Is elective vulvar plastic surgery ever warranted, and what screening should be conducted preoperatively?

INTRODUCTION: Elective vulvar plastic surgery was the topic of a heated discussion on the list-serve of the International Society for the Study of Women's Sexual Medicine. At the suggestion of a board member, it was determined that this discussion might of interest to journal readers in the form of a published controversy. METHODS: Six people with expertise and/or strong opinions in the area of vulvar health, several of whom had been involved in the earlier online discussion, were invited to submit evidence-based opinions on the topic. MAIN OUTCOME MEASURE: To provide food for thought, discussion, and possible further research in a poorly discussed area of sexual medicine. RESULTS: Goodman believes that patients should make their own decisions. Bachmann further states that, while that is a woman's right, she should be counseled first, because variations in looks of the vulvar region are normal. Johnson furthers this thought, discussing the requirement for counseling before performing reinfibulation surgery on victims of female genital cutting. Fourcroy emphasizes the need to base surgical procedures on safety and efficacy in the long term, and not merely opportunity at the moment. Goldstein and Goldstein state that, based on the four principles of ethical practice of medicine, vulvar plastic surgery is not always ethical, but not always unethical. Sklar pursues this thought further, pointing out specific examples in regard to the principles of ethics. CONCLUSION: Vulvar plastic surgery may be warranted only after counseling if it is still the patient's preference, provided that it is conducted in a safe manner and not solely for the purpose of performing surgery.

Customs, culture, and tradition--what role do they play in a woman's sexuality?

INTRODUCTION: Sexual health is an assumed right for every individual, but we know little regarding customs, culture, or tradition and the role they play on the sexual experiences for a woman. A woman's sexuality must be considered in the context of the environment in which she and her partner live. Culture, social customs of the community, and religion often determine the acceptance and achievement of sexual health for both men and women. AIM: This is a review of the available literature on the impact of culture on a woman's sexual satisfaction, with emphasis placed on information from cultures practicing female genital circumcision (FGC). RESULTS: FGC provides a spectrum of surgical excisions and outcomes. The spectrum of FGC surgical excisions can alter well-being, obstetrical outcomes, and sexual responses. The psychologic aspects of a painful procedure in a young child may also impact her future sexual responsiveness. CONCLUSION: There is a paucity of information on which to base conclusions and the effect of culture on a woman's sexual satisfaction. Preliminary data suggest the need for further research using markers specific to the culture and her satisfaction.

Efficacy and safety of a novel once-daily extended-release ciprofloxacin tablet formulation for treatment of uncomplicated urinary tract infection in women.

The efficacy and safety of a novel once-daily extended-release ciprofloxacin (ciprofloxacin ER) 500-mg dose were compared with those of an immediate-release ciprofloxacin (ciprofloxacin IR) 250-mg twice-daily dose, each administered orally for 3 days in the treatment of acute uncomplicated urinary tract infection (uUTI) in women. Adult female outpatients (mean age, 39 years) with clinical signs and symptoms of acute uUTI and a positive pretreatment urine culture (> or =10(5) CFU/ml) were enrolled in a multicenter, randomized, double-blind, noninferiority trial. Patients were assessed at a test-of-cure visit (4 to 11 days posttreatment) and a late-posttreatment visit (4 to 6 weeks posttreatment) for microbiological and clinical outcomes and safety. The primary efficacy endpoint and microbiological eradication rate at the test-of-cure visit in the ciprofloxacin ER group (254/272; 93.4%) were noninferior to those in the ciprofloxacin IR group (225/251; 89.6%) (95% confidence interval [CI] of difference, -0.99%, 8.59%). Clinical-cure rates at the test-of-cure visit were 85.7% (233/272) for ciprofloxacin ER and 86.1% (216/251) for ciprofloxacin IR (95% CI of difference, -6.37%, 5.57%). At the late-posttreatment visit, microbiological and clinical outcomes were similar for the two treatments and consistent with test-of-cure results. Both treatments were well tolerated, but the frequencies of nausea and diarrhea were lower in the ciprofloxacin ER group than in the ciprofloxacin IR group (nausea, ER, 0.6%; IR, 2.2%; P = 0.033; diarrhea, ER, 0.2%; IR, 1.4%; P = 0.037). Once-daily ciprofloxacin ER was safe, effective, and noninferior to twice-daily ciprofloxacin IR in the treatment of acute uUTI. Additionally, ciprofloxacin ER was associated with significantly reduced frequencies of nausea and diarrhea.

Method validation and measurement of biomarkers in nonclinical and clinical samples in drug development: a conference report.

Biomarkers are increasingly used in drug development to aid scientific and clinical decisions regarding the progress of candidate and marketed therapeutics. Biomarkers can improve the understanding of diseases as well as therapeutic and off-target effects of drugs. Early implementation of biomarker strategies thus promises to reduce costs and time-to-market as drugs proceed through increasingly costly and complex clinical development programs. The 2003 American Association of Pharmaceutical Sciences/Clinical Ligand Assay Society Biomarkers Workshop (Salt Lake City, UT, USA, October 24-25, 2003) addressed key issues in biomarker research, with an emphasis on the validation and implementation of biochemical biomarker assays, covering from preclinical discovery of efficacy and toxicity biomarkers through clinical and postmarketing implementation. This summary report of the workshop focuses on the major issues discussed during presentations and open forums and noted consensus achieved among the participants on topics from nomenclature to best practices. For example, it was agreed that because reliable and accurate data provide the basis for sound decision making, biomarker assays must be validated in a manner that enables the creation of such data. The nature of biomarker measurements often precludes direct application of regulatory guidelines established for clinical diagnostics or drug bioanalysis, and future guidance on biomarker assay validation should therefore be adaptable enough that validation criteria do not stifle creative biomarker solutions.

Female sexual dysfunction: potential for pharmacotherapy.

The act of sex includes a woman's sexual self and self-image, intimate relationships, family, society and culture. The complexities of her environment, sexual and partner history, past relationships, mental health status, current medical problems and hormonal status all play a role. An interdisciplinary consensus conference panel expanded the former Diagnostic and Statistical Manual of Mental Disorders-IV classifications of female sexual dysfunction to include psychogenic and organic causes of desire, arousal, orgasm and sexual pain disorders that cause personal distress. The US FDA Guidance paper details the recommendations for the clinical development of drugs for the treatment of female sexual dysfunction. In this document, great emphasis is placed on orgasm as a clinical trial endpoint and it would appear that satisfactory sexual intercourse is of secondary importance to the Agency. However, there is no evidence to suggest that the majority of women correlate their sexual enjoyment and satisfaction with numbers of orgasms or even the likelihood of orgasm during a given sexual interaction. Nonetheless, any drug coming through the regulatory agency in the US will need to follow these recommendations. Currently, there are six major pharmaceutical therapeutic paths being pursued for treatment of female sexual disorders and/or postmenopausal symptoms. These include dopaminergic agonists and related substances, melanocortin-stimulating hormones, adrenoceptor antagonists, nitric oxide delivery systems, prostaglandins, and androgens. A number of compounds that target these pathways are undergoing development for female sexual dysfunction. The array of pharmacological agents that are being developed for female sexual dysfunction must prove to be efficacious and have a good safety profile at a time when there are increasing worries that hormonal replacement with estrogen and progestogens are not safe. It is unclear if any of these pharmaceutical pathways will prove to be both safe and effective for the treatment of female sexual disorders; however, studies investigating this area will provide important scientific data for the future.