Effectiveness and Safety of TENS Therapy for Premature Ejaculation
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18-62
SponsorBoston Medical Group
About this trial
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).
Eligibility criteria
Qualifiers
Primary premature ejaculation according to the definition of the International Society for Sexual Medicine (ISSM-International Society for Sexual Medicine) (30): a) ejaculation always or almost always occurs within the first minute after penetration, b) inability to delay ejaculation in all or almost all penetrations, c) negative personal consequences are generated, such as stress, annoyance, frustration and/or avoidance of sexual intimacy.
Age between 18 and 62 years.
PEDT score greater than 11.
Stable heterosexual relationship for at least 6 months with interest in maintaining it for at least the duration of the study.
Disqualifiers
IIEF-EF score less than 26.
Glaucoma
Clinically significant comorbidity: cardiovascular, hepatic, thromboembolic, neurological, locomotor, endocrine, oncological, renal or rheumatological.
History of retroperitoneal surgery, radiotherapy or multiple sclerosis.
Trial design
Treatments tested in this trial
- Tens therapy
- Dapoxetine placebo
- Standard treatment (dapoxetine 30 mg as needed)
- Placebo therapy
Treatment groups
129 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov