TPTNS for Treating Patients With Premature Ejaculation

Sponsor

Boston Medical Group (Industry)

Overall Status

Completed

CT.gov ID

NCT03204890

Collaborator

(none)

Enrollment

Location

Arm

16.5

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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 and the PEDT scale will be evaluated on week 6, at the end of treatment and three months after completing the protocol.

Condition or Disease	Intervention/Treatment	Phase
Premature Ejaculation	Other: Transcutaneous Posterior Tibial Nerve Stimulation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Transcutaneous Posterior Tibial Nerve Stimulation (TPTNS) for Treating Patients With Premature Ejaculation. Phase II Clinical Trial

Actual Study Start Date :

Jun 14, 2017

Actual Primary Completion Date :

Jan 15, 2018

Actual Study Completion Date :

Oct 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TPTNS Transcutaneous Posterior Tibial Nerve Stimulation	Other: 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.

Arm

Intervention/Treatment

Experimental: TPTNS

Transcutaneous Posterior Tibial Nerve Stimulation

Other: 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.

Outcome Measures

Primary Outcome Measures

Clinical improvement [Three months after completion.]
Proportion 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 Outcome Measures

Change in the basal PDET score [Three months after completion.]
Magnitude of the change in the PEDT score [Three months after completion.]
Frequency and severity of adverse events [During the therapy]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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 DSM 5 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 IIFE 5 (score under 21).
A 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 precoital premature ejaculation.
Use of barrier contraceptive methods or local anesthetics.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boston Medical Group Colombia	Bogotá	Cundinamarca	Colombia	11022

Sponsors and Collaborators

Boston Medical Group

Investigators

Principal Investigator: José P Saffon, Doctor, Boston Medical Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Boston Medical Group

ClinicalTrials.gov Identifier:

NCT03204890

Other Study ID Numbers:

BMGC-2

First Posted:

Jul 2, 2017

Last Update Posted:

Feb 4, 2019

Last Verified:

May 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Premature Birth

Premature Ejaculation

Study Results

No Results Posted as of Feb 4, 2019