Studies

We are partnering with leading physicians pioneering research in the field of light-emitting diodes (LEDs) and the treatment of pelvic floor disorders and sexual function issues impacting millions of women globally. Highlighted below are important studies we've been a part of, in addition to other studies, white papers and industry articles from luminaries in this field. If you have a proposal for a clinical study, email us at clinicalstudy@joylux.com.

Regulatory clearances and claims vary from country to country. vSculpt is not cleared by the FDA and is not for sale in the US.
  • The Use of Monochromatic Infrared Energy in Wound Management - Joylux

    The Use of Monochromatic Infrared Energy in Wound Management

    Hunter, Susan MSN, RN; Langemo, Diane PhD, RN, FAAN; Hanson, Darlene MS, RN; Anderson, Julie PhD, RN, CCRC; Thompson, Patricia MS, RN

    Monochromatic infrared energy has been used to treat a variety of wounds, including venous ulcers, diabetic ulcers, and recalcitrant dermal lesions. The objective of this article is to describe how infrared therapy impacts cell function and wound healing.

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  • Female sexual function following different degrees of perineal tears - Joylux

    Female sexual function following different degrees of perineal tears

    Waleed Ali Sayed Ahmed, Eman Ahmed Kishk, Rasha Imam Farhan, & Rasha Elsayed Khamees

    Perineal tears may have a negative impact on female sexual function (FSF). The aim of the study was to assess the effect of different degrees of perineal tears sustained during delivery on subsequent FSF.

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  • Investigating the Effect of Perineal Heating Pad on the Frequency of Episiotomies and Perineal Tears in Primiparous Females - Joylux

    Investigating the Effect of Perineal Heating Pad on the Frequency of Episiotomies and Perineal Tears in Primiparous Females

    Fatemeh Alihosseni, Parvin Abedi, Pourandokht Afshary, Mohammad Reza Haghighi, and Najva Hazeghi

    Female reproductive system injury caused after vaginal delivery is very common, and episiotomy and spontaneous tears, or both are the most important contributing factors in this regard... the present study was conducted to determine the effect of perineal heating pad on the frequency of episiotomies and perineal tears in primiparous females.

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  • A Review of Episiotomy and Modalities for Relief of Episiotomy Pain - Joylux

    A Review of Episiotomy and Modalities for Relief of Episiotomy Pain

    Rutuja G. Choudhari, Surekha A. Tayade, Shreya V. Venurkar, and Vaishnavi P. Deshpande

    This review aims to offer the most thorough understanding of episiotomy, its current concept, and episiotomy pain relief, with a particular focus on infrared lamp therapy and sitz baths.

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  • Effect of Infrared Lamp Therapy versus Warm Sitz Bath on Episiotomy Wound Healing and Pain among Puerperal Mothers - Joylux

    Effect of Infrared Lamp Therapy versus Warm Sitz Bath on Episiotomy Wound Healing and Pain among Puerperal Mothers

    Nemat Ismail Abdel Aziz Ismail, Violet Nicola Ghattas

    Based on the findings of this study, it can be concluded that H1 is accepted; while H0, and H2 are rejected, where the puerperal mothers who applied infrared lamp therapy on their episiotomy wound experience faster wound healing and less pain than those who applied warm sitz bath. The application of infrared lamp therapy has a significant effect on reducing episiotomy pain and promoting wound healing among postnatal mothers.

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  • A study to evaluate the effectiveness of infrared lamp therapy on healing of episiotomy wound among postnatal mothers - Joylux

    A study to evaluate the effectiveness of infrared lamp therapy on healing of episiotomy wound among postnatal mothers

    Ms. Prabhjot Kaur, Mrs. Anita Prakasam, Mrs.Varinderdeep Kaur

    The findings revealed that there was improvement in overall healing of episiotomy wound in experimental group as compared to control group. There was a statistically significant difference between the pre-test and post- test healing score of episiotomy wound between experimental group and control group significant at=14.607(p<0.05). Hence the research (H1.1) hypothesis was accepted.

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  • Multimodal Vaginal Toning for Bladder Symptoms and Quality of Life in Stress Urinary Incontinence - Joylux

    Multimodal Vaginal Toning for Bladder Symptoms and Quality of Life in Stress Urinary Incontinence

    Sarah de la Torre, MD and Larry E. Miller, PhD

    Treatment options for women with stress urinary incontinence (SUI) have limitations. We hypothesized that multimodal vaginal toning therapy would improve bladder symptoms and quality of life in women with postpartum SUI and sexual function complaints.

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  • The Rationale for Photobiomodulation Therapy of Vaginal Tissue for Treatment of Genitourinary Syndrome of Menopause - Joylux

    The Rationale for Photobiomodulation Therapy of Vaginal Tissue for Treatment of Genitourinary Syndrome of Menopause

    Raymond J. Lanzafame, MD, Sarah de la Torre, MD, Gustavo H. Leibaschoff, MD

    “The Rationale for Photobiomodulation Therapy of Vaginal Tissue for Treatment of Genitourinary Syndrome of Menopause: An Analysis of Its Mechanism of Action, and Current Clinical Outcomes,” published in the July issue of Photobiomodulation, Photomedicine, and Laser Surgery, one of the leading peer-reviewed medical journals for energy-based devices.

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  • Pelvic Floor Disorders: Epidemiology and Pathophysiology and New Treatment Options - Joylux

    Pelvic Floor Disorders: Epidemiology and Pathophysiology and New Treatment Options

    Sarah de la Torre, MD and Jeff Muir, MD

    The female pelvic floor is composed of the musculature, soft tissues, and connective tissues providing structural support for the bowel, bladder, uterus, and other pelvic organs. Disorders affecting one or more of these organs, broadly referred to as pelvic floor disorders(PFDs), are a common occurrence following pregnancy, childbirth—in particular vaginal deliveries—and menopause. The weakening of the pelvic floor or relaxation of the vaginal muscles, also referred to as vaginal relaxation syndrome (VRS), is one of the most common PFDs. VRS causes a loss of voluntary muscle control and decreased vaginal sensation, impacting urinary control and sexual function. Distention of the vaginal wall musculature leads to a cascade of cellular changes that ultimately weaken impact protein and collagen metabolism, thus resulting in patient morbidity. Another common consequence associated with aging, especially after menopause, is vaginal atrophy (VA), when estrogen deprivation accelerates the process of deterioration of vaginal tissue, leading to vaginal dryness and irritation, among other conditions. While the health implications of these problems are significant, they also negatively impacts self-esteem and quality of life for women.

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  • Device-Based Treatment for Vaginal Wellness Manuscript - Joylux

    Device-Based Treatment for Vaginal Wellness Manuscript

    Macrene Alexiades, MD, PhD1,2

    An at-home transvaginal device (vSculpt/VFit, Joylux) uses light-emitting diodes (LEDs) in the red and infrared range (662-855 nm) to heat the vaginal surface to 41 °C (38.6 °C- 44.1 °C). The device also employs vibration at 80 to 110 Hz for up to 10-minute treatment sessions. Improvement in UI showed 84% of patients with >50% improvement, with a reduction in the 1-hour median pad weight test from 18 g to 0 g.38 On the UDI and Incon- tinence Impact Questionnaire Short Form (IIQ), UDI improved by >50% in 92% of patients, and IIQ improved in 85% of patients and decreased in 69%. On the FSFI and FSDS, improvements in 77% and 81% of patients, respectively, were reported. Patient satisfaction was rated as moderate to extreme at 83%.38 On histology, increases in collagen and elastin production in cells by irradiated fibroblasts were observed. This production was proportional to the duration of exposure.

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  • Beyond Kegels. The Vaginal Rejuvenation Movement. - Joylux

    Beyond Kegels. The Vaginal Rejuvenation Movement.

    Wendy Lewis

    Discouraged by the limitations of Kegels, HRT, and Poise®, a record number of women are seeking procedures that address both their functional concerns, and the myriad of changes that accompany childbirth and ageing. Women are becoming more empowered to take steps to improve their health, confidence, and sex lives.

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  • Fractional Co2 Laser Treatment of the Vulva and Vagina and the Effect of Postmenopausal Duration on Efficacy - Joylux

    Fractional Co2 Laser Treatment of the Vulva and Vagina and the Effect of Postmenopausal Duration on Efficacy

    Macrene R. Alexiades, MD, PhD
    Dermatology and Laser Surgery Center of New York, Yale University School of Medicine, New York, New York

    More studies are needed to assess the long‐term safety profile and clinical out- comes of lasers and energy‐based devices to treat the symptoms associated with vulvovaginal atrophy. This study evaluated a series of three fractional CO2 laser treatments to the vulva and vagina with a 1‐year follow‐ up in a postmenopausal population.

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  • Vaginal Rejuvenation Using Energy-Based Devices - Joylux

    Vaginal Rejuvenation Using Energy-Based Devices

    Cheryl Karcher, MD and Neil Sadick, MD

    Physiologic changes in a woman’s life, such as childbirth, weight fluctuations, and hormonal changes due to aging and menopause, may alter the laxity of the vaginal canal, damage the pelvic floor, and devitalize the mucosal tone of the vaginal wall. These events often lead to the development of genitourinary conditions such as stress urinary incontinence; vaginal atrophy; dryness; and physiologic distress affecting a woman’s quality of life, self-confidence, and sexuality. Various treatment modalities are currently available to manage these indications, varying from invasive vaginal surgery to more benign treatments like topical vaginal hormonal gels or hormone-replacement therapy. A new trend gaining momentum is the advent of energy-based devices for vaginal rejuvenation that apply thermal or nonthermal energy to the various layers of the vaginal tissue, stimulating collagen regeneration contracture of elastin fibers, neovascularization, and improved vaginal lubrication. This review aims to present the available technologies offering vaginal rejuvenation and the scientific evidence that underlines their safety and efficacy for this indication.

