Pain Scores and Exposure Rates after Polypropylene Mesh for Pelvic Organ Prolapse.

OBJECTIVES: To characterize pain and exposure after Prolift placement and identify risk factors. METHODS: A case series of women who underwent Prolift vaginal mesh were surveyed. Pain was assessed using a visual analog scale. Exposure was evaluated clinically. RESULTS: Of 183 eligible patients, 160 completed the survey, and 45 returned for examination. Mean preoperative pain score was 0.97 and postoperative was 1.35 (P = 0.12). Pre- and postoperative pain scores by compartment were: anterior (1.34 vs 1.25, mean change -0.09, P = 0.84), posterior (1.30 vs 1.56, mean change 0.26, P = 0.72), and total (0.63 vs 1.34, mean change 0.71, P = 0.05). Graft exposure was confirmed in 23 of 183 patients (12.6%); however, because asymptomatic patients were not examined, the true exposure rate may be underestimated. Hematoma formation is independently associated with mesh exposure, adjusted odds ratio 18.4 (95% confidence interval 3.4-147.4, P = 0.01). CONCLUSIONS: Although pain scores did not increase overall, there was a trend toward increased pain score in the patients with total (anterior and posterior) Prolift. Hematoma formation was significantly associated with mesh exposure.

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.

Endometriosis after laparoscopic supracervical hysterectomy with uterine morcellation: a case control study.

STUDY OBJECTIVE: To compare the incidence of new-onset endometriosis after laparoscopic supracervical hysterectomy (LSH) with uterine morcellation to traditional routes. DESIGN: Single center case-control study (Canadian Task Force classification II-2) of hysterectomies performed from January 2006 through December 2008. PATIENTS: Two hundred seventy-seven laparoscopic supracervical hysterectomies with morcellation (cases) and 187 transvaginal or abdominal hysterectomies without morcellation (controls) were performed from January 2006 through December 2008. INTERVENTIONS: A total of 464 women underwent hysterectomy, 277 cases via laparoscopic supracervical approach (LSH) with morcellation and 187 performed either transvaginally or abdominally without morcellation. Repeat operative procedures were performed for other benign indications on 16 of 464 (3.5%) patients who had undergone prior hysterectomy. MEASUREMENTS AND MAIN RESULTS: One hundred two patients had endometriosis at the time of hysterectomy diagnosed by pathologic evaluation or gross visualization. In those without endometriosis, repeat operative procedures were performed for pain and bleeding in 3.3% (12/362). Sixty percent (3/5) of patients treated with LSH and 28.6% (2/7) of the control group were found to have newly diagnosed endometriosis, conferring a rate of 1.4% (3/217) in the LSH group and 1.4% (2/145) in the control subjects. In patients with endometriosis, repeat operative procedures for pain or bleeding occurred in 2.9% (3/102): 3/60 patients treated with LSH and none in the control group (0/42). Two of these 3 patients undergoing a second surgery had recurrent/continued endometriosis. CONCLUSION: Newly diagnosed endometriosis was noted in 1.4% of patients after hysterectomy, with a similar incidence between the LSH and control groups. Reoperation for those with endometriosis at the time of LSH with morcellation was infrequent, but endometriosis was usually found. Further research is needed to delineate risk factors for development of de novo endometriosis after hysterectomy.

Clinical practice guideline for abnormal uterine bleeding: hysterectomy versus alternative therapy.

STUDY OBJECTIVE: To develop recommendations in selecting treatments for abnormal uterine bleeding (AUB). DESIGN: Clinical practice guidelines. SETTING: Randomized clinical trials compared bleeding, quality of life, pain, sexual health, satisfaction, the need for subsequent surgery, and adverse events between hysterectomy and less-invasive treatment options. PATIENTS: Women with AUB, predominantly from ovulatory disorders and endometrial causes. INTERVENTIONS: On the basis of findings from a systematic review, clinical practice guidelines were developed. Rating the quality of evidence and the strength of recommendations followed the Grades for Recommendation Assessment, Development, and Evaluation system. MEASUREMENTS AND MAIN RESULTS: This paper identified few high-quality studies that directly compared uterus-preserving treatments (endometrial ablation, levonorgestrel intrauterine system and systemically administered medications) with hysterectomy. The evidence from these randomized clinical trials demonstrated that there are trade-offs between hysterectomy and uterus-preserving treatments in terms of efficacy and adverse events. CONCLUSION: Selecting an appropriate treatment for AUB requires identifying a woman's most burdensome symptoms and incorporating her values and preferences when weighing the relative benefits and harms of hysterectomy versus other treatment options.

