HIFEM (Emsella) to restore pelvic floor strength after a first vaginal birth

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a non-randomized community interventional trial comparing primiparous women who receive BTL Emsella HIFEM treatment with those who follow natural recovery after a term vaginal delivery. Eligible participants are asymptomatic, singleton, full-term mothers enrolled between 6 and 12 weeks postpartum. Pelvic floor muscle strength and structure will be measured at baseline and follow-up using clinical measures and imaging (for example, transperineal ultrasound). The trial aims to determine whether adding HIFEM leads to greater recovery of pelvic floor function than natural recovery alone.

Why it matters

Who can join: the full rules

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

Where it's running

• Centro Procrear
  Tarragona, Tarragona, Spain Recruiting

Study contacts

• Principal investigator: Lys Garcia Vilaplana, Midwife. Phd Student — Universitat Rovira I Virgili. Procrear Medical Center
• Study coordinator: LYS GARCIA VILAPLANA, Lead Researcher
• Email: lys@procrear.es
• Phone: +34619357158

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.