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

Effectiveness of HIFEM (High Intensity Focused Electro-Magnetic Technology) for Improving Pelvic Floor Muscle Tone in Postpartum Women: Study Protocol.

The goal of this non-randomized community clinical trial is to test how effective HIFEM (High Intensity Focused Electromagnetic) technology (BTL Emsella) is in strengthening pelvic floor muscles. The study focuses on first-time mothers who have recently given birth (postpartum) via vaginal delivery and are not showing symptoms of dysfunction.

The main question this study aims to answer is:

- Can pelvic floor strength be restored after being exposed to weakening risk factors like pregnancy and childbirth?

How to study works; The researcher will compare two groups of women to see how their muscles recover:

1. Those who receive the Emsella HIFEM treatment.
2. Those who follow their natural recovery without the treatment.

Participant Journey:

• Initial Check-up: Once the standard 6-week postpartum recovery period (quarantine) is over.
• Eligibility: The researcher checks if participants meet the study criteria.
• Decision: After receiving full information and signing a consent form, participants decide whether or not to undergo the treatment.
• Final Results: A follow-up assessment is conducted 3 months after the first visit, regardless of whether the treatment was used.

Study Overview

• Status: Recruiting
• Conditions: Pelvic Floor Muscle Dysfunction
• Intervention / Treatment: Device: HIFEM (HIGH INTENSITY FOCUSED ELECTROMAGNETIC) BTL EMSELLA

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: LYS GARCIA VILAPLANA, Lead Researcher; Phone Number: +34619357158; Email: lys@procrear.es
• Study Contact Backup: Name: CRISTINA REY REÑONES, DOCTORA; Phone Number: +34686853715; Email: cristina.rey@urv.cat

Study Locations

• Spain
  • TARRAGONA
    • Tarragona, TARRAGONA, Spain, 43002
      • Recruiting
      • Centro Procrear
      • Contact: CRISTINA REY
      • Contact: LYS GARCIA VILAPLANA; Phone Number: +34619357158; Email: lys@procrear.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Primiparous women
• Vaginal delivery.
• Single-fetus pregnancy / Singleton pregnancy.
• Full-term pregnancy (> 37 weeks of gestation).
• Asymptomatic: No symptoms associated with pelvic floor muscle weakening, such as any type of incontinence or presence of prolapse.
• Post-quarantine period: Between 6 and 12 weeks postpartum

Exclusion Criteria:

• Implanted devices: Such as pacemakers, defibrillators, or neurostimulators.
• Electronic implants.
• Drug delivery pumps (e.g., insulin pumps or medication infusion pumps).
• Metallic implants.
• Intrauterine devices (IUDs) containing any type of metal.
• Application over the growth plate area.
• Severe or life-threatening disorders.
• Pulmonary insufficiency.
• Cardiac disorders / Heart conditions.
• Decompensated hemorrhagic conditions.
• Decompensated blood coagulation disorders.
• Malignant tumors / Malignancy.
• Fever.
• Epilepsy.
• Menstruation
• Pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Primiparous women undergoing HIFEM technology treatment (BTL Emsella); Participants meeting the inclusion criteria upon evaluation who consent to the use of Emsella HIFEM technology.	Device: HIFEM (HIGH INTENSITY FOCUSED ELECTROMAGNETIC) BTL EMSELLA; Eight sessions twice weekly, with a two-week gap between the first and second blocks of four sessions
No Intervention: First-time mothers in the non-treatment group; Participants meeting the inclusion criteria at baseline who opt out of the treatment. These individuals will undergo a follow-up evaluation after 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Puborectalis Muscle Strain	Measurement of the puborectalis muscle length (in centimeters) using transperineal ultrasound.	At baseline assessment (post-quarantine) and at the 3-month follow-up, in both group
Pelvic Floor Muscle Pressure (Dynamometry)	Pelvic floor muscle strength will be quantified by measuring the pressure exerted in Newtons with a specialized vaginal dynamometer. Measurements will be recorded at rest and during active voluntary contraction, yielding two separate measurements, both of which will be recorded	At baseline assessment (post-quarantine) and at the 3-month follow-up, in both group
Pelvic Floor Muscle Performance (PERFECT Scheme)	escription: Clinical assessment of muscle function using the PERFECT scheme, which is based on the Modified Oxford Scale (0-5). The evaluation includes: P (Power): Maximum contraction strength. E (Endurance): Duration of the contraction. R (Repetitions): Number of repetitions maintained at original power. F (Fast): Number of quick, 1-second contractions. ECT (Every Contraction Timed): Total timing of the performance	At baseline assessment (post-quarantine) and at the 3-month follow-up, in both group

