Premature EjaculationNCT04207723
Transcutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation
A study testing Transcutaneous posterior tibial nerve stimulation and Paroxetine in people with Premature Ejaculation, run by Boston Medical Group at 1 site in Colombia.
Trial summary
Objective: Evaluate the effectiveness and safety of transcutaneous electrostimulation of the posterior tibial nerve alone and combined with standard pharmacological treatment, in men with primary premature ejaculation, compared to standard pharmacological treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Premature Ejaculation
- What is being tested?
- Transcutaneous posterior tibial nerve stimulation and Paroxetine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteColombia
- Study dates
- 15 Jul 2020to 9 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary premature ejaculation as defined by the International Society for Sexual Medicine (ISSM-International Society for Sexual Medicine) (30): a) ejaculation occurs always or almost always within the first minute after penetration, b) disability to delay ejaculation in all or almost all penetrations, c) negative personal consequences are generated, such as stress, discomfort, frustration and / or avoidance of sexual intimacy.
- Age equal to or greater than 18 years.
- PEDT score greater than 11.
- Stable heterosexual relationship of at least 6 months with the interest of maintaining it for at least the duration of the study.
- Sexual activity at least once a week.
- Minimum chronicity of PE of 6 months.
- Voluntary participation in the study.
- Signature of informed consent prior to participation in the study.
Who cannot join
- IIEF-EF score greater than 25.
- Clinically significant comorbidity: cardiovascular, hepatic, thromboembolic, neurological, locomotive, endocrine, oncological, renal or rheumatologic.
- History of retroperitoneal surgery, radiotherapy or multiple sclerosis.
- History of mental illness: depression, anxiety, suicidal behavior, bipolar disorder, agoraphobia, dysthymia, social phobia, obsessive compulsive disorder, post-traumatic stress, psychiatric disorder, referred by the patient or by the use of a medication for one of these terms.
- Consumption of medications that affect ejaculatory control such as psychiatric medications, opioid analgesics, alpha blockers.
- Treatment for PD in the last 3 months.
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- Treatment for epileptic syndromes or Parkinson's disease.
- Use of pacemaker or cardiac defibrillator.
- Skin lesions in the electrode placement area.
- Abuse or dependence on piscoactive substances: alcohol, hallucinogenic drugs.
- Couple in a state of pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Safety of Transcutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation Treatment
Objective: Evaluate the effectiveness and safety of transcutaneous electrostimulation of the posterior tibial nerve alone and combined with standard pharmacological treatment, in men with primary premature ejaculation, compared to standard pharmacological treatment.
Patients and methods: Randomized controlled clinical trial. Patients diagnosed with premature ejaculation attending Boston Medical Group clinics in Colombia and Spain will be included. Participants will be assigned by randomization to one of three treatment groups:
Read more
- Group 1: Tens + placebo drug therapy
- Group 2: Standard treatment (paroxetine 20 mg) + placebo therapy
- Group 3: Tens therapy + standard treatment (paroxetine mg)
The change in intravaginal latency time measured with the couple's sustained stopwatch, the change in the PEDT scale, the perception of the change in their initial condition after treatment (Global Clinical impression of change scale), and the change in different domains of the EP (PEP Scale - Profile Ejaculation Premature) at the end of treatment (week 12) and at three months of follow-up (week 24).
- Conditions
- Premature Ejaculation
- Being tested
- Transcutaneous posterior tibial nerve stimulation, Paroxetine
- 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 per 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.
ParoxetineDrug
paroxetine 20 mg / day taken in the morning hours, per 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| TENS Therapy | Experimental | Tens therapy + placebo drug therapy Receives: Other: Transcutaneous posterior tibial nerve stimulation |
| Control | Sham comparator | Standard treatment (paroxetine 20 mg) + sham therapy Receives: Drug: Paroxetine |
| Combination therapy | Experimental | Tens therapy + standard treatment (paroxetine 20 mg) Receives: Other: Transcutaneous posterior tibial nerve stimulation; Drug: Paroxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intravaginal latency time at week 12
Mean change in intravaginal latency time, measured with a stopwatch by the couple, at week 12.
Measured: Week 12
Secondary outcomes (2)
Change in Premature Ejaculation Diagnostic Tool (PEDT) questionnaire score
Patients with a change in Premature Ejaculation Diagnostic Tool questionnaire score at weeks 12 and 24. A score of 11 or more suggests PE. A score of 9 or 10 may be found in men with PE; it is a "borderline" score. A score of 8 or less suggests that a man does not have PE. The minimum and maximum values are 0 and 20, respectively.
Measured: weeks 12 and 24
Clinical improvement
Three-fold increase in intravaginal ejaculatory latency time
Measured: weeks 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start15 Jul 2020
- Primary completion9 Jan 2026
- Study completion9 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Héctor Corredor, Md, Principal investigator, Boston Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207723
- Sponsor's protocol ID
- BMGC-5
- Status last verified
- May 2026
- First submitted
- 19 Dec 2019
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Transcutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation Treatment
- ClinicalTrials.gov ID
- NCT04207723
- Acronym / sponsor ID
- BMGC-5
- Conditions
- Premature Ejaculation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Boston Medical GroupIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 9 Jan 2026 (actual)
- Study completion
- 9 Apr 2026 (actual)
- First posted
- 23 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: Evaluate the effectiveness and safety of transcutaneous electrostimulation of the posterior tibial nerve alone and combined with standard pharmacological treatment, in men with primary premature ejaculation, compared to standard pharmacological treatment.
Patients and methods: Randomized controlled clinical trial. Patients diagnosed with premature ejaculation attending Boston Medical Group clinics in Colombia and Spain will be included. Participants will be assigned by randomization to one of three treatment groups:
- Group 1: Tens + placebo drug therapy
- Group 2: Standard treatment (paroxetine 20 mg) + placebo therapy
- Group 3: Tens therapy + standard treatment (paroxetine mg)
The change in intravaginal latency time measured with the couple's sustained stopwatch, the change in the PEDT scale, the perception of the change in their initial condition after treatment (Global Clinical impression of change scale), and the change in different domains of the EP (PEP Scale - Profile Ejaculation Premature) at the end of treatment (week 12) and at three months of follow-up (week 24).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TENS Therapy | Experimental | Other: Transcutaneous posterior tibial nerve stimulationTens therapy + placebo drug therapy |
| Control | Sham comparator | Drug: ParoxetineStandard treatment (paroxetine 20 mg) + sham therapy |
| Combination therapy | Experimental | Other: Transcutaneous posterior tibial nerve stimulation, Drug: ParoxetineTens therapy + standard treatment (paroxetine 20 mg) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Primary premature ejaculation as defined by the International Society for Sexual Medicine (ISSM-International Society for Sexual Medicine) (30): a) ejaculation occurs always or almost always within the first minute after penetration, b) disability to delay ejaculation in all or almost all penetrations, c) negative personal consequences are generated, such as stress, discomfort, frustration and / or avoidance of sexual intimacy.
- Age equal to or greater than 18 years.
- PEDT score greater than 11.
- Stable heterosexual relationship of at least 6 months with the interest of maintaining it for at least the duration of the study.
- Sexual activity at least once a week.
Key exclusion criteria (11 listed)
- IIEF-EF score greater than 25.
- Clinically significant comorbidity: cardiovascular, hepatic, thromboembolic, neurological, locomotive, endocrine, oncological, renal or rheumatologic.
- History of retroperitoneal surgery, radiotherapy or multiple sclerosis.
- History of mental illness: depression, anxiety, suicidal behavior, bipolar disorder, agoraphobia, dysthymia, social phobia, obsessive compulsive disorder, post-traumatic stress, psychiatric disorder, referred by the patient or by the use of a medication for one of these terms.
- Consumption of medications that affect ejaculatory control such as psychiatric medications, opioid analgesics, alpha blockers.
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 per 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. | Other | Combination therapy, TENS Therapy |
| Paroxetineparoxetine 20 mg / day taken in the morning hours, per 12 weeks. | Drug | Combination therapy, Control |
Primary outcome
Intravaginal latency time at week 12
Time frame: Week 12
Mean change in intravaginal latency time, measured with a stopwatch by the couple, at week 12.
2 secondary outcomes
Change in Premature Ejaculation Diagnostic Tool (PEDT) questionnaire score
Time frame: weeks 12 and 24
Clinical improvement
Time frame: weeks 12 and 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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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.
Héctor Corredor, Md 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 and Paroxetine 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 8 inclusion and 11 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 12 May 2026. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intravaginal latency time at week 12 (time frame: Week 12). 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 12 May 2026.