Transparency and Disclosure.

Disclosure of medical errors and adverse outcomes is expected by regulatory agencies and society as a whole. Disclosure should occur in a systematic way that ensures honesty and transparency regarding the care that has been provided. It is often appropriate to seek professional help from Clinical Risk Management to assist with disclosure of any serious safety event that resulted in harm. Disclosure of medical errors facilitates efforts to prevent recurrence of safety events.

Salpingo-oophorectomy at the Time of Benign Hysterectomy: A Systematic Review.

OBJECTIVE: To compare the long-term risks associated with salpingo-oophorectomy with ovarian conservation at the time of benign hysterectomy. DATA SOURCES: MEDLINE, ClinicalTrials.gov, and the Cochrane Central Register of Controlled Trials were searched from inception to January 30, 2015. We included prospective and retrospective comparative studies of women with benign hysterectomy who had either bilateral salpingo-oophorectomy (BSO) or conservation of one or both ovaries. METHODS OF STUDY SELECTION: Reviewers double-screened 5,568 citations and extracted eligible studies into customized forms. Twenty-six comparative studies met inclusion criteria. Studies were assessed for results, quality, and strength of evidence. TABULATION, INTEGRATION, AND RESULTS: Studies were extracted for participant, intervention, comparator, and outcomes data. When compared with hysterectomy with BSO, prevalence of reoperation and ovarian cancer was higher in women with ovarian conservation (ovarian cancer risk of 0.14-0.7% compared with 0.02-0.04% among those with BSO). Hysterectomy with BSO was associated with a lower incidence of breast and total cancer, but no difference in the incidence of cancer mortality was found when compared with ovarian conservation. All-cause mortality was higher in women younger than age 45 years at the time of BSO who were not treated with estrogen replacement therapy (hazard ratio [HR] 1.41, 95% confidence interval [CI] 1.04-1.92). Coronary heart disease (HR 1.26, 95% CI 1.04-1.54) and cardiovascular death were higher among women with BSO (HR 1.84, 95% CI 1.27-2.68), especially women younger than 45 years who were not treated with estrogen. Finally, there was an increase in the prevalence of dementia and Parkinson disease among women with BSO compared with conservation, especially in women younger than age 50 years. Clinical practice guidelines were devised based on these results. CONCLUSION: Bilateral salpingo-oophorectomy offers the advantage of effectively eliminating the risk of ovarian cancer and reoperation but can be detrimental to other aspects of health, especially among women younger than age 45 years.

Prevalence, Awareness, and Understanding of Pelvic Floor Disorders in Adolescent and Young Women.

OBJECTIVES: The objective of this study was to characterize symptom prevalence, awareness of pelvic floor disorders (PFDs) in family/friends, and understanding of factors contributing to the development of PFDs in women aged 19 to 30 years. METHODS: This study is a cross-sectional study via online questionnaire survey of female students aged 19 to 30 years enrolled at the University of Alabama at Birmingham. Results of "adolescent women" aged 19 to 24 years were compared with "young women" aged 25 to 30 years. RESULTS: A total of 1092 questionnaires were completed with the mean age being 23.5 ± 3.1 years. The overall rate of urinary incontinence (UI) was 10.3% without a difference between adolescent and young women (P = 0.61). There were no differences in rates of urgency UI (P = 0.061), stress UI (P = 0.29), or pelvic organ prolapse (POP) symptoms (P = 0.56) between groups. There was no difference between groups in awareness of family members with UI, fecal incontinence (FI), or POP symptoms (P ≥ 0.24). However, logistic regression showed that the young women were more likely to have received education regarding UI (adjusted odds ratio [aOR], 2.6; 95% confidence interval [CI], 1.8-3.6), FI (aOR, 3.3; 95% CI, 2.2-4.8), POP (aOR, 2.9; 95% CI, 2.1-4.2), and have greater understanding regarding causes of UI (aOR, 2.9; 95% CI, 1.7-4.8), FI (aOR, 1.6; 95% CI, 1.1-2.3), and POP (aOR, 1.9; 95% CI, 1.3-2.9). CONCLUSIONS: Women aged 25 to 30 years had more awareness and understanding of PFDs compared with adolescent women. These data may have implications for primary prevention strategies of PFDs.

