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

NCT07528560 | Recruiting DMC FDA Device

• 1 other identifier: 001/2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• 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.

Conditions

Pelvic Floor Muscle Dysfunction

Keywords

Puborectalis muscle; pelvic floor; transperineal ultrasound; posapartum; Electromagnetic therapy; female; incontinence; perineum; delivery; strain; ultrasonography; cesarean section; electroestimulation; pregnancy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Participant Age

  Baseline (Day 1)

• Body Weight

  Baseline visit. Self-reported weight

• Body Height

  Baseline visit. Self-reported heigh

• Body Mass Index (BMI)

  Baseline (Day 1)

• Gestational Age at Delivery

  Data will be self-reported by the participant at the baseline visit.

Study Arms (2)

Primiparous women undergoing HIFEM technology treatment (BTL Emsella)

EXPERIMENTAL

Participants meeting the inclusion criteria upon evaluation who consent to the use of Emsella HIFEM technology.

Device: HIFEM (HIGH INTENSITY FOCUSED ELECTROMAGNETIC) BTL EMSELLA

First-time mothers in the non-treatment group

NO INTERVENTION

Participants meeting the inclusion criteria at baseline who opt out of the treatment. These individuals will undergo a follow-up evaluation after 3 months

Interventions

HIFEM (HIGH INTENSITY FOCUSED ELECTROMAGNETIC) BTL EMSELLA DEVICE

Eight sessions twice weekly, with a two-week gap between the first and second blocks of four sessions

Primiparous women undergoing HIFEM technology treatment (BTL Emsella)

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Investigacio Sanitaria Pere Virgili: lead

Study Sites (1)

Centro Procrear

Tarragona, TARRAGONA, 43002, Spain

RECRUITING

Related Publications (32)

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MeSH Terms

Conditions

Sprains and Strains

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• LYS GARCIA VILAPLANA, MIDWIFE. PHD STUDENT

  UNIVERSITAT ROVIRA I VIRGILI. PROCREAR MEDICAL CENTER

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LYS GARCIA VILAPLANA, Lead Researcher

CONTACT

+34619357158; lys@procrear.es

CRISTINA REY REÑONES, DOCTORA

CONTACT

+34686853715; cristina.rey@urv.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MIDWIFE

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 14, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)