Actively Recruiting
Effectiveness and Safety of TENS Therapy for Premature Ejaculation
Led by Boston Medical Group · Updated on 2024-05-22
129
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this clinical trial is to evaluate the effectiveness and safety of transcutaneous posterior tibial nerve stimulation therapy in patients with premature ejaculation. The main question to answer is: Can the effectiveness and safety of transcutaneous electrostimulation of the posterior tibial nerve alone and combined with standard pharmacological treatment be evaluated in men with lifelong premature ejaculation, compared to standard pharmacological treatment with dapoxetine? Patients will: Be randomized in acontrolled clinical trial. Patients with a diagnosis of premature ejaculation who attend Boston Medical Group clinics in Mexico City will be included. Be assigned by randomization to one of three treatment groups: * Group 1: Tens therapy + dapoxetine placebo on demand. * Group 2: Standard treatment (dapoxetine 30 mg as needed) + placebo therapy. * Group 3: Tens therapy + standard treatment (dapoxetine 30 mg as needed).
CONDITIONS
Official Title
Effectiveness and Safety of TENS Therapy for Premature Ejaculation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary premature ejaculation according to International Society for Sexual Medicine definition
- Age between 18 and 62 years
- PEDT score greater than 11
- Stable heterosexual relationship for at least 6 months with interest in continuing during study
- Sexual activity at least once a week
- Premature ejaculation lasting at least 6 months
- Voluntary participation and signing informed consent
You will not qualify if you...
- IIEF-EF score less than 26
- Glaucoma
- Significant cardiovascular, hepatic, thromboembolic, neurological, locomotor, endocrine, oncological, renal or rheumatological disease
- History of retroperitoneal surgery, radiotherapy or multiple sclerosis
- History of mental illness including depression, anxiety, bipolar disorder, or other psychiatric disorders
- Use of medications affecting ejaculation such as psychiatric drugs, opioid analgesics, alpha blockers
- Treatment for premature ejaculation in last 3 months
- Treatment for epileptic syndromes or Parkinson's disease
- Use of pacemaker or cardiac defibrillator
- Skin lesions where electrodes would be placed
- Abuse or dependence on psychoactive substances including alcohol and hallucinogenic drugs
- Partner who is pregnant or planning pregnancy in next 3 months
AI-Screening
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Trial Site Locations
Total: 1 location
1
Boston Medical Group
Mexico City, Mexico, 01000
Actively Recruiting
Research Team
C
Carolina Sandoval, Master
CONTACT
H
Héctor Corredor, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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