An interventional study of Transcutaneous Posterior Tibial Nerve Stimulation in Premature Ejaculation, sponsored by Boston Medical Group. Completed at 1 site in Colombia. Open to male participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-04-15.
Sponsored by Boston Medical Group · Not applicable, Interventional, and Treatment
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.
106 studies on the registry are indexed under Premature Ejaculation; 17 are open to participants now.
This study's enrollment of 26 is below the median of 84 across 89 interventional studies indexed under Premature Ejaculation.
Browse Premature Ejaculation studies →Boston Medical Group is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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)
Time frame: Three months after completion.
Change in the Basal PDET Score
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.
Time frame: Three months after completion.
Magnitude of the Change in the PEDT Score
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.
Time frame: Three months after completion.
Frequency of Adverse Events
Number of patients with adverse events or side effects with the therapy
Time frame: up to 6 months
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.
| Milestone | TPTNS |
|---|---|
| Started | 12 |
| Completed | 11 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
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)
| Participants | TPTNS |
|---|---|
| Clinical Improvement | 8 |
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.
| participants | TPTNS |
|---|---|
| Change in the Basal PDET Score | 7 |
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.
| score on a scale | TPTNS |
|---|---|
| Magnitude of the Change in the PEDT Score | 10.5 ± 5.2 |
Number of patients with adverse events or side effects with the therapy
| Participants | TPTNS |
|---|---|
| Frequency of Adverse Events | 2 |
Collected over 9 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TPTNS | 0/11 (0%) | 0/11 (0%) | 2/11 (18.2%) |
| Event | TPTNS |
|---|---|
| Not seriousGastrointestinal disorders | 1/11 |
| Not seriuosSkin and subcutaneous tissue disorders | 1/11 |
| Age, Customized(years) | TPTNS |
|---|---|
| Median | 30 (21 to 49) |
| Sex/Gender, Customized(participants) | TPTNS |
|---|---|
| Men | 12 |
| Race and Ethnicity Not Collected(Participants) | TPTNS |
|---|
| Region of Enrollment(Participants) | TPTNS |
|---|---|
| Colombia | 12 |
| Baseline Intravaginal ejaculation latency time (IELT)(seconds) | TPTNS |
|---|---|
| Median | 30 (3 to 180) |
| Premature Ejaculation Diagnostic Tool (PEDT) score(units on a scale) | TPTNS |
|---|---|
| Median | 16 (11 to 20) |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2017 to primary completion in Jan 2018, 7 months.
Results were first posted in Apr 2024, 6 years 3 months after primary completion.
Of 25 interventional studies with no phase under Premature Ejaculation, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 39. This study's 7 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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