Heidi S. Harvie

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.

Patient preferences for uterine preservation and hysterectomy in women with pelvic organ prolapse

OBJECTIVE The purpose of this study was to describe patient preferences for uterine preservation and hysterectomy in women with pelvic organ prolapse symptoms and to describe predictors of preference for uterine preservation. STUDY DESIGN This multicenter, cross-sectional study evaluated patient preferences for uterine preservation vs hysterectomy in women with prolapse symptoms who were being examined for initial urogynecologic evaluation. Before meeting the physician, the women completed a questionnaire that asked them to indicate their prolapse treatment preference (uterine preservation vs hysterectomy) for scenarios in which the efficacy of treatment varied. Patient characteristics that were associated with preferences were determined, and predictors for uterine preservation preference were identified with multivariable logistic regression. RESULTS Two hundred thirteen women participated. Assuming outcomes were equal between hysterectomy and uterine preservation, 36% of the women preferred uterine preservation; 20% of the women preferred hysterectomy, and 44% of the women had no strong preference. If uterine preservation was superior, 46% of the women preferred uterine preservation, and 11% of the women preferred hysterectomy. If hysterectomy was superior, 21% of the women still preferred uterine preservation, despite inferior efficacy. On multivariable logistic regression, women in the South had decreased odds of preferring uterine preservation compared with women in the Northeast (odds ratio [OR], 0.17; 95% CI, 0.05-0.66). Women with at least some college education (OR, 2.87; 95% CI, 1.08-7.62) and those who believed that the uterus is important for their sense of self (OR, 28.2; 95% CI, 5.00-158.7) had increased odds for preferring uterine preservation. CONCLUSION A higher proportion of women with prolapse symptoms who were examined for urogynecologic evaluation preferred uterine preservation, compared with hysterectomy. Geographic region, education level, and belief that the uterus is important for a sense of self were predictors of preference for uterine preservation.

Venous thromboembolism prophylaxis in gynecologic surgery: A systematic review

OBJECTIVE: To comprehensively review and critically assess the available gynecologic surgery venous thromboembolism prophylaxis literature and provide clinical practice guidelines. DATA SOURCES: MEDLINE and Cochrane databases from inception to July 2010. We included randomized controlled trials in gynecologic surgery populations. Interventions and comparators included graduated compression stockings, intermittent pneumatic compression, unfractionated heparin, and low molecular weight heparin; placebo and routine postoperative care were allowed as comparators. METHODS OF STUDY SELECTION: One thousand two hundred sixty-six articles were screened, and 14 randomized controlled trials (five benign gynecologic, nine gynecologic oncology) met eligibility criteria. In addition, nine prospective or retrospective studies with at least 150 women were identified and provided data on venous thromboembolism risk stratification, gynecologic laparoscopy, and urogynecologic populations. TABULATION, INTEGRATION, AND RESULTS: Two reviewers independently screened articles with discrepancies adjudicated by a third. Eligible randomized controlled trials were extracted for these characteristics: study, participant, surgery, intervention, comparator, and outcomes data, including venous thromboembolism incidence and bleeding complications. Studies were individually and collectively assessed for methodologic quality and strength of evidence. Overall incidence of clinical venous thromboembolism was 0–2% in the benign gynecologic population. With use of intermittent pneumatic compression for benign major procedures, venous thromboembolism incidence was less than 1%. No venous thromboembolisms were identified in prospective studies of benign laparoscopic procedures. Overall quality of evidence in the benign gynecologic literature was poor. Gynecologic–oncology randomized controlled trials reported venous thromboembolism incidence (including “silent” venous thromboembolisms) of 0–14.8% with prophylaxis and up to 34.6% without prophylaxis. Fair quality of evidence supports that unfractionated heparin and intermittent pneumatic compression are both superior to placebo or no intervention but insufficient to determine whether heparins are superior to intermittent pneumatic compression for venous thromboembolism prevention. Combining two of three risks (aged 60 years or older, cancer, or personal venous thromboembolism history) substantially elevated the risk of venous thromboembolism. CONCLUSION: Intermittent pneumatic compression provides sufficient prophylaxis for the majority of gynecology patients undergoing benign surgery. Additional risk factors warrant the use of combined mechanical and pharmacologic prophylaxis.

Outcomes of abdominal and minimally invasive sacrocolpopexy: a retrospective cohort study.

Objective To compare perioperative and postoperative surgical outcomes between and among open and minimally invasive sacrocolpopexies (MISCs). Methods We performed a multicenter retrospective cohort study comparing abdominal sacrocolpopexy (ASC) and MISC from January 1999 to December 2010. Results A total of 1124 subjects underwent sacrocolpopexy, with 589 ASCs and 535 MISCs. Within the MISC group, 273 were laparoscopic (LSC) and 262 were robotic (RSC). Abdominal sacrocolpopexy was associated with greater overall complication rate compared with MISC (20.0% vs 12.7%; P = 0.001). After controlling for difference in length of follow-up, there was no significant difference in the rate of anatomical failure between the ASC and MISC groups. The MISC group had shorter hospitalization, less blood loss, but longer operative times compared with the ASC group. When comparing LSC to RSC, there was no difference in anatomic failures (7.7% vs 6.9%; P = 0.74). However, LSC was associated with more complications compared with RSC (18% vs 7%; P < 0.02). In addition, LSC had higher blood loss, less operative time, and shorter hospital stay compared with RSC. Conclusion Although anatomic results are similar, ASC is associated with a higher rate of complications compared with MISC.

The Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment: ROSETTA Trial,

We present the rationale for and design of a randomized, open-label, active-control trial comparing the effectiveness of 200 units of onabotulinum toxin A (Botox A®) versus sacral neuromodulation (InterStim®) therapy for refractory urgency urinary incontinence (UUI). The Refractory Overactive Bladder: Sacral NEuromodulation vs. BoTulinum Toxin Assessment (ROSETTA) trial compares changes in urgency urinary incontinence episodes over 6 months, as well as other lower urinary tract symptoms, adverse events and cost effectiveness in women receiving these two therapies. Eligible participants had previously attempted treatment with at least 2 medications and behavioral therapy. We discuss the importance of evaluating two very different interventions, the challenges related to recruitment, ethical considerations for two treatments with significantly different costs, follow-up assessments and cost effectiveness. The ROSETTA trial will provide information to healthcare providers regarding the technical attributes of these interventions as well as the efficacy and safety of these two interventions on other lower urinary tract and pelvic floor symptoms. Enrollment began in March, 2012 with anticipated end to recruitment in mid 2014.

Functional status and postoperative morbidity in older women with prolapse.

PURPOSE We determined the relationship of preoperative functional status to postoperative morbidity after pelvic organ prolapse surgery in women older than 60 years. MATERIALS AND METHODS We performed a retrospective cohort study of 223 women older than 60 years who underwent surgery for stage II or greater pelvic organ prolapse. Our exposure was preoperative functional status, defined as American Society of Anesthesiologists (ASA) physical status class. We compared postoperative outcomes (length of stay in a medical facility, and number and severity of postoperative complications) in women with low functional status (ASA class III) to those in women with high functional status (ASA classes I and II). We determined the association of preoperative functional status with postoperative outcomes on multivariate analysis. RESULTS Women in ASA class III were significantly likely to be older (mean ± SD age 72.7 ± 7.3 vs 68.3 ± 6.5 years) and of nonwhite ethnicity (36.1% vs 20.1%), have a higher body mass index (mean 29.5 ± 5.6 vs 26.1 ± 3.8 kg/m(2)) and worse functional comorbidity score (median 3 vs 2), and have undergone obliterative surgery (33.3% vs 9.1%) than women in ASA classes I and II (each p <0.05). Low preoperative functional status was independently associated with increased length of stay in a medical facility (2.13 days, 95% CI 0.57, 3.70, p <0.01) and postoperative complications (OR 2.17, 95% CI 1.03, 4.56), after adjusting for age, body mass index, nonwhite ethnicity, number of comorbidities, surgeon and type of surgery. CONCLUSIONS As defined by ASA class, preoperative functional status is significantly associated with postoperative length of stay and complications. Preoperative functional status is useful for predicting postoperative outcomes in older women who undergo pelvic organ prolapse surgery.

A retrospective multicenter study on outcomes after midurethral polypropylene sling revision for voiding dysfunction

Objectives: The purpose of this study was to determine outcomes of sling revision after midurethral sling (MUS) placement and whether timing of sling revision affected those outcomes. Materials and Methods: This is a multicenter study including patients who underwent MUS placement and subsequent sling revision secondary to voiding dysfunction. Diagnostic outcomes before and after sling revision were compared for all sling revision patients with complete data. Logistic regression analyses were performed to determine if revision timing predicted voiding dysfunction and stress incontinence. Results: One hundred seventy-five patients who met the study criteria had complete data. Overall, 70% (133) of MUS were retropubic and 30% (56) were obturator slings. Midurethral sling revision was accomplished by cutting (54%), excision (29%), and pulling down on the mesh (18%). Stress urinary incontinence (SUI) resolved in 38%, urinary tract infections (UTIs) in 69%, and overactive bladder (OAB) in 75%. In comparison, 21% experienced de novo SUI; 18%, de novo UTIs; and 12%, de novo OAB symptoms after revision. Voiding dysfunction resolved in 80%, however 10% experienced new voiding dysfunction symptoms. Retropubic slings displayed more voiding dysfunction, higher de novo/worsened OAB, and more UTIs after revision than obturator slings. Sling revision timing did not predict persistent voiding dysfunction but did predict SUI with earlier revision (≤2 weeks) resulting in less postrevision SUI when compared to revisions at 15-90 days or greater than 90 days. The method of sling revision (cut, excised, pulled down) did not predict SUI, OAB, or obstructive voiding symptoms. Conclusions: Sling revision resolves voiding dysfunction symptoms, UTIs and post-sling OAB symptoms in the majority of patients. Resolution of voiding dysfunction is independent of method and timing of revision; however earlier revision is associated with decreased postrevision SUI.

Incidence of Unanticipated Uterine Pathology at the Time of Minimally Invasive Abdominal Sacrocolpopexy

STUDY OBJECTIVE To determine the incidence of unanticipated uterine pathologic findings in women undergoing hysterectomy concomitant with minimally invasive sacrocolpopexy. DESIGN Retrospective case series (Canadian Task Force classification III). SETTING Four institutions in the United States. PATIENTS Women undergoing laparoscopic or robotically assisted sacrocolpopexy with hysterectomy. INTERVENTIONS Concurrent hysterectomy and minimally invasive sacrocolpopexy. MEASUREMENTS AND MAIN RESULTS We measured the incidence of clinically important uterine disease at minimally invasive sacrocolpopexy. A total of 324 women underwent concurrent hysterectomy and minimally invasive sacrocolpopexy. Their mean age was 56.1 years, and body mass index was 26.9 kg/m(2). Sixty-four percent were postmenopausal. Only 3 patients (0.92%) had abnormal uterine pathologic findings. No significant differences were noted in age, body mass index, or parity between the women with normal and abnormal uterine pathologic findings. None of the 3 women reported abnormal uterine bleeding before surgery. All lesions were premalignant and focal. No invasive carcinomas were identified. No patients required further follow-up or treatment of abnormal pathologic findings. CONCLUSION The risk of unanticipated uterine pathologic findings during minimally invasive sacrocolpopexy to treat pelvic organ prolapse is low.

Prolapse-related knowledge and attitudes toward the uterus in women with pelvic organ prolapse symptoms.

OBJECTIVE The objective of the study was to describe the basic knowledge about prolapse and attitudes regarding the uterus in women seeking care for prolapse symptoms. STUDY DESIGN This was a cross-sectional study of English-speaking women presenting with prolapse symptoms. Patients completed a self-administered questionnaire that included 5 prolapse-related knowledge items and 6 benefit-of-uterus attitude items; higher scores indicated greater knowledge or more positive perception of the uterus. The data were analyzed using descriptive statistics and multiple linear regression. RESULTS A total of 213 women were included. The overall mean knowledge score was 2.2 ± 1.1 (range, 0-5); 44% of the items were answered correctly. Participants correctly responded that surgery (79.8%), pessary (55.4%), and pelvic muscle exercises (34.3%) were prolapse treatment options. Prior evaluation by a female pelvic medicine and reconstructive surgery specialist (beta = 0.57, P = .001) and higher education (beta = 0.3, P = .07) was associated with a higher mean knowledge score. For attitude items, the overall mean score was 15.1 (4.7; range, 6-30). A total of 47.4% disagreed with the statement that the uterus is important for sex. The majority disagreed with the statement that the uterus is important for a sense of self (60.1%); that hysterectomy would make me feel less feminine (63.9%); and that hysterectomy would make me feel less whole (66.7%). Previous consultation with a female pelvic medicine and reconstructive surgery specialist was associated with a higher mean benefit of uterus score (beta = 1.82, P = .01). CONCLUSION Prolapse-related knowledge is low in women seeking care for prolapse symptoms. The majority do not believe the uterus is important for body image or sexuality and do not believe that hysterectomy will negatively affect their sex lives.

Management of vesicovaginal fistulae: a multicenter analysis from the Fellows' Pelvic Research Network.

Objectives Vesicovaginal fistulae (VVF) are the most commonly acquired fistulae of the urinary tract, but we lack a standardized algorithm for their management. The purpose of this multicenter study was to describe practice patterns and treatment outcomes of VVF in the United States. Methods This institutional review board–approved multicenter review included 12 academic centers. Cases were identified using International Classification of Diseases codes for VVF from July 2006 through June 2011. Data collected included demographics, VVF type (simple or complex), location and size, management, and postoperative outcomes. &khgr;2, Fisher exact, and Student t tests, and odds ratios were used to compare VVF management strategies and treatment outcomes. Results Two hundred twenty-six subjects were included. The mean age was 50 (14) years; mean body mass index was 29 (8) kg/m2. Most were postmenopausal (53.0%), nonsmokers (59.5%), and white (71.4%). Benign gynecologic surgery was the cause for most VVF (76.2%). Most of VVF identified were simple (77.0%). Sixty (26.5%) VVF were initially managed conservatively with catheter drainage, of which 11.7% (7/60) resolved. Of the 166 VVF initially managed surgically, 77.5% resolved. In all, 219 subjects underwent surgical treatment and 83.1% of these were cured. Conclusions Most of VVF in this series was managed initially with surgery, with a 77.5% success rate. Of those treated conservatively, only 11.7% resolved. Surgery should be considered as the preferred approach to treat primary VVF.