Clinical trial NCT06425224: Effectiveness and Safety of TENS Therapy for Premature Ejaculation
Official title: Effectiveness and Safety of Transcutaneous Posterior Tibial Nerve Stimulation Therapy for the Management of Patients With Premature Ejaculation. Phase III Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Premature Ejaculation
Sex Disorder
TEN
Lead sponsor: Boston Medical Group
Sponsor class: INDUSTRY
First posted: 2024-05-22
Enrollment: 129
Sex: MALE
Minimum age (years): 18
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria:

* 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.
* Sexual activity at least once a week.
* Minimum chronicity of PD of 6 months.
* Voluntary participation in the study.
* Signing of the informed consent prior to participation in the study.

Exclusion Criteria:

* 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.
* History of mental illness: depression, anxiety, suicidal behavior, bipolar disorder, agoraphobia, dysthymia, social phobia, obsessive-compulsive disorder, post-traumatic stress disorder, psychiatric disorder, reported by the patient or due to the use of a medication for one of these conditions.
* Consumption of medications that affect ejaculatory control such as psychiatric medications, opioid analgesics, alpha blockers.
* Treatment for PE in the last 3 months.
* Treatment for epileptic syndromes or Parkinson's disease.
* Use of pacemaker or cardiac defibrillator.
* Skin lesions in the area where the electrodes are placed.
* Abuse or dependence on psychoactive substances: alcohol, hallucinogenic drugs.
* Couple who are pregnant or interested in conceiving a pregnancy in the next 3 months.

Primary outcomes:
measure: Change in intravaginal latency time
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in intravaginal latency time
timeFrame: 24 weeks
measure: Clinical improvement in premature ejaculation
timeFrame: At weeks 12 (end of therapy) and 24 (three months of follow-up).
measure: Change in the diagnosis of premature ejaculation
timeFrame: At weeks 12 and 24 (greater than 12 to less than 12).
measure: Global Impression of Change Scale
timeFrame: Weeks 12 and 24.
measure: PEP (Premature Ejaculation Profile) questionnaire score
timeFrame: At weeks 12 and 24
measure: Adverse events
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Ciudad de México
country: Mexico
facility: Boston Medical Group
Study officials:
affiliation: Boston Medical Group
name: Jorge Barba, MD
role: PRINCIPAL_INVESTIGATOR
References: