Premature EjaculationNCT03204890
TPTNS for Treating Patients With Premature Ejaculation
A study testing Transcutaneous Posterior Tibial Nerve Stimulation in people with Premature Ejaculation, run by Boston Medical Group at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Premature Ejaculation
- What is being tested?
- Transcutaneous Posterior Tibial Nerve Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteColombia
- Study dates
- 14 Jun 2017to 30 Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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 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.
Who cannot join
- Diagnosis of erectile dysfunction according to the International Index Function Erectile (IIFE-5) (score under 21).
- A premature ejaculatory diagnosis tool (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.
Show all 12Show fewer
- 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 pre-coital premature ejaculation.
- Use of barrier contraceptive methods or local anesthetics.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcutaneous Posterior Tibial Nerve Stimulation (TPTNS) for Treating Patients With Premature Ejaculation. Phase II Clinical Trial
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
- Being tested
- Transcutaneous Posterior Tibial Nerve Stimulation
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Posterior Tibial Nerve StimulationOther
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 group | Role | What they receive |
|---|---|---|
| TPTNS | Experimental | Transcutaneous Posterior Tibial Nerve Stimulation Receives: Other: Transcutaneous Posterior Tibial Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Three months after completion.
Secondary outcomes (3)
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.
Measured: 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.
Measured: Three months after completion.
Frequency of Adverse Events
Number of patients with adverse events or side effects with the therapy
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start14 Jun 2017
- Primary completion15 Jan 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Premature EjaculationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- José P Saffon, Doctor, Principal investigator, Boston Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03204890
- Sponsor's protocol ID
- BMGC-2
- Status last verified
- Oct 2023
- First submitted
- 28 Jun 2017
- Last updated
- 15 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Posterior Tibial Nerve Stimulation (TPTNS) for Treating Patients With Premature Ejaculation. Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT03204890
- Acronym / sponsor ID
- BMGC-2
- Conditions
- Premature Ejaculation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Boston Medical GroupIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Posted 15 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TPTNS | Experimental | Other: Transcutaneous Posterior Tibial Nerve StimulationTranscutaneous Posterior Tibial Nerve Stimulation |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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 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.
Key exclusion criteria (12 listed)
- Diagnosis of erectile dysfunction according to the International Index Function Erectile (IIFE-5) (score under 21).
- A premature ejaculatory diagnosis tool (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Posterior Tibial Nerve StimulationThree (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. | Other | TPTNS |
Primary outcome
Clinical Improvement
Time frame: Three months after completion.
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)
3 secondary outcomes
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 of Adverse Events
Time frame: up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Premature Ejaculation
Not yet recruiting
Male Pelvic Floor Muscle Rehabilitation Exercises
Erectile Dysfunction, Urinary Incontinence
RecruitingObservational study
Ejaculatory and Orgasmic Dysfunction Registry
Ejaculatory Dysfunction, Premature Ejaculation
RecruitingPhase 2
Study to Evaluate the Potential Effects of KH-001 on Intravaginal Ejaculatory Latency Time (IELT), Patient-Reported Outcomes, and Safety in Men With Lifelong Premature Ejaculation (LPE)
Premature Ejaculation
Not yet recruitingPhase 2
Evaluate the Efficacy and Safety of VV913 Capsules in the Treatment of PE
Premature Ejaculation
Recruiting
Pelvic Floor Therapies for Lifelong Premature Ejaculation
Premature Ejaculation, Lifelong Premature Ejaculation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José P Saffon, Doctor principal investigator
Boston Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Posterior Tibial Nerve Stimulation in people with Premature Ejaculation, run by Boston Medical Group at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Improvement (time frame: Three months after completion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.