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Age	Age of the participant in years, calculated based on the date of birth provided at the time of enrollment	Baseline (Day 1)
Body Weight	Measurement of the participant's height, recorded in centimeters (cm) using a professional stadiometer	Baseline visit. Self-reported weight
Body Height	Measurement of the participant's height, recorded in meters (m)	Baseline visit. Self-reported heigh
Body Mass Index (BMI)	Calculation of the body mass index derived from the weight (kg) and height (m) measurements [Formula: weight (kg) / height (m)²]	Baseline (Day 1)
Gestational Age at Delivery	Total duration of the pregnancy recorded in weeks at the time of childbirth	Data will be self-reported by the participant at the baseline visit.
Pregnancy Weight Gain	Total maternal weight increase during the pregnancy, measured in kilograms (kg)	Data will be self-reported by the participant at the baseline visit
Newborn Birth Weight	The weight of the neonate at the time of delivery, recorded in grams (g)	Data will be self-reported by the participant at the baseline visit
Mode of Vaginal Delivery	Categorization of the delivery process into two types: Spontaneous (Eutocic): Delivery without instrumental assistance. Instrumental: Delivery requiring the use of forceps, vacuum extractor, or spatula	Data will be self-reported by the participant at the baseline visit
Perineal Outcome (Perineal Status)	Classification of the perineum condition after delivery, categorized as: Intact: No trauma to the perineal area. Tear: Spontaneous laceration (including grade/degree if applicable). Episiotomy: Surgical incision performed during the second stage of labor.	Data will be self-reported by the participant at the baseline visit

Collaborators and Investigators

• Sponsor: Institut Investigacio Sanitaria Pere Virgili
• Investigators: Principal Investigator: LYS GARCIA VILAPLANA, MIDWIFE. PHD STUDENT, UNIVERSITAT ROVIRA I VIRGILI. PROCREAR MEDICAL CENTER

