Clinical trial NCT03204890: TPTNS for Treating Patients With Premature Ejaculation
Official title: Transcutaneous Posterior Tibial Nerve Stimulation (TPTNS) for Treating Patients With Premature Ejaculation. Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Ejaculation
Lead sponsor: Boston Medical Group
Sponsor class: INDUSTRY
First posted: 2017-07-02
Enrollment: 26
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Improvement
timeFrame: Three months after completion.
Secondary outcomes:
measure: Change in the Basal PDET Score
timeFrame: Three months after completion.
measure: Magnitude of the Change in the PEDT Score
timeFrame: Three months after completion.
measure: Frequency of Adverse Events
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Boston Medical Group Colombia
state: Cundinamarca
Study officials:
affiliation: Boston Medical Group
name: José P Saffon, Doctor
role: PRINCIPAL_INVESTIGATOR
References: