Leah S. Millheiser, MD, FACOG, NCMP

All Publications

• Evaluation of Online Telehealth Platforms for Treatment of Erectile Dysfunction. Letter. The Journal of urology Stahl, P. J., Millheiser, L. n., Carroll, P. n. 2021: 101097JU0000000000001681

  View details for DOI 10.1097/JU.0000000000001681

  View details for PubMedID 33591810

• FLIBANSERIN: ENHANCED PHARMACOVIGILANCE STUDY TO ASSESS AND ANALYZE THE RISKS OF ADVERSE EVENTS OF SPECIAL INTEREST Millheiser, L., Faragasso, A., Donatucci, S., Brown, L. ELSEVIER SCI LTD. 2020: S31

  View details for Web of Science ID 000565226600064

• IMPROVEMENTS IN FEMALE SEXUAL FUNCTION INDEX (FSFI) DOMAINS OVER TIME AFTER FLIBANSERIN TREATMENT IN PREMENOPAUSAL WOMEN WITH HYPOACTIVE SEXUAL DESIRE DISORDER (HSDD) Simon, J., Millheiser, L., Clayton, A., Kingsberg, S., Kim, N. ELSEVIER SCI LTD. 2020: S42

  View details for Web of Science ID 000565226600085

• HSDD, FLIBANSERIN, AND EYE DYNAMICS: A DOUBLE-BLIND RANDOMIZED PLACEBO-CONTROLLED CLINICAL TRIAL Blagogee, T., Cacioppo, S., Millheiser, L. ELSEVIER SCI LTD. 2020: S2–S3

  View details for DOI 10.1016/j.jsxm.2019.11.008

  View details for Web of Science ID 000505047600006

• FLIBANSERIN: ENHANCED PHARMACOVIGILANCE STUDY TO ASSESS AND ANALYZE THE RISKS OF ADVERSE EVENTS OF SPECIAL INTEREST Millheiser, L., Faragasso, A., Donatucci, S., Brown, L. ELSEVIER SCI LTD. 2020: S66

  View details for DOI 10.1016/j.jsxm.2019.11.189

  View details for Web of Science ID 000505047600134

• Effects of Alcohol Administered With Flibanserin in Healthy Premenopausal Women: A Randomized, Double-Blind, Single-Dose Crossover Study. The journal of sexual medicine Simon, J. A., Clayton, A. H., Parish, S. J., Apfel, S. C., Millheiser, L. 2019

  Abstract

  INTRODUCTION: Flibanserin is approved in the United States and Canada for the treatment of hypoactive sexual desire disorder in premenopausal women.AIM: The purpose of this trial was to evaluate the safety of concomitant administration of flibanserin with alcohol.METHODS: In this single-center, randomized, double-blind, single-dose, crossover study, participants were randomly assigned to 1 of 12 sequences to receive each of 7 treatments: flibanserin 100 mg or placebo with ethanol 0.2 g/kg, 0.4 g/kg, or 0.6 g/kg, or flibanserin 100 mg only. Treatments were administered using a worst-case approach that included morning dosing and consumption of alcohol within 10 minutes.MAIN OUTCOME MEASURE: The primary end point was the proportion of participants who experienced dizziness, syncope, or hypotension. Safety end points included orthostatic vital signs.RESULTS: The study included 96 premenopausal women (mean age 31 ± 8 years). The incidence of dizziness for ethanol+ flibanserin was 39.8% for ethanol 0.6 g/kg, 34.1% for 0.4 g/kg, and 27.4% for 0.2 g/kg compared with 31.1% for flibanserin without ethanol. Based on the available vital signs data, there was no effect of ethanol concentration on orthostatic blood pressure, vertigo, or hypotension; no instances of syncope were observed. The overall incidence of adverse events (AEs) was similar when flibanserin was administered alone (96.7%) or with ethanol (90.5-97.6%).CLINICAL IMPLICATIONS: Consumption of the tested amounts of alcohol (0.2-0.6 g/kg) does not have an additive effect on the AE profile of flibanserin 100 mg in healthy premenopausal women.STRENGTHS & LIMITATIONS: Strengths include the study population (premenopausal women, as indicated for flibanserin) and range of ethanol doses. Limitations include the morning dosing of study medication, which is inconsistent with the bedtime dosing recommended for flibanserin, and the method of handling missing vital sign measurements.CONCLUSION: Co-administration of flibanserin 100 mg with varying doses of ethanol resulted in few AEs of special interest, with no notable alcohol dose response. However, a significantly greater percentage of participants administered flibanserin with 0.6 g/kg and 0.4 g/kg of alcohol were characterized as "Participants in Whom Standing Blood Pressure Was Not Obtained" compared with participants administered flibanserin alone. Simon JA, Clayton AH, Parish SJ, etal. Effects of Alcohol Administered With Flibanserin in Healthy Premenopausal Women: A Randomized, Double-Blind, Single-Dose Crossover Study. J Sex Med 2019;XX:XXX-XXX.

