Impact of Pilates Exercises on Diabetic Erectile Dysfunction.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- penile perfusion
研究概览
简要总结
Erectile dysfunction (ED) has a prevalence of 52.5% in diabetic male patients, as described in a meta-analysis of 145 studies, including 88,577 men with type 1 and type 2 diabetes.
In men, ED can cause sexual dissatisfaction and distress, unsatisfactory relationships, and marital tension
详细描述
Pilates emerged as a method of rehabilitation during World War I, when Joseph Hubertus Pilates applied his knowledge to rehabilitate injured men. The popularity of the method grew most in the 1980. More recently, Pilates has been used resulting in improved fitness (flexibility, strength and balance) and body consciousness. The method features ground-based exercises created by Joseph Pilates.
Because most Pilates exercises are performed in conjunction with the recruitment of PF muscle fibres, many Pilates instructors believe that the method can produce a significant increase in the force or contractility of the muscles. Furthermore, if Pilates promotes an improvement in the functioning of the pelvic floor muscles (PFM), it may be an alternative for the treatment and prevention of pelvic floor dysfunction.
Up till now, no published trials about impact of Pilate exercises on diabetic erectile dysfunction.
A total of 60 patients (n=30 per group), diagnosed with diabetic erectile dysfunction in the past 6 months. Participants will be recruited from Benha University hospital and local andrology and urology clinics in benha and giza . Participants will be screened for eligibility prior to being enrolled in the study participating in the study assessments.
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
- Single (Outcomes Assessor)
盲法说明
Outcomes Assessor blinded This is a parallel group randomized controlled trial with two arms receiving different interventions.
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men aged 40-60 years.
- •Diagnosed with type 2 diabetes mellitus for >5 years, with initial diagnosis confirmed by HbA1c >6.5%.
- •Arteriogenic erectile dysfunction (ED) of >6 months' duration, confirmed by penile Doppler ultrasonography showing peak systolic velocity (PSV) of the cavernosal arteries <25 cm/s.
- •Body mass index (BMI) <30 kg/m².
排除标准
- •Poorly controlled diabetes mellitus (HbA1c >9%).
- •Neurogenic, venogenic, or psychogenic ED.
- •Cardiac conditions contraindicating sexual activity.
- •Neurological disorders or spinal cord injury.
- •Alcohol abuse or illicit drug use.
- •Chronic hematological disorders.
- •Active genitourinary infection.
- •Severe hypogonadism.
- •History of radical prostatectomy, pelvic surgery, or pelvic trauma.
- •Penile prosthesis implantation.
- •Current or previous participation in a structured pelvic floor muscle training or sexual rehabilitation program.
研究组 & 干预措施
Experimental
study group
干预措施: Pilate Exercises (Other)
Experimental
study group
干预措施: Home based pelvic floor muscle training (Other)
Active comparator
control
干预措施: Home based pelvic floor muscle training (Other)
Experimental
study group
干预措施: Sildenafil therapy (Drug)
Active comparator
control
干预措施: Sildenafil therapy (Drug)
结局指标
主要结局
penile perfusion
时间窗: Base line and after 12 weeks
Colour-coded duplex sonography (5-10 MHz probes) will be used for the evaluation of penile perfusion. Half ml of a vasoactive agent (trimix solution) will be injected into the corpus cavernosum. The systolic and diastolic velocities (cm/s) will be performed at 10 and 30 min for both cavernous artery. Re-dosing with 0.5 ml of trimax solution will be performed for patients who did not achieve adequate hardness. The highest values obtained will be recorded. The Doppler indices of the right and left cavernous arteries: peak systolic velocity (PSV)
次要结局
- International Index of Erectile Function-5 (IIEF-5) scale.(Baseline and after 12 weeks)
研究者
Mahmoud Hamada Mohamed
Associate Professor of Physical Therapy
Benha University