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Vacuum-Induced Clitoral Engorgement for Treatment of Female Sexual Dysfunction

Presented at the Female Sexual Function Forum, Boston University Medical Center, October 2000, Boston, MA

Kevin L. Billups, Laura Berman, Jennifer Berman, Michael E. Metz, Margaret E. Glennon, and Irwin Goldstein. Corresponding author: 7455 France Ave. S., PMB 362, Centennial Lakes Plaza, Edina, MN 55435

Introduction: We recently tested a small, battery powered, hand held clitoral vacuum device, the Eros Therapy™ (NuGyn, Inc.). The Eros Therapy is designed to increase blood flow to the clitoris, enhance clitoral engorgement, and ultimately improve arousal in women with Female Sexual Dysfunction (FSD). The objective of this study was to obtain short-term data concerning sexual arousal with the use of the device in women with and without female sexual dysfunction.

Methods: A total of 32 subjects, 20 with FSD (9 pre-menopausal, 11 post-menopausal) and 12 without FSD (10 pre-menopausal, 2 post-menopausal) were studied. In-office instructions concerning device use were provided. Subjects were instructed to use the device with or without a partner. Subjects placed the device over the clitoris and adjusted the vacuum level (maximum 9.8 ” Hg) for an amount of time (5-15 minutes) based on their own satisfaction and arousal. Outcome efficacy was assessed by a 5 item Female Intervention Index (FIEI) which subjectively assessed changes in sensation, lubrication, orgasm and sexual satisfaction.

Results: The following table summarizes the study results. Changes in sensation, lubrication, ability to achieve orgasm and sexual satisfaction were evaluated after using the Eros Therapy.

Evaluated Parameter
With FSD
Without FSD
Greater Sensation
90%
58%
Increased Lubrication
80%
33%
Increased Ability to Achieve Orgasm
55%
42%
Increased Sexual Satisfaction
80%
25%

In addition, comparing post- to pre-menopausal FSD subjects, greater improvement in achieving orgasm was experienced by (post-) 64% vs. (pre-) 44%. No side effects were noted with use of the device.

Conclusions: Preliminary short-term safety and efficacy data in a limited sample of subjects with and without FSD revealed improvements in sexual arousal response in FSD subjects. This improvement in response is perhaps directly related to an increase in clitoral blood flow and indirectly to activation of an autonomic reflex that triggers vaginal arterial vasodilatation with increases in vaginal engorgement and lubrication. Normal subjects exhibited only limited improvement in sexual arousal. Further studies in larger subject populations followed for longer periods of study are indicated.

 

A Prospective Duplex Doppler Ultrasonographic Study in Women with Sexual Arousal Disorder to Objectively Assess Genital Engorgement Following Therapeutic Use with the Eros Therapy

Munarriz-Talakoub-Goldstein Study

Presented at the Female Sexual Function Forum, October 2001, Boston, MA

Elizabeth Flaherty, Scott Maitland, Sandra P. Garcia Ricardo Munarriz, Lily Talakoub, and Irwin Goldstein. Center for Sexual Medicine. Department of Urology, Boston University School of Medicine

INTRODUCTION: The Eros Therapy is a FDA-approved device for the treatment of women with sexual dysfunction. The device provides three levels of gentle vacuum suction (low, medium and high) during application to the glans clitoris. In women with sexual arousal disorder, use of Eros Therapy has been shown to improve sexual function and satisfaction.

PURPOSE: The aim of this prospective, IRB-approved study was to obtain objective information regarding the effectiveness of the Eros Therapy to increase genital blood flow to the clitoris following therapeutic use in women with sexual arousal disorder.

METHODS: Seven patients with sexual arousal disorder completed questionnaires (Female Sexual Function Index) and were instructed as to the use of the Eros Therapy device. Instructions included correct placement of the device over the clitoris, using the device at the lowest vacuum setting for approximately 10 seconds, and, if there was no discomfort, using the device at different vacuum settings. Subjects then completed a diary recording a minimum of 4 home use therapies and until they felt comfortable with the device. During the second office visit, subjects underwent a baseline duplex Doppler ultrasound, similar to the one they underwent during the initial office visit for assessment of sexual dysfunction. The following ultrasound variables were recorded: clitoral shaft diameter in the region of the suspensory ligament, right cavernosal artery peak systolic, end diastolic velocity and resistive index values, right corpus spongiosum diameter, right corpus spongiosum artery peak systolic, end diastolic velocity and resistive index values. Subjects then privately utilized the Eros Therapy for approximately 10 minutes of therapeutic use. Following the post-Eros Therapy ultrasound study, a brief physical examination was then performed.

