessitating a good understanding of the underlying physiology in question.

Comprehensive evaluation of the effect of bariatric surgery on pelvic floor disorders.

BACKGROUND The association of pelvic floor disorders (PFD) with obesity is well documented. The spectrum of PFD includes stress urinary incontinence (SUI), urge urinary incontinence (UUI), pelvic organ prolapse (POP), and fecal incontinence (FI). Resolution or improvement of SUI after bariatric surgery has been previously reported. However, the data regarding UUI and other forms of PFD with objective testing are sparse. OBJECTIVES Prospectively evaluate the effects of bariatric surgery on the prevalence and severity of pelvic floor disorders. SETTING U.S. Academic Hospital. METHODS From December 2008 to December 2012, patients who screened positive on a screening questionnaire were asked to participate in the study. Participants completed 3 validated condition-specific questionnaires before surgery and 6-12 months after. A subgroup consented to gynecologic examination (Pelvic Organ Prolapse Quantification [POP-Q] test) and urodynamic testing at similar time points. RESULTS Seventy-two study patients underwent laparoscopic gastric bypass (n = 65), sleeve gastrectomy (n = 5), and gastric banding (n = 2). Mean BMI decreased from 47.5 to 32.7 kg/m(2) 1 year after surgery (P<.001). Based on questionnaires, the most prevalent PFD was SUI, identified in 60 (83.3%) patients at baseline and 32 (44.4%, P<.001) at follow-up. There was significant improvement in PFD-related symptoms, quality of life, POP, and sexual function at follow-up. Decrease in prevalence of SUI after surgery was also confirmed with urodynamic testing (from 76.9% to 30.8%, P = .01). There was no significant change in prevalence and severity of POP based on POP-Q exam. CONCLUSIONS Bariatric surgery is associated with a decrease in prevalence and severity of diverse forms of urinary incontinence as well as improvement in quality of life and sexual function of morbidly obese women.

Ultrasound Evaluation of Midurethral Sling Position and Correlation to Physical Examination and Patient Symptoms

Objective The primary objective was to evaluate the position and angle variation between 3 different midurethral slings (MUSs) using 3-dimensional ultrasound (US) technology. The secondary objective was to compare differences in findings on physical examination and symptoms of incontinence and sexual dysfunction between subjects. Methods This was a cross-sectional study of 61 subjects who had undergone MUS placement without concomitant anterior or apical compartment prolapse surgery (21 retropubic [RP], 19 out-to-in transobturator [TOT], 21 in-to-out transobturator [TVT-O]). Subjects completed validated questionnaires (Sandvik Incontinence Severity Index, Urogenital Distress Inventory 6) and underwent a pelvic examination and standardized 2-dimensional and 3-dimensional ultrasonography evaluation. Results On translabial US, the median RP sling angle was 108.2 degrees (72.6–135.9), significantly more acute than the angle of TOT and TVT-O slings (119.3 degrees [72.3–140.4, P = 0.02] and 118.5 degrees [99.0–154.7, P = 0.004]). There was no difference in the sling angles between the TOT and TVT-O slings (P = 0.86). No difference was noted in the position of the sling along the urethra (P = 0.82). The TOT sling was more often palpable (57.8%, P = 0.02) compared with the RP or TVT-O groups. Fifteen patients (4 RP, 5 TOT, 6 TVT-O) reported discomfort during intercourse that they attributed to the MUS. Three of 19 TOT subjects reported that their partner experienced pain with intercourse because of the sling. However, sexual function and urinary symptoms were not statistically different between the 3 groups. Conclusions On 3-dimensional US, RP sling angle was found to be significantly more acute than the angles of the TOT and TVT-O slings, and there was no difference between the 2 transobturator slings. The TOT sling was more often palpable on examination, but this finding did not correlate with increased pain on palpation.

Vaginal mesh in pelvic reconstructive surgery: Controversies, current use, and complications

In 2001, the Food and Drug Administration approved the first surgical mesh product specifically designed for the surgical repair of pelvic organ prolapse and between 2004 and 2008, the use of vaginal mesh in gynecologic surgery was at its peak. Unfortunately, the rise in transvaginal mesh use was accompanied by a surge of adverse events and mesh-related complications. As a result, the Food and Drug Administration put forth several efforts to regulate the manufacturing of vaginal mesh products. These notifications have been supported by several gynecologic societies, and recommendations now exist not only on the placement of mesh and patient selection, but also on the evaluation and management of mesh-related complications. In addition, data on outcomes following management of these complications are now emerging.

Risk factors for robotic gynecologic procedures requiring conversion to other surgical procedures.

To determine the incidence of, and risk factors for, conversion from robotic gynecologic procedures to other procedure types.

Studying surgical innovations: Challenges of the randomized controlled trial

The randomized controlled trial (RCT) is designed to measure the efficacy of an intervention and is considered to be the most rigorous form of research, allowing for causal inferences to be made between treatments and outcomes. When designing an RCT, one must consider its essential methodological components including randomization, allocation, blinding, choice of outcome measures, sample size, loss to follow-up, and crossover. In contrast to RCTs of medical therapy, surgical trials face unique challenges that can affect study design, implementation, and interpretation of results. However, there are strategies that researchers can use to try to mitigate many of these challenges to improve the validity of the study. In addition, there are unique ethical considerations that must be examined when designing surgical trials, and steps must be taken to acknowledge them while maintaining the integrity of the study design. RCTs remain the best design to evaluate the efficacy of novel surgical treatments; however, researchers should be aware of and address the unique challenges inherent to surgical trials.