The TVT Worldwide Observational Registry for Long-Term Data: safety and efficacy of suburethral sling insertion approaches for stress urinary incontinence in women.

PURPOSE: We examined the clinical effectiveness of a single incision sling in women with stress urinary incontinence and obtained comparative perioperative and postoperative data on retropubic and transobturator slings. MATERIALS AND METHODS: Women who underwent a cough stress test were treated with surgery using a single incision, retropubic or obturator sling (Gynecare® TVT SECUR™, TVT™ or TVT Obturator System, respectively) with the choice of sling based on surgeon preference. Objective cure was assessed by the standing cough stress test at 1 year. Subjective outcomes were assessed by the Incontinence Quality of Life Questionnaire and EQ-5D™. Perioperative data and return to normal activity were recorded. RESULTS: Of the 1,398 women who underwent surgery there were postoperative data on 1,334, including 32.8%, 17.8% and 49.4% who received a tension free vaginal tape, obturator tension free vaginal tape and SECUR, respectively. After obturator tension free vaginal tape surgery fewer women had a positive cough stress test than after TVT and SECUR surgery (4 of 110 or 3.6% vs 24 of 187 or 12.8% and 59 of 374 or 15.8%, respectively). Incontinence Quality of Life Questionnaire effect size was 1.87, 1.42 and 1.56, respectively, indicating a large treatment effect. Using our Incontinence Quality of Life Questionnaire response definition 85.4%, 79.0% and 85.2% of the TVT, TVT outside-in obturator system and SECUR cohorts, respectively, were treatment responders (p = 0.11).The SECUR cohort had the shortest operative time, the lowest proportion of women who required an overnight stay and the most women who underwent surgery under local anesthesia. Median time to return to employment, housework, sex life and hobbies was most rapid for SECUR. CONCLUSION: This registry demonstrates the high effectiveness of all 3 approaches. The single incision sling appeared to have objective and subjective efficacy similar to that of the retropubic sling and it can be performed under local anesthesia in an office environment.

Laparoscopic supracervical hysterectomy versus laparoscopic-assisted vaginal hysterectomy.

OBJECTIVES: To compare the incidence of perioperative complications and postoperative healthcare utilization and costs in laparoscopic supracervical hysterectomy (LSH) versus laparoscopic-assisted vaginal hysterectomy (LAVH) patients. METHODS: Women 18 years with LSH or LAVH were extracted using a large national commercial claims database from 1/1/2007 through 9/30/2008. Outcome was perioperative complications and gynecologic-related postoperative resource use and costs. Multivariate analysis was performed to compare postsurgical outcomes between the cohorts. RESULTS: The final sample consisted of 6,198 LSH patients and 14,181 LAVH patients. LSH patients were significantly more likely to have dysfunctional uterine bleeding and leiomyomas and less likely to have endometriosis and prolapse as the primary diagnosis, and also significantly more likely to have a uterus that weighed 250 grams than LAVH patients. Compared with LAVH patients, LSH patients had significantly lower overall infection rates (7.4% versus 6.2%, P .002) and lower total gynecologic related postoperative costs ($252 versus $385, P .001, within 30 days of follow-up and $350 versus $569, P .001, within 180 days of follow-up). Significant cost differences remained following multivariate adjustment for patient characteristics. CONCLUSIONS: LSH patients demonstrated fewer perioperative complications and lower GYN-related postoperative costs compared to LAVH patients.

The burden of uterine fibroids in five European countries.

OBJECTIVE: To quantify the burden of uterine fibroids (UF) on health-related quality of life (HRQOL) and work productivity in a general population of women. STUDY DESIGN: Women diagnosed with or experiencing UF-related symptoms living in five Western European countries (France, Germany, Italy, Spain, and the United Kingdom) were identified through a cross-sectional Internet-based survey. The following parameters and outcomes of interest were captured and analysed: patient history and demographics, treatment and diagnosis patterns, symptom severity and HRQOL, work productivity and activity impairment, and disease or symptom-related health care resource use for the past year (e.g., provider visits, hospitalisation). RESULTS: This analysis included 1756 women (France, 358; Germany, 345; Italy, 351; Spain, 352; United Kingdom, 350). Prevalence of a diagnosis of UF ranged from 11.7% to 23.6%, and that of undiagnosed bleeding symptoms from 14.7% to 24.6% across the five countries. Between 9.0% and 32.5% of women waited > or =5 years before seeking treatment for UF. Mean UFS-QOL symptom severity scores ranged from 24.7 (95% confidence interval [CI], 21.1-28.3) to 37.6 (95% CI, 32.2-43.0; P<0.001), suggesting mild to moderate severity. Mean UFS-QOL scores ranged from 59.2 (95% CI, 54.2-64.2) to 69.7 (95% CI, 66.5-73.0; P=0.002), suggesting moderate impairment. In pooled analyses, absenteeism was reported by 32.7% of employed women with a diagnosis of UF. Overall worker productivity was reduced by 36.1% and general activity was impaired by 37.9%. CONCLUSIONS: UF are common in women residing in Western Europe. They are associated with impairment of HRQOL and productivity. A substantial number of women delay seeking medical help. Encouraging symptomatic women to seek help and treatment earlier may benefit women by improving their HRQOL and may also benefit society through enhanced worker productivity.

Cost-analysis comparison of outpatient see-and-treat hysteroscopy service with other hysteroscopy service models.

STUDY OBJECTIVE: To conduct a cost analysis of 3 different hysteroscopy service models. DESIGN: Decision-analytic model constructed from the UK National Health Service perspective (Canadian Task Force classification III). SETTING: Tertiary-care hospital. PATIENTS: Women undergoing hysteroscopy (N=1109). INTERVENTIONS: Three hysteroscopy service models: outpatient see-and-treat service; outpatient diagnostic hysteroscopy followed by referral for operative hysteroscopy under general anesthesia (outpatient and referral service); and general anesthesia see-and-treat service. MEASUREMENTS AND MAIN RESULTS: Costs were measured in 2008 UK pounds sterling. Of the 3 treatment arms, total costs were lowest with outpatient see-and-treat service. The lower cost of the outpatient see-and-treat service was observed across a number of patient subgroups (age, menopause status, and indication) and when subjected to sensitivity analyses. CONCLUSIONS: Outpatient see-and-treat hysteroscopy was associated with the lowest treatment costs. This service model may reduce the total cost of care in women referred for hysteroscopy.

Rate, type, and cost of pelvic organ prolapse surgery in Germany, France, and England.

OBJECTIVE: To estimate the rate, type and costs of surgical interventions for pelvic organ prolapse (POP) in Germany, France, and England. STUDY DESIGN: We identified the number, rate, and type of hospital admissions for pelvic floor surgery in 2005 from national hospital activity databases in each country: the German Hospital Episode, the French Medical Care Program Information System, and the National Health Service England Hospital Episode Statistics. Costs to the payer were estimated using the Diagnosis-Related Group reimbursement rates for each country. RESULTS: In 2005, the number (rate) of admissions for POP surgery was 36,854 (0.87 per 1000 women) in Germany, 36,679 (1.14 per 1000 women) in France, and 28,959 (1.13 per 1000 women) in England. Admissions for POP surgery constituted 10.4%, 16.7% and 16.9% of all admissions for female genital tract therapeutic interventions in Germany, France and England, respectively. At least 20% of hysterectomies were performed for the primary indication of POP. 57.4%, 45.0%, and 40.1% of all admissions for POP surgery included a hysterectomy. The costs to payers were 144,236,557 euro, 83,067,825 euro, and 81,030,907 euro in Germany, France, and England, respectively. CONCLUSION: Burden and costs associated with POP surgery are substantial in the three countries studied. Thus, programs aimed at reducing the burden of this disease are desirable.

Rate, type, and cost of invasive interventions for uterine myomas in Germany, France, and England.

STUDY OBJECTIVE: The objective of our study was to quantify the rate, type, and cost of interventions for uterine myomas to payers in Germany, France, and England. DESIGN: Computations using data from national hospital activity databases. DESIGN CLASSIFICATION: II-3. SETTING: Hospital admissions in Germany, France, and England. PATIENTS: Women admitted for a surgical or radiologic intervention for uterine myomas. INTERVENTIONS: Surgical or radiologic interventions for uterine myomas. MEASUREMENTS AND MAIN RESULTS: We identified the number and type of hospital admissions involving surgical or radiologic interventions for uterine myomas, through the analysis of national hospital activity databases from each country. We calculated the costs of these hospitalizations to payers in these countries using the diagnosis-related group reimbursement rates. In 2005, the number (rate) of hospital admissions involving interventions for uterine myomas was 64 299 (1.53/1000 women) in Germany, 37 787 (1.17/1000 women) in France, and 18 274 (0.71/1000 women) in England. The annual costs of these interventions to payers were euro212 313 090 in Germany, euro73 278 270 in France (excluding surgeon and anesthetist fees for interventions in the private sector), and euro52 674 672 in England. The percentage of interventions for uterine myomas that included a hysterectomy was 84.9% in Germany, 59.7% in France, and 64.1% in England. CONCLUSION: The number of admissions and costs associated with interventions for uterine myomas are substantial in the 3 European countries studied. Hysterectomy is the most frequent surgical intervention used to treat uterine myomas. The results in this article provide useful information for policy makers wishing to evaluate the cost effectiveness and budget impact of new, less invasive interventions.