Effectiveness of Radiofrequency Combined With Ultrasound for the Treatment of Postpartum Dyspareunia

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.

The EXILIS ULTRA 360™ treatment is proposed as an effective solution for pain secondary to episiotomy scars. The application of this technology promotes internal remodeling, improves fibrosis and adhesions, and stimulates new collagen and elastin formation, potentially resolving the underlying cause of pain in a high proportion of patients. The device is FDA-approved and holds European certification (CE2460).

RATIONALE AND OBJECTIVE The majority of women undergoing vaginal delivery suffer lacerations and tissue damage in the vulvovaginal area. These lesions and subsequent scarring are primary drivers of dyspareunia. Given the evidence that radiofrequency improves dyspareunia in menopausal women with GSM, and considering the lack of scientific evidence regarding non-invasive treatments for postpartum scarring, this quasi-experimental study aims to demonstrate the effectiveness of this technology in women of childbearing age diagnosed with postpartum scar-related dyspareunia. The investigators hypothesize that this non-invasive regenerative therapy will lead to the resolution of the dyspareunia diagnosis.

METHODOLOGY

Study Design:

A community-based, non-randomized, quasi-experimental study. A pre-post intervention analysis will be conducted, comparing outcomes within the same individual before and after treatment.

Setting:

Specialized outpatient health centers belonging to independently managed public sector institutions.

Target Population:

Women from industrialized countries diagnosed with dyspareunia following at least one vaginal delivery involving an episiotomy or perineal tear.

Study Sample and Recruitment:

The study population consists of women of childbearing age attending the designated medical centers\* who meet the inclusion criteria and provide informed consent to participate.

\*Procrear Medical Center (Reus and Tarragona). Health Center Code: E43924348.

Sample Size Calculation:

Assuming an alpha risk of 0.05 and a statistical power greater than 0.8 in a two-tailed test, a sample size of 34 subjects is required to detect a statistically significant difference of 0.5 units or greater. A common standard deviation of 0.9 is estimated based on previous literature (Fernández-Cuadros et al., 2020). The calculation accounts for an estimated follow-up loss rate (attrition) of 30% DATA COLLECTION AND MANAGEMENT

Recruitment and Informed Consent:

Patients attending the designated centers for pelvic floor or intimate health assessments will be informed about the study and invited to participate. Each potential participant will receive a detailed information sheet and a written informed consent form. Participants may be referred by other healthcare professionals or seek consultation independently, having received prior information during pregnancy, delivery, or the postpartum period.

Screening and Clinical Assessment:

Data collection begins with a clinical history interview to verify fulfillment of the inclusion and exclusion criteria. This is followed by a physical vulvovaginal examination, including visual inspection of the introitus and vaginal mucosa, and digital vaginal palpation. The objective is to diagnose the presence of scarring and localized pain points resulting from vaginal delivery. All findings will be documented in the patient's electronic medical record (EMR).

Intervention and Procedures:

Following the assessment, therapeutic recommendations will be explained. Patients indicated for BTL Exilis Ultra 360™ treatment will decide voluntarily whether to undergo the procedure. Those who agree will receive a secondary specific consent form for the treatment. All clinical activities, including assessments and the intervention, will be performed by the Principal Investigator (PI) at two private specialized centers located in Reus and Tarragona (Center Code: E43924348). To ensure consistency and reduce inter-observer bias, the PI will conduct all baseline and post-treatment evaluations.

DATA MANAGEMENT AND CONFIDENTIALITY All patient data will be recorded in the centers' EMR systems, which are managed by a third-party firm specialized in Data Protection Law compliance. Access to these systems is restricted via secure credentials.

For the purpose of statistical analysis, data will be strictly pseudonymized; participants will be assigned a unique identification code to ensure that no personal identifiers appear in the evaluation tables. Only the Principal Investigator will have access to the master list linking codes to patient identities.

ETHICS AND PRIVACY The Principal Investigator (Lys Garcia Vilaplana) is the data controller and is responsible for ensuring confidentiality in accordance with Organic Law 3/2018 (December 5th) on the Protection of Personal Data and Guarantee of Digital Rights. Participant anonymity will be strictly maintained in all final reports and scientific communications.

INTERVENTION / PROCEDURAL METHODS

Baseline Assessment:

Participants of childbearing age with a history of vaginal delivery and reports of dyspareunia will undergo a detailed clinical history and physical examination (visual and digital vaginal inspection). Participants will be asked to quantify their pain intensity during penetrative sexual intercourse using the validated Visual Analogue Scale (VAS), ranging from 0 to 10.

Treatment Protocol:

Patients diagnosed with dyspareunia will be offered treatment with the BTL EXILIS 360™ (Ultrafemme 360™ version). Upon providing specific informed consent for the procedure and the use of pseudonymized data for research purposes, the following protocol will be implemented:

1. Session 1: Initial treatment application. 2. Interval: A 4-6 week waiting period between sessions. 3. Session 2: Conducted 4-6 weeks after the first session. 4. Mid-point Evaluation: 4-6 weeks after the second session, a follow-up assessment will be performed to re-quantify pain using the VAS. 5. Conditional Session 3: If the VAS score remains ≥ 4 (moderate to severe pain), a third session will be administered immediately. 6. Final Evaluation: 4-6 weeks after the third session (if applicable), a final VAS assessment will be conducted to determine the primary outcome.

Technical Specifications of the Intervention

The treatment utilizes the Exilis Ultra 360™ device, which combines monopolar radiofrequency and ultrasound technology for vaginal application. Following the manufacturer's clinical guidelines, each session consists of:

* Vaginal Application: 8 minutes using the designated internal handpiece. * External Application: 3 minutes prior to and 3 minutes following the internal phase, focusing on the fourchette and introitus. * Power Settings: 80-100 W (as per standardized protocol). * Conductive Medium: A lubricating gel will be used to ensure patient comfort and optimal energy transmission during the internal and introital application.

Data Privacy and Coding:

All participants are protected under the Data Protection Law (LOPD) managed by the clinical centers. For research purposes, each patient will be assigned a unique identification number to ensure that personal identifiers are not used during data collection or analysis ETHICAL CONSIDERATIONS

Informed Consent and Participant Information:

• Obstetric History: Parity [Срок оценки: Baseline (Day 1)]
• Time Since Last Delivery [Срок оценки: Baseline (Day 1)]
• History of Prior Deliveries (Years) [Срок оценки: Baseline (Day 1)]
• Presence of Perineal Scarring [Срок оценки: Baseline (Day 1)]
• Patient Age [Срок оценки: Baseline (Day 1)]