RESULTS: All seven subjects (mean age 45, range 25–63 years; mean height 1.65 ± 6.3 (1.57–1.72) meters, mean weight of 69.1 ± 12.2 (63–69) kg) met inclusion and exclusion criteria including having normal hormonal values at the time of the study (mean total testosterone 42.4 ng/dl (normal 15–70 ng/dl); bioavailable testosterone 2.61 ng/dl (normal 0.6–5.0 ng/dl); mean estradiol 82.8 pg/ml; mean estrone 60 pg/ml). All subjects were receiving androgen replacement therapy. A total of 4 subjects were pre-menopausal and three were post-menopausal. The mean duration of clinical symptoms of sexual dysfunction until presentation was 7 ± 10 years. Varying degrees of clitoral phimosis were present in 29%. The mean FSFI scores were 57 ± 16.4 /95. All seven subjects were able to comfortably operate the device and 6/7 used only 4 home sessions until comfort with the device was reached. All seven reported either slight–moderate pleasure or orgasm at home with the device. Pleasure from the therapy lasted seconds, 1–10 minutes, and 10 minutes to 1 hours following release of the vacuum in 2, 3 and 2 subjects, respectively. There were no adverse events observed including clitoral or labial pain, discomfort, irritation, or increased sensitivity. The pre and post Eros Therapy ultrasound values are presented in table 1. There were no differences in the hemodynamic increases of those with and without clitoral phimosis. The increase in pre- and post-arousal corpus spongiosum diameter directly correlated (p = 0.04) with an increase in both the pre- and post-arousal corpus spongiosum end diastolic velocity values.

Baseline
Post Eros Therapy
P-value
Clitoral diameter (cm)
0.9 ± 0.2 (0.8–1.3)
1.2 ± 0.2 (1–1.5)
0.005
R Clitoral Art PSV (cm/sec)
7.1 ± 6 (0–13.8)
26.2 ± 16 (15–60.9)
0.01
R Clitoral Art EDV (cm/sec)
2.1 ± 1.5 (0–3.4)
8.4 ± 8.4 (2.8–26.3)
0.05
R Clitoral Art RI
0.48 ± 0.34 (0–0.84)
0.71 ± 0.11 (0.57–0.87)
0.23
R Corp. Spong. diameter (cm)
1.2 ± 0.3 (0.9–1.7)
1.6 ± 0.3 (0.8–1.3)
0.003
R Corp. Spong. Art PSV (cm/sec)
9.4 ± 9.3 (0–27.7)
21.0 ± 15 (10–50.8)
0.02
R Corp. Spong. Art EDV (cm/sec)
4.1 ± 3.8 (0–10.9)
7.1 ± 5.7 (2.1–19.1)
0.04
R Corp. Spong. RI
0.4 ± 0.28 (0–0.62)
0.66 ± 0.11 (0.51–0.80)
0.1

CONCLUSIONS: A prospective Duplex Doppler ultrasound study in women with sexual arousal disorder has shown that Eros Therapy is associated with significant increases in clitoral and corpus spongiosum diameter as well as clitoral and corpus spongiosum peak systolic and end-diastolic velocity values.

 

A NON-PHARMACOLOGICAL METHOD TO INCREASE VAGINAL BLOOD FLOW IN PATIENTS WITH SEXUAL AROUSAL DISORDER

Rachel N Pauls, MD, Laura Berman, PhD, and Jennifer Berman, MD

Presented at the Female Sexual Function Forum, October 2001, Boston, MA

Introduction

A relationship between low genital blood flow and sexual arousal disorder has been suggested. The vacuum clitoral therapy device (Eros Therapy) is a non-pharmacological device that has been shown to improve genital sensation, vaginal lubrication, orgasm and overall satisfaction. While the device increases clitoral blood flow via a gentle vacuum, it is unclear whether this affects vaginal blood flow. The goal of this pilot study was to determine effects of the Eros-Therapy on vaginal blood flow.

Methods

Twelve patients with complaints of sexual arousal disorder were evaluated. All patients completed a Sexual Distress Scale. Vaginal arterial blood flow was measured using Duplex Doppler ultrasonography. Peak systolic and end-diastolic velocities were recorded at baseline and following application with the Eros Therapy. The device was placed over the clitoris and the vacuum was adjusted (max 9.8 inHg) over 5-10 minutes. Data was analyzed using a standard two-tailed test.

Results

Mean age of study participants was 40 (+/-15) with a range of 25-68. Mean performance on the Sexual Distress Scale was 37 (+/- 8.8) of a possible 48. Seven patients were premenopausal and five were postmenopausal. Mean peak systolic velocity was 29.26cm/sec (+/- 8.35) at baseline and 47.27cm/sec (+/- 23.07) post application with the Eros-Therapy (p<0.009). Differences in post application vaginal blood flow measurements between premenopausal and postmenopausal women were not significant.

Conclusions

The Eros Therapy causes a significant increase in vaginal blood flow in pre and postmenopausal women with sexual arousal disorder. This supports previous data demonstrating that use of the device increases vaginal lubrication and sexual arousal.

References: Billups KL, Berman L, Berman J, Metz ME, Glennon ME, Goldstein I. A New Non-Pharmacological Vacuum Therapy for Female Sexual Dysfunction. Journal of Sex and Marital Therapy, 27, 2001.

 

Treating Symptoms of Female Sexual Dysfunction with the EROS-Clitoral Therapy Device

Presented at the Female Sexual Function Forum, Boston University Medical Center, October 2000
Boston, MA

Steven K. Wilson, M.D., John R. Delk II, M.D. and Kevin L. Billups, M.D., 2010 Chestnut St., Suite A, Van Buren, AR 72956

Introduction: The EROS-Clitoral Therapy Device (CTD) is a new treatment for Female Sexual Dysfunction (FSD) caused by decreased blood flow to the genitalia. The Eros Therapy™ increases clitoral engorgement when a gentle vacuum is applied to the clitoris. The goal of the study was to evaluate the effectiveness of the Eros Therapy in enhancing subjective parameters of sexual response including sensation, lubrication, orgasm and overall sexual satisfaction in women with and without FSD.

Methods: Twenty women, 10 with FSD and 10 with no complaints of FSD, were enrolled in the IRB-approved study. A complete medical history was taken and a physical and pelvic exam performed. Subjects were included in the FSD group if they had arousal disorder with or without low sexual desire. Outcome efficacy was assessed by the Female Intervention Efficacy Index (FIEI) that subjectively assessed changes in sensation, lubrication, orgasm and sexual satisfaction.

A female nurse instructed the subjects in the proper and safe use of the device. The device was used three or more times per week for a period of six weeks. Each session lasted for a period of 3 to 5 minutes, during which the vacuum was alternately applied to the clitoris and then released. Subjects released the vacuum depending on their level of comfort and arousal. A diary was kept documenting use of the device, clitoral and labial engorgement, lubrication, orgasm and changes in sexual satisfaction. The subject returned to the office for a follow-up visit at the end of the six weeks.

Results: The following table summarizes the study results. Changes in sensation, lubrication, ability to achieve orgasm and sexual satisfaction were evaluated after using the Eros Therapy. Nineteen subjects completed the study with one subject lost to follow-up.

Evaluated
Women with FSD,
n=10
Women with no Complaints of FSD, n=9
More than before
Same
More than before
Same
Sensation
80%
20%
89%
11%
Lubrication
70%
30%
67%
33%
Ability to achieve orgasm
60%
40%
78%
22%
Sexual satisfaction
90%
10%
89%
11%

Conclusions: Use of the Eros Therapy resulted in statistically significant changes in sensation, lubrication, ability to achieve orgasm and sexual satisfaction in both women with FSD and without complaints of sexual dysfunction. This improvement in response is perhaps directly related to an increase in clitoral blood flow and indirectly to activation of an autonomic reflex that triggers vaginal arterial vasodilatation with increases in vaginal engorgement and lubrication. This device gives physicians the ability to prescribe a non-pharmacological treatment for patients experiencing symptoms of FSD.

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Eros Therapy: A desirable solution.

Eros Therapy is a device that provides a natural way to recondition your sexual response. It was cleared by the FDA in April 2000 to treat sexual arousal and orgasmic disorders. Since then, thousands of women have experienced the benefits of Eros Therapy that include: increased lubrication, clitoral sensation, ability to achieve an orgasm, and overall improvement in sexual satisfaction.

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