A systematic review comparing hysterectomy with less-invasive treatments for abnormal uterine bleeding.

STUDY OBJECTIVE: To compare hysterectomy with less-invasive alternatives for abnormal uterine bleeding (AUB) in 7 clinically important domains. DESIGN: Systematic review. SETTING: Randomized clinical trials comparing bleeding, quality of life, pain, sexual health, satisfaction, need for subsequent surgery, and adverse events between hysterectomy and less-invasive treatment options. PATIENTS: Women with AUB, predominantly from ovulatory disorders and endometrial causes. INTERVENTIONS: Systematic review of the literature (from inception to January 2011) comparing hysterectomy with alternatives for AUB treatment. Eligible trials were extracted into standardized forms. Trials were graded with a predefined 3-level rating, and the strengths of evidence for each outcome were evaluated with the Grades for Recommendation, Assessment, Development and Evaluation system. MEASUREMENTS AND MAIN RESULTS: Nine randomized clinical trials (18 articles) were eligible. Endometrial ablation, levonorgestrel intrauterine system, and medications were associated with lower risk of adverse events but higher risk of additional treatments than hysterectomy. Compared to ablation, hysterectomy had superior long-term pain and bleeding control. Compared with the levonorgestrel intrauterine system, hysterectomy had superior control of bleeding. No other differences between treatments were found. CONCLUSION: Less-invasive treatment options for AUB result in improvement in quality of life but carry significant risk of retreatment caused by unsatisfactory results. Although hysterectomy is the most effective treatment for AUB, it carries the highest risk for adverse events.

Defining success after surgery for pelvic organ prolapse.

OBJECTIVES: To describe pelvic organ prolapse surgical success rates using a variety of definitions with differing requirements for anatomic, symptomatic, or re-treatment outcomes. METHODS: Eighteen different surgical success definitions were evaluated in participants who underwent abdominal sacrocolpopexy within the Colpopexy and Urinary Reduction Efforts trial. The participants' assessments of overall improvement and rating of treatment success were compared between surgical success and failure for each of the definitions studied. The Wilcoxon rank sum test was used to identify significant differences in outcomes between success and failure. RESULTS: Treatment success varied widely depending on definition used (19.2-97.2%). Approximately 71% of the participants considered their surgery "very successful," and 85.2% considered themselves "much better" than before surgery. Definitions of success requiring all anatomic support to be proximal to the hymen had the lowest treatment success (19.2-57.6%). Approximately 94% achieved surgical success when it was defined as the absence of prolapse beyond the hymen. Subjective cure (absence of bulge symptoms) occurred in 92.1% while absence of re-treatment occurred in 97.2% of participants. Subjective cure was associated with significant improvements in the patient's assessment of both treatment success and overall improvement, more so than any other definition considered (P<.001 and <.001, respectively). Similarly, the greatest difference in symptom burden and health-related quality of life as measured by the Pelvic Organ Prolapse Distress Inventory and Pelvic Organ Prolapse Impact Questionnaire scores between treatment successes and failures was noted when success was defined as subjective cure (P<.001). CONCLUSION: The definition of success substantially affects treatment success rates after pelvic organ prolapse surgery. The absence of vaginal bulge symptoms postoperatively has a significant relationship with a patient's assessment of overall improvement, while anatomic success alone does not. LEVEL OF EVIDENCE: II.

Association between urinary incontinence and depressive symptoms in overweight and obese women.

OBJECTIVE: The objective of the study was to determine the association between urinary incontinence (UI) and depressive symptoms. STUDY DESIGN: The study was a cross-sectional study of 338 incontinent and overweight women at baseline in the Program to Reduce Incontinence by Diet and Exercise trial. Depressive symptoms were defined as a Beck Depression Inventory score of 10 or greater. UI frequency was determined by a 7-day voiding diary. Symptom bother and quality of life were determined using the Urogenital Distress Inventory (UDI) and the Incontinence Impact Questionnaire (IIQ). Multivariable regression was used to estimate the association between UI and depressive symptoms. RESULTS: Women with depressive symptoms (n = 101) reported a higher mean number of UI episodes per week (28 vs 23; P = .005) and higher (worse) mean scores on the UDI (176 vs 162; P = .02) and IIQ (136 vs 97; P < .001) compared with women without depressive symptoms. The risk of having depressive symptoms increased with each 7-episode increase in UI per week (adjusted odds ratio [AOR], 1.10; 95% confidence interval [CI], 1.01-1.21), each 50-point increase in UDI (AOR, 1.27; 95% CI, 1.01-1.60), and each 50-point increase in IIQ (AOR, 1.44; 95% CI, 1.22-1.71). CONCLUSION: Urinary incontinence frequency, symptom bother, and quality of life are independently associated with depressive symptoms in overweight and obese women.

The minimum important differences for the urinary scales of the Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire.

OBJECTIVE: We sought to estimate the minimum important difference (MID) for the Urinary Distress Inventory (UDI), UDI-stress subscale of the Pelvic Floor Distress Inventory, and Urinary Impact Questionnaire (UIQ) of the Pelvic Floor Impact Questionnaire. STUDY DESIGN: We calculated MID using anchor- and distribution-based approaches from a randomized trial for nonsurgical stress incontinence treatment. Anchors included a global impression of change, incontinence episodes from a urinary diary, and the Incontinence Severity Index. Effect size and standard error of measurement were the distribution methods used. RESULTS: Anchor-based MIDs ranged from -22.4 to -6.4 points for the UDI, -16.5 to -4.6 points for the UDI-stress, and -17.0 to -6.5 points for the UIQ. These data were supported by 2 distribution-based estimates. CONCLUSION: Reasonable estimates of MID are 11, 8, and 16 points for the UDI, UDI-stress subscale, and UIQ, respectively. Statistically significant improvements that meet these thresholds should be considered clinically important.

Predictors of success with postoperative voiding trials after a mid urethral sling procedure.

PURPOSE: We identified predictors of passing a voiding trial after incontinence surgery with a mid urethral sling and examined if successful performance on a voiding trial was maintained. MATERIALS AND METHODS: A total of 89 women scheduled for incontinence surgery were enrolled from July 2005 until April 2006. Voiding trials were performed the day of discharge from the hospital, with a two-thirds volume void after a 300 ml fill considered passing. Those who passed underwent a second voiding trial 3 hours later. RESULTS: Of the participants 60 (67.4%) underwent tension-free vaginal tape surgery, 29 underwent transobturator tape (32.6%) and 64 (71.9%) underwent concurrent vaginal repairs. A total of 59 (67.0%) participants passed the first voiding trial. Univariate analysis identified 12 potential predicting variables for passing the first voiding trial. From these 12, model building via backward stepwise logistic regression found maximum flow on preoperative uroflowmetry to be the only significant predictive variable (p = 0.0002). Of the 59 women who passed the initial voiding trial 9 (16.4%) failed the second voiding trial. None of the 11 participants who had maximal flow rates greater than 30 cc per second failed the first or second voiding trial, whereas 17 of 22 subjects (77.3%) who had maximal flow rates less than 15 cc per second failed either of these trials. CONCLUSIONS: Maximum flow rates on preoperative uroflowmetry were the best predictor of passing an initial voiding trial after undergoing a mid urethral sling procedure for incontinence. However, the ability to maintain performance on a second voiding trial, even only 3 hours after passing an initial trial, is not assured.

Graft use in transvaginal pelvic organ prolapse repair: a systematic review.

