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ESTUDIO CLÍNICO ORIGINAL
Una nueva Terapia de Succión No Farmacológica para la Disfunción Sexual Femenina
Journal of Sex & Marital Therapy: 27: 2001
Resultados de los ensayos clínicos originales, según lo publicado por:
Billups, K; Berman, J; Berman, L;, Metz, M; Glennon, M; Goldstein, I
9 out of 10
Reportó un aumento de la sensibilidad genital después de usar Eros
6 out of 10
Reportó mayor capacidad para llegar al orgasmo después de usar Eros
8 out of 10
Reportó un aumento de la lubricación vaginal después de usar Eros
8 out of 10
Reportó un aumento de la satisfacción sexual general después de usar Eros
CITAS
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A Non-Pharmacological Method to Increase Vaginal Blood Flow in Patients with Sexual Arousal Disorder. [Método no farmacológico para aumentar el flujo sanguíneo vaginal en pacientes con Trastorno de Excitación Sexual]. Rachel N. Pauls, MD; Laura Berman, PhD; Jennifer Berman, MD; Los Angeles, CA. El objetivo de este estudio piloto fue para determinar los efectos del dispositivo Eros Therapy™ en el flujo sanguíneo vaginal.
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A Prospective Duplex Doppler Ultrasonographic Study in Women with Sexual Arousal Disorder to Objectively Assess Genital Engorgement Following Therapeutic Use with Eros Therapy [Un Estudio de Ultrasonido Dúplex Doppler prospectivo en mujeres con Trastorno de Excitación Sexual para evaluar objetivamente la hinchazón genital después del uso terapéutico con Eros Therapy™] . Ricardo Munarriz, Lily Talakoub, Irwin Goldstein; Universidad de Boston, Boston, MA. La finalidad de este estudio prospectivo aprobado por la Junta de Revisión Institucional (IRB) fue obtener información objetiva sobre la eficacia de Eros Therapy™ para aumentar el flujo sanguíneo genital hacia el clítoris tras su uso terapéutico en mujeres con Trastorno de Excitación Sexual.
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1.A new Non-Pharmacological Vacuum Therapy for Female Sexual Dysfunction [Una nueva Terapia de Succión No Farmacológica para la Disfunción Sexual Femenina]. Kevin Billups, M.D., Billups Institute for Sexual Health & Medicine [Instituto Billups para Medicina y Salud Sexual], St. Paul, MN ,Irwin Goldstein, M.D., Universidad de Boston, Boston, MA. El objetivo de este estudio realizado con 32 personas fue determinar si el uso de Eros Therapy™ mejoraba la excitación sexual.
ESTUDIO DE SEGUIMIENTO
Tratando los síntomas del Trastorno de Excitación Sexual Femenina con el dispositivo de Eros Therapy™ para el Clítoris
Journal of Gender Specific Medicine, Vol.4/No. 2, 2001
Estudio de seguimiento publicado por: Wilson, S; Delk, J; Billups, K
8 out of 10
Reportó un aumento de la sensibilidad genital después de usar Eros
6 out of 10
Reportó mayor capacidad para llegar al orgasmo después de usar Eros
7 out of 10
Reportó un aumento de la lubricación vaginal después de usar Eros
9 out of 10
Reportó un aumento de la satisfacción sexual general después de usar Eros
CITAS
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Treating Symptoms of Female Sexual Arousal Disorder With the Eros-Clitoral Therapy Device (Eros Therapy™) [Tratando los síntomas del Trastorno de Excitación Sexual femenina con el dispositivo de Eros Therapy™ para el Clítoris (Terapia Eros™)]. Steve Wilson, M.D. y Barbara Wilson, Urología Wilson, Van Buren, AR. Fueron inscritas diecinueve personas en este estudio, 10 de ellas con síntomas de Disfunción Sexual Femenina y 9 sin Disfunción Sexual Femenina.
