clinical studies/ research

We are partnering with leading physicians pioneering research in the field of light-emitting diodes (LEDs) and the treatment of pelvic floor disorders 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 clinicalstudies@joyluxinc.com.

Not all the products highlighted below are available for sales in the US. Regulatory clearances and claims vary from country to country. 


 
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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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Histological Outcomes in the Treatment of Vulvovaginal Atrophy Using Photobiomodulation Technology

Gustavo H Leibaschoff, MD; Sarah de la Torre, MD

Photobiomodulation (PBM) has become a popular modality to treat a multitude of medical conditions either as a stand-alone or an adjunctive therapy given the technologies’ ability to stimulate tissue healing, restore cellular function, and relieve pain and inflammation. Early clinical work using PBM for the treatment of vulvovaginal atrophy (VVA)—a medical condition affecting millions of postmenopausal women—suggests that patients can benefit from this therapeutic modality. While research to date has focused on subjective outcomes such as quality of life (QoL) questionnaires, lack of vaginal histological data post PBM treatment raises skepticism about clinical effectiveness.


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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 elf-esteem and quality of life for women.


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

Hoon ChungTianhong Dai PhDSulbha K. SharmaYing-Ying HuangJames 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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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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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.