Publications and helpful links

General Publications

• Durnea CM, Khashan AS, Kenny LC, Durnea UA, Dornan JC, O'Sullivan SM, O'Reilly BA. What is to blame for postnatal pelvic floor dysfunction in primiparous women-Pre-pregnancy or intrapartum risk factors? Eur J Obstet Gynecol Reprod Biol. 2017 Jul;214:36-43. doi: 10.1016/j.ejogrb.2017.04.036. Epub 2017 Apr 23.
• Handa VL, Blomquist JL, Knoepp LR, Hoskey KA, McDermott KC, Munoz A. Pelvic floor disorders 5-10 years after vaginal or cesarean childbirth. Obstet Gynecol. 2011 Oct;118(4):777-84. doi: 10.1097/AOG.0b013e3182267f2f.
• Cho ST, Kim KH. Pelvic floor muscle exercise and training for coping with urinary incontinence. J Exerc Rehabil. 2021 Dec 27;17(6):379-387. doi: 10.12965/jer.2142666.333. eCollection 2021 Dec.
• Silantyeva E, Zarkovic D, Astafeva E, Soldatskaia R, Orazov M, Belkovskaya M, Kurtser M; Academician of the Russian Academy of Sciences. A Comparative Study on the Effects of High-Intensity Focused Electromagnetic Technology and Electrostimulation for the Treatment of Pelvic Floor Muscles and Urinary Incontinence in Parous Women: Analysis of Posttreatment Data. Female Pelvic Med Reconstr Surg. 2021 Apr 1;27(4):269-273. doi: 10.1097/SPV.0000000000000807.
• Palacios S, Ramirez M, Lilue M, Vega B. Evaluation of Femaxeen(R) for control of urinary incontinence in women: A randomized, double-blind, placebo-controlled study. Maturitas. 2020 Mar;133:1-6. doi: 10.1016/j.maturitas.2019.12.008. Epub 2019 Dec 16.
• Johnston SL. Pelvic floor dysfunction in midlife women. Climacteric. 2019 Jun;22(3):270-276. doi: 10.1080/13697137.2019.1568402. Epub 2019 Mar 11.
• Pires T, Pires P, Moreira H, Viana R. Prevalence of Urinary Incontinence in High-Impact Sport Athletes: A Systematic Review and Meta-Analysis. J Hum Kinet. 2020 Jul 21;73:279-288. doi: 10.2478/hukin-2020-0008. eCollection 2020 Jul.
• Bustelo SM, Morales AF, Patiño Núñez S, Viñas Diz S, Martínez Rodríguez A. Entrevista clínica y valoración funcional del suelo pélvico Clínical interview and functional assessment of pelvic floor. Vol. 26. 2004
• Romero-Culleres G, Pena-Pitarch E, Jane-Feixas C, Arnau A, Montesinos J, Abenoza-Guardiola M. Intra-rater reliability and diagnostic accuracy of a new vaginal dynamometer to measure pelvic floor muscle strength in women with urinary incontinence. Neurourol Urodyn. 2017 Feb;36(2):333-337. doi: 10.1002/nau.22924. Epub 2015 Nov 20.
• Romero-Culleres G, Jane-Feixas C, Vilaseca-Grane A, Arnau A, Montesinos J, Abenoza-Guardiola M. Inter-rater reliability of the digital palpation of pelvic floor muscle by the modified Oxford Grading Scale in continent and incontinent women. Arch Esp Urol. 2019 Jul;72(6):602-607. English, Spanish.
• Pendiente P. Dispositivo para la medición de la fuerza del SUELO PÉLVICO [Internet]. Pol. Ind. Ibarluze. 2012. Available from: www.bexenmedical.com
• Tosun H, Akinsal EC, Bas U, Sonmez G, Baydilli N, Demirci D. Evaluating the Efficacy of High-Intensity Focused Electromagnetic (HIFEM) Therapy for Postprostatectomy Incontinence in Men. Ther Clin Risk Manag. 2025 Aug 30;21:1309-1315. doi: 10.2147/TCRM.S534674. eCollection 2025.
• Elena S, Dragana Z, Ramina S, Evgeniia A, Orazov M. Electromyographic Evaluation of the Pelvic Muscles Activity After High-Intensity Focused Electromagnetic Procedure and Electrical Stimulation in Women With Pelvic Floor Dysfunction. Sex Med. 2020 Jun;8(2):282-289. doi: 10.1016/j.esxm.2020.01.004. Epub 2020 Mar 4.
• Beléndez A. Electromagnetic Unification. Ingenierias [Internet]. 2006;9(31):24-38.https://www.researchgate.net/profile/Jose_Morones_Ibarra/publication/294260657_Ondas_ gravitacionales/links/56bf7ca508ae44da37fa65e5.pdf
• Gonzalez-Isaza P, Sanchez-Borrego R, Lugo Salcedo F, Rodriguez N, Velez Rizo D, Fusco I, Callarelli S. Pulsed Magnetic Stimulation for Stress Urinary Incontinence and Its Impact on Sexuality and Health. Medicina (Kaunas). 2022 Nov 24;58(12):1721. doi: 10.3390/medicina58121721.
• Caufriez M, Fernández-Domínguez JC, Deman C, Wary-Thys C. Contribution to the study of pelvic floor muscle tone. Prog Obstet Ginecol. 2007;50(5):282-91.
