HIFEM in Pospartum (High Intensity Focused Electro-Magnetic Technology)

BACKGROUND AND SCIENTIFIC RATIONALE The pelvic floor muscles (PFM) constitute a critical functional unit that frequently undergoes weakening due to cumulative risk factors over time. This degradation often leads to clinical conditions such as urinary incontinence (UI), sexual dysfunction, pelvic organ prolapse (POP), and other urogenital symptoms. Among these factors, pregnancy and childbirth (specifically vaginal delivery) are identified as the most significant contributors to PFM strength depletion. Scientific evidence indicates that mechanical trauma-such as levator ani tears, episiotomy, or the use of forceps-alongside increased intra-abdominal pressure during gestation and postpartum hormonal changes (including reduced collagen production), significantly compromise muscular tonicity and structural integrity.

TECHNOLOGY AND MECHANISM OF ACTION In 2018, the U.S. Food and Drug Administration (FDA) cleared the BTL EMSELLA device, utilizing High-Intensity Focused Electromagnetic (HIFEM) technology, for the treatment of urinary incontinence resulting from pelvic floor muscle weakness. Unlike conventional vaginal electrostimulation or voluntary Kegel exercises, HIFEM technology induces supramaximal muscle contractions, recruiting a higher percentage of muscle fibers than is physiologically possible through voluntary effort. This process promotes muscular hypertrophy, hyperplasia, increased vascularization, and neuromodulation. The stimulation is deep, homogeneous, and non-invasive, allowing for a painless, operator-independent treatment that can be performed while the patient remains fully clothed.

STUDY OBJETIVES AND HYPOTHESIS While current literature provides evidence of HIFEM efficacy in symptomatic women, there is a clinical interest in evaluating its preventive potential. Since pregnancy and childbirth are primary debilitating factors, this community-based clinical trial aims to evaluate the effectiveness of HIFEM technology as an early intervention in postpartum women who have been exposed to these risk factors for the first time but remain asymptomatic.

The study is designed to compare an experimental group receiving the HIFEM treatment protocol against a control group receiving standard care. The primary objective is to verify the efficacy of this technology in improving PFM tone and functional recovery in patients with muscle weakness prior to the onset of clinical symptoms. The investigator hypothesize that early application (recommended between 6 and 12 weeks postpartum) will result in a statistically significant improvement in muscle strength and a reduction in the long-term risk of urogenital dysfunction compared to the control group

METHODOLOGY Study Design This is a non-randomized, community-based clinical trial designed to compare two distinct cohorts. The Intervention Group will receive the treatment protocol utilizing High-Intensity Focused Electromagnetic (HIFEM) technology, while the Control Group will follow standard postpartum observation without the HIFEM intervention.

Setting The study will be conducted in specialized consultation health centers belonging to independently managed institutions within the public sector. Specifically, the clinical activities will take place at the Procrear Medical Centers located in Reus and Tarragona (Healthcare Center Code: E43924348).

Reference Population and Study Population The reference population consists of primiparous women from industrialized countries who have completed the postpartum period (quarantine) following a singleton vaginal delivery. The study population will include women attending the aforementioned medical centers who meet all eligibility criteria and provide informed consent to participate in the trial.

Sample Size and Statistical Power The required sample size is estimated at 30 participants. This calculation is based on accepting an alpha risk of 0.05 and a statistical power exceeding 0.80 in a two-sided contrast. The study aims to detect a statistically significant difference of 0.3 units or greater, assuming a common standard deviation of 0.55, based on the parameters established by Silantyeva E, et al. (Analysis of Posttreatment Data in Parous Women). To account for potential attrition, a follow-up loss rate of 10% has been integrated into the final recruitment target.

DATA COLLECTION AND INFORMATION SOURCES Recruitment and Informed Consent Potential participants attending the specialized pelvic floor units (Procrear Reus and Tarragona) will be screened for eligibility. Candidates will receive comprehensive verbal and written information regarding the study objectives, the HIFEM technology, and the clinical protocol. Participation is voluntary; eligible women will be invited to sign a specialized Informed Consent Form (ICF), which details both the device specifications and the study's privacy protocols. Participants may be self-referred or directed by other healthcare professionals during the pregnancy or postpartum period.

Study Group Allocation Following an initial clinical assessment of the pelvic floor and subsequent therapeutic recommendations, participants will personally elect their study arm. Those choosing to undergo immediate High-Intensity Focused Electromagnetic (HIFEM) therapy will constitute the Experimental Group, while those opting for a "wait-and-see" approach will form the Control Group. This non-randomized allocation respects the patient's clinical decision-making process in a private healthcare setting.

Clinical Assessment Timeline

To ensure data consistency, all physical examinations and functional assessments will be conducted by a single investigator (the Principal Investigator). The follow-up schedule is defined as follows:

• Initial Visit: Conducted after the 6-week postpartum period (quarantine) for both groups. This visit includes the collection of physical variables, pregnancy-related history, and the baseline pelvic floor muscle (PFM) assessment.
• Follow-up Visit (Experimental Group): Conducted one month after the completion of the HIFEM treatment protocol.
• Follow-up Visit (Control Group): Conducted three months after the initial baseline assessment to evaluate spontaneous recovery versus intervention.

Data Management and Confidentiality All clinical data will be recorded in the centers' proprietary electronic medical record (EMR) systems, which are managed by a specialized firm ensuring compliance with the General Data Protection Regulation (GDPR) and the Spanish Organic Law 3/2018. Access to these records is restricted via encrypted credentials. For the purpose of statistical analysis, data will be strictly pseudonymized using unique alphanumeric identification codes. Only the Principal Investigator (Lys Garcia Vilaplana) will hold the master key linking participant identities to their study codes.

Ethical Considerations The study guarantees absolute anonymity in any subsequent scientific communications or final reports. The Principal Investigator is the designated Data Controller, ensuring that the processing of personal data remains confidential and aligned with current digital rights and data protection legislation.

Intervention/Procedure Experimental Group: HIFEM Technology Protocol Participants electing the intervention will undergo a structured pelvic floor rehabilitation program using the BTL EMSELLA™, a device powered by patented High-Intensity Focused Electromagnetic (HIFEM) technology. The treatment is non-invasive and designed to stimulate the pelvic floor muscles (PFM) through supramaximal contractions.

Phase 1: Intensive Postpartum Recovery During the first two consecutive weeks, subjects will receive two sessions per week, with a minimum interval of 48 hours between treatments. Each session will last 20 minutes using the specialized "Postpartum" pre-set program. This specific configuration utilizes a shorter pulse interval (Tesla wave exposure) compared to standard protocols. The clinical rationale is to provide a higher density of stimulation to muscles recently weakened by pregnancy and childbirth, thereby accelerating functional recovery.

Phase 2: Consolidation and Maintenance Following the intensive phase, a two-week rest period will be observed to allow for muscular adaptation. Subsequently, participants will undergo a final two-week cycle consisting of two sessions per week. During this phase, a maintenance program with a longer interval between electromagnetic stimuli will be applied to reinforce the initial gains and stabilize muscle tone.

Treatment Administration and Positioning Each therapeutic session will be conducted with the participant seated at the center of the device's chair-like applicator. Proper ergonomic positioning is mandatory: feet must be flat on the floor, with a 90-degree angle at the knees and the thighs fully supported by the seat.

To ensure optimal PFM stimulation, the Principal Investigator (operator) will verify and adjust the patient's posture before and during each session. The intensity of the electromagnetic stimulus will be initiated at 0% and progressively titrated to the maximum level tolerated by the participant (up to 100%), ensuring the highest possible therapeutic recruitment of muscle fibers without causing discomfor

STATISCAL ANALYSIS PLAN Data Extraction and Masking Study data will be extracted from the centralized database and pseudonymized. Allocation masking will be implemented to ensure that the personnel responsible for the statistical analysis remain blinded to the group assignments, thereby minimizing potential bias.

