Overview
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.
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.
Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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