OBJECTIVE: To estimate the anatomic and symptomatic efficacy of graft use in transvaginal prolapse repair and to estimate the rates and describe the spectrum of adverse events associated with graft use. DATA SOURCES: Eligible studies, published between 1950 and November 27, 2007, were retrieved through Medline and bibliography searches. METHODS OF STUDY SELECTION: To assess anatomic and symptomatic efficacy of graft use, we used transvaginal prolapse repair studies that compared graft use with either native tissue repair or repair with a different graft. To estimate rates of adverse events from graft use, all comparative studies and case series with at least 30 participants were included. For spectrum of adverse events, all study designs were included. TABULATION, INTEGRATION AND RESULTS: Eligible studies were extracted onto standardized forms by one reviewer and confirmed by a second reviewer. Comparative studies were classified by vaginal compartment (anterior, posterior, apical, or multiple), graft type (biologic, synthetic-absorbable, synthetic nonabsorbable) and outcome (anatomic, symptomatic). We found 16 comparative studies, including six randomized trials, 37 noncomparative studies with at least 30 women, 11 case series with fewer than 30 women, and 10 case reports of adverse events. One randomized trial and one prospective comparative study evaluating synthetic, nonabsorbable graft use in the anterior compartment reported favorable anatomic and symptomatic outcomes with graft use. Data regarding graft use for posterior and apical compartments or for biologic or synthetic absorbable graft use in the anterior compartment were insufficient to determine efficacy. Rates and spectrum of adverse events associated with graft use included bleeding (0-3%), visceral injury (1-4%), urinary infection (0-19%), graft erosion (0-30%), and fistula (1%). There were insufficient data regarding dyspareunia, sexual, voiding, or defecatory dysfunction. CONCLUSION: Overall, the existing evidence is limited to guide decisions regarding whether to use graft materials in transvaginal prolapse surgery. Adequately powered randomized trials evaluating anatomic and symptomatic efficacy as well as adverse events are needed.

Outcomes of combination treatment of fecal incontinence in women.

OBJECTIVE: To describe how women with fecal incontinence (FI) respond to combined pharmacologic therapy and pelvic floor muscle exercises (PFME). STUDY DESIGN: Validated questionnaires (Fecal Incontinence Severity Index and Modified Manchester Health Questionnaire) were mailed to 80 women who received combined therapy for FI and had complete baseline assessments. Regression models were constructed to identify predictors of change in questionnaire scores. RESULTS: Response rate was 69%. Mean age was 59 +/- 12 years. All women were taught PFME with digital palpation, and 87% of the women received medications. FI severity scores and quality-of-life (QOL) improved from baseline to follow-up (P < .001 and P = .02, respectively). A fair/normal external anal sphincter (EAS) contraction resulted in greater improvements in FI severity (13 points, P = .006) and QOL scores (22 points, P < .001). CONCLUSION: FI severity and QOL improved after combination therapies, and a fair/normal EAS contraction predicted greater improvement.

Intraabdominal pressure changes associated with lifting: implications for postoperative activity restrictions.

OBJECTIVE: The purpose of this study was to describe the effect of the lifting maneuver and the quantity of weight lifted on the generation of intraabdominal pressure. STUDY DESIGN: Forty-one women who underwent urodynamic evaluation performed 4 lifting maneuvers, each while lifting 0, 2.5, 5, 10, and 15 kg. The lifting maneuvers were routine activities that included squatting with and without assistance, lifting from a counter, and receiving weight. Pressure was recorded with a rectal microtip catheter. Each lift was performed twice, and the average pressure change was analyzed. RESULTS: When controlled for potential confounding variables, repeated-measures analysis of variance revealed a significant interaction between lift weight and lift maneuver (P < .001). Squatting was associated with generation of higher intraabdominal pressure than lifting from a counter or receiving weights into outstretched arms (P < .001). Lifting > or = 2.5 kg resulted in significant changes in intraabdominal pressure, regardless of lift maneuver (P < .001). CONCLUSION: Both the lifting maneuver and the quantity of weight should be considered when counseling patients regarding postoperative lifting.

Usage of spot urine protein to creatinine ratios in the evaluation of preeclampsia.

OBJECTIVE: The objective of the study was to prospectively compare spot urine protein to creatinine (P:C) ratios with 24 hour urine collections for protein in women being evaluated for preeclampsia. STUDY DESIGN: A spot urine P:C ratio was obtained at the beginning of 24 hour urine collections from 126 patients admitted to evaluate for preeclampsia. Correlation between the spot P:C ratio with the 24 hour urine collections was calculated. Receiver operator characteristic curves were constructed to determine best P:C cut-offs for 300 mg and 5000 mg protein per 24 hours. RESULTS: Random spot P:C ratios were strongly correlated with 24 hour urine protein levels (Pearson r = 0.88). The optimal P:C cut-offs were 0.21 (300 mg per 24 hours) and 3.0 (5000 mg per 24 hours). A P:C ratio of less than 0.21 (300 mg per 24 hours) had a negative predictive value (NPV) of 83.3% and a P:C ratio of less than 3.0 (5000 mg per 24 hours) had 100% NPV. CONCLUSION: Urine spot P:C ratio correlated well with 24 hour urine collections for protein but was not justified as a substitute for timed collections.

Outcomes with porcine graft placement in the anterior vaginal compartment in patients who undergo high vaginal uterosacral suspension and cystocele repair.

OBJECTIVE: The purpose of this study was to prospectively assess the cases of patients who had undergone a high uterosacral suspension and anterior repair with anterior compartment placement of porcine dermis graft. STUDY DESIGN: Thirty-six patients who underwent transvaginal high uterosacral suspension and cystocele repair with graft augmentation from June 2001 to July 2004 were identified from the University of Alabama at Birmingham Genitourinary Disorders database. Analysis included the pre- and postoperative Pelvic Organ Prolapse Quantification examinations and incontinence impact questionnaire-7/urogenital distress inventory-6. RESULTS: Mean Pelvic Organ Prolapse Quantification Ba improved from +3.3 +/- 2.2 cm to -0.6 +/- 1.7 cm (P < .01). Postoperative Ba was prolapse stage II or greater in 50% of subjects. Mean incontinence impact questionnaire-7 scores improved from 36.2 +/- 31.9 to 15.6 +/- 26.2 (P < .01), as did mean urogenital distress inventory-6 scores from 58.2 +/- 26.8 to 23.8 +/- 22.6 (P < .01). CONCLUSION: Significant improvements in Pelvic Organ Prolapse Quantification measures, urinary symptoms, and the impact of incontinence were seen after the operation. However, a significant proportion of patients had Pelvic Organ Prolapse Quantification stage II prolapse or greater, which made it unclear whether graft use confers a significant advantage.

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.

Regret, satisfaction, and symptom improvement: analysis of the impact of partial colpocleisis for the management of severe pelvic organ prolapse.

OBJECTIVE: The purpose of this study was to assess a cohort of patients who underwent a colpocleisis procedure more than 1 year post operation to determine: 1) the proportion of patients who regretted having the procedure, 2) patient satisfaction with the procedure, and 3) changes in symptom severity after surgery. STUDY DESIGN: Using the University of Alabama at Birmingham (UAB) Genitourinary Disorders Center database, a prospective analysis was performed on 54 patients who underwent colpocleisis between August 1996 and April 2003. From August to October of 2004, participants were contacted by an investigator not involved with the surgery and were asked 1) "do you regret having your surgery, and, if so, why?," 2) "how satisfied are you with your progress (completely, somewhat, or not)?," and 3) to repeat the short form Incontinence Impact Questionnaire/Urogenital Distress Inventory (IIQ-7/UDI-6). RESULTS: Fifty-nine percent (32/54) of potential candidates participated in the study. Nine percent (3/32) of patients regretted having colpocleisis performed. Fifty-seven percent (16/28) were completely satisfied, 29% (8/28) somewhat satisfied, and 14% (4/28) not satisfied. Mean IIQ score improved significantly from 40.9 (+/-31.7) at baseline to 14.1 (+/-26.7) at last interview (P = .003). Mean UDI score improved significantly from 63.1 (+/-24.3) at baseline to 24.2 (+/-26.7) at last interview (P = .001). There was a negative correlation between change in UDI scores with time since procedure (r = -.397, P = .055) and age (r = -.435, P = .034). CONCLUSION: Few patients reported regret after partial colpocleisis. There was a high rate of patient satisfaction and significant symptom improvement more than a year post surgery. Stable but smaller improvements were reported with longer time from surgery and increasing age.

