HIFEM (Emsella) to restore pelvic floor strength after a first vaginal birth
Effectiveness of HIFEM (High Intensity Focused Electro-Magnetic Technology) for Improving Pelvic Floor Muscle Tone in Postpartum Women: Study Protocol.
This trial tests whether HIFEM (Emsella) treatments can help strengthen pelvic floor muscles in first-time mothers after a vaginal birth who do not have symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Institut Investigacio Sanitaria Pere Virgili Academic / other |
| Locations | 1 site (Tarragona, TARRAGONA) |
| Trial ID | NCT07528560 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are first-time mothers who had a single-term vaginal delivery, are 6–12 weeks postpartum, currently have no pelvic floor symptoms, and have no contraindicated implants or serious medical conditions.
Not a fit: Women who already have pelvic floor symptoms, major pelvic trauma, are pregnant or menstruating, or who have implanted electronic or metallic devices or other exclusionary health conditions are unlikely to benefit from this preventive intervention.
Why it matters
Potential benefit: If successful, the treatment could restore or preserve pelvic floor strength after childbirth and lower the future risk of incontinence, prolapse, or sexual dysfunction.
How similar studies have performed: HIFEM/Emsella received FDA clearance in 2018 for urinary incontinence and prior studies have shown improvements in pelvic floor strength and incontinence symptoms, but preventive use in asymptomatic postpartum women is less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Tarragona, TARRAGONA
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.