TPTNS for Treating Patients With Premature Ejaculation (NCT03204890) | Clinical Trial Compass
CompletedNot Applicable
TPTNS for Treating Patients With Premature Ejaculation
Colombia26 participantsStarted 2017-06-14
Plain-language summary
Background: Transcutaneous posterior tibial nerve stimulation is an effective therapy for controlling urinary incontinence. Premature ejaculation (PE) and urinary incontinence are anatomically and physio-pathologically similar. Based on this, the use of this therapy is considered to be viable for the control of PE.
Objective: To evaluate the efficacy of transcutaneous posterior tibial nerve electrostimulation for the ejaculatory reflex.
Patients and Methods: Phase II clinical trial. Patients with a diagnosis of premature ejaculation who are treated at the Colombia Boston Medical Group clinic will be included. The participants will receive 3 transcutaneous posterior tibial nerve stimulation therapies per week for 12 weeks. The IELT (Intravaginal ejaculatory latency time) and the PEDT (Premature Ejaculatory Diagnosis Tool) scale will be evaluated on week 6, at the end of treatment, and three months after completing the protocol.
Who can participate
Age range
18 Years – 50 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:
* Over 18 years of age and less than 50 years of age with no cardiovascular risk factor other than age.
* Having been diagnosed with primary premature ejaculation according to the American Psychiatric Society's Diagnostic and Statistical Manual.
* Agreeing to participate and providing signed informed consent.
* Stable relationship for over 6 months, with frequent intercourse at least once per week.
Exclusion Criteria:
* Diagnosis of erectile dysfunction according to the International Index Function Erectile (IIFE-5) (score under 21).
* A premature ejaculatory diagnosis tool (PEDT) score under 8.
* Use of treatment for premature ejaculation during the study or over the 6 months prior to beginning the study.
* Use of pacemaker or heart defibrillator.
* Epilepsy or convulsions
* Venous insufficiency (varices) or cutaneous wounds or injuries on the lower extremities.
* Congenital or acquired anatomical abnormalities of the penis.
* Taking medications that affect ejaculation control, including psychiatric medications, opioid analgesics, and medications for pathologies of the prostate such as alpha-blockers.
* Psychological or psychiatric disorders that prevent the patient from undergoing the treatment or recording the measurements as established.
* Difficulty going to the clinic 3 times per week as required by the protocol.
* Patients with pre-coital premature ejaculation.
* Use of barrier contraceptive methods or local anesthetics.
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.