INVESTIGACIÓN CLÍNICA
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Treating Symptoms of Female Sexual Arousal Disorder With the Eros-Clitoral Therapy Device (Eros Therapy™) [Tratando los síntomas del Trastorno de Excitación Sexual femenina con el dispositivo de Eros Therapy™ para el Clítoris (Terapia Eros™)]. Steve Wilson, M.D. y Barbara Wilson, Urología Wilson, Van Buren, AR. Fueron inscritas diecinueve personas en este estudio, 10 de ellas con síntomas de Disfunción Sexual Femenina y 9 sin Disfunción Sexual Femenina.
Clinical Study 1: Treating Symptoms of Female Sexual Dysfunction With the Eros Clitoral Therapy Device Expertise This IRB-approved clinical study was conducted by Steven K. Wilson, MD, John R. Delk II, MD, and Kevin L. Billups, MD and presented at Boston University Medical Center. Evidence Twenty women (10 with FSD, 10 without) used the Eros device three or more times per week for six weeks. Outcomes were measured using the Female Intervention Efficacy Index and patient diaries. Women with FSD reported significant improvements in sensation (80%), lubrication (70%), orgasm ability (60%), and sexual satisfaction (90%). Women without FSD showed smaller but measurable improvements. Authority This study reinforced the role of clitoral vacuum therapy as a non-pharmacologic treatment option for women with vascular-related sexual dysfunction. Trust No device-related complications occurred. Limitations included short duration and reliance on subjective measures.
Clinical Study 2: A Non-Pharmacological Method to Increase Vaginal Blood Flow in Sexual Arousal Disorder Expertise This pilot study was conducted by Rachel N. Pauls, MD, Laura Berman, PhD, and Jennifer Berman, MD and presented at the Female Sexual Function Forum. The investigators are recognized authorities in women’s sexual health. Evidence Twelve women with sexual arousal disorder underwent duplex Doppler assessment of vaginal arterial blood flow before and after use of the Eros device. Peak systolic velocity increased significantly from baseline to post-treatment. Importantly, increased vaginal blood flow was observed in both pre- and postmenopausal women. Authority This study demonstrated that clitoral vacuum therapy produces downstream vaginal vascular effects, supporting earlier findings of improved lubrication and arousal. Trust No adverse events occurred. Authors appropriately described the study as preliminary and supportive of further research.
Clinical Study 3: Prospective Duplex Doppler Ultrasonographic Study Assessing Genital Engorgement Expertise This IRB-approved prospective study was conducted by investigators from the Center for Sexual Medicine, Boston University School of Medicine, including Ricardo Munarriz and Irwin Goldstein, leaders in genital vascular physiology research. Evidence Seven women with sexual arousal disorder underwent duplex Doppler ultrasound measurements before and after therapeutic use of the Eros device. Objective measures included clitoral diameter, cavernosal artery peak systolic velocity, end-diastolic velocity, and resistive index. Use of the device resulted in statistically significant increases in clitoral diameter and genital blood-flow velocities, confirming physiologic genital engorgement following treatment. Authority This study provided objective vascular evidence, not just subjective reporting, strengthening the biologic mechanism underlying Eros Therapy. Trust No pain, irritation, or adverse events were reported. Small sample size was noted as a limitation.
Clinical Study 4: Vacuum-Induced Clitoral Engorgement for Treatment of Female Sexual Dysfunction Expertise This study was conducted by sexual-medicine specialists including Kevin L. Billups, Laura Berman, Jennifer Berman, and Irwin Goldstein and was presented at the Female Sexual Function Forum at Boston University Medical Center. These authors are widely published in sexual medicine and urology. Evidence Thirty-two women participated, including 20 with female sexual dysfunction (FSD) and 12 without FSD. Participants used the Eros clitoral vacuum device during partnered or solo sexual activity. Outcomes were assessed using a validated Female Intervention Efficacy Index (FIEI). Women with FSD reported substantial improvements in genital sensation (90%), lubrication (80%), orgasm ability (55%), and sexual satisfaction (80%). Improvements were less pronounced in women without baseline dysfunction. Authority This study contributed early clinical evidence supporting vacuum-induced clitoral engorgement as a physiologically plausible, non-pharmacologic treatment for female sexual dysfunction and informed subsequent FDA clearance. Trust No adverse effects were reported. Authors acknowledged the short-term nature of the study and recommended larger, longer trials.
Clinical Study 5: Clitoral Therapy Device for Alleviating Sexual Dysfunction After Female Genital Mutilation (FGM) Expertise This randomized controlled trial was conducted by a multidisciplinary academic team from Badr University in Cairo, Suez University, Cairo University, and Sinai University. The study was published in JMIR Rehabilitation and Assistive Technologies, a peer-reviewed journal focusing on evidence-based rehabilitative interventions. Evidence Eighty married women aged 20–45 years with sexual dysfunction following Type I female genital mutilation were randomized into two groups. The intervention group received a clitoral therapy device (Eros-CTD) in addition to structured psychosexual education, while the control group received psychosexual education alone for three months. Sexual function was assessed using the validated Arabic version of the Female Sexual Function Index (FSFI). Women using the clitoral therapy device demonstrated statistically significant improvements across all six FSFI domains—desire, arousal, lubrication, orgasm, satisfaction, and pain—compared to baseline. In the control group, improvements were observed in most domains, but orgasm scores did not improve significantly. Authority This trial was registered on ClinicalTrials.gov (NCT05039775), reinforcing transparency and methodological rigor. The device evaluated is FDA-cleared for improving female sexual function, lending regulatory relevance to the findings. Trust No device-related adverse events were reported. Authors concluded that clitoral therapy devices represent a safe, non-invasive rehabilitation option for sexual dysfunction following FGM. Limitations include restriction to Type I FGM and short-term follow-up.
Clinical Study 6: Clitoral Therapy Device for Sexual Dysfunction in Irradiated Cervical Cancer Patients Expertise This pilot clinical study was conducted by clinicians from the University of Chicago, University of Illinois at Chicago, and Northwestern University Schools of Medicine. Results were published in the International Journal of Radiation Oncology, Biology, Physics, a leading peer-reviewed oncology journal. Evidence Thirteen cervical cancer survivors with sexual arousal and/or orgasmic disorders following pelvic radiotherapy used the Eros clitoral therapy device four times weekly for three months. Sexual outcomes were assessed using the Female Sexual Function Index (FSFI), Derogatis Interview for Sexual Functioning (DISF), and gynecologic examinations. Statistically significant improvements were observed across all FSFI domains, with median total scores increasing from 17 to 29.4. DISF scores improved from the lowest decile of normative sexual functioning to the normal range. Objective gynecologic exams demonstrated improved vaginal tissue color, moisture, elasticity, and reduced bleeding. Authority The study builds on FDA clearance of the device and extends its evaluation into cancer survivorship, an area with limited non-pharmacologic treatment options. Trust No conflicts of interest were reported by investigators. The device was well tolerated with no serious adverse effects. Authors appropriately recommend larger randomized trials to confirm findings.
Clinical Study 7: Eros Therapy in Postmenopausal Women Not Using Hormone Replacement Therapy Expertise This clinical study was conducted by investigators affiliated with the University of Chicago, University of Illinois at Chicago, and Northwestern University. Findings were published as an abstract supplement in Obstetrics & Gynecology, a high-impact peer-reviewed journal. Evidence Twenty-two postmenopausal women with female sexual dysfunction who were not receiving hormone replacement therapy used the Eros device four times weekly for three months. Sexual function was evaluated using FSFI, DISF, and gynecologic examinations. Median FSFI scores increased from 16.7 to 28.3, with statistically significant improvements across desire, arousal, lubrication, orgasm, satisfaction, and pain. Objective exams showed improved vaginal mucosal health and elasticity. Authority This study is particularly relevant for women who cannot or prefer not to use estrogen-based therapies, reinforcing the clinical relevance of non-hormonal, FDA-cleared options. Trust No adverse events were reported. As an abstract-level publication, detailed methodology is limited, but results are consistent with larger peer-reviewed studies.
Clinical Study 8: Clitoral Vacuum Suction vs. Vibratory Stimulation in Neurogenic Orgasmic Dysfunction Expertise This randomized controlled trial was conducted at two academic medical centers and published in Archives of Physical Medicine and Rehabilitation, the official journal of the American Congress of Rehabilitation Medicine. Evidence Thirty-one women with multiple sclerosis or spinal cord injury were randomized to clitoral vacuum suction therapy or vibratory stimulation for 12 weeks. Outcomes were measured using FSFI and the Female Sexual Distress Scale (FSDS). Women using clitoral vacuum suction experienced statistically significant improvements across multiple sexual function domains and sustained benefits four weeks after treatment ended. Vibratory stimulation improved orgasm scores only during active use. Authority The trial provides comparative evidence supporting clitoral vacuum therapy for women with complex neurogenic sexual dysfunction, reinforcing its role in rehabilitation medicine. Trust Both interventions were safe. Authors concluded clitoral vacuum therapy may be preferred when multiple sexual domains are affected or when vibration is insufficient.
Clinical Study 9: Eros Device in the Management of Female Anorgasmia (Colombia) Expertise This prospective observational case series was conducted at a specialized sexology clinic in Armenia, Quindío, Colombia, and published in Universidad y Salud, a peer-reviewed academic journal. Evidence Thirty-nine women with primary or secondary anorgasmia used the Eros clitoral therapy device during partnered sexual activity and self-stimulation. Sexual outcomes were assessed using the validated FSFI-6 over an average follow-up of nearly two years. At study completion, 89.7% of participants reported overall satisfaction with treatment. Improvements were sustained over long-term follow-up, and no device-related complications were reported. Authority The study contributes long-term real-world safety and effectiveness data supporting prior controlled clinical trials. Trust Absence of a control group limits causal inference; however, extended follow-up and lack of adverse events strengthen safety confidence.
Sexuality and Reproductive Health in Adults with Spinal Cord Injury Clinical practice guidelines from the Consortium for Spinal Cord Medicine identify external clitoral vacuum devices, including EROS Therapy, as an option that may support arousal and orgasm in women with spinal cord injury. Expertise A publication was developed by the Consortium for Spinal Cord Medicine in collaboration with Paralyzed Veterans of America, with contributions from physicians, rehabilitation specialists, psychologists, nurses, and sexual health experts across major U.S. medical and professional organizations. It is based on the Consortium’s Clinical Practice Guidelines for Health-Care Professionals and is intended to translate evidence-based clinical knowledge into patient-accessible guidance. Evidence The guide provides comprehensive, evidence-informed education on sexuality and reproductive health following spinal cord injury (SCI). In the section addressing genital arousal and orgasm in women, the guide explicitly identifies external sexual assistive devices as a clinically recognized option for enhancing arousal and orgasm when neurologic injury limits sensory or vascular response. Specifically, the guide notes that: External devices that increase genital blood flow may support arousal and orgasm in women with SCI. Increased clitoral blood flow is associated with improved vaginal lubrication and enhanced orgasmic potential This information aligns with physiologic principles of genital vasocongestion and is consistent with findings from peer-reviewed clinical trials evaluating clitoral vacuum therapy in neurogenic populations. Authority The Consortium for Spinal Cord Medicine represents a coalition of leading organizations, including: American Academy of Physical Medicine and Rehabilitation American Congress of Rehabilitation Medicine American Spinal Injury Association U.S. Department of Veterans Affairs Christopher & Dana Reeve Foundation Its guidelines are widely recognized in rehabilitation medicine and are frequently used by clinicians caring for individuals with SCI. The inclusion of EROS Therapy within this authoritative consumer guide places the device within accepted clinical discussions of sexual rehabilitation, rather than promotional or anecdotal contexts. Trust The guide presents Eros Therapy in a balanced, non-commercial manner, emphasizing: Patient education and informed decision-making Physician involvement and prescription requirements Awareness of potential risks, including autonomic dysreflexia in individuals with high-level injuries The importance of individualized clinical evaluation No claims are made that the device is curative or universally effective. Instead, it is framed as one option among several evidence-supported approaches to sexual health after SCI. This conservative positioning reinforces credibility and aligns with best practices for medical guidance.
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