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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erectile Dysfunction | Experimental | 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 | Experimental | 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 | Experimental | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic exercises | Behavioral | Recognition of the pelvic area, respiratory management, lumbo-pelvic mobilization, discrimination of abdomino-pelvic contraction and myofascial release techniques. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in baseline intravaginal latency time (IVLT) | Change in baseline intravaginal latency time (IVLT) at the end of therapy. (Groups 1,3) | 12 weeks |
| Change in International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score | International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score change at the end of therapy. (Groups 2,3) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in baseline intravaginal latency time (IVLT) at follow-up | Change in IVLT at 3 and 6 months of follow-up. (Groups 1,3) | 3 and 6 months of follow-up. |
| Change Premature Ejaculation Perfil (PEP) score |
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Inclusion Criteria:
Overall:
For the premature ejaculation group:
For the erectile dysfunction group:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carolina Sandoval, Master | Contact | +573133920816 | csandoval@bostonmedical.com.co | |
| Héctor Corredor, MD | Contact | +573174317162 | hcorredor@bostonmedical.com.co |
| Name | Affiliation | Role |
|---|---|---|
| Cristina Amaya | Boston Medical Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Group Colombia | Recruiting | Bogotá | Cundinamarca | 11022 | Colombia |
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| Perineal electromyographic biofeedback | Device | Free muscle work and gross motor coordination: |
|
| Electrical stimulation | Device | Muscular proprioceptive work: 50 Hz 300 µs |
|
Change in baseline PEP score at the end of therapy, 3 and 6 months of follow-up. (Groups 1,3)
| 12 weeks, 3 and 6 months follow-up. |
| Change in Premature Ejaculation Diagnosis Tool (PEDT) questionnnaire score | Change in baseline PEDT questionnaire score at the end of therapy, 3 and 6 months follow-up. (Groups 1,3) | 12 weeks, 3 and 6 months follow-up. |
| Change Intracavity Assessment | Change in the parameters of the baseline Intracavity Assessment at the end of therapy, 3 and 6 months follow-up. | 12 weeks, 3 and 6 months follow-up. |
| Side Effects | Incidente of side effects related to therapy. | 12 weeks, 3 and 6 months follow-up. |
| Change in International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score at 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) | 3 and 6 months of follow-up. |
| Change in Erection Hardness Score (EHS) | Increase of 1 point in the baseline EHS at the end of therapy, 3 and 6 months of follow-up. (Groups 2,3) | 12 weeks, 3 and 6 months of follow-up. |
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| D047928 | Premature Birth |
| D061686 | Premature Ejaculation |
| D001247 | Asthenia |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000097910 | Ejaculatory Dysfunction |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D004558 | Electric Stimulation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D010812 | Physical Stimulation |
| D008919 | Investigative Techniques |
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