  View details for DOI 10.1016/j.jsxm.2019.10.004

  View details for PubMedID 31735618

• Safety and Tolerability of Evening Ethanol Consumption and Bedtime Administration of Flibanserin in Healthy Premenopausal Female Subjects. Sexual medicine Millheiser, L., Clayton, A. H., Parish, S. J., Kingsberg, S. A., Kim, N. N., Simon, J. A. 2019

  Abstract

  INTRODUCTION: Flibanserin, a treatment for hypoactive sexual desire disorder, carries warnings for increased risk of severe hypotension and syncope when used with alcohol. However, these warnings are not informed by studies that used flibanserin's recommended bedtime dosing because previous alcohol studies assessed flibanserin's safety during the day.AIM: The aim of this study was to assess the effects of ethanol in a real-world context in premenopausal women taking flibanserin at bedtime.METHODS: In a randomized, placebo-controlled, double-blind study, 24 healthy premenopausal women (mean age= 34.5 ± 9.9 years; mean body mass index= 25.2 ± 3.4 kg/m2) were dosed with flibanserin or placebo for 3 days to achieve steady-state plasma levels. In a clinical research unit, subjects (n= 22) were provided 2 units of wine (150 mL/unit; 12% ethanol content) or a nonalcoholic beverage with a standardized 3-course evening meal. Flibanserin 100 mg or placebo was administered at bedtime 2.5 hours after the end of the evening meal. On a separate day, subjects were provided the alternative beverage (± alcohol) with the same evening meal and dosed with the same treatment (flibanserin or placebo) at bedtime. After a 5-day washout period, subjects crossed over to the other treatment arm and the protocol was repeated.MAIN OUTCOME MEASURE: Adverse events (AEs) and vital signs were monitored.RESULTS: In the absence of ethanol, headaches and hypotension were the only AEs that occurred in ≥2 subjects after flibanserin dosing (placebo corrected rates were 17.4% and 8.7%, respectively). After ethanol consumption, the rate of hypotension after flibanserin dosing was no greater than with flibanserin or placebo after nonalcoholic beverage consumption. There were no instances of orthostatic hypotension or syncope and no serious AEs or AEs leading to study discontinuation.CONCLUSION: Flibanserin dosed at bedtime after moderate amounts of alcohol with an evening meal was well-tolerated with no evidence of clinically significant hypotension or syncope. Millheiser L, Clayton AH, Parish SJ, etal. Safety and Tolerability of Evening Ethanol Consumption and Bedtime Administration of Flibanserin in Healthy Premenopausal Female Subjects. Sex Med 2019;XX:XXX-XXX.

  View details for DOI 10.1016/j.esxm.2019.08.003

  View details for PubMedID 31519497

• Early onset of action with a 17beta-estradiol, softgel, vaginal insert for treating vulvar and vaginal atrophy and moderate to severe dyspareunia. Menopause (New York, N.Y.) Constantine, G., Millheiser, L. S., Kaunitz, A. M., Parish, S. J., Graham, S., Bernick, B., Mirkin, S. 2019

  Abstract

  OBJECTIVE: The softgel 17beta-estradiol (E2) vaginal inserts (4 and 10 mug; 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 mug, 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.

  View details for DOI 10.1097/GME.0000000000001394

  View details for PubMedID 31433355

• EFFECTS OF ALCOHOL ADMINISTERED WITH FLIBANSERIN IN HEALTHY PREMENOPAUSAL WOMEN: A RANDOMIZED, DOUBLE-BLIND, SINGLE DOSE, SEVEN-WAY CROSSOVER STUDY Sicard, E., Clayton, A., Simon, J., Parish, S., Millheiser, L., Apfel, S. ELSEVIER SCI LTD. 2019: S15–S16

  View details for DOI 10.1016/j.jsxm.2019.03.490

  View details for Web of Science ID 000469967600034

• THE EFFECT OF EVENING ALCOHOL CONSUMPTION AND BEDTIME ADMINISTRATION OF FLIBANSERIN ON THE SAFETY OF FLIBANSERIN Sicard, E., Clayton, A., Simon, J., Parish, S., Kingsberg, S., Millheiser, L. ELSEVIER SCI LTD. 2019: S38–S39