Effect of hormonal contraception on the function of plasmacytoid dendritic cells and distribution of immune cell populations in the female reproductive tract.

OBJECTIVE: Epidemiological evidence suggests an association between the use of hormonal contraception and an increased risk of acquiring sexually transmitted diseases including HIV-1. We sought to elucidate the biological mechanisms underlying the effect of hormonal contraception on the immune system. DESIGN: Cross-sectional study. METHODS: To delineate the biological mechanisms underlying the effect of hormonal contraceptives on the immune system, we analyzed the functional capacity of circulating plasmacytoid dendritic cells (pDCs), the distribution of vaginal immune cell populations, and the systemic and genital levels of immune mediators in women using depot medroxyprogesterone acetate (DMPA), NuvaRing, or combined oral contraceptives (COC). RESULTS: The use of DMPA or NuvaRing was associated with reduced capacity of circulating pDCs to produce interferon (IFN)-α and tumor necrosis (TNF-α) in response to TLR-9 stimulation. Systemic levels of IFN-α and cervicovaginal fluid levels of IFN-α, CXCL10, monocyte chemotactic protein-1, and granulocyte-colony stimulating factor were significantly lower in DMPA users compared to control volunteers not using hormonal contraception. The density of CD207 Langerhans cells in the vaginal epithelium was reduced in NuvaRing and combined oral contraceptive users but not in DMPA users. CONCLUSIONS: The presented evidence suggests that the use of some types of hormonal contraception is associated with reduced functional capacity of circulating pDCs and altered immune environment in the female reproductive tract.

Outcomes of midurethral sling procedures in women with mixed urinary incontinence.

INTRODUCTION AND HYPOTHESIS: The objective was to compare midurethral sling (MUS) urinary outcomes in women with stress urinary incontinence (SUI) only versus mixed UI (MUI). METHODS: This was a retrospective cohort study of women who underwent primary MUS surgery for SUI. MUI was defined as at least "moderately" bothersome urgency and stress incontinence on the Urinary Distress Inventory (UDI-6) subscale of the Pelvic Floor Distress Inventory-20 (PFDI-20). The primary outcome was SUI cure defined by a response of "no," "not at all," or "somewhat" bothersome SUI on both of the two UDI-6 stress subscale items. Symptom impact was assessed using the Urinary Impact Questionnaire (UIQ-7). Multivariable models assessed the effect of MUI on SUI outcomes. RESULTS: One thousand one hundred and ninety-one primary MUS procedures were reviewed. Seven hundred and fifteen out of 1,191 (60%) questionnaires were returned and 534 out of 715 (75%) had completed baseline and follow-up questionnaires. Mean (± SD) follow-up time was 35 ± 15 months. Women with MUI had a higher (worse) baseline total score on the UDI-6 (p ≤ 0.001). A lower proportion of women with MUI had SUI success compared with the SUI only group (64 vs 84.5%, p < 0.001). On multivariable analyses, women in the MUI group were at an increased risk of SUI failure (OR 2.5, 95% CI 1.6, 4.0), but greater improvements in UDI-6 (-31.6 ± 30.6 vs -15.5 ± 25.1), and UIQ-7 scores (-21.7 ± 35.3 vs -15.1 ± 28.2) compared with women with SUI only (all p < 0.02). CONCLUSIONS: Women with MUI are at an increased risk of SUI failure after MUS compared with women with SUI only, but experience greater overall improvement in the impact of urinary symptoms on the quality of life.

Medication effects on periurethral sensation and urethral sphincter activity.

