Effectiveness of Pelvic Floor Therapy for the Management of Erectile Dysfunction and Premature Ejaculation.
NCT ID: NCT06425211
Last Updated: 2026-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
66 participants
INTERVENTIONAL
2021-10-30
2026-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Erectile Dysfunction
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
Therapeutic exercises
Recognition of the pelvic area, respiratory management, lumbo-pelvic mobilization, discrimination of abdomino-pelvic contraction and myofascial release techniques.
Perineal electromyographic biofeedback
Free muscle work and gross motor coordination:
Electrical stimulation
Muscular proprioceptive work: 50 Hz 300 µs
Premature Ejaculation
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
Therapeutic exercises
Recognition of the pelvic area, respiratory management, lumbo-pelvic mobilization, discrimination of abdomino-pelvic contraction and myofascial release techniques.
Perineal electromyographic biofeedback
Free muscle work and gross motor coordination:
Electrical stimulation
Muscular proprioceptive work: 50 Hz 300 µs
Premature Ejaculation + Erectile Dysfunction
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
Therapeutic exercises
Recognition of the pelvic area, respiratory management, lumbo-pelvic mobilization, discrimination of abdomino-pelvic contraction and myofascial release techniques.
Perineal electromyographic biofeedback
Free muscle work and gross motor coordination:
Electrical stimulation
Muscular proprioceptive work: 50 Hz 300 µs
Interventions
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Therapeutic exercises
Recognition of the pelvic area, respiratory management, lumbo-pelvic mobilization, discrimination of abdomino-pelvic contraction and myofascial release techniques.
Perineal electromyographic biofeedback
Free muscle work and gross motor coordination:
Electrical stimulation
Muscular proprioceptive work: 50 Hz 300 µs
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
100 Years
MALE
No
Sponsors
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Boston Medical Group
INDUSTRY
Responsible Party
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Principal Investigators
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Cristina Amaya
Role: PRINCIPAL_INVESTIGATOR
Boston Medical Group
Locations
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Boston Medical Group Colombia
Bogotá, Cundinamarca, Colombia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BMGC-6
Identifier Type: -
Identifier Source: org_study_id
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