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  • Mechanisms and applications of the anti-inflammatory effects of photobiomodulation - Joylux

    Mechanisms and applications of the anti-inflammatory effects of photobiomodulation

    Michael R Hamblin
    AIMS Biophysics

    Photobiomodulation (PBM) also known as low-level level laser therapy is the use of red and near-infrared light to stimulate healing, relieve pain, and reduce inflammation. The primary chromophores have been identified as cytochrome c oxidase in mitochondria, and calcium ion channels (possibly mediated by light absorption by opsins). Secondary effects of photon absorption include increases in ATP, a brief burst of reactive oxygen species, an increase in nitric oxide, and modulation of calcium levels. Tertiary effects include activation of a wide range of transcription factors leading to improved cell survival, increased proliferation and migration, and new protein synthesis. There is a pronounced biphasic dose response whereby low levels of light have stimulating effects, while high levels of light have inhibitory effects. It has been found that PBM can produce ROS in normal cells, but when used in oxidatively stressed cells or in animal models of disease, ROS levels are lowered. PBM is able to up-regulate anti-oxidant defenses and reduce oxidative stress. It was shown that PBM can activate NF-kB in normal quiescent cells, however in activated inflammatory cells, inflammatory markers were decreased. One of the most reproducible effects of PBM is an overall reduction in inflammation, which is particularly important for disorders of the joints, traumatic injuries, lung disorders, and in the brain. PBM has been shown to reduce markers of M1 phenotype in activated macrophages. Many reports have shown reductions in reactive nitrogen species and prostaglandins in various animal models. PBM can reduce inflammation in the brain, abdominal fat, wounds, lungs, spinal cord.

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  • The Nuts and Bolts of Low-Level Laser (Light) Therapy - Joylux

    The Nuts and Bolts of Low-Level Laser (Light) Therapy

    Hoon Chung, Tianhong Dai PhD, Sulbha K. Sharma, Ying-Ying Huang, James D. Carroll, and Michael R. Hamblin

    Soon after the discovery of lasers in the 1960s it was realized that laser therapy had the potential to improve wound healing and reduce pain, inflammation and swelling. In recent years the field sometimes known as photobiomodulation has broadened to include light-emitting diodes and other light sources, and the range of wavelengths used now includes many in the red and near infrared. The term “low level laser therapy” or LLLT has become widely recognized and implies the existence of the biphasic dose response or the Arndt-Schulz curve. This review will cover the mechanisms of action of LLLT at a cellular and at a tissular level and will summarize the various light sources and principles of dosimetry that are employed in clinical practice. The range of diseases, injuries, and conditions that can be benefited by LLLT will be summarized with an emphasis on those that have reported randomized controlled clinical trials. Serious life-threatening diseases such as stroke, heart attack, spinal cord injury, and traumatic brain injury may soon be amenable to LLLT therapy.

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  • LED-Low Level Light Therapy in Aesthetic Practice - Joylux

    LED-Low Level Light Therapy in Aesthetic Practice

    R. Glen Calderhead, MSc PhD and David B. Vasily, MD

    Before discussing either the photobiological basics or clinical applications of light-emitting diode photo-therapy for the ageing face, the author believes that the title itself raises three major questions to which the reader needs an answer prior to proceeding. First, what is ‘low level light therapy?’ Second, what are light-emitting diodes (LEDs)? And third, what is the rationale behind using LEDs in phototherapy (or photobiomodulation) when there are other well-established light sources such as laser diodes, filtered xenon lamps, and even defocused surgical lasers? With these three pivotal points having been addressed, the application of this non-invasive modality in clinical practice, particularly in photorejuvenation of the ageing face, can then be discussed together with the science behind it.

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  • Low-Level Laser (Light) Therapy (LLLT) in Skin: Stimulating, Healing, Restoring - Joylux

    Low-Level Laser (Light) Therapy (LLLT) in Skin: Stimulating, Healing, Restoring

    Pinar Avci, MD, Asheesh Gupta, PhD, Magesh Sadasivam, MTech, Daniela Vecchio, PhD, Zeev Pam, MD, Nadav Pam, MD, and Michael R. Hamblin, PhD

    Low-level laser (light) therapy (LLLT) is a fast-growing technology used to treat a multitude of conditions that require stimulation of healing, relief of pain and inflammation, and restoration of function. Although skin is naturally exposed to light more than any other organ, it still responds well to red and near-infrared wavelengths. The photons are absorbed by mitochondrial chromophores in skin cells. Consequently, electron transport, adenosine triphosphate nitric oxide release, blood flow, reactive oxygen species increase, and diverse signaling pathways are activated. Stem cells can be activated, allowing increased tissue repair and healing. In dermatology, LLLT has beneficial effects on wrinkles, acne scars, hypertrophic scars, and healing of burns. LLLT can reduce UV damage both as a treatment and as a prophylactic measure. In pigmentary disorders such as vitiligo, LLLT can increase pigmentation by stimulating melanocyte proliferation and reduce depigmentation by inhibiting autoimmunity. Inflammatory diseases such as psoriasis and acne can also be managed. The noninvasive nature and almost complete absence of side effects encourage further testing in dermatology.

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