Low-dose 17-ß-estradiol cream for vaginal atrophy in a cohort without prolapse: Serum levels and vaginal response including tissue biomarkers associated with tissue remodeling.

OBJECTIVES: Describe the effect of 50 mcg vaginal 17-ß-estradiol (E2) cream on vaginal maturation, serum estrogen levels, atrophic symptoms, and biomarkers of oxidative stress and tissue remodeling in postmenopausal women without prolapse. METHODS: Seventeen women, 65 years or older, applied intravaginal E2 cream nightly for eight weeks, then twice weekly for eight weeks. Vaginal biopsies, serial blood draws, and atrophic symptoms were obtained at baseline, eight, and sixteen weeks. Changes in atrophic symptoms, vaginal maturation indices (VMI), and serum E2 were measured. Immunohistochemical staining characterized levels of transforming growth factor-beta (TGF-ß), nuclear factor kappa B (NFKB), inducible nitric oxide synthase (iNOS), endothelial nitric oxide synthase (eNOS), and thrombospondin (TSP). RESULTS: Serum E2 levels (pg/ml) were unchanged from baseline (mean (SD)) 7.7 (3.3) to eight 9.7 (5.7) and sixteen 8.7 (5.8) (p=0.24) weeks. VMI (mean (SD)) improved from baseline 34.2 (18.3) to eight 56.7 (13.1) and sixteen 54.5 (11.3) (p<0.001) weeks with no difference between eight and sixteen weeks. Vaginal dryness (p=0.03) and itching (p=0.02) improved. Tissue biomarker levels did not change (TGF-ß p=0.35, NFKB p=0.74, eNOS p=0.80, iNOS p=0.24, TSP p=0.80). DISCUSSION: Vaginal E2 improved atrophic symptoms and VMI without elevating serum E2. Tissue remodeling biomarkers did not change.

Life Space Assessment in Older Women Undergoing Non-Surgical Treatment for Urinary Incontinence.

OBJECTIVES: Urinary incontinence (UI) impacts all aspects of life activities. This study aims to characterize change in mobility within the community utilizing the Life Space Assessment (LSA) questionnaire in women undergoing non-surgical UI treatment. DESIGN: Prospective cohort study, performed from July 2007 to March 2009, which followed women seeking non-surgical UI treatment and assessed their mobility and symptoms using LSA, Urogenital Distress Inventory (UDI-6), and Incontinence Impact Questionnaire (IIQ-7) at baseline and 2, 6, and 12 months post-treatment. Estimated Percent Improvement (EPI) and Patient Satisfaction Question (PSQ) were obtained post-treatment. SETTING: Outpatient tertiary-care clinic. PARTICIPANTS: 70 ambulatory, community-dwelling women, aged 65 years or older, seeking non-surgical care for UI. INTERVENTION: Multi-component behavioral and/or pharmacologic therapies. MEASUREMENTS: We hypothesized LSA would improve with treatment. Repeated measures analysis with Tukey's HSD and backwards selection linear regression model were performed. RESULTS: LSA score decreased from baseline to 2 months (mean±SD; 63±29 to 56±28, p<0.001) and was sustained at 6 and 12 months (54±28, 54±28). UDI scores improved from 36±23 to 25±24, p<0.001, at 2 months, and improvement persisted at 6 and 12 months (22±22, 21±24). Improvements in UDI and patient perceived improvement in UI were not associated with LSA change. Age, race, and depression impacted LSA, which decreased 1-point for each additional year of age (p=0.004), 6-points for each point higher on the Geriatric Depression Scale (GDS) (p=0.002), and 6-points for African American race (p=0.048). CONCLUSION: Decreased mobility represented by LSA was related to age, depression, and race, but not UI symptom improvement.

