TPTNS for Treating Patients With Premature Ejaculation

• ClinicalTrials.gov Identifier: NCT03204890
• Recruitment Status: Completed
• First Posted: July 2, 2017
• Last Update Posted: February 4, 2019
• Sponsor: Boston Medical Group
• Information provided by (Responsible Party): Boston Medical Group

Tracking Information

• First Submitted Date: June 28, 2017
• First Posted Date: July 2, 2017
• Last Update Posted Date: February 4, 2019
• Actual Study Start Date: June 14, 2017
• Actual Primary Completion Date: January 15, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 28, 2017)

Clinical improvement [ Time Frame: 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)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 28, 2017)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Premature Ejaculation

Intervention

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.

Study Arms

Experimental: TPTNS

Transcutaneous Posterior Tibial Nerve Stimulation

Intervention: Other: Transcutaneous Posterior Tibial Nerve Stimulation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 28, 2017): 26
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: October 30, 2018
• Actual Primary Completion Date: January 15, 2018 (Final data collection date for primary outcome measure)

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 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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Colombia

Administrative Information

• NCT Number: NCT03204890
• Other Study ID Numbers: BMGC-2
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Boston Medical Group
• Study Sponsor: Boston Medical Group
• Collaborators: Not Provided

Investigators

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

• PRS Account: Boston Medical Group
• Verification Date: May 2018