Early onset of action with a 17ß-estradiol, softgel, vaginal insert for treating vulvar and vaginal atrophy and moderate to severe dyspareunia.

OBJECTIVE: The softgel 17ß-estradiol (E2) vaginal inserts (4 and 10 µg; Imvexxy; TherapeuticsMD, Boca Raton, FL) are FDA approved for treating moderate to severe dyspareunia associated with postmenopausal vulvar and vaginal atrophy (VVA). The objective here was to determine responder rates at week 2 and whether week-2 findings predicted week-12 responders in the REJOICE trial. METHODS: Postmenopausal women received E2 vaginal inserts 4, 10, or 25 µg, or placebo for 12 weeks. Proportion of responders (having ≥2 of the following: vaginal superficial cells >5%, vaginal pH <5.0, or dyspareunia improvement of ≥1 category) were calculated. Odds ratios (ORs) for positive response at week 12 given a positive response at week 2 were determined in the efficacy evaluable (EE) population. RESULTS: The responder rate (in EE population [n = 695]) was 74% to 82% with E2 inserts versus 24% with placebo at week 2, and 72% to 80% versus 33% at week 12. Positive treatment responses were 9- to 14-fold higher with vaginal E2 than with placebo at week 2, and 5- to 8-fold higher at week 12. Response at week 2 predicted response at week 12 in the total population (OR 13.1; 95% CI, 8.8-19.7) and with active treatment only (OR 7.9; 95% CI, 4.7-13.2). CONCLUSIONS: A high percentage of postmenopausal women with moderate to severe dyspareunia responded with the E2 softgel vaginal insert at week 2, and a positive response at week 2 predicted a positive response at week 12.

Fertility issues in cancer survivorship.

Breakthroughs in cancer diagnosis and treatment have led to dramatic improvements in survival and the need to focus on survivorship issues. Chemotherapy and radiotherapy can be gonadotoxic, resulting in impaired fertility. Techniques to help cancer survivors reproduce have been improving over the past decade. Discussion of the changes to a patient's reproductive health after cancer treatment is essential to providing comprehensive quality care. The purpose of this review is to aid in pre- and posttreatment counseling, focusing on fertility preservation and other strategies that may mitigate risks to the patient's reproductive, sexual, and overall health.

Sexual health issues in women with cancer.

INTRODUCTION: Sexual health issues for women who have cancer are an important and under-diagnosed and under-treated survivorship issue. Survivorship begins at the time a cancer is detected and addresses health-care issues beyond diagnosis and acute treatment. This includes improving access to care and quality-of-life considerations, as well as dealing with the late effects of treatment. Difficulties with sexual function are one of the more common late effects in women. AIM: This article attempted to characterize the etiology, prevalence, and treatment for sexual health concerns for women with gynecological cancer. METHODS: A systematic survey of currently available relevant literature published in English was conducted. RESULTS: The issue of sexual health for women with cancer is a prevalent medical concern that is rarely addressed in clinical practice. The development of sexual morbidity in the female cancer survivor is a multifactorial problem incorporating psychological, physiologic, and sociological elements. Treatments such as chemotherapy, radiation therapy, surgery, and hormonal manipulation appear to have the greatest influence on the development of sexual consequences. Sexual complaints include but are not limited to changes in sexual desire, arousal, and orgasmic intensity and latency. Many women suffer from debilitating vaginal dryness and painful intercourse. CONCLUSIONS: Many of the sexual health issues experienced by cancer survivors can be addressed in clinical practice. A multimodal treatment paradigm is necessary to effectively treat these sexual complaints in this special patient population.

Radiofrequency treatment of vaginal laxity after vaginal delivery: nonsurgical vaginal tightening.

