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

NCT07528560 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-14

No results posted yet for this study

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:

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.

Conditions

  • Pelvic Floor Muscle Dysfunction

Interventions

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

Sponsors & Collaborators

  • Institut Investigacio Sanitaria Pere Virgili

    lead OTHER

Principal Investigators

  • LYS GARCIA VILAPLANA, MIDWIFE. PHD STUDENT · UNIVERSITAT ROVIRA I VIRGILI. PROCREAR MEDICAL CENTER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2026-07-01
Completion
2026-12-31
FDA Device
Yes

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07528560 on ClinicalTrials.gov