Effectiveness of Pelvic Floor Therapy for the Management of Erectile Dysfunction and Premature Ejaculation.
- Conditions
- Pelvic Floor; WeakErectile DysfunctionPremature (Early) EjaculationPremature Ejaculation
- Interventions
- Behavioral: Therapeutic exercisesDevice: Perineal electromyographic biofeedbackDevice: Electrical stimulation
- Registration Number
- NCT06425211
- Lead Sponsor
- Boston Medical Group
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 66
Overall:
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Premature Ejaculation + Erectile Dysfunction Electrical stimulation 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 Erectile Dysfunction Perineal electromyographic biofeedback 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 Premature Ejaculation + Erectile Dysfunction Therapeutic exercises 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 Erectile Dysfunction Therapeutic exercises 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 Premature Ejaculation Electrical stimulation 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 Erectile Dysfunction Electrical stimulation 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 Premature Ejaculation Therapeutic exercises 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 Premature Ejaculation Perineal electromyographic biofeedback 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 Premature Ejaculation + Erectile Dysfunction Perineal electromyographic biofeedback 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
- Primary Outcome Measures
Name Time Method Change in International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score 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) 12 weeks Change in baseline intravaginal latency time (IVLT) at the end of therapy. (Groups 1,3)
- Secondary Outcome Measures
Name Time Method Change in Premature Ejaculation Diagnosis Tool (PEDT) questionnnaire score 12 weeks, 3 and 6 months follow-up. Change in baseline PEDT questionnaire score at the end of therapy, 3 and 6 months follow-up. (Groups 1,3)
Change in Erection Hardness Score (EHS) 12 weeks, 3 and 6 months of follow-up. Increase of 1 point in the baseline EHS at the end of therapy, 3 and 6 months of follow-up. (Groups 2,3)
Change Intracavity Assessment 12 weeks, 3 and 6 months follow-up. Change in the parameters of the baseline Intracavity Assessment at the end of therapy, 3 and 6 months follow-up.
Change in baseline intravaginal latency time (IVLT) at follow-up 3 and 6 months of follow-up. Change in IVLT at 3 and 6 months of follow-up. (Groups 1,3)
Change Premature Ejaculation Perfil (PEP) score 12 weeks, 3 and 6 months follow-up. Change in baseline PEP score at the end of therapy, 3 and 6 months of follow-up. (Groups 1,3)
Side Effects 12 weeks, 3 and 6 months follow-up. Incidente of side effects related to therapy.
Change in International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score at follow-up 3 and 6 months of follow-up. International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score change at the 3 and 6 months of follow-up. (Groups 2,3)
Trial Locations
- Locations (1)
Boston Medical Group Colombia
🇨🇴Bogotá, Cundinamarca, Colombia