Efficacy of PFMT and sEMG-triggered Electrostimulation in Treating the Very Weak Pelvic Floor: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pelvic Floor Muscles (PFM) Strength
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double (participants, principal investigator). To improve the effect of blindness, participants were informed that the trial intended to compare the effects of two Electrical Stimulation (ES) methods for Stress Urinary Incontinence (SUI)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
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
- •women who were virgo intacta
- •women who declined vaginal examinations for any reasons
- •before four months of pregnancy
- •Having significant cognitive impairment or dementia
- •Unsafe to exercise (severe cardiopulmonary disease)
- •Unable/unwilling to provide informed consent
- •Patient has on physical examination, neurological and/or vaginal examination results which, in the opinion of the investigator, should exclude the subject.
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 (Other)
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 (Device)
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 (Other)
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)
研究者
DR. GIANFRANCO LAMBERTI
Director, Rehabilitative Medicine Department
Azienda Unita Sanitaria Locale di Piacenza