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New treatment option for Pelvic Floor Muscle Dysfunction
Official title HIFEM in Pospartum (High Intensity Focused Electro-Magnetic Technology)
ClinicalTrials.gov ID: NCT07528560
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join 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.
You likely can't join 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.
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Tarragona, TARRAGONA, Spain
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tarragona, TARRAGONA, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.