Premature Ejaculation
Conditions
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.
Interventions
Three (3) sessions per week for twelve (12) consecutive weeks, with a duration of 30 minutes each, with the application of 20 Hertz with a pulse amplitude of 200 MI sec. in each session. The intensity will be applied individually for each patient depending on the tolerance of the individual. In each session, it is normal to have plantar flexion of the foot and flexion of the first toe, and after the session and particularly during the first sessions there is the possibility of muscle pain, which should be tolerable.
Sponsors
Boston Medical Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Improvement | Three months after completion. | Number of patients with clinical improvement of premature ejaculation, defined as a tripling of the baseline time (without treatment), as measured by the IELT (intravaginal ejaculation latency time) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Basal PDET Score | Three months after completion. | The premature ejaculation diagnostic tool (PEDT), is a questionnaire for the diagnosis of premature ejaculation. The questionnaire has 5 questions and each of them scores from 0 to 4. The score is the sum of all the answers (range 0-20), with higher scores suggesting more difficulties with premature ejaculation. A score ≥11 points suggested the presence of premature ejaculation. This outcome indicates the number of patients who decrease their initial PEDT score after 3 months after completing treatment. |
| Magnitude of the Change in the PEDT Score | Three months after completion. | The premature ejaculation diagnostic tool (PEDT), is a questionnaire for the diagnosis of premature ejaculation. The questionnaire has 5 questions and each of them scores from 0 to 4. The score is the sum of all the answers (range 0-20), with higher scores suggesting more difficulties with premature ejaculation. A score ≥11 points suggested the presence of premature ejaculation. This outcome indicates the average change that patients had in their PEDT score at baseline, 3 months after completing treatment. |
| Frequency of Adverse Events | up to 6 months | Number of patients with adverse events or side effects with the therapy |
Countries
Colombia
Participant flow
Recruitment details
Ninety subjects with premature ejaculation were invited to participate in the study. Twenty-six men fulfilled the selection criteria and were enrolled between June 14, 2017 and March 14, 2018, in a specialized institute.
Pre-assignment details
Fourteen participants had an IELT value \>1 min during the evaluation with a stopwatch in the 2 weeks prior to the start of therapy and were excluded from the study.
Participants by arm
| Arm | Count |
|---|---|
| TPTNS Transcutaneous Posterior Tibial Nerve Stimulation
Transcutaneous Posterior Tibial Nerve Stimulation: Three (3) sessions per week for twelve (12) consecutive weeks, with a duration of 30 minutes each, with the application of 20 Hertz with a pulse amplitude of 200 MI sec. in each session. The intensity will be applied individually for each patient depending on the tolerance of the individual. In each session, it is normal to have plantar flexion of the foot and flexion of the first toe, and after the session and particularly during the first sessions there is the possibility of muscle pain, which should be tolerable. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | TPTNS | — |
|---|---|---|
| Age, Customized | 30 years | — |
| Baseline Intravaginal ejaculation latency time (IELT) | 30 seconds | — |
| Premature Ejaculation Diagnostic Tool (PEDT) score | 16 units on a scale | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Colombia | 12 Participants | — |
| Sex/Gender, Customized Men | 12 participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 2 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Clinical Improvement
Number of patients with clinical improvement of premature ejaculation, defined as a tripling of the baseline time (without treatment), as measured by the IELT (intravaginal ejaculation latency time)
Time frame: Three months after completion.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TPTNS | Clinical Improvement | 8 Participants |
Secondary
Change in the Basal PDET Score
The premature ejaculation diagnostic tool (PEDT), is a questionnaire for the diagnosis of premature ejaculation. The questionnaire has 5 questions and each of them scores from 0 to 4. The score is the sum of all the answers (range 0-20), with higher scores suggesting more difficulties with premature ejaculation. A score ≥11 points suggested the presence of premature ejaculation. This outcome indicates the number of patients who decrease their initial PEDT score after 3 months after completing treatment.
Time frame: Three months after completion.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TPTNS | Change in the Basal PDET Score | 7 participants |
Secondary
Frequency of Adverse Events
Number of patients with adverse events or side effects with the therapy
Time frame: up to 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TPTNS | Frequency of Adverse Events | 2 Participants |
Secondary
Magnitude of the Change in the PEDT Score
The premature ejaculation diagnostic tool (PEDT), is a questionnaire for the diagnosis of premature ejaculation. The questionnaire has 5 questions and each of them scores from 0 to 4. The score is the sum of all the answers (range 0-20), with higher scores suggesting more difficulties with premature ejaculation. A score ≥11 points suggested the presence of premature ejaculation. This outcome indicates the average change that patients had in their PEDT score at baseline, 3 months after completing treatment.
Time frame: Three months after completion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TPTNS | Magnitude of the Change in the PEDT Score | 10.5 score on a scale | Standard Deviation 5.2 |