INTRODUCTION: All women who have given birth vaginally experience stretching of their vaginal tissue. Long-term physical and psychological consequences may occur, including loss of sensation and sexual dissatisfaction. One significant issue is the laxity of the vaginal introitus. AIM: To evaluate safety and tolerability of nonsurgical radiofrequency (RF) thermal therapy for treatment of laxity of the vaginal introitus after vaginal delivery. We also explored the utility of self-report questionnaires in assessing subjective effectiveness of this device. METHODS: Pilot study to treat 24 women (25-44 years) once using reverse gradient RF energy (75-90 joules/cm(2) ), delivered through the vaginal mucosa. Post-treatment assessments were at 10 days, 1, 3, and 6 months. MAIN OUTCOME MEASURES: Pelvic examinations and adverse event reports to assess safety. The author modified Female Sexual Function Index (mv-FSFI) and Female Sexual Distress Scale-Revised (FSDS-R), Vaginal Laxity and Sexual Satisfaction Questionnaires (designed for this study) to evaluate both safety and effectiveness, and the Global Response Assessment to assess treatment responses. RESULTS: No adverse events were reported; no topical anesthetics were required. Self-reported vaginal tightness improved in 67% of subjects at one month post-treatment; in 87% at 6 months (P<0.001). Mean sexual function scores improved: mv-FSFI total score before treatment was 27.6 ± 3.6, increasing to 32.0 ± 3.0 at 6 months (P < 0.001); FSDS-R score before treatment was 13.6 ± 8.7, declining to 4.3 ± 5.0 at month 6 post-treatment (P < 0.001). Twelve of 24 women who expressed diminished sexual satisfaction following their delivery; all reported sustained improvements on SSQ at 6 months after treatment (P = 0.002). CONCLUSION: The RF treatment was well tolerated and showed an excellent 6-month safety profile in this pilot study. Responses to the questionnaires suggest subjective improvement in self-reported vaginal tightness, sexual function and decreased sexual distress. These findings warrant further study.

Is infertility a risk factor for female sexual dysfunction? A case-control study.

OBJECTIVE: To determine the impact of infertility on female sexual function. DESIGN: A case-control study. SETTING: Academic infertility and gynecology practices. PATIENT(S): One hundred nineteen women with infertility and 99 healthy female controls without infertility between the ages of 18 and 45 years were included in this study. INTERVENTION(S): Anonymous survey and Female Sexual Function Index. MAIN OUTCOME MEASURE(S): Female Sexual Function Index scores, frequency of sexual intercourse and masturbation, and sex-life satisfaction. RESULT(S): Twenty-five percent of our control group had Female Sexual Function Index scores that put them at risk for sexual dysfunction (<26.55), whereas 40% of our patients with infertility met this criterion. Compared with the control group, the patients with infertility had significantly lower scores in the desire and arousal domains and lower frequency of intercourse and masturbation. The patients with infertility retrospectively reported a sex-life satisfaction score that was similar to that of the controls before their diagnosis, whereas their current sex-life satisfaction scores were significantly lower than those of the controls. CONCLUSION(S): Women with a diagnosis of infertility were found to be at higher risk for sexual dysfunction on the basis of their Female Sexual Function Index scores compared with women without infertility. The interaction of sexual function and infertility is complex and deserves further study.

Severe vaginal pain caused by a neuroma in the rectovaginal septum after posterior colporrhaphy.

BACKGROUND: Traumatic vaginal neuromas are a rarely documented finding in the setting of vaginal pain after posterior colporrhaphy. They arise as a result of trauma or surgery and are often mistaken for scar tissue. CASE: After a total vaginal hysterectomy and posterior colporrhaphy, a 32-year-old woman presented with debilitating vaginal pain, presumed to be secondary to scar tissue formation. Excision of the tissue from the rectovaginal septum revealed a traumatic neuroma. After the removal of the neuroma, the patient's vaginal pain resolved. CONCLUSION: Traumatic neuromas may be a cause of significant point tenderness and thickened tissue after vaginal surgery or repair of obstetric lacerations. If conservative treatment methods have failed, surgical excision of the neuroma can be considered.