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Clobetasol Compared With Fractionated Carbon Dioxide Laser for Lichen Sclerosus: A Randomized Controlled Trial

Burkett, Linda S; Siddique, Moiuri; Zeymo, Alexander; Brunn, Elizabeth A; Gutman, Robert E; Park, Amy J; Iglesia, Cheryl B
OBJECTIVE:To compare 6-month safety and efficacy outcomes of fractionated CO2 laser (laser) with topical clobetasol propionate (steroid) for treatment of symptomatic vulvar lichen sclerosus. METHODS:We conducted a single-center randomized controlled trial that compared fractionated CO2 laser with steroid treatment for patients with biopsy-proven lichen sclerosus. Randomization was stratified by prior clobetasol propionate use. The primary outcome was mean change in Skindex-29 score at 6 months. A total sample size of 52 participants were recruited to detect a mean difference of 16 points on the Skindex-29 (SD±22) with 80% power, based on a one-sided two-sample t test with α=0.05, accounting for 10% attrition. Secondary outcomes included validated subjective and objective measures. Intention-to-treat, per protocol, and regression analysis based on prior steroid exposure were performed. RESULTS:From October 2015 to July 2018, 202 women were screened, 52 were randomized, and 51 completed a 6-month follow-up. No significant difference was found in baseline demographics, symptoms, and physician assessment scores. There was greater improvement in the Skindex-29 score in the laser arm at 6-months (10.9 point effect size, 95% CI 3.42-18.41; P=.007). Overall, 89% (23/27) of patients in the laser group rated symptoms as being "better or much better" compared with 62% (13/24) of patients in the steroid group, P=.07. More patients (81%, 21/27) were "satisfied or very satisfied" with laser treatment compared with steroid treatment (41%, 9/24); P=.01. After stratification for previous steroid use, the significant change of Skindex-29 score was only seen in the previously exposed group. There was one adverse event in each group: minor burning and blistering at the laser site and reactivation of genital herpes 1 week after starting steroid. CONCLUSION:Fractionated CO2 laser treatment showed significant improvement in subjective symptoms and objective measures compared with clobetasol propionate, without serious safety or adverse events at 6 months. CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov, NCT02573883.
PMID: 33957642
ISSN: 1873-233x
CID: 5197722

Risk Factors for Incomplete Bladder Emptying After Prolapse Repairs and Slings

Smithling, Katelyn R; Mwesigwa, Patricia J; Siddiquie, Moiuri M; Gutman, Robert E
OBJECTIVE:The aim of this study was to determine the risk factors for catheter use and incomplete bladder emptying (IE) more than 1 week after prolapse repairs and slings. METHODS:This is a case-control study of women with prolapse repairs and/or sling from June 2011 to April 2016. All underwent standardized postoperative voiding trial before discharge. Controls and cases of IE were identified by codes and chart review; cases were defined as those needing any postoperative catheterization. We excluded patients with preoperative catheter use or postvoid residual (PVR) greater than 150 mL and those needing postoperative catheterization for reasons other than IE. Univariate and multivariate analyses were performed. RESULTS:A total of 475 (30.6%) cases and 478 controls were identified from 1552 eligible patients. Any catheter use was associated with higher uroflow PVR (71.2 vs 54.1 mL, P = 0.006), lower uroflow maximum flow (19.4 vs 25.4 mL/s, P < 0.001), and less detrusor overactivity (DO) (22.0% vs 28.7%, P = 0.03). Seventy-seven (5.0%) patients used catheters more than 1 week, and 15 patients (1.5%) required sling revision.Factors on multivariate analysis associated with any catheter use include office PVR [odds ratio (OR), 1.004; 1.00-1.008], uroflow maximum flow (OR, 0.96; 0.94-0.98), sling (OR, 2.40; 1.51-3.81), and anterior repair (OR, 1.81; 1.15-2.85). Factors associated with IE more than 1 week include uroflow maximum flow (OR, 0.90; 0.84-0.95), DO (OR, 0.21; 0.05-0.83), sling (OR, 3.68; 1.32-10.20), and uterosacral suspensions (OR, 3.43; 1.23-9.54). CONCLUSIONS:Overall, the incidence of short-term catheter use was 31%, prolonged IE more than 1 week was 5%, and 1.5% required sling revision. Sling placement, lower maximum flow, and higher preoperative PVR, anterior repair, and uterosacral ligament suspension are risk factors for IE, and presence of DO is protective.
PMID: 31172984
ISSN: 2154-4212
CID: 5902052

