Effectiveness of Combined Monopolar Radiofrequency and Ultrasound (BTL EXILIS ULTRA 360™) for the Improvement of Dyspareunia Caused by Postpartum Scarring in Women of Childbearing Age: A Study Protoco

STUDY OVERVIEW This research protocol aims to evaluate the effectiveness of monopolar radiofrequency combined with ultrasound in improving dyspareunia caused by scarring following at least one vaginal delivery in women of childbearing age.

IMPACT OF VAGINAL DELIVERY ON TISSUES AND DYSPAREUNIA Vaginal delivery can result in trauma and scarring, leading to subcutaneous adhesions in internal planes, fibrosis, loss of elasticity, and sexual pain (dyspareunia) caused by nerve ending entrapment and traction on adjacent structures. Approximately 70% of women undergoing vaginal delivery experience perineal damage. Obstetric lacerations may lead to chronic pain, dyspareunia, and incontinence. Furthermore, such damage can cause vaginal laxity, altered genital sensitivity, and decreased sexual satisfaction. Pain may persist from the early postpartum weeks into the long term, significantly affecting quality of life.

DYSPAREUNIA: DEFINITION AND EVALUATION Dyspareunia is defined as pain during sexual intercourse; it is subjective and challenging to quantify. In this study, it is evaluated using the Visual Analogue Scale (VAS), which measures pain intensity on a 10 cm line: mild (<3), moderate (4-7), and severe (≥8). The VAS is a validated tool for diagnosing dyspareunia, a condition with higher prevalence in women than men. Dyspareunia can be superficial or deep, negatively impacting quality of life and interpersonal relationships. It is frequently associated with a history of assisted vaginal delivery or pelvic floor surgeries.

CURRENT TREATMENTS FOR DYSPAREUNIA There is limited research on non-invasive treatments specifically targeting postpartum scars. Low-intensity monopolar radiofrequency combined with other physiotherapy techniques has shown to reduce dyspareunia, though often without a specific focus on scarring or chronic pelvic pain. While Botulinum Toxin A shows some evidence of pain reduction at 6 months, data remains limited. A recent study using BTL Exilis 360™ in menopausal women demonstrated improvement in severe dyspareunia caused by Genitourinary Syndrome of Menopause (GSM).

RADIOFREQUENCY AND ULTRASOUND TECHNOLOGIES The Exilis Ultra 360™ device combines ultrasound and radiofrequency, allowing for precise temperature control and greater therapeutic depth. This technology induces neocollagenesis, neoelastogenesis, and neoangiogenesis in vulvovaginal tissues. It improves vaginal laxity and elasticity, strengthening the mucosa and reducing pain. A single procedure may be effective and durable for up to 12 months, with high patient tolerance and no reported adverse effects. The synergy of both technologies allows the target temperature to be reached faster while enhancing the mechanical effect. It is the first device on the market to combine ultrasound and radiofrequency for this clinical indication.