Regulatory issues in female sexual dysfunction.

Female sexual dysfunction (FSD) remains an enigmatic area to some, a controversial area to others and the subject of continued, intense debate in the literature. Questions remain regarding the legitimacy of FSD as a bona fide disease; the definition of FSD; the methods of diagnosis; and, the treatment of FSD. In this timely perspective, Jean Fourcroy, Consultant in Urology, Endocrinology and Regulatory Issues, discusses the controversies that continue to plague FSD.

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.

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.

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.

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 role of neuromodulation in the management of urinary urge incontinence.

Objective: To examine the benefit-risk profile of neuromodulation in treating refractory urinary urge incontinence and other voiding disorders.

Patients And Methods: The outcome measures from all patients in pivotal clinical trials who had undergone sacral nerve stimulation were analysed retrospectively.

Results: Neuromodulation was effective in several clinical studies; the response is durable and the benefit-risk profile good.

Regulatory Issues in Prostate Cancer Studies.

Quality of life and informed consent are two of the important issues for designers of clinical trials. The former has physical, psychological, economic, and social components. Investigators must understand the features of the various measurement instruments and select one that is appropriate to the circumstances.

Urogynecology update: incontinence.

Physicians need to be more sensitive to urinary incontinence, because patients are unlikely to introduce the subject unless the symptoms are incapacitating. Failure to discuss the issue prevents patients from taking advantage of the many new drugs and mechanical devices that have become available. The vast majority of cases are treatable, often by relatively simple means.

Flutamide hepatotoxicity.

Purpose: Observed and expected reporting rates were compared in patients who died or were hospitalized due to hepatotoxicity associated with the use of flutamide.

Materials And Methods: Case series were submitted to the MedWatch Spontaneous Reporting System of the Food and Drug Administration. Reporting rates for serious hepatotoxicity due to flutamide were calculated and compared to rates for hospitalized patients with acute idiopathic hepatitis in the medical literature.

Women and the development of drugs: why can't a woman be more like a man?

Most health providers and researchers would agree that the FDA provides the finest and safest methods to ensure safety and efficacy for the consumer. All proposed regulations or changes are published in the Federal Register (Title 21 Code of Federal Regulations). The 70 kg white male is no longer considered the norm.

Fibrous hamartoma of infancy in the genital region: findings in 15 cases.

Fibrous hamartoma of infancy is a benign myofibroblastic proliferation that typically occurs in the axillary or shoulder region of male infants. We describe 15 cases of this condition, which involved the inguinal region in 5, scrotum in 5, spermatic cord in 1, perineum in 1, labium majus in 1, the suprapubic region in 1 and the pubic area in 1. Patient median and mean ages were 10 and 6.

Laboratory methods for assessing human semen in epidemiologic studies: a consensus report.

It is clear that additional methodologic work needs to be performed. Some data gaps described above are being actively investigated. Other standards were not addressed at this meeting; statistical handling of the data, differences among CASA machines, and factors to consider as potential confounders in analysis are just a few.

Food and Drug Administration guidelines for reproductive toxicity testing.

The Food and Drug Administration generally requires reproductive toxicity testing of all new drugs to be used by pregnant women or women or men of reproductive potential. These requirements may vary among the centers within the FDA. Reproductive and developmental toxicity is usually tested in one or two animal species and is divided into three segments to represent treatment throughout the reproductive process.

A unique case of Sertoli cell only syndrome with normal gonadotropins.

A 23-year-old male presented with primary infertility, normal male phenotype, and azoospermia. He had normal basal T, FSH, and LH levels and responded normally to clomiphene citrate stimulation. He also had normal androgen receptors in cultured pubic skin fibroblasts.

Prenatal diagnosis by ultrasonography of genitourinary abnormalities.

Prenatal ultrasound has resulted in the earlier recognition of genitourinary-related abnormalities. This is a review for urologists of the normal developmental anatomy, physiology, and ultrasound characteristics of representative urogenital abnormalities with guidelines for diagnostic or therapeutic intervention.