Pelvic floor therapy for erectile dysfunction and premature ejaculation
Effectiveness of Pelvic Floor Therapy for the Management of Erectile Dysfunction and Premature Ejaculation.
This study is testing if pelvic floor therapy can help men with erectile dysfunction and premature ejaculation feel better after 12 weeks of treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Male |
| Sponsor | Boston Medical Group Industry-sponsored |
| Locations | 1 site (Bogotá, Cundinamarca) |
| Trial ID | NCT06425211 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of pelvic floor therapy, which includes electrostimulation, biofeedback, and therapeutic exercises, for managing erectile dysfunction and premature ejaculation. Participants will undergo an initial consultation, receive 24 therapy sessions over 12 weeks, and have follow-up evaluations at 3 and 6 months. The study includes three groups: those with premature ejaculation, those with erectile dysfunction, and those with both conditions. The primary outcomes will assess changes in erectile function and intravaginal latency time.
Who should consider this trial
Good fit: Ideal candidates are men over 18 with erectile dysfunction or premature ejaculation lasting at least 6 months and who engage in sexual activity at least once a week.
Not a fit: Patients currently receiving pharmacological treatment for erectile dysfunction or premature ejaculation may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a non-pharmacological treatment option for men suffering from erectile dysfunction and premature ejaculation.
How similar studies have performed: While pelvic floor therapy is a recognized approach, the specific combination of therapies in this trial is relatively novel and has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bogotá, Cundinamarca
- Boston Medical Group Colombia — Bogotá, Cundinamarca, Colombia (Recruiting)
Study contacts
- Principal investigator: Cristina Amaya — Boston Medical Group
- Study coordinator: Carolina Sandoval, Master
- Email: csandoval@bostonmedical.com.co
- Phone: +573133920816
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.