Trial Outcomes & Findings for TPTNS for Treating Patients With Premature Ejaculation (NCT NCT03204890)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

26 participants

Primary outcome timeframe

Three months after completion.

Results posted on

2024-04-15

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	12
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TPTNS n=12 Participants 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.
Age, Customized	30 years n=12 Participants
Sex/Gender, Customized Men	12 participants n=12 Participants
Region of Enrollment Colombia	12 Participants n=12 Participants
Baseline Intravaginal ejaculation latency time (IELT)	30 seconds n=12 Participants
Premature Ejaculation Diagnostic Tool (PEDT) score	16 units on a scale n=12 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	TPTNS n=11 Participants 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.
Clinical Improvement	8 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	TPTNS n=11 Participants 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.
Change in the Basal PDET Score	7 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	TPTNS n=12 Participants 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.
Magnitude of the Change in the PEDT Score	10.5 score on a scale Standard Deviation 5.2

SECONDARY outcome

Timeframe: up to 6 months

Number of patients with adverse events or side effects with the therapy

Outcome measures

Outcome measures
Measure	TPTNS n=11 Participants 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.
Frequency of Adverse Events	2 Participants

Adverse Events

TPTNS

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	TPTNS n=11 participants at risk 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.
Gastrointestinal disorders Not serious	9.1% 1/11 • Number of events 1 • 9 months
Skin and subcutaneous tissue disorders Not seriuos	9.1% 1/11 • Number of events 1 • 9 months

Additional Information

Dr. José Pablo Saffon

Boston Medical Group

Phone: +573208899777

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place