AIM: The aim of this study was to characterize urethral neuromuscular function before and 2 weeks after medication therapy. METHODS: Premenopausal women without lower urinary tract symptoms were randomly allocated to 1 of the 6 medications for 2 weeks (pseudoephedrine ER of 120 mg, imipramine of 25 mg, cyclobenzaprine of 10 mg, tamsulosin of 0.4 mg, solifenacin of 5 mg, or placebo). At baseline and after medication, participants underwent testing: quantitative concentric needle electromyography (CNE) of the urethral sphincter using automated multimotor unit action potential software, current perception threshold (CPT) testing to measure periurethral sensation, and standard urodynamic pressure flow studies (PFS). Nonparametric tests were used to compare pre-post differences. RESULTS: Fifty-six women had baseline testing, 48 (85.7%) completed follow-up CNE, and 49 (87.5%) completed follow-up CPT and PFS testing. Demographics showed no significant differences among medication groups with respect to age (mean, 34.3; SD, 10.1), body mass index (mean, 31.8; SD, 7.5), parity (median, 1; range, 0-7), or race (14% Caucasian, 80% African American). The PFS parameters were not significantly different within medication groups. No significant pre-post changes in CNE values were noted; however, trends in amplitudes were in a direction consistent with the expected physiologic effect of the medications. With CPT testing, a trend toward increased urethral sensation at the 5-Hz stimulation level was observed after treatment with pseudoephedrine (0.15-0.09 mA at 5 Hz, P = 0.03). CONCLUSIONS: In women without lower urinary tract symptoms, pseudoephedrine improved urethral sensation but not urethral neuromuscular function on CNE or PFS. Imipramine, cyclobenzaprine, tamsulosin, solifenacin, and placebo did not change urethral sensation or neuromuscular function.

Sling surgery for stress urinary incontinence in women: a systematic review and metaanalysis.

OBJECTIVE: Understanding the long-term comparative effectiveness of competing surgical repairs is essential as failures after primary interventions for stress urinary incontinence (SUI) may result in a third of women requiring repeat surgery. STUDY DESIGN: We conducted a systematic review including English-language randomized controlled trials from 1990 through April 2013 with a minimum 12 months of follow-up comparing a sling procedure for SUI to another sling or Burch urethropexy. When at least 3 randomized controlled trials compared the same surgeries for the same outcome, we performed random effects model metaanalyses to estimate pooled odds ratios (ORs). RESULTS: For midurethral slings (MUS) vs Burch, metaanalysis of objective cure showed no significant difference (OR, 1.18; 95% confidence interval [CI], 0.73-1.89). Therefore, we suggest either intervention; the decision should balance potential adverse events (AEs) and concomitant surgeries. For women considering pubovaginal sling vs Burch, the evidence favored slings for both subjective and objective cure. We recommend pubovaginal sling to maximize cure outcomes. For pubovaginal slings vs MUS, metaanalysis of subjective cure favored MUS (OR, 0.40; 95% CI, 0.18-0.85). Therefore, we recommend MUS. For obturator slings vs retropubic MUS, metaanalyses for both objective (OR, 1.16; 95% CI, 0.93-1.45) and subjective cure (OR, 1.17; 95% CI, 0.91-1.51) favored retropubic slings but were not significant. Metaanalysis of satisfaction outcomes favored obturator slings but was not significant (OR, 0.77; 95% CI, 0.52-1.13). AEs were variable between slings; metaanalysis showed overactive bladder symptoms were more common following retropubic slings (OR, 1.413; 95% CI, 1.01-1.98, P = .046). We recommend either retropubic or obturator slings for cure outcomes; the decision should balance AEs. For minislings vs full-length MUS, metaanalyses of objective (OR, 4.16; 95% CI, 2.15-8.05) and subjective (OR, 2.65; 95% CI, 1.36-5.17) cure both significantly favored full-length slings. Therefore, we recommend a full-length MUS. CONCLUSION: Surgical procedures for SUI differ for success rates and complications, and both should be incorporated into surgical decision-making. Low- to high-quality evidence permitted mostly level-1 recommendations when guidelines were possible.

Cystoscopy and other urogynecologic procedures.

Female pelvic medicine and reconstructive surgery (FPMRS) is a rapidly expanding surgical specialty that focuses on the evaluation and treatment of pelvic floor disorders in women. Evaluation and treatment of several pelvic floor disorders can be accomplished with office-based procedures, yielding significant advantages to the patient, physician, and health system. This article describes the common and more useful office-based procedures for the FPMRS physician, covering 4 major categories: cystourethroscopy, procedures for stress urinary incontinence, procedures for urge urinary incontinence, and management of surgical complications.

Incontinence outcomes in women undergoing primary and repeat midurethral sling procedures.

OBJECTIVE: To assess stress urinary incontinence (SUI) and other lower urinary tract symptom outcomes in women undergoing repeat midurethral sling procedures compared with those undergoing primary midurethral sling procedures. METHODS: Cure was defined as responses of "not at all" or "somewhat" to both questions of the SUI subscale of the Urogenital Distress Inventory-6; symptom effect was assessed using the Incontinence Impact Questionnaire-7. Multivariable models were created controlling for baseline Medical Epidemiologic and Social Aspects of Aging questionnaire urge score and Urogenital Distress Inventory-6 stress subscale score. RESULTS: One thousand three hundred sixteen patients had charts available for review: 135 of 1,316 (10.2%) had undergone prior midurethral sling procedures; 799 of 1,316 (61%) questionnaires were returned, with 92 from those having undergone prior midurethral sling procedures. Median follow-up time was 36.4 months with a range of 11.4-71.5 months. Cure rates were 71% (95% confidence interval [CI] 67.7-74.3%) in the primary midurethral sling group and 54% (95% CI 43.8-64.2%) in the repeat midurethral sling group (P<.001). Women undergoing repeat midurethral sling procedures experienced significantly greater improvement in symptom-specific quality of life (QOL) compared with those undergoing primary midurethral sling procedures (-28.87±37.6 compared with -18.42±32.73, P=.01). Multivariable analyses revealed that women in the repeat midurethral sling group had increased risk of SUI failure (odds ratio 1.7, 95% CI 1.1-2.8). CONCLUSION: Women undergoing repeat midurethral sling procedures had almost two times the odds of SUI treatment failure but greater improvement in symptom effect on QOL than did those undergoing a primary midurethral sling procedure. This information can help counsel patients regarding their expectations of repeat midurethral sling surgery for recurrent SUI . LEVEL OF EVIDENCE: II.

Survey of robotic surgery credentialing requirements for physicians completing OB/GYN residency.

STUDY OBJECTIVE: To describe credentialing requirements for newly graduated resident physicians for robotic-assisted gynecologic surgery in Alabama. DESIGN: Cross-sectional study (Canadian Task Force classification III). SETTING: Hospitals in the state of Alabama in the United States. PARTICIPANTS: Credentialing authorities at hospitals in Alabama that currently use robotic surgery in the field of gynecology. INTERVENTIONS: Participants completed an online questionnaire about credentialing policies. MEASUREMENTS AND MAIN RESULTS: Fifteen of 16 hospitals (94%) in Alabama that use robotic technology for gynecologic surgery participated in this survey. All hospitals had a credentialing policy for robotic surgery; however, only 9 of the 15 hospitals (60%) had a separate pathway for physicians with recent residency training. This pathway consisted of an attestation letter from a residency program director in all of the 9 hospitals, a robotic case list in 3 (33%), and proctored cases after residency in 2 (22%). Five hospitals (55%) required a certain number of hysterectomy procedures (median, 5; range, 2-10). CONCLUSION: Robotic surgery credentialing requirements in Alabama vary. Validation of requirements in best practices for robotic surgery by graduating resident physicians is needed.

