Cheryl B. Iglesia

Vaginal Mesh for Prolapse A Randomized Controlled Trial

OBJECTIVE: To present 3-month outcomes of a double-blind, multicenter randomized controlled trial comparing traditional vaginal prolapse surgery without mesh with vaginal surgery with mesh. METHODS: Women with pelvic organ prolapse quantification prolapse stages 2–4 were randomized to vaginal colpopexy repair with mesh or traditional vaginal colpopexy without mesh. The primary outcome measure was objective treatment success (pelvic organ prolapse quantification stage 1 or lower) at 3 months. Secondary outcome measures included quality-of-life variables and complication rates. RESULTS: Sixty-five women were recruited from January 2007 to August 2009, when the study was halted due to predetermined stopping criteria for vaginal mesh erosion at a median follow-up of 9.7 months (range, 2.4–26.7 months). Thirty-two women underwent mesh colpopexy (24 anterior mesh, eight total mesh), and 33 women had vaginal colpopexies without mesh (primarily uterosacral ligament suspension) and concurrent colporrhaphy. There were no statistically significant baseline differences between the mesh and no-mesh groups with respect to demographics, menopausal status, and race. Analysis of the mesh and no-mesh women found no difference with respect to overall recurrence (mesh: 19 [59.4%] compared with no mesh: 24 [70.4%], P=.28). There were five (15.6%) vaginal mesh erosions. Two cystotomies and one blood transfusion occurred in the mesh group only. Subjective cure of bulge symptoms was noted in 93.3% of mesh patients and 100% of no-mesh patients. Furthermore, subjective quality-of-life measurements did not differ between the two groups at baseline or 3 months postoperatively. CONCLUSION: At 3 months, there is a high vaginal mesh erosion rate (15.6%) with no difference in overall objective and subjective cure rates. This study questions the value of additive synthetic polypropylene mesh for vaginal prolapse repairs. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, www.clinicaltrials.gov, NCT00475540. LEVEL OF EVIDENCE: I

Effect of Weight Change on Natural History of Pelvic Organ Prolapse

OBJECTIVE: To evaluate the relationship between change in weight and pelvic organ prolapse (POP) progression/regression in women during a 5-year period. METHODS: Postmenopausal women with uteri (N=16,608), ages 50 to 79, who were enrolled in the Women’s Health Initiative (WHI) Estrogen plus Progestin Clinical Trial between 1993 and 1998 were included in this secondary analysis. Baseline pelvic examination, repeated annually, assessed uterine prolapse, cystocele, and rectocele using the WHI Prolapse Classification System. Statistical analyses included univariate and multiple logistic regression methods. RESULTS: During the 5-year time period, the majority of women (9,251, 55.7%) gained weight (mean 4.43 kg, ±5.95 kg), and the overall rate of prolapse (WHI Prolapse Classification System: grades 1–3) increased from 40.9% at baseline to 43.8% at year 5 of evaluation. Controlling for age, parity, race, and other health/physical variables, being overweight (body mass index [BMI] between 25 and 29.9) or obese (BMI of at least 30) at baseline was associated with progression in cystocele, rectocele, and uterine prolapse compared with women with healthy BMIs (BMI is calculated as weight (kg)/[height (m)]2). Specifically, the risk of prolapse progression in overweight and obese women as compared with the participants with healthy BMIs increased by 32% and 48% for cystocele, by 37% and 58% for rectocele, and by 43% and 69% for uterine prolapse, respectively. Adjusting for women with prolapse at baseline and baseline BMI, a 10% weight change was associated with minimal change in overall POP. Specifically, a 10% weight loss was associated with a borderline worsening of uterine prolapse (odds ratio [OR] 0.93, 95% confidence interval [CI] 0.88–0.97) and a minimal regression of cystocele (OR 1.03, 95% CI 1.00–1.05) and rectocele (OR 1.04, 95% CI 1.01–1.07). CONCLUSION: Being overweight or obese is associated with progression of POP. Weight loss does not appear to be significantly associated with regression of POP, suggesting that damage to the pelvic floor related to weight gain might be irreversible. LEVEL OF EVIDENCE: II

One-year objective and functional outcomes of a randomized clinical trial of vaginal mesh for prolapse

OBJECTIVE The purpose of this study was to show 12-month outcomes of a randomized trial that compared vaginal prolapse repair with and without mesh. STUDY DESIGN Women with stage ≥2 prolapse were assigned randomly to vaginal repair with or without mesh. The primary outcome was prolapse stage ≤1 at 12 months. Secondary outcomes included quality of life and complications. RESULTS All 65 evaluable participants were followed for 12 months after trial stoppage for mesh exposures. Thirty-two women had mesh repair; 33 women had traditional repair. At 12 months, both groups had improvement of pelvic organ prolapse-quantification test points to similar recurrence rates. The quality of life improved and did not differ between groups: 96.2% mesh vs 90.9% no-mesh subjects reported a cure of bulge symptoms; 15.6% had mesh exposures, and reoperation rates were higher with mesh. CONCLUSION Objective and subjective improvement is seen after vaginal prolapse repair with or without mesh. However, mesh resulted in a higher reoperation rate and did not improve 1-year cure.

Single-Incision Mini-Sling Compared With Tension-Free Vaginal Tape for the Treatment of Stress Urinary Incontinence: A Randomized Controlled Trial.

OBJECTIVE: To compare the efficacy of a single-incision mini-sling, placed in the “U” position, with tension-free vaginal tape (TVT) in the treatment of stress urinary incontinence. METHODS: Women with urodynamic stress incontinence with or without genital prolapse were randomized to receive a mini-sling or TVT (N=263). Those randomized to the mini-sling received two “sham” suprapubic incisions to facilitate blinding. The primary outcome was subjective cure (absence of any urinary incontinence or retreatment) as assessed at 1 year. This trial was a noninferiority study design. RESULTS: Participants receiving the mini-sling were less likely to have a bladder injury (0.8% compared with 4.8%; P=.0.46), more likely to be discharged without a catheter (78.5% compared with 63%; P=.008), and had less pain for postoperative days 1–3. One year after surgery, the rate of cure was similar between treatment groups (mini-sling 55.8% compared with TVT 60.6%; mean difference, 4.8%; 95% confidence interval, −16.7 to +7.2); however, this did not meet our predefined noninferiority criteria of −12%. Incontinence severity at 1 year was greater with the mini-sling than with TVT (mean severity score ± SD: 2.2±2.7 compared with 1.5±1.9; P=.015), resulting predominantly from a higher proportion of participants with “severe” incontinence postoperatively (16% compared with 5%; P=.025). CONCLUSION: The mini-sling placed in the “U” position results in similar subjective cure rates to TVT 1 year after surgery but postoperative incontinence severity is greater with the mini-sling than with TVT. LEVEL OF EVIDENCE: I

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.

Brachial Plexus Injury after Laparoscopic and Robotic Surgery

The objective of this article was to review the literature regarding brachial plexus injury (BPI) in laparoscopic and robotic surgery. BPI complicates gynecologic laparoscopic surgery with an estimated incidence of 0.16%. Nevertheless, as the numbers of advanced laparoscopic and robotic procedures increase, the anticipated risk of this complication may rise as well. Robotic surgery often requires steeper Trendelenburg positioning and longer operative times when compared with traditional laparoscopic surgery. In this article we review the anatomy, pathophysiology, diagnosis, and treatment of position-related BPI in the context of laparoscopic and robotic gynecologic surgery. We suggest a multidisciplinary approach to the diagnosis and treatment of BPI. Recommendations for prevention of this complication are also provided.

Female genital cosmetic surgery: a review of techniques and outcomes

The aesthetic and functional procedures that comprise female genital cosmetic surgery (FGCS) include traditional vaginal prolapse procedures as well as cosmetic vulvar and labial procedures. The line between cosmetic and medically indicated surgical procedures is blurred, and today many operations are performed for both purposes. The contributions of gynecologists and reconstructive pelvic surgeons are crucial in this debate. Aesthetic vaginal surgeons may unintentionally blur legitimate female pelvic floor disorders with other aesthetic conditions. In the absence of quality outcome data, the value of FGCS in improving sexual function remains uncertain. Women seeking FGCS need to be educated about the range and variation of labia widths and genital appearance, and should be evaluated for true pelvic support disorders such as pelvic organ prolapse and stress urinary incontinence. Women seeking FGCS should also be screened for psychological conditions and should act autonomously without coercion from partners or surgeons with proprietary conflicts of interest.

Interest in cosmetic vulvar surgery and perception of vulvar appearance

OBJECTIVE The objective of the study was to determine whether reproductive-age women are more likely to perceive their vulva as abnormal compared with older-aged women. STUDY DESIGN Women aged 18-44 years (group 1) and 45-72 years (group 2) completed a survey on demographics, grooming patterns, vulvar perceptions, and source of information about the vulva. RESULTS There was no difference between group 1 and group 2 in how often women looked at their vulva or their perception of having a normal vulva (91% vs 93%, P = .76). Both groups were satisfied with the appearance of their vulva (81% vs 82%, P = .71). A higher percentage in group 2 would consider cosmetic surgery if cost were not an issue versus group 1 (15% vs 8%, P = .05). CONCLUSION A womans age does not have an impact on her perception of a normal vulva. The majority of women perceived their vulva to be normal and were satisfied with its appearance. However, older women are more interested in cosmetic vulvar surgery.

Light and energy based therapeutics for genitourinary syndrome of menopause: Consensus and controversies

Gynecologist and plastic surgeons pioneered the application of lasers in medicine and surgery almost 5 decades ago, initially used to treat cervical and vaginal pathologies. Ever since, energy‐based devices have been deployed to treat pelvic pathologies and improve fertility. Recent technological developments triggered an unprecedented wave of publications, assessing the efficacy of fractional laser, and radiofrequency on the vaginal wall in reversing natural aging processes. Studies have shown that a certain degree of thermal energy deposited on the vaginal wall stimulates proliferation of the glycogen‐enriched epithelium, neovascularization, and collagen formation in the lamina propria, and improves natural lubrication and control of urination. This review aimed to review such data and to guide future research. A unique assembly of experts from around the globe, compiled and edited this manuscript based on a thorough literature review and personal experience. Lasers Surg. Med. 49:137–159, 2017.

Vaginal and laparoscopic mesh hysteropexy for uterovaginal prolapse: a parallel cohort study

BACKGROUND: There is growing interest in uterine conservation at the time of surgery for uterovaginal prolapse, but limited data compare different types of hysteropexy. OBJECTIVE: We sought to compare 1‐year efficacy and safety of laparoscopic sacral hysteropexy and vaginal mesh hysteropexy. STUDY DESIGN: This multicenter, prospective parallel cohort study compared laparoscopic sacral hysteropexy to vaginal mesh hysteropexy at 8 institutions. We included women ages 35–80 years who desired uterine conservation, were done with childbearing, and were undergoing 1 of the above procedures for stage 2–4 symptomatic anterior/apical uterovaginal prolapse (anterior descent at or beyond the hymen [Aa or Ba ≥ 0] and apical descent at or below the midvagina [C ≥ –TVL/2]). We excluded women with cervical elongation, prior mesh prolapse repair, cervical dysplasia, chronic pelvic pain, uterine abnormalities, and abnormal bleeding. Cure was defined as no prolapse beyond the hymen and cervix above midvagina (anatomic), no vaginal bulge sensation (symptomatic), and no reoperations. Pelvic Organ Prolapse Quantification examination and validated questionnaires were collected at baseline and 12 months including the Pelvic Floor Distress Inventory Short Form, Female Sexual Function Index, and Patient Global Impression of Improvement. In all, 72 subjects/group were required to detect 94% vs 75% cure (80% power, 15% dropout). Intention‐to‐treat analysis was used with logistic regression adjusting for baseline differences. RESULTS: We performed 74 laparoscopic sacral hysteropexy and 76 vaginal mesh hysteropexy procedures from July 2011 through May 2014. Laparoscopic patients were younger (P < .001), had lower parity (P = .006), were more likely premenopausal (P = .008), and had more severe prolapse (P = .02). Laparoscopic procedure (174 vs 64 minutes, P < .0001) and total operating time (239 vs 112 minutes, P < .0001) were longer. There were no differences in blood loss, complications, and hospital stay. One‐year outcomes for the available 83% laparoscopic and 80% vaginal hysteropexy patients revealed no differences in anatomic (77% vs 80%; adjusted odds ratio, 0.48; P = .20), symptomatic (90% vs 95%; adjusted odds ratio, 0.40; P = .22), or composite (72% vs 74%; adjusted odds ratio, 0.58; P = .27) cure. Mesh exposures occurred in 2.7% laparoscopic vs 6.6% vaginal hysteropexy (P = .44). A total of 95% of each group were very much better or much better. Pelvic floor symptom and sexual function scores improved for both groups with no difference between groups. CONCLUSION: Laparoscopic sacral hysteropexy and vaginal mesh hysteropexy had similar 1‐year cure rates and high satisfaction.