Erectile Dysfunction, Pelvic Floor; Weak, Premature (Early) Ejaculation, Premature Ejaculation
Conditions
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.
Interventions
BEHAVIORALTherapeutic exercises
Recognition of the pelvic area, respiratory management, lumbo-pelvic mobilization, discrimination of abdomino-pelvic contraction and myofascial release techniques.
DEVICEPerineal electromyographic biofeedback
Free muscle work and gross motor coordination:
DEVICEElectrical stimulation
Muscular proprioceptive work: 50 Hz 300 µs
Sponsors
Boston Medical Group
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in baseline intravaginal latency time (IVLT) | 12 weeks | Change in baseline intravaginal latency time (IVLT) at the end of therapy. (Groups 1,3) |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 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. |
| 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) |
| 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) |
Countries
Colombia
Contacts
CONTACTCarolina Sandoval, Master
CONTACTHéctor Corredor, MD
PRINCIPAL_INVESTIGATORCristina Amaya
Boston Medical Group
Outcome results
None listed