Baseline Comparability and Descriptive Analysis An initial analysis will be conducted to compare the intervention and control groups, evaluating their homogeneity and the similarity in the distribution of key variables at baseline. The proportion of participants lost to follow-up in each group will be quantified, and an assessment will be performed to determine if these losses are independent of the study intervention. Standard descriptive statistics will be employed to summarize the data: quantitative variables will be expressed as means and standard deviations, while qualitative variables will be presented as frequencies and proportions.

Inferential Statistics Baseline quantitative characteristics will be compared using the Student's t-test. For qualitative variables, Pearson's chi-square test will be utilized. Data will be analyzed and compared both at baseline and at the conclusion of the study period.

EFFECTIVENESS EVALUATION To assess the effectiveness of the HIFEM intervention, Odds Ratios (OR) will be calculated to determine the association between groups. Both crude and adjusted ORs will be estimated, accounting for clinically relevant covariates and any pertinent interactions between variables.

Software and Significance Level All statistical procedures will be performed using SPSS version 25.0 or later. A p-value of <0.05 will be considered statistically significant for all tests.

ETHICAL CONSIDERATIONS Informed Consent and Participant Information All participants who agree to enroll in the study will be thoroughly informed about the trial's nature, its specific objectives, and all activities directly linked to their participation. Potential subjects will be provided with a Participant Information Sheet in written format, allowing sufficient time for review and discussion before being asked to sign the Informed Consent Form (ICF).

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.

ETHICS COMIITEE APPROVAL The study project has been formally reviewed, approved, and is currently supervised by the Ethics Committee for Clinical Research (CEIC) of the Pere Virgili Institute for Health Research (IISPV). All recommendations and requirements set forth by the committee have been fully integrated into the study protocol to ensure the highest ethical standards.

EXPECTED RESULTS The primary objective of this study is to generate robust scientific evidence regarding the use of High-Intensity Focused Electromagnetic (HIFEM) technology during the postpartum period and its impact on pelvic floor muscle (PFM) recovery. The investigators aim to demonstrate whether exposure to recognized risk factors significantly debilitates the pelvic floor and if targeted HIFEM intervention facilitates accelerated functional recovery.

Furthermore, this study will provide a unique comparison of muscular evolution within a population that remains underrepresented in current literature. Given that there are currently no published studies specifically evaluating the BTL EMSELLA™ device in asymptomatic women following pregnancy, the data generated may offer critical insights for health policy decision-making across various clinical and public health contexts.

APPLICABILITY AND POTENTIAL OF THE TREATMENT This clinical trial will evaluate the preventive efficacy of HIFEM technology in women exposed to high-risk factors (pregnancy and childbirth) before the manifestation of clinical symptoms. The resulting evidence has the potential to shift the focus toward the early prevention of pelvic floor dysfunctions rather than reactive treatment. While the majority of existing research focuses on symptomatic urinary incontinence, this study addresses a significant gap by focusing on asymptomatic postpartum women.

STUDY LIMITATIONS The study identifies a potential selection bias, as participants are volunteers from private clinics who may have higher motivation and resources than the general population. To mitigate this, researchers will perform a systematic comparative analysis to control for these confounding variables and ensure the study's validity.

TIMELINE AND WORK PLAN

The project follows a strategic operational plan organized into six key phases spanning from 2022 to the final dissemination of results:

Preparatory Phase (2022-2025): Includes the comprehensive literature review on HIFEM technology and the formal study design and protocol drafting.

Regulatory Phase (Dec 2024 - Feb 2026): Ethical oversight and official approval from the IISPV Ethics Committee.

Operational Phase (Apr 2026 - Dec 2026): Active recruitment, intervention, and participant follow-up.

Final Phase: Statistical data analysis followed by the dissemination of findings in peer-reviewed journals and congresses.

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.