NCT06425211 Effectiveness of Pelvic Floor Therapy for the Management of Erectile Dysfunction and Premature Ejaculation.
| NCT ID | NCT06425211 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Medical Group |
| Condition | Erectile Dysfunction |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2021-10-30 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 66 participants in total. It began in 2021-10-30 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Cristina Amaya
PRINCIPAL INVESTIGATOR
Boston Medical Group
Frequently Asked Questions
Who can join the NCT06425211 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 100 Years, studying Erectile Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06425211 currently recruiting?
Yes, NCT06425211 is actively recruiting participants. Contact the research team at csandoval@bostonmedical.com.co for enrollment information.
Where is the NCT06425211 trial being conducted?
This trial is being conducted at Bogotá, Colombia.
Who is sponsoring the NCT06425211 clinical trial?
NCT06425211 is sponsored by Boston Medical Group. The principal investigator is Cristina Amaya at Boston Medical Group. The trial plans to enroll 66 participants.