Effectiveness of Pelvic Floor Therapy for the Management of Erectile Dysfunction and Premature Ejaculation.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change in International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score
研究概览
简要总结
The objective of this clinical trial is to evaluate the effectiveness of pelvic floor therapy for the management of erectile dysfunction and premature ejaculation in patients with erectile dysfunction and premature ejaculation. The main question to answer is:
What is the effectiveness of pelvic floor therapy (electrostimulation, biofeedback, and therapeutic exercise) for the treatment of patients with erectile dysfunction and or premature ejaculation?
Patients will:
- Have an initial consultation of pelvic floor rehabilitation before therapy.
- Be given pelvic floor therapy.
- Have a secondary consultation of pelvic floor rehabilitation after therapy.
Three intervention groups will be included: Group 1: Patients with premature ejaculation Group 2: Patients with erectile dysfunction Group 3: Patients with erectile dysfunction and premature ejaculation.
详细描述
The objective of this clinical trial is to evaluate the effectiveness of pelvic floor therapy for the management of erectile dysfunction and premature ejaculation in patients with erectile dysfunction and premature ejaculation.
Methodology: Pre-post study. Erectile function or intravaginal latency time will be evaluated before and after pelvic floor therapy, in three groups of patients, independently:
- Group 1: Patients with premature ejaculation
- Group 2: Patients with erectile dysfunction
- Group 3: Patients with erectile dysfunction and premature ejaculation
66 patients will be included and will receive 24 sessions of pelvic floor therapy during 12 weeks. Outcomes will be evaluated at the end of therapy (12 weeks), 3 and 6 months follow-up.
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men over 18 years of age
- •Erectile dysfunction or premature ejaculation for at least 6 months
- •Sexual activity with a heterosexual partner at least once a week
- •Signing of informed consent before the start of the study
- •For the premature ejaculation group:
- •Premature ejaculation according to the International Society of Sexual Medicine (ISSM) criteria
- •Premature Ejaculation Diagnosis Tool (PEDT) questionnaire score greater than 11
- •For the erectile dysfunction group:
- •Clinical diagnosis of primary erectile dysfunction
- •International Index Erectile Function - Erectile Function domain (IIEF-EF) score less than 26
排除标准
- •Pharmacological treatment for erectile dysfunction or premature ejaculation in the last 3 months
- •Erection Hardness Score (EHS) greater than 3 for patients with erectile dysfunction
- •History of hypogonadism or suspected hypogonadism due to Aging Males Symptoms (AMS) score greater than 36 for patients with erectile dysfunction
- •History of pelvic radiotherapy
- •Pacemaker or cardiac arrhythmia, epilepsy
- •History of spinal cord trauma or spinal surgeries.
- •Inability to attend therapies or controls
- •Illiteracy or cognitive disability that prevents you from completing the questionnaires
- •Psychiatric, psychological disorders, or cognitive deficiencies
- •Injuries in the area of application of the therapy
- •Active pelvic organ cancer
研究组 & 干预措施
Erectile Dysfunction
The therapy depends if patient is classified within muscular hyperactivity or muscular hypoactivity.
For muscular hypoactivity:
Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-7 Muscle workout: sessions 8-15 Functional training: sessions 16-23 Final evaluation: Session 24
For muscular hyperactivity they will be given:
Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-7 Muscle workout: sessions 8-15 Functional training: sessions 16-23 Final evaluation: session 24
These interventions include: Therapeutic exercises, Perineal electromyographic biofeedback, and Electrical stimulation
干预措施: Therapeutic exercises (Behavioral)
Erectile Dysfunction
The therapy depends if patient is classified within muscular hyperactivity or muscular hypoactivity.
For muscular hypoactivity:
Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-7 Muscle workout: sessions 8-15 Functional training: sessions 16-23 Final evaluation: Session 24
For muscular hyperactivity they will be given:
Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-7 Muscle workout: sessions 8-15 Functional training: sessions 16-23 Final evaluation: session 24
These interventions include: Therapeutic exercises, Perineal electromyographic biofeedback, and Electrical stimulation
干预措施: Perineal electromyographic biofeedback (Device)
Erectile Dysfunction
The therapy depends if patient is classified within muscular hyperactivity or muscular hypoactivity.
For muscular hypoactivity:
Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-7 Muscle workout: sessions 8-15 Functional training: sessions 16-23 Final evaluation: Session 24
For muscular hyperactivity they will be given:
Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-7 Muscle workout: sessions 8-15 Functional training: sessions 16-23 Final evaluation: session 24
These interventions include: Therapeutic exercises, Perineal electromyographic biofeedback, and Electrical stimulation
干预措施: Electrical stimulation (Device)
Premature Ejaculation
Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-15 Muscle workout: sessions 16-19 Functional training: sessions 20-23 Final evaluation: session 24
These interventions include: Therapeutic exercises, Perineal electromyographic biofeedback, and Electrical stimulation
干预措施: Therapeutic exercises (Behavioral)
Premature Ejaculation
Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-15 Muscle workout: sessions 16-19 Functional training: sessions 20-23 Final evaluation: session 24
These interventions include: Therapeutic exercises, Perineal electromyographic biofeedback, and Electrical stimulation
干预措施: Perineal electromyographic biofeedback (Device)
Premature Ejaculation
Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-15 Muscle workout: sessions 16-19 Functional training: sessions 20-23 Final evaluation: session 24
These interventions include: Therapeutic exercises, Perineal electromyographic biofeedback, and Electrical stimulation
干预措施: Electrical stimulation (Device)
Premature Ejaculation + Erectile Dysfunction
Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-12 Muscle workout: sessions 13-20 Functional training: sessions 20-23 Final evaluation: session 24
These interventions include: Therapeutic exercises, Perineal electromyographic biofeedback, and Electrical stimulation
干预措施: Therapeutic exercises (Behavioral)
Premature Ejaculation + Erectile Dysfunction
Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-12 Muscle workout: sessions 13-20 Functional training: sessions 20-23 Final evaluation: session 24
These interventions include: Therapeutic exercises, Perineal electromyographic biofeedback, and Electrical stimulation
干预措施: Perineal electromyographic biofeedback (Device)
Premature Ejaculation + Erectile Dysfunction
Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-12 Muscle workout: sessions 13-20 Functional training: sessions 20-23 Final evaluation: session 24
These interventions include: Therapeutic exercises, Perineal electromyographic biofeedback, and Electrical stimulation
干预措施: Electrical stimulation (Device)
结局指标
主要结局
Change in International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score
时间窗: 12 weeks
International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score change at the end of therapy. (Groups 2,3)
Change in baseline intravaginal latency time (IVLT)
时间窗: 12 weeks
Change in baseline intravaginal latency time (IVLT) at the end of therapy. (Groups 1,3)
次要结局
- Change in Premature Ejaculation Diagnosis Tool (PEDT) questionnnaire score(12 weeks, 3 and 6 months follow-up.)
- Change in Erection Hardness Score (EHS)(12 weeks, 3 and 6 months of follow-up.)
- Change Intracavity Assessment(12 weeks, 3 and 6 months follow-up.)
- Change in baseline intravaginal latency time (IVLT) at follow-up(3 and 6 months of follow-up.)
- Change Premature Ejaculation Perfil (PEP) score(12 weeks, 3 and 6 months follow-up.)
- Side Effects(12 weeks, 3 and 6 months follow-up.)
- Change in International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score at follow-up(3 and 6 months of follow-up.)