  View details for Web of Science ID 000469967600085

• THE IMPACT OF THE TIMING OF ALCOHOL CONSUMPTION ON THE SAFETY AND TOLERABILITY OF FLIBANSERIN Sicard, E., Clayton, A., Simon, J., Parish, S., Kingsberg, S., Millheiser, L. ELSEVIER SCI LTD. 2019: S38

  View details for Web of Science ID 000469967600084

• Weight Loss in Women Taking Flibanserin for Hypoactive Sexual Desire Disorder (HSDD): Insights Into Potential Mechanisms. Sexual medicine reviews Simon, J. A., Kingsberg, S. A., Goldstein, I. n., Kim, N. N., Hakim, B. n., Millheiser, L. n. 2019

  Abstract

  Flibanserin, a multifunctional serotonin receptor agonist and antagonist, is currently approved in the United States and Canada for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. A post hoc analysis of HSDD clinical trial data found that flibanserin treatment was associated with statistically significant weight loss relative to placebo, even though study patients were not selected for being overweight/obese and were provided no expectation for weight reduction or interventions intended to promote weight loss.To understand possible mechanisms by which flibanserin may produce weight loss.A literature review was performed using Medline database for relevant publications on the mechanisms of action by which flibanserin may provide weight loss and the links between sexual function and weight management.Examination of (i) biopsychosocial factors regulating sexual desire, food intake, and weight regulation; (ii) clinical pharmacology of flibanserin; (iii) neurobiology of brain reward circuitry; and (iv) identification of possible mechanisms common to flibanserin and weight loss.Based on flibanserin clinical trial data, there was no consistent correlation between weight loss and improvement in sexual function, as assessed by HSDD outcome measures. Nausea, a common adverse event associated with flibanserin use, also did not appear to be a contributing factor to weight loss. Hypothetical links between flibanserin treatment and weight loss include modulation of peripheral 5-HT2A receptors and factors such as improved mood and improved sleep.Mechanisms of flibanserin-induced weight loss have not been well characterized but may involve indirect beneficial effects on peripheral 5-HT2A receptors and central regulation of mood and sleep. Future research may better elucidate the links between sexual function and weight management and the mechanism(s) by which flibanserin use may result in weight loss. Simon JA, Kingsberg SA, Goldstein I, et al. Weight Loss in Women Taking Flibanserin for Hypoactive Sexual Desire Disorder (HSDD): Insights into Potential Mechanisms. Sex Med Rev 2019;XX:XXX-XXX.

  View details for DOI 10.1016/j.sxmr.2019.04.003

  View details for PubMedID 31196764

• Effects of Timing of Flibanserin Administration Relative to Alcohol Intake in Healthy Premenopausal Women: A Randomized, Double-Blind, Crossover Study. The journal of sexual medicine Simon, J. A., Clayton, A. H., Kingsberg, S. A., Parish, S. J., Kim, N. N., Millheiser, L. n. 2019

  Abstract

  Flibanserin is approved in the United States and Canada for the treatment of acquired, generalized, hypoactive sexual desire disorder in premenopausal women. Sedation-related side effects are among the most prevalent adverse events. Although infrequent, hypotension and syncope remain safety concerns because of possible interaction of flibanserin with alcohol.To evaluate the impact of the timing of alcohol consumption on flibanserin safety and tolerability.In this single-center, randomized, double-blind, placebo-controlled, 4-treatment crossover study, 64 healthy premenopausal women (mean age 32.5 ± 8.7 years; range 20‒52 years) received once-daily flibanserin 100 mg or placebo during each of two 10-day treatment periods. Study medication was administered on days 1-3 to achieve steady state. On days 4, 6, 8, and 10, after a standard breakfast, participants consumed 0.4 g/kg ethanol (approximately equivalent to two 5-oz glasses of wine) administered with orange juice 2, 4, or 6 hours before taking study medication or orange juice alone (no ethanol) 2 hours before taking study medication.The primary endpoint was percentage of participants experiencing syncope or orthostatic hypotension-associated adverse events requiring medical intervention. Secondary endpoints included the incidence of hypotension, the incidence of orthostatic hypotension, and rates of adverse events of special interest (syncope, orthostatic hypotension, dizziness, and somnolence).1 participant experienced a primary endpoint event (syncope) during treatment with placebo taken 4 hours after ethanol consumption. Within each ethanol dose-timing treatment, there were no statistically significant differences for flibanserin compared with placebo. Rates of hypotension were 53.3-66.7% after flibanserin dosing and 57.4-63.3% after placebo dosing. Rates for orthostatic hypotension were 0.0-5.0% after flibanserin dosing and 1.7-6.6% after placebo dosing.Ethanol interaction with flibanserin was not observed in this study.This study provides information regarding the use of flibanserin after the consumption of moderate amounts of ethanol (0.4 g/kg). However, daytime administration of flibanserin is not consistent with the drug's indicated bedtime dosing.Flibanserin, at steady state taken 2, 4, or 6 hours after 0.4 g/kg of ethanol intake did not increase the incidence of hypotension, orthostatic hypotension, or syncope compared with either flibanserin alone or ethanol alone. Simon JA, Clayton AH, Kingsberg SA, et al. Effects of Timing of Flibanserin Administration Relative to Alcohol Intake in Healthy Premenopausal Women: A Randomized, Double-Blind, Crossover Study. J Sex Med 2020;XX:XXX-XXX.

  View details for DOI 10.1016/j.jsxm.2019.08.006

  View details for PubMedID 31522985

• Early onset of action with a 17β-estradiol, softgel, vaginal insert for treating vulvar and vaginal atrophy and moderate to severe dyspareunia. Menopause (New York, N.Y.) Constantine, G. n., Millheiser, L. S., Kaunitz, A. M., Parish, S. J., Graham, S. n., Bernick, B. n., Mirkin, S. n. 2019; 26 (11): 1259–64

  Abstract

  The softgel 17β-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.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.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).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.

  View details for DOI 10.1097/GME.0000000000001394

  View details for PubMedID 31688572

• A 17 beta-estradiol, Softgel, Vaginal Capsule (TX-004HR) had an Early Onset of Action for Treating Vulvar and Vaginal Atrophy (VVA) and Moderate-to-Severe Dyspareunia Constantine, G., Millheiser, L. S., Kaunitz, A. M., Graham, S., Bernick, B., Mirkin, S. LIPPINCOTT WILLIAMS & WILKINS. 2018: 1501

  View details for Web of Science ID 000457791300088

• SEX & RELATIONSHIP PEER SUPPORT GROUPS: A MIXED METHOD STUDY ON THE IMPACT ON FEMALE SEXUAL HEALTH Costa, P., Bellin, Z., Canning, T., Blair, B., Millheiser, L. ELSEVIER SCI LTD. 2018: S118

  View details for Web of Science ID 000433425400056

• THE IMPACT OF FIERA plus REMOTE ON FEMALE SEXUAL FUNCTION, RELATIONSHIP SATISFACTION, AND SEXUAL QUALITY OF LIFE Millheiser, L. ELSEVIER SCI LTD. 2018: S118

  View details for Web of Science ID 000433425400055

• The WISDOM Survey: Physicians' Behaviors and Attitudes towards Treating Vulvar and Vaginal Atrophy (VVA) Kingsberg, S. A., Minkin, M., Millheiser, L. S., Graham, S., Bernick, B., Mirkin, S. LIPPINCOTT WILLIAMS & WILKINS. 2017: 1427–28

  View details for Web of Science ID 000423298900047

• Sexual Health and Religion: A Primer for the Sexual Health Clinician JOURNAL OF SEXUAL MEDICINE Spadt, S. K., Rosenbaum, T. Y., Dweck, A., Millheiser, L., Pillai-Friedman, S., Krychman, M. 2014; 11 (7): 1607-1618

  View details for Web of Science ID 000339071200003

• Fertility issues in cancer survivorship. CA: a cancer journal for clinicians Kort, J. D., Eisenberg, M. L., Millheiser, L. S., Westphal, L. M. 2014; 64 (2): 118-134

  Abstract

  Answer questions and earn CME/CNE 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. CA Cancer J Clin 2014;64:118-134. (©) 2013 American Cancer Society.

  View details for DOI 10.3322/caac.21205

  View details for PubMedID 24604743

• Sexual Health Issues in Women with Cancer JOURNAL OF SEXUAL MEDICINE Krychman, M., Millheiser, L. S. 2013; 10: 5-15

  Abstract

  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.This article attempted to characterize the etiology, prevalence, and treatment for sexual health concerns for women with gynecological cancer.A systematic survey of currently available relevant literature published in English was conducted.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.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.

  View details for DOI 10.1111/jsm.12034

  View details for Web of Science ID 000314871200003

  View details for PubMedID 23387907

• Improving women's sexual health: a quantitative evaluation of an educational intervention for healthcare professionals SEX EDUCATION-SEXUALITY SOCIETY AND LEARNING Blair, B., Arnow, B. A., Haas, A., Millheiser, L. 2013; 13 (5): 535-547

  View details for DOI 10.1080/14681811.2013.771774

  View details for Web of Science ID 000343710300005

• Female Sexual Function During Pregnancy and Postpartum JOURNAL OF SEXUAL MEDICINE Millheiser, L. 2012; 9 (2): 635-636

  View details for DOI 10.1111/j.1743-6109.2011.02637.x

  View details for Web of Science ID 000299729900032

  View details for PubMedID 22296607

• Is infertility a risk factor for female sexual dysfunction? A case-control study FERTILITY AND STERILITY Millheiser, L. S., Helmer, A. E., Quintero, R. B., Westphal, L. M., Milki, A. A., Lathi, R. B. 2010; 94 (6): 2022-2025

  Abstract

  To determine the impact of infertility on female sexual function.A case-control study.Academic infertility and gynecology practices.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.Anonymous survey and Female Sexual Function Index.Female Sexual Function Index scores, frequency of sexual intercourse and masturbation, and sex-life satisfaction.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.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.

  View details for DOI 10.1016/j.fertnstert.2010.01.037

  View details for PubMedID 20206929

• Radiofrequency Treatment of Vaginal Laxity after Vaginal Delivery: Nonsurgical Vaginal Tightening JOURNAL OF SEXUAL MEDICINE Millheiser, L. S., Pauls, R. N., Herbst, S. J., Chen, B. H. 2010; 7 (9): 3088-3095

  Abstract

  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.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.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.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.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).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.

  View details for DOI 10.1111/j.1743-6109.2010.01910.x

  View details for PubMedID 20584127

• WOMEN WITH HYPOACTIVE SEXUAL DESIRE DISORDER COMPARED TO NORMAL FEMALES: A FUNCTIONAL MAGNETIC RESONANCE IMAGING STUDY NEUROSCIENCE Arnow, B. A., Millheiser, L., Garrett, A., Polan, M. L., Glover, G. H., Hill, K. R., Lightbody, A., Watson, C., Banner, L., Smart, T., Buchanan, T., Desmond, J. E. 2009; 158 (2): 484-502

  Abstract

  Lack of sexual interest is the most common sexual complaint among women. However, factors affecting sexual desire in women have rarely been studied. While the role of the brain in integrating the sensory, attentional, motivational, and motor aspects of sexual response is commonly acknowledged as important, little is known about specific patterns of brain activation and sexual interest or response, particularly among women. We compared 20 females with no history of sexual dysfunction (NHSD) to 16 women with hypoactive sexual desire disorder (HSDD) in a functional magnetic resonance imaging (fMRI) study that included assessment of subjective sexual arousal, peripheral sexual response using a vaginal photoplethysmograph (VPP), as well as brain activation across three time points. Video stimuli included erotic, sports, and relaxing segments. Subjective arousal to erotic stimuli was significantly greater in NHSD participants compared with HSDD. In the erotic-sports contrast, NHSD women showed significantly greater activation in the bilateral entorhinal cortex than HSDD women. In the same contrast, HSDD females demonstrated higher activation than NHSD females in the medial frontal gyrus (Brodmann area (BA) 10), right inferior frontal gyrus (BA 47) and bilateral putamen. There were no between group differences in VPP-correlated brain activation and peripheral sexual response was not significantly associated with either subjective sexual response or brain activation patterns. Findings were consistent across the three experimental sessions. The results suggest differences between women with NHSD and HSDD in encoding arousing stimuli, retrieval of past erotic experiences, or both. The findings of greater activation in BA 10 and BA 47 among women with HSDD suggest that this group allocated significantly more attention to monitoring and/or evaluating their responses than NHSD participants, which may interfere with normal sexual response.

  View details for DOI 10.1016/j.neuroscience.2008.09.044

  View details for Web of Science ID 000262959900012

  View details for PubMedID 18976696

• Severe vaginal pain caused by a neuroma in the rectovaginal septum after posterior colporrhaphy OBSTETRICS AND GYNECOLOGY Millheiser, L. S., Chen, B. 2006; 108 (3): 809-811

  Abstract

  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.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.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.

  View details for Web of Science ID 000247038500042

  View details for PubMedID 17018512