Effectiveness of HIFEM (High Intensity Focused Electro-Magnetic Technology) for Improving Pelvic Floor Muscle Tone in Postpartum Women: Study Protocol.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Puborectalis Muscle Strain
研究概览
简要总结
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:
- Those who receive the Emsella HIFEM treatment.
- 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.
详细描述
BACKGROUND AND SCIENTIFIC RATIONALE The pelvic floor muscles (PFM) constitute a critical functional unit that frequently undergoes weakening due to cumulative risk factors over time. This degradation often leads to clinical conditions such as urinary incontinence (UI), sexual dysfunction, pelvic organ prolapse (POP), and other urogenital symptoms. Among these factors, pregnancy and childbirth (specifically vaginal delivery) are identified as the most significant contributors to PFM strength depletion. Scientific evidence indicates that mechanical trauma-such as levator ani tears, episiotomy, or the use of forceps-alongside increased intra-abdominal pressure during gestation and postpartum hormonal changes (including reduced collagen production), significantly compromise muscular tonicity and structural integrity.
TECHNOLOGY AND MECHANISM OF ACTION In 2018, the U.S. Food and Drug Administration (FDA) cleared the BTL EMSELLA device, utilizing High-Intensity Focused Electromagnetic (HIFEM) technology, for the treatment of urinary incontinence resulting from pelvic floor muscle weakness. Unlike conventional vaginal electrostimulation or voluntary Kegel exercises, HIFEM technology induces supramaximal muscle contractions, recruiting a higher percentage of muscle fibers than is physiologically possible through voluntary effort. This process promotes muscular hypertrophy, hyperplasia, increased vascularization, and neuromodulation. The stimulation is deep, homogeneous, and non-invasive, allowing for a painless, operator-independent treatment that can be performed while the patient remains fully clothed.
STUDY OBJETIVES AND HYPOTHESIS While current literature provides evidence of HIFEM efficacy in symptomatic women, there is a clinical interest in evaluating its preventive potential. Since pregnancy and childbirth are primary debilitating factors, this community-based clinical trial aims to evaluate the effectiveness of HIFEM technology as an early intervention in postpartum women who have been exposed to these risk factors for the first time but remain asymptomatic.
The study is designed to compare an experimental group receiving the HIFEM treatment protocol against a control group receiving standard care. The primary objective is to verify the efficacy of this technology in improving PFM tone and functional recovery in patients with muscle weakness prior to the onset of clinical symptoms. The investigator hypothesize that early application (recommended between 6 and 12 weeks postpartum) will result in a statistically significant improvement in muscle strength and a reduction in the long-term risk of urogenital dysfunction compared to the control group
METHODOLOGY Study Design This is a non-randomized, community-based clinical trial designed to compare two distinct cohorts. The Intervention Group will receive the treatment protocol utilizing High-Intensity Focused Electromagnetic (HIFEM) technology, while the Control Group will follow standard postpartum observation without the HIFEM intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
- •Epilepsy.
- •Menstruation
研究组 & 干预措施
Primiparous women undergoing HIFEM technology treatment (BTL Emsella)
Participants meeting the inclusion criteria upon evaluation who consent to the use of Emsella HIFEM technology.
干预措施: HIFEM (HIGH INTENSITY FOCUSED ELECTROMAGNETIC) BTL EMSELLA (Device)
First-time mothers in the non-treatment group
Participants meeting the inclusion criteria at baseline who opt out of the treatment. These individuals will undergo a follow-up evaluation after 3 months
结局指标
主要结局
Puborectalis Muscle Strain
时间窗: At baseline assessment (post-quarantine) and at the 3-month follow-up, in both group
Measurement of the puborectalis muscle length (in centimeters) using transperineal ultrasound.
Pelvic Floor Muscle Pressure (Dynamometry)
时间窗: At baseline assessment (post-quarantine) and at the 3-month follow-up, in both group
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
Pelvic Floor Muscle Performance (PERFECT Scheme)
时间窗: At baseline assessment (post-quarantine) and at the 3-month follow-up, in both group
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
次要结局
- 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.)
- Pregnancy Weight Gain(Data will be self-reported by the participant at the baseline visit)
- Newborn Birth Weight(Data will be self-reported by the participant at the baseline visit)
- Mode of Vaginal Delivery(Data will be self-reported by the participant at the baseline visit)
- Perineal Outcome (Perineal Status)(Data will be self-reported by the participant at the baseline visit)
研究者
Lys Garcia Vilaplana
MIDWIFE
Institut Investigacio Sanitaria Pere Virgili