Nonsurgical management of heavy menstrual bleeding: a systematic review.

OBJECTIVE: To compare the effectiveness of nonsurgical abnormal uterine bleeding treatments for bleeding control, quality of life (QOL), pain, sexual health, patient satisfaction, additional treatments needed, and adverse events. DATA SOURCES: MEDLINE, Cochrane databases, and Clinicaltrials.gov were searched from inception to May 2012. We included randomized controlled trials of nonsurgical treatments for abnormal uterine bleeding presumed secondary to endometrial dysfunction and abnormal uterine bleeding presumed secondary to ovulatory dysfunction. Interventions included the levonorgestrel intrauterine system, combined oral contraceptive pills (OCPs), progestins, nonsteroidal anti-inflammatory drugs (NSAIDs), and antifibrinolytics. Gonadotropin-releasing hormone agonists, danazol, and placebo were allowed as comparators. METHODS OF STUDY SELECTION: Two reviewers independently screened 5,848 citations and extracted eligible trials. Studies were assessed for quality and strength of evidence. TABULATION, INTEGRATION, AND RESULTS: Twenty-six articles met inclusion criteria. For reduction of menstrual bleeding in women with abnormal uterine bleeding presumed secondary to endometrial dysfunction, the levonorgestrel intrauterine system (71-95% reduction), combined OCPs (35-69% reduction), extended cycle oral progestins (87% reduction), tranexamic acid (26-54% reduction), and NSAIDs (10-52% reduction) were all effective treatments. The levonorgestrel intrauterine system, combined OCPs, and antifibrinolytics were all superior to luteal-phase progestins (20% increase in bleeding to 67% reduction). The levonorgestrel intrauterine system was superior to combined OCPs and NSAIDs. Antifibrinolytics were superior to NSAIDs for menstrual bleeding reduction. Data were limited on other important outcomes such as QOL for women with abnormal uterine bleeding presumed secondary to endometrial dysfunction and for all outcomes for women with abnormal uterine bleeding presumed secondary to ovulatory dysfunction. CONCLUSION: For the reduction in mean blood loss in women with heavy menstrual bleeding presumed secondary to abnormal uterine bleeding presumed secondary to endometrial dysfunction, we recommend the use of the levonorgestrel intrauterine system over OCPs, luteal-phase progestins, and NSAIDs. For other outcomes (QOL, pain, sexual health, patient satisfaction, additional treatments needed, and adverse events) and for treatment of abnormal uterine bleeding presumed secondary to ovulatory dysfunction, we were unable to make recommendations based on the limited available data.

Systematic review highlights difficulty interpreting diverse clinical outcomes in abnormal uterine bleeding trials.

OBJECTIVES: (1) To systematically collect and organize into clinical categories all outcomes reported in trials for abnormal uterine bleeding (AUB); (2) to rank the importance of outcomes for patient decision making; and (3) to improve future comparisons of effects in trials of AUB interventions. STUDY DESIGN AND SETTING: Systematic review of English-language randomized controlled trials of AUB treatments in MEDLINE from 1950 to June 2008. All outcomes and definitions were extracted and organized into major outcome categories by an expert group. Each outcome was ranked "critically important," "important," or "not important" for informing patients' choices. RESULTS: One hundred thirteen articles from 79 trials met the criteria. One hundred fourteen different outcomes were identified, only 15 (13%) of which were ranked as critically important and 29 (25%) as important. Outcomes were grouped into eight categories: (1) bleeding; (2) quality of life; (3) pain; (4) sexual health; (5) patient satisfaction; (6) bulk-related complaints; (7) need for subsequent surgical treatment; and (8) adverse events. CONCLUSION: To improve the quality, consistency, and utility of future AUB trials, we recommend assessing a limited number of clinical outcomes for bleeding, disease-specific quality of life, pain, sexual health, and bulk-related symptoms both before and after treatment and reporting satisfaction and adverse events. Further development of validated patient-based outcome measures and the standardization of outcome reporting are needed.