Assessment of Effectiveness of Pelvic Floor Muscle Training (PFMT) With Biofeedback in Male With Hypogonadism and Erectile Dysfunction (ED) a Randomised Control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Erectile performance
研究概览
简要总结
The goal of this clinical trial is to learn if Pelvic Floor Muscle Training (PFMT) with biofeedback works to treat Erectile Disorders (ED) in males with Functional Hipogonadism. The main hypothesis is:
1. Biofeedback-assisted Pelvic Floor Muscle Training will cause greater improvement in pelvic floor muscle strength and endurance and sexual life than in group without biofeedback and control group in males with Erectile Disorders caused by functional hypogonadism.
The main questions it aims to answer are:
- Does biofeedback-assisted pelvic floor muscle training cause greater improvement in pelvic floor muscle strength and endurance and sexual life than in group without biofeedback and control group.
- Does using handheld biofeedback trainer device improves technique of Pelvic Floor Muscle Training performance compare to NO biofeedback.
- Does 12-week intervention cause greater improvement in analyzed parameters than 6-week intervention.
- Does participants using biofeedback will have greater adherence to training protocol than no biofeedback group.
Research will compare biofeedback-assisted Pelvic Floor Muscle Training to non-biofeedback Pelvic Floor Muscle Training and control group to see if Pelvic Floor Muscle Training works to treat Erectile Disorders in males with functional hypogonadism.
Participants will:
- Be measured using questionnaires and pelvic floor muscle electromyography
- Do Pelvic Floor Muscle Training for 12 weeks
- Provide a diary of their training routine
- Have repeated measurements in 6 and 12 weeks
详细描述
Background and study aims:
The study aims to evaluate whether pelvic floor muscle training (PFMT), supported by biofeedback improves the treatment outcomes in male with erectile dysfunction (ED) and functional hypogonadism, compared to PFMT alone and standard pharmacological therapy. ED is a common condition affecting approximately 30-60% of men, with prevalence increasing with age. The aetiology of ED is multifactorial and includes vascular, hormonal, neurological, and psychological factors. Despite its prevalence only 25% of them seek treatment.
Current ED treatment relies primarily on pharmacotherapy, including testosterone replacement therapy (in confirmed deficiency) and PDE5 inhibitors, which are effective in many patients (60-80%) but less so in specific populations, such as those with diabetes. There is increasing interest in physiotherapy interventions, particularly PFMT, as a supportive treatment for ED. However, evidence regarding its effectiveness in hormonally driven ED remains limited.
The primary hypothesis is that PFMT supported by biofeedback will lead to greater improvements in pelvic floor muscle function, erectile performance, and sexual quality of life compared with PFMT without biofeedback and pharmacological treatment alone. Additional hypotheses suggest that biofeedback enhances exercise technique, increases patient adherence to training, and that longer intervention (12 weeks vs. 6 weeks) leads to superior outcomes.
Study design and material:
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •diagnosed functional hypogonadism
- •diagnosed erectile disorders
- •no diagnosed neurological disorders in pelvic floor area
- •no surgical interventions in pelvic floor area
- •no cancer in its active phase
- •ability to give individual consent
- •consent of participation and following the protocol
排除标准
- •severe cardiovascular diseases
- •cancer treatment in progress
- •scars and surgical interventions in the pelvic floor area
- •neurological disorders affecting to pelvic floor
- •scars that makes measurements impossible
- •other treatment that affects sexual field similar to this protocol
- •participation in other rehabilitation programme less than 6 months before this programme
- •severe neurological disorders that makes cooperation impossible
- •no technical possibilities to do the measures to the patient
- •disagreement to participate in the programme
结局指标
主要结局
Erectile performance
时间窗: From enrollment to the end of treatment at 12 weeks
Measured by International Index of Erectile Function (IIEF) questionnaire. Patient can get from 0 to 75 points (15 questions rated from 0 to 5 each). Lower score means more severe problem.
Maximal Voluntary Contraction (MVC)
时间窗: From enrollment to the end of treatment at 12 weeks
Measured by EMG device in micro volts.
Fatigue
时间窗: From enrollment to the end of treatment at 12 weeks
Measured by EMG device as an increase in the amplitude and duration of the muscle action potential
次要结局
- Sexual quality of life(From enrollment to the end of treatment at 12 weeks)
- Adherence to protocol(From enrollment to the end of treatment at 12 weeks)
研究者
Wojciech Pawlowski
PhD Student
Poznan University of Physical Education