Clinical trial NCT04207723: Transcutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation
Official title: Effectiveness and Safety of Transcutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Premature Ejaculation
Lead sponsor: Boston Medical Group
Sponsor class: INDUSTRY
First posted: 2019-12-23
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: Evaluate the effectiveness and safety of transcutaneous electrostimulation of the posterior tibial nerve alone and combined with standard pharmacological treatment, in men with primary premature ejaculation, compared to standard pharmacological treatment.

Patients and methods: Randomized controlled clinical trial. Patients diagnosed with premature ejaculation attending Boston Medical Group clinics in Colombia and Spain will be included. Participants will be assigned by randomization to one of three treatment groups:

* Group 1: Tens + placebo drug therapy
* Group 2: Standard treatment (paroxetine 20 mg) + placebo therapy
* Group 3: Tens therapy + standard treatment (paroxetine mg)

The change in intravaginal latency time measured with the couple's sustained stopwatch, the change in the PEDT scale, the perception of the change in their initial condition after treatment (Global Clinical impression of change scale), and the change in different domains of the EP (PEP Scale - Profile Ejaculation Premature) at the end of treatment (week 12) and at three months of follow-up (week 24).


Eligibility criteria: Inclusion Criteria:

* Primary premature ejaculation as defined by the International Society for Sexual Medicine (ISSM-International Society for Sexual Medicine) (30): a) ejaculation occurs always or almost always within the first minute after penetration, b) disability to delay ejaculation in all or almost all penetrations, c) negative personal consequences are generated, such as stress, discomfort, frustration and / or avoidance of sexual intimacy.
* Age equal to or greater than 18 years.
* PEDT score greater than 11.
* Stable heterosexual relationship of at least 6 months with the interest of maintaining it for at least the duration of the study.
* Sexual activity at least once a week.
* Minimum chronicity of PE of 6 months.
* Voluntary participation in the study.
* Signature of informed consent prior to participation in the study.

Exclusion Criteria:

* IIEF-EF score greater than 25.
* Clinically significant comorbidity: cardiovascular, hepatic, thromboembolic, neurological, locomotive, endocrine, oncological, renal or rheumatologic.
* 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, psychiatric disorder, referred by the patient or by the use of a medication for one of these terms.
* Consumption of medications that affect ejaculatory control such as psychiatric medications, opioid analgesics, alpha blockers.
* Treatment for PD in the last 3 months.
* Treatment for epileptic syndromes or Parkinson's disease.
* Use of pacemaker or cardiac defibrillator.
* Skin lesions in the electrode placement area.
* Abuse or dependence on piscoactive substances: alcohol, hallucinogenic drugs.
* Couple in a state of pregnancy.

Primary outcomes:
measure: Intravaginal latency time at week 12
timeFrame: Week 12
Secondary outcomes:
measure: Change in Premature Ejaculation Diagnostic Tool (PEDT) questionnaire score
timeFrame: weeks 12 and 24
measure: Clinical improvement
timeFrame: weeks 12 and 24
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Boston Medical Group
Study officials:
affiliation: Boston Medical Group
name: Héctor Corredor, Md
role: PRINCIPAL_INVESTIGATOR
References: