TPTNS for Treating Patients With Premature Ejaculation
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|ClinicalTrials.gov Identifier: NCT03204890|
Recruitment Status : Completed
First Posted : July 2, 2017
Last Update Posted : February 4, 2019
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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Transcutaneous Posterior Tibial Nerve Stimulation (TPTNS) for Treating Patients With Premature Ejaculation. Phase II Clinical Trial|
|Actual Study Start Date :||June 14, 2017|
|Actual Primary Completion Date :||January 15, 2018|
|Actual Study Completion Date :||October 30, 2018|
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.
- 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)
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03204890
|Boston Medical Group Colombia|
|Bogotá, Cundinamarca, Colombia, 11022|
|Principal Investigator:||José P Saffon, Doctor||Boston Medical Group|