Effects of transvaginal repair of symptomatic rectocele on symptom-specific distress and impact on quality of life.

OBJECTIVE: To determine symptom-specific distress and quality-of-life impact outcomes among women who had undergone transvaginal repair of symptomatic rectocele. METHODS: Women who underwent transvaginal repair of symptomatic rectocele at the University of Alabama at Birmingham, USA, between April 2006 and June 2009 were included in a retrospective case series. Minimum follow-up was 1 year post-surgery. Women who underwent concomitant surgery, other than perineoplasty and/or midurethral sling, were excluded. End points were assessed using the Pelvic Floor Distress Inventory (PFDI-20) and the Pelvic Floor Impact Questionnaire (PFIQ-7). RESULTS: Overall, 113 women underwent repair of symptomatic rectocele, of whom 69 (61.1%) completed preoperative questionnaires and 66 (58.4%) responded to follow-up questionnaires. Mean time from surgery was 31.2±11.2 months. PFDI-20 and PFIQ-7 scores were significantly improved following surgery, with a median pre- and post-surgery difference of 35.4 (P<0.001) and 31.0 (P=0.002), respectively. CONCLUSION: Patients who underwent transvaginal repair of symptomatic rectocele reported improvements in symptom-specific distress and impact on quality of life.

Utility of preoperative endometrial assessment in asymptomatic women undergoing hysterectomy for pelvic floor dysfunction.

INTRODUCTION AND HYPOTHESIS: Uterine morcellation during laparoscopy for pelvic floor repair has prompted adoption of uterine screening tests by some surgeons. We report a case series of uterine malignancy incidentally diagnosed at the time of pelvic floor surgery. METHODS: We reviewed records from patients undergoing hysterectomy for pelvic organ prolapse (POP) and/or urinary incontinence (UI) from January 2004 to December 2009 and abstracted preoperative screening trends and final pathologic diagnoses. RESULTS: Of the 708 women in the study, 125 (18%) had preoperative endometrial biopsy (EB), 43 (6%) had pelvic ultrasound (US), and 21 (3%) had EB and US. Surgical route included vaginal (58%), abdominal (23%), and laparoscopic (18%). Most (97.1%) final pathologic diagnoses were benign. Five cancers (0.6%) were detected; four of these women had normal preoperative screening, including EB (2), US (1), or both tests (1). CONCLUSIONS: Screening with EB + US was found to be ineffective in our cohort of patients due to the low prevalence of undetected uterine cancer in asymptomatic women planning POP/UI surgery.

Testing and validation of a low-cost cystoscopy teaching model: a randomized controlled trial.

OBJECTIVE: To estimate whether the use of a low-cost cystoscopy model effectively trains residents in cystourethroscopy and to validate the model as a teaching tool. METHODS: A randomized, controlled, and evaluator-blinded study was performed. Twenty-nine obstetrician-gynecologist residents had access to fresh-frozen cadavers on which baseline cystoscopic skills were assessed using the validated Objective Structured Assessment of Technical Skills checklists for cystourethroscopy. Subsequently, residents were randomized to one of two arms, a didactic study arm using the cystoscopy model and a control arm. Repeated technical skills testing was performed. RESULTS: The study group demonstrated statistically significant decreases in cystoscope assembly time (128.8 seconds at baseline to 54.9 seconds postintervention; P=.005), and increases in task-specific checklist scores (from 59.3 at baseline to 92.9 postintervention; P<.001) and in global rating scale scores (from 61.0 at baseline to 87.8 postintervention; P<.001). Further, there was a significant improvement in task-specific checklist (P<.001), global rating scale (P=.002), and knowledge quiz scores (P=.011) in the study arm compared with the control arm. CONCLUSION: Use of the bladder model exhibited validity in enhancing performance and knowledge of cystourethroscopy among ob-gyn residents. LEVEL OF EVIDENCE: I.