• Samuels JB, Pezzella A, Berenholz J, Alinsod R. Safety and Efficacy of a Non-Invasive High-Intensity Focused Electromagnetic Field (HIFEM) Device for Treatment of Urinary Incontinence and Enhancement of Quality of Life. Lasers Surg Med. 2019 Nov;51(9):760-766. doi: 10.1002/lsm.23106. Epub 2019 Jun 7.
• Wu YM, McInnes N, Leong Y. Pelvic Floor Muscle Training Versus Watchful Waiting and Pelvic Floor Disorders in Postpartum Women: A Systematic Review and Meta-analysis. Female Pelvic Med Reconstr Surg. 2018 Mar/Apr;24(2):142-149. doi: 10.1097/SPV.0000000000000513.
• Handa VL, Blomquist JL, McDermott KC, Friedman S, Munoz A. Pelvic floor disorders after vaginal birth: effect of episiotomy, perineal laceration, and operative birth. Obstet Gynecol. 2012 Feb;119(2 Pt 1):233-9. doi: 10.1097/AOG.0b013e318240df4f.
• van den Noort F, van der Vaart CH, Grob ATM, van de Waarsenburg MK, Slump CH, van Stralen M. Deep learning enables automatic quantitative assessment of puborectalis muscle and urogenital hiatus in plane of minimal hiatal dimensions. Ultrasound Obstet Gynecol. 2019 Aug;54(2):270-275. doi: 10.1002/uog.20181. Epub 2019 Jun 26.
• Zhou M, Du H, Ying T, Shui W, Dou C. Value of high-frequency two-dimensional ultrasound on evaluating puborectalis muscle. Arch Gynecol Obstet. 2020 May;301(5):1347-1352. doi: 10.1007/s00404-020-05523-4. Epub 2020 Apr 7.
• Das S, Hansen HHG, Hendriks GAGM, van den Noort F, Manzini C, van der Vaart CH, de Korte CL. 3D Ultrasound Strain Imaging of Puborectalis Muscle. Ultrasound Med Biol. 2021 Mar;47(3):569-581. doi: 10.1016/j.ultrasmedbio.2020.11.016. Epub 2020 Dec 23.
• Grob ATM, Hitschrich N, van de Waarsenburg MK, Withagen MIJ, Schweitzer KJ, van der Vaart CH. Changes in global strain of puborectalis muscle during pregnancy and postpartum. Ultrasound Obstet Gynecol. 2018 Apr;51(4):537-542. doi: 10.1002/uog.17488.
• Alketbi MSG, Meyer J, Robert-Yap J, Scarpa R, Gialamas E, Abbassi Z, Balaphas A, Buchs N, Roche B, Ris F. Levator ani and puborectalis muscle rupture: diagnosis and repair for perineal instability. Tech Coloproctol. 2021 Aug;25(8):923-933. doi: 10.1007/s10151-020-02392-6. Epub 2021 Mar 20.
• Fritel X. [Pelvic floor and pregnancy]. Gynecol Obstet Fertil. 2010 May;38(5):332-46. doi: 10.1016/j.gyobfe.2010.03.008. Epub 2010 Apr 24. French.
• Blomquist JL, Carroll M, Munoz A, Handa VL. Pelvic floor muscle strength and the incidence of pelvic floor disorders after vaginal and cesarean delivery. Am J Obstet Gynecol. 2020 Jan;222(1):62.e1-62.e8. doi: 10.1016/j.ajog.2019.08.003. Epub 2019 Aug 8.
• Joseph C, Srivastava K, Ochuba O, Ruo SW, Alkayyali T, Sandhu JK, Waqar A, Jain A, Poudel S. Stress Urinary Incontinence Among Young Nulliparous Female Athletes. Cureus. 2021 Sep 15;13(9):e17986. doi: 10.7759/cureus.17986. eCollection 2021 Sep.
• Bodner-Adler B, Kimberger O, Laml T, Halpern K, Beitl C, Umek W, Bodner K. Prevalence and risk factors for pelvic floor disorders during early and late pregnancy in a cohort of Austrian women. Arch Gynecol Obstet. 2019 Nov;300(5):1325-1330. doi: 10.1007/s00404-019-05311-9. Epub 2019 Oct 10.
• Feldman MK, VanBuren WM, Barnard H, Taffel MT, Kho RM. Systematic interpretation and structured reporting for pelvic magnetic resonance imaging studies in patients with endometriosis: value added for improved patient care. Abdom Radiol (NY). 2020 Jun;45(6):1608-1622. doi: 10.1007/s00261-019-02182-1.
• Grimes WR, Stratton M. Pelvic Floor Dysfunction. 2023 Jun 26. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK559246/
• Segedi LM, Ilic KP, Curcic A, Visnjevac N. [Quality of life in women with pelvic floor dysfunction]. Vojnosanit Pregl. 2011 Nov;68(11):940-7. doi: 10.2298/vsp1111940m. Serbian.
• Suriyut J, Muro S, Baramee P, Harada M, Akita K. Various significant connections of the male pelvic floor muscles with special reference to the anal and urethral sphincter muscles. Anat Sci Int. 2020 Jun;95(3):305-312. doi: 10.1007/s12565-019-00521-2. Epub 2019 Dec 23.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: cesarean section; pregnancy; delivery; female; ultrasonography; incontinence; pelvic floor; strain; perineum; transperineal ultrasound; Electromagnetic therapy; Puborectalis muscle; posapartum; electroestimulation
• Additional Relevant MeSH Terms: Wounds and Injuries; Sprains and Strains
• Other Study ID Numbers: 001/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes