A cost-effectiveness analysis of vaginal carbon dioxide laser therapy compared with standard medical therapies for genitourinary syndrome of menopause-associated dyspareunia.

BACKGROUND: Topical vaginal estrogen therapy is considered the gold standard treatment for genitourinary syndrome of menopause-associated dyspareunia, but early investigations of energy-based devices show promise for patients with contraindications or those who are refractory to vaginal estrogen cream therapy. Although evaluating safety, efficacy, and long-term outcomes for novel technologies is critically important when new technologies become available to treat unmet healthcare needs, evaluation of the costs of these new technologies compared with existing therapies is also critically important but often understudied. OBJECTIVE: We sought to perform a cost-effectiveness analysis of 3 therapies for genitourinary syndrome of menopause, including vaginal estrogen therapy, oral ospemifene therapy, and vaginal CO2 laser therapy and determine if vaginal laser therapy is a cost-effective treatment strategy for dyspareunia associated with genitourinary syndrome of menopause. STUDY DESIGN: An institutional review board-exempt cost-effectiveness analysis was performed by constructing a decision tree using decision analysis software (TreeAge Pro; TreeAge Software, Inc, Williamstown, MA) using integrated empirical data from the published literature. Tornado plots and 1-way and 2-way sensitivity analyses were performed to assess how changes in the model's input parameters altered the overall outcome of the cost-effectiveness analysis model. RESULTS: All 3 treatment methods were found to be cost-effective below the willingness-to-pay threshold of $50,000.00 per quality-adjusted life year for moderate dyspareunia. The incremental cost-effectiveness ratio for vaginal CO2 laser therapy was $16,372.01 and the incremental cost-effectiveness ratio for ospemifene therapy was $5711.14. Although all 3 treatment strategies were on the efficient frontier, vaginal CO2 laser therapy was the optimal treatment strategy with the highest effectiveness. In a 1-way sensitivity analysis of treatment adherence, vaginal CO2 laser therapy was no longer cost-effective when the adherence fell below 38.8%. Vaginal estrogen cream and ospemifene therapies remained cost-effective treatment strategies at all ranges of adherence. When varying the adherence to 100% for all strategies, oral ospemifene therapy was "dominated" by both vaginal CO2 laser therapy and vaginal estrogen cream therapy. In a 2-way sensitivity analysis of vaginal CO2 laser therapy adherence and vaginal CO2 laser therapy cost, vaginal CO2 laser therapy still remained the optimal treatment strategy at 200% of its current cost ($5554.00) when the adherence was >55%. When the cost fell to 20% of its current cost ($555.40), it was the optimal treatment strategy at all adherence values above 29%. CONCLUSION: This study showed that vaginal fractional CO2 laser therapy is a cost-effective treatment strategy for dyspareunia associated with GSM, as are both vaginal estrogen and oral ospemifene therapies. In our model, vaginal CO2 laser therapy is the optimal cost-effective treatment strategy, and insurance coverage should be considered for this treatment option if it is proven to be safe and effective in FDA trials.

Breast Cancer and the Obstetrician-Gynecologist: A Focus on Screening, Risk Assessment and Treatment of Survivors With Genitourinary Syndrome of Menopause.

Because of conflicting guidelines, providing appropriate breast cancer screening recommendations to our patients has become challenging. Given the high prevalence of genitourinary syndrome of menopause (GSM) overall, and among breast cancer survivors, and the understandable reluctance of physicians to prescribe effective hormonal treatments to survivors with this condition, addressing the needs of breast cancer survivors with bothersome GSM is both a common and controversial issue. In this review, we detail current breast cancer screening recommendations, breast cancer risk assessment, and management of GSM in breast cancer survivors.

Genitourinary Complications Are a Leading and Expensive Cause of Emergency Department and Inpatient Encounters for Persons With Spinal Cord Injury.

OBJECTIVES: To determine the rates of emergency department (ED) visits and inpatient hospitalizations for genitourinary (GU) complications after spinal cord injury (SCI) using a national sample; to examine which patient and facility factors are associated with inhospital mortality; and to estimate direct medical costs of GU complications after SCI. DESIGN: Retrospective cross-sectional and cost analysis of the 2006 to 2015 National Inpatient Sample and National Emergency Department Sample from the Healthcare Cost and Utilization Project. PARTICIPANTS: SCI-related encounters using various International Classification of Disease, Ninth Edition, Clinical Modification diagnosis codes. The inpatient sample included 1,796,624 hospitalizations, and the ED sample included 618,118 treat-and-release visits. MAIN OUTCOME MEASURES: The exposure included a GU complication, identified by International Classification of Disease, Ninth Edition, Clinical Modification codes 590-599. The outcomes then included an ED visit or hospitalization, death prior to discharge, and direct medical costs estimated from reported hospital charges. RESULTS: For the inpatient sample, we observed a 2.5% annual increase (95% confidence interval [CI], 1.8-3.2) in the proportion of SCI-related hospitalizations with any GU complication from 2006 to 2011, and a lesser rate of increase of 0.9% (95% CI, 0.4-1.4) each year from 2011 to 2015. Age, level of injury, and payer source were correlated to inhospital mortality. The costs of GU-related health care use exceeded $4 billion over the study period. CONCLUSIONS: This study shows the rates and economic burden of health care use associated with GU complications in persons with SCI in the United States. The need to develop strategies to effectively deliver health care to the SCI population for these conditions remains great.

Midterm prospective comparison of vaginal repair with mesh vs Prolift system devices for prolapse.

OBJECTIVE: To compare midterm clinical outcome using modified pelvic floor reconstructive surgery with mesh (MPFR) vs Prolift devices for the treatment of pelvic organ prolapse (POP). STUDY DESIGN: This prospective observational cohort study involved 223 women with POP stages III-IV who were assigned to either MPFR (n=131) or Prolift device (n=92). Outcomes were analyzed at 6 and 12 months and the last follow-up visit postoperatively. Main outcome measures included pelvic organ prolapse quantification measurement, Short Form-20 Pelvic Floor Distress Inventory (PFDI-20), Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ) questionnaires, perioperative outcomes, complications, and a personal interview about urinary and sexual symptoms. Statistical analysis included comparison of means (Wilcoxon test or Student's t-test) and proportions (Chi-square test). Multivariate analysis was carried out using Cox proportional hazard model. RESULTS: At follow-up (median, 36 months; range, 17-58 months), anatomic success for MPFR and Prolift was 87.07% and 93.41%, respectively (P=0.1339). Both operations significantly improved quality of life, and PFDI-20 scores were lower in the Prolift group than the MPFR group (P=0.03). Complication rates did not differ significantly between the two groups and the prevalence of urinary symptoms decreased postoperatively in both groups. The cost of operation, however, was RMB ¥11,882.86 yuan for MPFR and ¥23,617.59yuan for Prolift (P=0.00). CONCLUSIONS: MPFR and Prolift had comparable anatomic outcomes, Prolift had better functional outcomes than MPFR, but MPFR is much cheaper than Prolift. MPFR is an alternative, cheap and effective surgical treatment option to mesh-kits for the management for POP.

Quality of life impairment among postmenopausal women varies according to race.

BACKGROUND: Few studies have addressed the impact of menopausal symptom severity over quality of life (QoL) in Latin American women with different ethnics. OBJECTIVE: To assess menopausal symptom severity and the QoL among postmenopausal Colombian women with three different ethnicities. METHOD: Data of healthy naturally occurring postmenopausal Hispanic, indigenous and black women aged 40-59 years who participated in a cross-sectional study filling out the Menopause Rating Scale (MRS) and a general questionnaire was analysed. RESULTS: A total of 579 women were included, 153 Hispanic, 295 indigenous and 131 Afro-descendent. Hispanic women had an average age of 55.3 +/- 3.3 years. Indigenous and black women were less educated than the Hispanic ones (2.2 +/- 1.8 and 4.6 +/- 4.4 vs. 6.4 +/- 3.5 years, p < 0.0001). Hispanic women displayed lower total MRS scores (better QoL) when compared to indigenous and black women. Urogenital scoring was worse among indigenous women compared to Hispanic and black women. Black women presented higher MRS psychological and somatic scorings than Hispanic and indigenous women. After adjusting for confounding factors, indigenous and black women continued to display a higher risk for impaired QoL, total MRS score > 16 (OR: 3.11, 95% CI: 1.30-7.44 and OR: 5.29, 95% CI: 2.52-11.10, respectively), which was significantly higher among indigenous women due to urogenital symptoms (OR: 102.75, 95% CI: 38.33-275.47) and black women due to psychological (OR: 6.58, 95% CI: 3.27-13.27) and somatic symptoms (OR: 3.88, 95% CI: 1.83-8.22). CONCLUSION: In this postmenopausal Colombian series, menopausal symptoms in indigenous (urogenital) and black (somatic/psychological) women were more severe (impaired QoL) when compared to Hispanic ones.

The levonorgestrel-releasing intrauterine system: an updated review of the contraceptive and noncontraceptive uses.

The levonorgestrel containing intrauterine system is an effective and safe form of long-term yet reversible birth control. Intrauterine contraception use in the United States fell dramatically after early studies reported an association between intrauterine contraception use and later tubal infertility. Subsequent evaluation suggests that these early studies were biased. Users often experience menstrual disturbances. Informing patients of these common side effects is important to improve compliance. In addition to its contraceptive effect, the levonorgestrel intrauterine system offers potential therapeutic benefits in other clinical contexts, including menorrhagia, symptomatic fibroids, endometriosis, and endometrial suppression.

Is triage an appropriate way of dealing with walk-in patients attending genitourinary medicine clinics?

Genitourinary medicine services have come under severe workload pressure to deal with unprecedented demand over the past five years. Waiting times for patients wishing to access the service have increased significantly. In order to maintain open access for those who require acute attention, many services have introduced triage systems for patients who attend without appointments (walk-ins). We have evaluated a policy of triage for such patients, and the incidence of sentinel sexually transmitted infections (STIs) (gonorrhoea and chlamydia) was determined in those who failed to meet the criteria. Our study has shown a low incidence of STI (1.7%) in those who failed to meet the triage criteria, thus validating the policy.

Assessment of frequency, transmission, and genitourinary complications of enterobiasis (pinworms).

BACKGROUND: Pinworms are the most common helminth infection in the USA and Western Europe, with prevalence rates in some communities of as high as 30-50%. Pinworms generally live in the gastrointestinal tract, and helminth infestations have been noted in over one-quarter of acute appendectomies on histologic examination. RESULTS & CONCLUSIONS: Although transmission is often attributed to the ingestion of infective eggs by nail biting and inadequate hand washing, inhalation and ingestion of airborne eggs also occur. The female Enterobius vermicularis migrates nightly to the perianal area to deposit her eggs, but some worms find their way into adjacent orifices, most commonly the female genitourinary tract, producing an array of symptoms. More consideration of this entity is justified in patients presenting with genitourinary complaints not responding to normal therapies. In the treatment of pinworms affecting genitourinary organs, treatment with possibly two oral agents, namely mebendazole and ivermectin, and a topical therapy for the eggs may be warranted.

Continuing education: Comprehensive menopausal assessment: an approach to managing vasomotor and urogenital symptoms in breast cancer survivors.

PURPOSE/OBJECTIVES: To describe the development and implementation of a comprehensive menopausal assessment (CMA) and intervention program for women with a history of breast cancer. DATA SOURCES: Published articles selected from computerized databases, conference proceedings, bibliographies of pertinent articles and books, and lay publications. DATA SYNTHESIS: The CMA program consisted of a structured, comprehensive assessment of three symptoms (hot flashes, vaginal dryness, and stress urinary incontinence) and an individualized plan of education, counseling, nonestrogen treatments, psychosocial support, referrals, and follow-up. CONCLUSIONS: A structured approach to evaluating and managing vasomotor and urogenital symptoms with, for example, the CMA, may help breast cancer survivors with severe symptoms more effectively manage these symptoms than "usual care." IMPLICATIONS FOR NURSING: Nurses providing care for women with a history of breast cancer can incorporate the key elements of the CMA program into their practice to facilitate more effective management of three common menopausal symptoms that often are undertreated in this patient population.

Urogenital atrophy: prevention and treatment.

Fifteen percent of premenopausal women, 10-40% of postmenopausal women, and 10-25% of women receiving systemic hormone therapy experience urogenital atrophy. The most common symptoms are dryness, burning, pruritus, irritation, and dyspareunia. Estrogen loss, drugs, and chemical sensitivities are causes. Estrogen or hormone replacement therapy (ERT-HRT) is the treatment of choice in postmenopausal women. Dosages prescribed for menopause symptoms or to prevent osteoporosis (and, potentially, other conditions) can restore the vagina to premenopausal physiology and relieve symptoms. Concomitant progestins are necessary for women with an intact uterus to minimize or eliminate estrogen-induced endometrial cancer. Low-dosage oral and vaginal ERT can relieve urogenital atrophy but might not produce systemic effects. Progestins are not necessary with vaginal rings and vaginal tablets. If ERT is given only to treat urogenital atrophy, estrogen creams 1 or 2 times/week may prevent recurrence after symptoms are resolved. Progestins are not required for occasional estrogen cream use. Vaginal moisturizers provide longer relief by changing the fluid content of endothelium and lowering vaginal pH. Vaginal lubricants provide short-term relief. Women with contraindications to ERT-HRT could use lubricants for intercourse-related dryness or moisturizers for more continuous relief. The lay press promotes agrimony, black cohosh, chaste tree, dong quai, witch hazel, and phytoestrogens for vaginal dryness and dyspareunia; however, no evidence exists to support these specific claims. Pharmacists should be actively involved in identifying, preventing, and treating urogenital atrophy.

[A classification system of anogenital findings. A diagnostic tool in the assessment of sexually abused children]. / Klassifikasjonsliste av anogenitale funn. Et hjelpemiddel i diagnostikken av seksuelle overgrep mot barn.

The assessment of suspected sexual child abuse demands teamwork where the paediatrician plays a central role. From a juridical point of view, the task of the paediatrician is to evaluate the anatomic, microbiologic and forensic medical findings. In 1995, in order to improve the quality of this work, Norwegian paediatricians established a peer review group which meets on a regular basis. Based on available literature and the experience of the individual members, a classification system for anogenital findings has been developed. The findings are divided into five classes. Class one comprises findings frequently seen in children who have not been abused. Class two comprises findings not considered to be normal, but for which there could be many different causes. Classes three, four and five represent findings which are increasingly predictive with respect to injury penetration or attempted penetration. Since our knowledge of anogenital anatomy in children who have not been abused is limited, our classification system should be updated regularly.

[Implants in urology]. / Implantate in der Urologie.

During the past three decades, the use of implants both in urology and other surgical specialties has experienced exponential growth. The development of implantable genitourinary prostheses has similarly grown from simple testicular substitutes to the large group of implantable penile prostheses, artificial urinary sphincters, prostheses in neurology, and possible future developments of artificial bladder and ureteral materials. The majority of urologic prostheses are constructed of silicone, because it is relatively inert, but nevertheless silicone causes some local tissue reactions and deteriorates with time. Currently, much research is underway studying the effects on the human host. Although multiple mechanical malfunctions of these prosthetic devices have occurred, periprosthetic infection is the most disastrous complication which usually leads to removal of the prostheses. This article gives the clinician an overview of common complex urologic implants, especially the current development of prostheses in the field of neurology.

Assessment of the impact of female circumcision on the gynecological, genitourinary and obstetrical health problems of women from Somalia: literature review and case series.

Approximately 80 million women worldwide have undergone surgery for circumcision. A variety of health risks resulting from the procedure have been reported in the literature including: bleeding, infection, shock, difficulties with menstruation and urination as well as painful intercourse. Prolonged labor and perinatal difficulties have also been noted. After an extensive literature review, a description of gynecological and obstetrical complications is provided. We had the opportunity to survey 12 Somali refugee women who were temporarily residing in a refugee center in Western New York about their personal experience with circumcision. We were interested in determining whether this convenient sample of women substantiated the clinical sequelae of circumcision reported in the literature. Structured interviews were conducted and included questions on sociodemographic, circumcision and health factors. Our findings, however limited, support the presence of heavy bleeding at the time of the surgery as a complication arising from circumcision.

PIP: 80 million women worldwide have been circumcised. At least 20 African countries practice female circumcision. They tend to have the highest child mortality ratios. Most women underwent circumcision between 4 and 8 years of age. Immediate complications of female circumcision are bleeding, shock, wound infection, and swelling. Delayed complications include urinary complications, especially chronic urinary tract infection; keloid scar formation; painful or difficult menstruation; chronic pelvic infection; painful intercourse; obstructed labor; prolonged pressure of the head of the vagina; prolonged Stage II labor; and hemorrhaging after delivery. Pharaonic circumcision is the removal of the clitoris, labia minora, and most of all the labia majora and the stitching together of sides leaving just a small opening through which urine and menstrual blood can pass. Women who underwent Pharaonic circumcision are more likely to find it difficult to urinate and to have urinary complications than those who underwent Sunna circumcision (removal of the tip of prepuce of the clitoris). In June-August 1990, twelve 8-75 year old female refugees from Mogadishu, Somalia, were interviewed at a refugee center in Buffalo, New York, while waiting to immigrate to Canada. The mean age of circumcision was 7.4 years 58% had undergone Pharaonic circumcision and infibulation. 5 women suffered from heavy bleeding after the circumcision. The circumcision was performed by a physician or nurse-midwife in 74% of the cases. 82% had their legs bound for about 10 days after the circumcision. 60%, 38%, and 27% respectively, experienced pain during menstruation, at other times during the month, and during urination. 38% had been treated for a urinary infection. Defibulation was achieved by a physician (4 cases), a husband's penis (1 case), a husband using other means (1 case), and a special woman (1 case). 4 women experienced pain during intercourse. 5 women did not want their daughters to undergo Pharaonic circumcision. 7 women supported Sunna circumcision.

[Urogenital estrogen deficiency syndrome. Investigation and treatment with special reference to hormone substitution]. / Urogenital østrogenmangel-syndrom. Utredning og behandling med vekt på hormonsubstitusjon.

The risk of developing urogenital disorders increases after menopause due to decline in oestrogen production in postmenopausal women. Symptoms due to atrophy of the squamous epithelium in the vagina, urethra and bladder, recurrent urinary tract infections and abnormal function of lower urinary tract comprise the urogenital oestrogen-deficiency syndrome. The symptoms are directly related to atrophic changes in the urogenital tract. They cause reduced quality of life and persist lifelong if not treated. The present review discusses the incidence, symptoms, pathogenesis and treatment of this syndrome. Substitution therapy with oestriol is effective and has no metabolic effects or serious side effects at the recommended dosage. Oestriol should be used lifelong. The syndrome is underreported and undertreated in Norway. Therefore, an evaluation of the general health condition of elderly women, should include direct questions about these symptoms, and oestriol treatment should be offered liberally. It is effective, safe and cost-effective.