NCT03204890

TPTNS for Treating Patients With Premature Ejaculation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Boston Medical Group · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Premature Ejaculation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-06-14
• Primary completion: 2018-01-15
• Completion: 2018-10-30
• First posted: 2017-07-02
• Last updated: 2024-04-15
• Results posted: 2024-04-15

Locations

1 site across 1 country: Colombia