Efficacy of PFMT and sEMG-triggered Electrostimulation in Treating the Very Weak Pelvic Floor: a Randomized Clinical Trial
概览
- 阶段
- 不适用
- 干预措施
- Pelvic Floor Muscle Training
- 疾病 / 适应症
- Pelvic Floor Muscle Weakness
- 发起方
- Azienda Unita Sanitaria Locale di Piacenza
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pelvic Floor Muscles (PFM) Strength
- 状态
- 已完成
- 最后更新
- 2个月前
概览
简要总结
This research will determine 1) whether the very weak pelvic floor can be improved with surface electromyography (s-EMG)-triggered electrostimulation added to pelvic floor muscle training and 2) whether sEMG-triggered electrostimulation added to pelvic floor muscle training can reduce leakage in Stress Urinary Incontinence (SUI)
详细描述
Among women with pelvic floor dysfunction, it has long been known that PFM training is the first-line therapy for stress incontinence. One of the difficulties that clinicians often find upon examination is that many women present a very weak pelvic floor and are unable to contract their PFM. There is overwhelming evidence to show that conservative treatment in the form of pelvic muscle exercises (and to a lesser degree, electrotherapy, and vaginal weight therapy) is effective in the treatment of stress urinary incontinence. To date, there is some evidence to support the use of electrical stimulation for stress urinary incontinence in women, but we are still very uncertain about the full potential of this treatment because of the low quality of the existing evidence.
研究者
DR. GIANFRANCO LAMBERTI
Director, Rehabilitative Medicine Department
Azienda Unita Sanitaria Locale di Piacenza
入排标准
入选标准
- •• Adult women (18 years old - 50 years old), with a Modified Oxford Score, determined by digital palpation, of 0 - 1, complaining leakage episode occurring more than once a week.
- •Between six and eighteen months after childbirth
- •Willing and able to be compliant with pelvic floor muscle exercise intervention (standard of care) for 12 weeks and to log compliance
- •Willing and able to undergo an extensive physical function evaluation
排除标准
- •• pregnancy
- •severe neurological disease (Multiple Sclerosis, Parkinson's disease, spinal cord injury, major stroke or neuromuscular junction diseases)
- •previous operation for cancer or radiotherapy in the lower abdomen
- •Prior surgical intervention for urinary incontinence within the past 12 months
- •Hysterectomy within 12 months
- •voiding dysfunction
- •pelvic pain
- •severe prolapse (≥ grade 3)
- •recurrent urinary tract infection
- •pelvic or disseminated malignancies
研究组 & 干预措施
Supervised Pelvic Floor Muscle Training + EMG-triggered ES
Group A (supervised PFMT + EMG-triggered ES) Supervised Pelvic Floor Muscle Training Twenty sessions will be applied, 2 per week for ten weeks Stimulation parameters: Duration: 15 min Electrode placement: vaginal probe Frequency: 50 Hz. - Pulse width 250 microseconds Intensity: to motor response (activation of PFM) Number of sessions: 20 Ramp up/down: 1 sec.
干预措施: Pelvic Floor Muscle Training
Supervised Pelvic Floor Muscle Training + EMG-triggered ES
Group A (supervised PFMT + EMG-triggered ES) Supervised Pelvic Floor Muscle Training Twenty sessions will be applied, 2 per week for ten weeks Stimulation parameters: Duration: 15 min Electrode placement: vaginal probe Frequency: 50 Hz. - Pulse width 250 microseconds Intensity: to motor response (activation of PFM) Number of sessions: 20 Ramp up/down: 1 sec.
干预措施: EMG-triggered ES
Supervised PFMT + sham EMG-triggered ES)
Group B: Supervised PFMT + sham EMG-triggered ES) Supervised Pelvic Floor Muscle Training Twenty sessions will be applied, 2 per week for ten weeks Stimulation parameters: Duration: 15 min Electrode placement: vaginal probe model xx Frequency: 2 Hz. - Pulse width 10 microseconds Intensity: to sensory response Number of sessions: 20 Ramp up/down: 1 sec.
干预措施: Pelvic Floor Muscle Training
结局指标
主要结局
Pelvic Floor Muscles (PFM) Strength
时间窗: Baseline, four weeks, 6 and 12 months follow-up
PFM strength by digital palpation done in the lithotomy position
次要结局
- International Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF)(Baseline, four weeks, 6 and 12 months follow-up)
- Frequency/volume chart(Baseline, four weeks, 6 and 12 months follow-up)