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

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

The objective of this community-based, non-randomized, quasi-experimental study is to assess the effectiveness of BTL EXILIS technology-based on combined radiofrequency and ultrasound-in women of childbearing age from an industrialized country with a diagnosis of dyspareunia following vaginal delivery.

The primary research question is:

- Do patients experience a resolution of pain during sexual intercourse after completing the treatment?

The researcher will compare the level of pain during intercourse-following at least one vaginal delivery involving a tear or episiotomy-before and after exposure to the BTL Exilis treatment in the same individual.

Participants:

• Assessment following childbirth with perineal involvement (tear or episiotomy) and presenting with dyspareunia.
• Verification of fulfillment of inclusion criteria.
• Decision on whether to undergo treatment, following a briefing by the researcher on the process and the signing of the informed consent form for study participation.
• Follow-up assessment one and a half months after completing the treatment.

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:

All participants who agree to take part will be fully briefed on the study's objectives and all activities related to their involvement. They will be provided with a patient information sheet detailing the study and the specific use of the treatment, along with an Informed Consent Form (ICF) which must be signed prior to enrollment.

Confidentiality and Data Protection:

The study guarantees compliance with current legal frameworks to ensure the absolute confidentiality of participants. This protection covers everything from the execution phase to the publication of scientific results, restricting access to clinical information solely under the internal protocols of the Procrear Center

Institutional Approval and Oversight:

The project has been formally approved and is overseen by the Clinical Research Ethics Committee (CEIC) of the Pere Virgili Health Research Institute (IISPV). All recommendations issued by the committee have been incorporated into the study protocol.

EXPECTED OUTCOMES

Clinical Efficacy and Evidence Generation:

Upon completion of this study, the investigators expect to provide robust evidence regarding the use of combined/synergistic radiofrequency and ultrasound therapy for women suffering from dyspareunia. The study aims to demonstrate that this intervention leads to a clinically significant reduction in pain during penetrative sexual intercourse.

Primary Objectives and Diagnostic Resolution:

The anticipated results are expected to show a significant decrease in pain scores, with a final Visual Analogue Scale (VAS) score of less than 4. Achieving this threshold would indicate a successful therapeutic response and the potential resolution of the dyspareunia diagnosis in the study population.

Scientific Contribution and Healthcare Impact:

This research aims to bridge a critical gap in the literature by evaluating the evolution of vaginal and perineal scarring-a condition that remains understudied in childbearing-age women. By documenting tissue response and clinical recovery over the study period, this intervention will provide high-quality scientific evidence on the effectiveness of non-invasive regenerative technology. These findings are intended to offer relevant data for health policy decision-making and the optimization of clinical practice both locally and in broader healthcare contexts.

APPLICABILITY AND STUDY LIMITATIONS

Clinical Applicability:

This research aims to provide robust evidence on the clinical utility of combined radiofrequency and ultrasound technology for treating dyspareunia caused by tissue tearing and scarring following at least one vaginal delivery. If the intervention's effectiveness is demonstrated, these findings could lead to a standardized treatment protocol for women diagnosed with postpartum dyspareunia. To date, there are no published studies evaluating the use of BTL EXILIS Ultra 360™ specifically for this indication in women of childbearing age.

Potential Limitations:

The study identifies three primary constraints that may impact the results:

Selection Bias: Recruitment is limited to volunteers seeking specialized care, which may not fully represent all women with postpartum dyspareunia.

Motivational and Socioeconomic Factors: Participants may have higher motivation or resources than the general population; however, data will be statistically analyzed to control for these variables.

Generalizability: As a quasi-experimental study in specific centers, results provide a foundational evidence base rather than a universal clinical standard TIMELINE AND WORK PLAN The project involves a structured operational plan running from 2022 to 2026, encompassing a comprehensive literature review, protocol design, and ethical approval from the IISPV CEIm committee. Clinical execution, including participant recruitment and data collection, is scheduled for March to December 2026, followed by analysis and dissemination of results RELEVANT BIBLIOGRAPHY The study incorporates an extensive list of scientific articles and clinical trials focused on pelvic floor muscle (PFM) dysfunctions, functional assessment techniques, and the clinical application of electromagnetic stimulation in postpartum recovery.

Inclusion Criteria:

• Women of childbearing age
• Medical history of at least one prior vaginal delivery
• Reported persistent pain during penetrative sexual intercourse
• Meeting the clinical criteria for dyspareunia
• Moderate to severe pain level, defined as a score of 4 or higher on the Visual Analogue Scale (VAS 0-10)
• Eligible patients must demonstrate a moderate to severe pain level, defined as a VAS score of 4 or higher
• No restriction on the time elapsed between the last delivery and the current clinical diagnosis.

Exclusion Criteria:

• Contraindications to the study treatment. Women with any medical condition that precludes the use of the study technology
• Non-postpartum dyspareunia