Effectiveness of Pelvic Floor Therapy for the Management of Erectile Dysfunction and Premature Ej… (NCT06425211) | Clinical Trial Compass
RecruitingNot Applicable
Effectiveness of Pelvic Floor Therapy for the Management of Erectile Dysfunction and Premature Ejaculation.
Colombia66 participantsStarted 2021-10-30
Plain-language 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.
Who can participate
Age range
18 Years – 100 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in baseline intravaginal latency time (IVLT)
Timeframe: 12 weeks
2
Change in International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score