Development of a Patient-Centered Pelvic Floor Complication Scale

Fitzgerald, Jocelyn; Siddique, Moiuri; Miranne, Jeannine Marie; Saunders, Pamela; Gutman, Robert
OBJECTIVE:The aim of the study was to evaluate patient responses on a survey of knowledge, perceptions, concerns, and fears about complications related to pelvic reconstructive surgery (PRS). This is the first step to create a simplified, patient-centered Pelvic Floor Complication Scale that evaluates complications from both the patient and surgeon perspective. METHODS:Subjects for this prospective study included women older than 18 years planning surgery within 12 weeks or who had undergone PRS more than 6 months ago. Patients were asked open-ended questions about postoperative complications as well as to rank the severity of potential PRS complications (as mild, moderate, severe). Using thematic analysis, responses were coded and analyzed using Dedoose (Version 8.0.35). RESULTS:Thirty-three women (16 preop, 17 postop) participated in telephone interviews (n = 26) and focus groups (n = 7). There were no differences in age, race, education, marital status, and previous surgery. Specific complications such as a single urinary tract infection, short-term constipation (<2 weeks), persistent constipation (present preop), bladder injury not requiring repair or catheterization, vascular injury without sequelae, and extra office visits were considered minor. New recurrent urinary tract infections, new persistent constipation, worsening postop constipation (present preop), blood transfusion, readmission, and reoperation were considered severe complications.The most common themes included the following: fears of surgical failure, anesthesia, mesh erosion, discharge with a catheter, and pain. Patients were overall very trusting of their female pelvic medicine and reconstructive surgery surgeons and potential risks did not impact surgical decisions. CONCLUSIONS:Our research findings provide significant insight into patient perceptions of complications related to PRS that will aid in future development of a patient-centered Pelvic Floor Complication Scale.
PMCID:6745003
PMID: 30883438
ISSN: 2154-4212
CID: 5197682

Hydronephrosis Associated With Pelvic Organ Prolapse: A Systematic Review

Siddique, Moiuri; Ingraham, Caitlin; Kudish, Bela; Iglesia, Cheryl B; Polland, Allison
OBJECTIVES:The aim of this study was to report the prevalence of hydronephrosis associated with pelvic organ prolapse (POP). METHODS:We conducted a MEDLINE and PubMed search from 1996 to October 2016 using PRISMA guidelines. Eight studies met criteria for inclusion, including 3 prospective and 5 retrospective studies. RESULTS:The prevalence of hydronephrosis ranged from 3.5% to 30.6% in studies that included multiple stages of prolapse. Hydronephrosis correlated with prolapse severity in multiple studies, but serum creatinine did not consistently predict hydronephrosis. Two studies reported a significantly higher prevalence of hydronephrosis in patients with uterovaginal prolapse compared with vaginal vault prolapse. Complete resolution of hydronephrosis was described in 56% to 83% of patients after undergoing surgical treatment for advanced prolapse. CONCLUSIONS:Hydronephrosis among patients with POP is not rare, and we suggest consideration of upper tract evaluation in patients presenting with POP, particularly in those with advanced uterovaginal prolapse electing to proceed with expectant or conservative management.
PMID: 30614832
ISSN: 2154-4212
CID: 5197672

Associations between intimate partner violence profiles and mental health among low-income, urban pregnant adolescents

Thomas, Jordan L; Lewis, Jessica B; Martinez, Isabel; Cunningham, Shayna D; Siddique, Moiuri; Tobin, Jonathan N; Ickovics, Jeannette R
BACKGROUND:Intimate partner violence (IPV) during pregnancy is associated with adverse maternal and child health outcomes, including poor mental health. Previous IPV research has largely focused on women's victimization experiences; however, evidence suggests young women may be more likely to engage in bilateral violence (report both victimization and perpetration) or perpetrate IPV (unilateral perpetration) during pregnancy than to report being victimized (unilateral victimization). This study examined prevalence of unilateral victimization, unilateral perpetration, and bilateral violence, and the association between these IPV profiles and mental health outcomes during pregnancy among young, low-income adolescents. METHODS:Survey data were collected from 930 adolescents (14-21 years; 95.4% Black and Latina) from fourteen Community Health Centers and hospitals in New York City during second and third trimester of pregnancy. Multivariable regression models tested the association between IPV profiles and prenatal depression, anxiety, and distress, adjusting for known predictors of psychological morbidity. RESULTS:Thirty-eight percent of adolescents experienced IPV during their third trimester of pregnancy. Of these, 13% were solely victims, 35% were solely perpetrators, and 52% were engaged in bilateral violence. All women with violent IPV profiles had significantly higher odds of having depression and anxiety compared to individuals reporting no IPV. Adolescents experiencing bilateral violence had nearly 4-fold higher odds of depression (OR = 3.52, 95% CI: 2.43, 5.09) and a nearly 5-fold increased likelihood of anxiety (OR = 4.98, 95% CI: 3.29, 7.55). Unilateral victims and unilateral perpetrators were also at risk for adverse mental health outcomes, with risk of depression and anxiety two- to three-fold higher, compared to pregnant adolescents who report no IPV. Prenatal distress was higher among adolescents who experienced bilateral violence (OR = 2.84, 95% CI: 1.94, 4.16) and those who were unilateral victims (OR = 2.21, 95% CI: 1.19, 4.12). CONCLUSIONS:All violent IPV profiles were associated with adverse mental health outcomes among pregnant adolescents, with bilateral violence having the most detrimental associations. Comprehensive IPV screening for both victimization and perpetration experiences during pregnancy is warranted. Clinical and community prevention efforts should target pregnant adolescents and their partners to reduce their vulnerability to violence and its adverse consequences. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov, NCT00628771 . Registered 29 February 2008.
PMCID:6485079
PMID: 31023259
ISSN: 1471-2393
CID: 5197692

Core Privileging and Credentialing: Hospitals' Approach to Gynecologic Surgery

Siddique, Moiuri; Shah, Nemi; Park, Amy; Chen, Beatrice; Emery, Stephen; Falcone, Tommaso; Margulies, Rebecca; Rardin, Charles; Iglesia, Cheryl
STUDY OBJECTIVE:Privileging and credentialing requirements are determined by medical staff leadership at the hospital level to ensure clinicians provide safe healthcare services. No standardized guidelines exist for gynecologic surgery. The objective of this study is to examine the variability of the criteria used to grant surgical privileges and credentials for gynecologic procedures at 5 high-volume academic and community-based US hospitals. DESIGN:We conducted a cross-sectional study (Canadian Task Force classification III). SETTING:Data was obtained from obtained from 5 geographically diverse hospital systems. INTERVENTION:We examined criteria for designating core gynecologic privileges, credentialing, and other training requirements as well as minimum and annual case numbers for initial granting and maintenance of surgical privileges. MEASUREMENTS AND MAIN RESULTS:Major inconsistencies in privileging were found across the 5 institutions. Hospitals varied widely in procedures designated as core versus those requiring advanced training. Institutions greatly contrasted in the case numbers and temporal factors used to define experience. Of particular concern was absent privileging criteria for 38.4% to 76.9% of minor procedures, 26.7% to 46.7% of endoscopic procedures, and 6.67% to 56.7% of major procedures. Initial and maintenance privileging requirements for special procedures (i.e., robotic-assisted surgery) were likewise discrepant, with minimum annual case numbers ranging from 3 to 48 across hospitals. CONCLUSION:Considerable variability exists in the criteria used by hospitals for granting and maintaining surgical privileges for gynecologic procedures. Standardization will likely require efforts at a national leadership level.
PMID: 27521980
ISSN: 1553-4669
CID: 5197662