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Tests treatment safety and results for Erectile Dysfunction
Official title Effectiveness of Pelvic Floor Therapy for the Management of Erectile Dysfunction and Premature Ejaculation.
ClinicalTrials.gov ID: NCT06425211
What this study is testing
- What it's testing
- 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?
- Time commitment: about 12 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100, men only
You may be able to join if
- 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:
You likely can't join if
- 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.
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bogotá, Cundinamarca, Colombia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bogotá, Cundinamarca, Colombia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.