An interventional study of Therapeutic exercises and Perineal electromyographic biofeedback in Erectile Dysfunction, Premature (Early) Ejaculation and Premature Ejaculation, sponsored by Boston Medical Group. Recruiting at 1 site in Colombia. Open to male participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-01-23.
Sponsored by Boston Medical Group · Not applicable, Interventional, and Treatment
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 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.
701 studies on the registry are indexed under Erectile Dysfunction; 125 are open to participants now.
This study's planned enrollment of 66 is close to the median of 70 across 551 interventional studies indexed under Erectile Dysfunction.
Browse Erectile Dysfunction studies →Boston Medical Group is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
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Overall:
For the premature ejaculation group:
For the erectile dysfunction group:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Behavioral: Therapeutic exercises · Device: Perineal electromyographic biofeedback · Device: 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
Behavioral: Therapeutic exercises · Device: Perineal electromyographic biofeedback · Device: 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
Behavioral: Therapeutic exercises · Device: Perineal electromyographic biofeedback · Device: Electrical stimulation
Recognition of the pelvic area, respiratory management, lumbo-pelvic mobilization, discrimination of abdomino-pelvic contraction and myofascial release techniques.
Free muscle work and gross motor coordination:
Muscular proprioceptive work: 50 Hz 300 µs
Change in baseline intravaginal latency time (IVLT)
Change in baseline intravaginal latency time (IVLT) at the end of therapy. (Groups 1,3)
Time frame: 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)
Time frame: 12 weeks
Change in baseline intravaginal latency time (IVLT) at follow-up
Change in IVLT at 3 and 6 months of follow-up. (Groups 1,3)
Time frame: 3 and 6 months of follow-up.
Change Premature Ejaculation Perfil (PEP) score
Change in baseline PEP score at the end of therapy, 3 and 6 months of follow-up. (Groups 1,3)
Time frame: 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)
Time frame: 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.
Time frame: 12 weeks, 3 and 6 months follow-up.
Side Effects
Incidente of side effects related to therapy.
Time frame: 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)
Time frame: 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)
Time frame: 12 weeks, 3 and 6 months of follow-up.
Plan to share: No
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