Premature EjaculationPhase 3TENSPE2NCT06425224
Effectiveness and Safety of TENS Therapy for Premature Ejaculation
A Phase 3 study testing Tens therapy and Standard treatment (dapoxetine 30 mg as needed) in people with Premature Ejaculation and Sex Disorder, run by Boston Medical Group at 1 site in Mexico.
Trial summary
The objective of this clinical trial is to evaluate the effectiveness and safety of transcutaneous posterior tibial nerve stimulation therapy in patients with premature ejaculation. Read more about this study
- Who is it for?
- Ages 18 to 62 years, men only
- Conditions the study is for
- Premature Ejaculation, Sex Disorder, TEN
- What is being tested?
- Tens therapy and Standard treatment (dapoxetine 30 mg as needed)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 1 siteMexico
- Study dates
- 15 Jun 2022to Jun 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 62 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Primary premature ejaculation according to the definition of the International Society for Sexual Medicine (ISSM-International Society for Sexual Medicine) (30): a) ejaculation always or almost always occurs within the first minute after penetration, b) inability to delay ejaculation in all or almost all penetrations, c) negative personal consequences are generated, such as stress, annoyance, frustration and/or avoidance of sexual intimacy.
- Age between 18 and 62 years.
- PEDT score greater than 11.
- Stable heterosexual relationship for at least 6 months with interest in maintaining it for at least the duration of the study.
- Sexual activity at least once a week.
- Minimum chronicity of PD of 6 months.
- Voluntary participation in the study.
- Signing of the informed consent prior to participation in the study.
Who cannot join
- IIEF-EF score less than 26.
- Glaucoma
- Clinically significant comorbidity: cardiovascular, hepatic, thromboembolic, neurological, locomotor, endocrine, oncological, renal or rheumatological.
- 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 disorder, psychiatric disorder, reported by the patient or due to the use of a medication for one of these conditions.
- Consumption of medications that affect ejaculatory control such as psychiatric medications, opioid analgesics, alpha blockers.
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- Treatment for PE in the last 3 months.
- Treatment for epileptic syndromes or Parkinson's disease.
- Use of pacemaker or cardiac defibrillator.
- Skin lesions in the area where the electrodes are placed.
- Abuse or dependence on psychoactive substances: alcohol, hallucinogenic drugs.
- Couple who are pregnant or interested in conceiving a pregnancy in the next 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Boston Medical Group
Mexico City, 01000
Carolina Sandoval, MSc, +573133920816, csandoval@bostonmedical.com.co
Héctor Corredor, Md, +573174317162, hcorredor@bostonmedical.com.co
About this study
Official title: Effectiveness and Safety of Transcutaneous Posterior Tibial Nerve Stimulation Therapy for the Management of Patients With Premature Ejaculation. Phase III Clinical Trial
The objective of this clinical trial is to evaluate the effectiveness and safety of transcutaneous posterior tibial nerve stimulation therapy in patients with premature ejaculation. The main question to answer is:
Can the effectiveness and safety of transcutaneous electrostimulation of the posterior tibial nerve alone and combined with standard pharmacological treatment be evaluated in men with lifelong premature ejaculation, compared to standard pharmacological treatment with dapoxetine?
Read more
Patients will:
Be randomized in acontrolled clinical trial. Patients with a diagnosis of premature ejaculation who attend Boston Medical Group clinics in Mexico City will be included.
Be assigned by randomization to one of three treatment groups:
- Group 1: Tens therapy + dapoxetine placebo on demand.
- Group 2: Standard treatment (dapoxetine 30 mg as needed) + placebo therapy.
- Group 3: Tens therapy + standard treatment (dapoxetine 30 mg as needed).
- Conditions
- Premature Ejaculation, Sex Disorder, TEN
- Being tested
- Tens therapy, Dapoxetine placebo, Standard treatment (dapoxetine 30 mg as needed), Placebo therapy
- Medical subject headings
- Premature Ejaculation, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tens therapyDevice
There will be 3 weekly therapy sessions for 12 continuous weeks, lasting 30 minutes each. 20 Hertz with a pulse width of 200 µsec will be administered in each session. The intensity will be applied to each patient depending on individual tolerance. TENT therapy will be performed as follows:
- The active electrode (cathode - red) is placed and adhered 3 - 5 cm above the internal malleolus and 1 cm behind the tibia.
The second reference electrode (anode - black) is attached to the calcaneus.
The equipment must previously be programmed under the following parameters:
Continuous current Frequency: 20 Hz. Pulse width: 200 µsec Time: 30 min. Intensity: to the patient's tolerance, gross motor perception to verify correct application, upon reaching it, increase the intensity to clearly sensory activation.
Dapoxetine placeboDrug
Patients in this group will receive dapoxetine placebo (capsules with only excipients without active ingredient) as needed, taken 3 to 4 hours before sexual intercourse during the 12 weeks of the intervention.
Standard treatment (dapoxetine 30 mg as needed)Drug
Patients in this group will receive dapoxetine 30 mg, taken 3 to 4 hours before sexual intercourse, for the 12 weeks of the study
Placebo therapyDevice
In addition to the medication, patients will receive three weekly sessions of placebo therapy for twelve continuous weeks, lasting 30 minutes each. For this, the black electrode will be placed on the external malleolus and the red one 4 finger widths towards the head on the lateral edge of the tibia. 20 Hertz with a pulse width of 200 µsec will be administered in each session.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Tens therapy + dapoxetine placebo on demand. | Active comparator | There will be 3 weekly therapy sessions for 12 continuous weeks, lasting 30 minutes each. 20 Hertz with a pulse width of 200 µsec will be administered in each session. The intensity will be applied to each patient depending on individual tolerance. TENT therapy will be performed as follows:
1. The active electrode is placed and adhered 3 - 5 cm above the internal malleolus and 1 cm behind the tibia.
The second reference electrode is attached to the calcaneus.
Continuous current, Frequency: 20 Hz Pulse width: 200 µsec, Time: 30 min. Intensity: to the patient's tolerance, gross motor perception to verify correct application, upon reaching it, increase the intensity to clearly sensory activation.
They will also receive dapoxetine placebo (capsules with only excipients without active ingredient) as needed, taken 3 to 4 hours before sexual intercourse during the 12 weeks of the intervention. Receives: Device: Tens therapy; Drug: Dapoxetine placebo |
| Group 2: Standard treatment (dapoxetine 30 mg as needed) + placebo therapy. | Active comparator | Patients in this group will receive dapoxetine 30 mg, taken 3 to 4 hours before sexual intercourse, for the 12 weeks of the study. In addition to the medication, patients will receive three weekly sessions of placebo therapy for twelve continuous weeks, lasting 30 minutes each. For this, the black electrode will be placed on the external malleolus and the red one 4 finger widths towards the head on the lateral edge of the tibia. 20 Hertz with a pulse width of 200 µsec will be administered in each session. Receives: Drug: Standard treatment (dapoxetine 30 mg as needed); Device: Placebo therapy |
| Group 3: Tens therapy + standard treatment (dapoxetine 30 mg as needed). | Experimental | Tens therapy + standard treatment (dapoxetine 30 mg as needed).
Patients in this group will receive electrostimulation therapy of the posterior tibial nerve, 3 weekly therapy sessions for 12 continuous weeks, lasting 30 minutes each. 20 Hertz with a pulse width of 200 µsec will be administered in each session. The intensity will be applied to each patient depending on individual tolerance.
In addition to the therapy, patients in this group will receive dapoxetine as needed, taken 3 to 4 hours before sexual intercourse during the 12 weeks of the intervention. Receives: Device: Tens therapy; Drug: Standard treatment (dapoxetine 30 mg as needed) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intravaginal latency time
Average change in intravaginal latency time, measured with a stopwatch by the couple.
Measured: 12 weeks
Secondary outcomes (6)
Change in intravaginal latency time
Average change in intravaginal latency time, measured with a stopwatch by the couple.
Measured: 24 weeks
Clinical improvement in premature ejaculation
Proportion of patients with clinical improvement in premature ejaculation, defined as a three-fold increase in the intravaginal ejaculatory latency time.
Measured: At weeks 12 (end of therapy) and 24 (three months of follow-up).
Change in the diagnosis of premature ejaculation
Proportion of patients with a change in the diagnosis of premature ejaculation according to the PEDT (Premature Ejaculation Diagnostic Tool) questionnaire score in the intervention groups
Measured: At weeks 12 and 24 (greater than 12 to less than 12).
Global Impression of Change Scale
Global Impression of Change Scale score
Measured: Weeks 12 and 24.
PEP (Premature Ejaculation Profile) questionnaire score
Change in the PEP (Premature Ejaculation Profile) questionnaire score
Measured: At weeks 12 and 24
Adverse events
Type, frequency and severity of adverse events during therapy.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start15 Jun 2022
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 129 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Medical Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jorge Barba, MD, Principal investigator, Boston Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06425224
- Sponsor's protocol ID
- BMGC-M1
- Acronym
- TENSPE2
- Status last verified
- May 2024
- First submitted
- 17 May 2024
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Transcutaneous Posterior Tibial Nerve Stimulation Therapy for the Management of Patients With Premature Ejaculation. Phase III Clinical Trial
- ClinicalTrials.gov ID
- NCT06425224
- Acronym / sponsor ID
- TENSPE2 / BMGC-M1
- Conditions
- Premature Ejaculation, Sex Disorder, TEN
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- Boston Medical GroupIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 22 May 2024 (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.
The objective of this clinical trial is to evaluate the effectiveness and safety of transcutaneous posterior tibial nerve stimulation therapy in patients with premature ejaculation. The main question to answer is:
Can the effectiveness and safety of transcutaneous electrostimulation of the posterior tibial nerve alone and combined with standard pharmacological treatment be evaluated in men with lifelong premature ejaculation, compared to standard pharmacological treatment with dapoxetine?
Patients will:
Be randomized in acontrolled clinical trial. Patients with a diagnosis of premature ejaculation who attend Boston Medical Group clinics in Mexico City will be included.
Be assigned by randomization to one of three treatment groups:
- Group 1: Tens therapy + dapoxetine placebo on demand.
- Group 2: Standard treatment (dapoxetine 30 mg as needed) + placebo therapy.
- Group 3: Tens therapy + standard treatment (dapoxetine 30 mg as needed).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Tens therapy + dapoxetine placebo on demand. | Active comparator | Device: Tens therapy, Drug: Dapoxetine placeboThere will be 3 weekly therapy sessions for 12 continuous weeks, lasting 30 minutes each. 20 Hertz with a pulse width of 200 µsec will be administered in each session. The intensity will be applied to each patient depending on individual tolerance. TENT therapy will be performed as follows: 1. The active electrode is placed and adhered 3 - 5 cm above the internal malleolus and 1 cm behind the tibia. The second reference electrode is attached to the calcaneus. Continuous current, Frequency: 20 Hz Pulse width: 200 µsec, Time: 30 min. Intensity: to the patient's tolerance, gross motor perception to verify correct application, upon reaching it, increase the intensity to clearly sensory activation. They will also receive dapoxetine placebo (capsules with only excipients without active ingredient) as needed, taken 3 to 4 hours before sexual intercourse during the 12 weeks of the intervention. |
| Group 2: Standard treatment (dapoxetine 30 mg as needed) + placebo therapy. | Active comparator | Drug: Standard treatment (dapoxetine 30 mg as needed), Device: Placebo therapyPatients in this group will receive dapoxetine 30 mg, taken 3 to 4 hours before sexual intercourse, for the 12 weeks of the study. In addition to the medication, patients will receive three weekly sessions of placebo therapy for twelve continuous weeks, lasting 30 minutes each. For this, the black electrode will be placed on the external malleolus and the red one 4 finger widths towards the head on the lateral edge of the tibia. 20 Hertz with a pulse width of 200 µsec will be administered in each session. |
| Group 3: Tens therapy + standard treatment (dapoxetine 30 mg as needed). | Experimental | Device: Tens therapy, Drug: Standard treatment (dapoxetine 30 mg as needed)Tens therapy + standard treatment (dapoxetine 30 mg as needed). Patients in this group will receive electrostimulation therapy of the posterior tibial nerve, 3 weekly therapy sessions for 12 continuous weeks, lasting 30 minutes each. 20 Hertz with a pulse width of 200 µsec will be administered in each session. The intensity will be applied to each patient depending on individual tolerance. In addition to the therapy, patients in this group will receive dapoxetine as needed, taken 3 to 4 hours before sexual intercourse during the 12 weeks of the intervention. |
Who may qualify
- Ages
- 18 to 62 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Primary premature ejaculation according to the definition of the International Society for Sexual Medicine (ISSM-International Society for Sexual Medicine) (30): a) ejaculation always or almost always occurs within the first minute after penetration, b) inability to delay ejaculation in all or almost all penetrations, c) negative personal consequences are generated, such as stress, annoyance, frustration and/or avoidance of sexual intimacy.
- Age between 18 and 62 years.
- PEDT score greater than 11.
- Stable heterosexual relationship for at least 6 months with interest in maintaining it for at least the duration of the study.
- Sexual activity at least once a week.
Key exclusion criteria (12 listed)
- IIEF-EF score less than 26.
- Glaucoma
- Clinically significant comorbidity: cardiovascular, hepatic, thromboembolic, neurological, locomotor, endocrine, oncological, renal or rheumatological.
- 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 disorder, psychiatric disorder, reported by the patient or due to the use of a medication for one of these conditions.
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 |
|---|---|---|
| Tens therapyThere will be 3 weekly therapy sessions for 12 continuous weeks, lasting 30 minutes each. 20 Hertz with a pulse width of 200 µsec will be administered in each session. The intensity will be applied to each patient depending on individual tolerance. TENT therapy will be performed as follows: 1. The active electrode (cathode - red) is placed and adhered 3 - 5 cm above the internal malleolus and 1 cm behind the tibia. The second reference electrode (anode - black) is attached to the calcaneus. The equipment must previously be programmed under the following parameters: Continuous current Frequency: 20 Hz. Pulse width: 200 µsec Time: 30 min. Intensity: to the patient's tolerance, gross motor perception to verify correct application, upon reaching it, increase the intensity to clearly sensory activation. | Device | Group 1: Tens therapy + dapoxetine placebo on demand., Group 3: Tens therapy + standard treatment (dapoxetine 30 mg as needed). |
| Dapoxetine placeboPatients in this group will receive dapoxetine placebo (capsules with only excipients without active ingredient) as needed, taken 3 to 4 hours before sexual intercourse during the 12 weeks of the intervention. | Drug | Group 1: Tens therapy + dapoxetine placebo on demand. |
| Standard treatment (dapoxetine 30 mg as needed)Patients in this group will receive dapoxetine 30 mg, taken 3 to 4 hours before sexual intercourse, for the 12 weeks of the study | Drug | Group 2: Standard treatment (dapoxetine 30 mg as needed) + placebo therapy., Group 3: Tens therapy + standard treatment (dapoxetine 30 mg as needed). |
| Placebo therapyIn addition to the medication, patients will receive three weekly sessions of placebo therapy for twelve continuous weeks, lasting 30 minutes each. For this, the black electrode will be placed on the external malleolus and the red one 4 finger widths towards the head on the lateral edge of the tibia. 20 Hertz with a pulse width of 200 µsec will be administered in each session. | Device | Group 2: Standard treatment (dapoxetine 30 mg as needed) + placebo therapy. |
Primary outcome
Change in intravaginal latency time
Time frame: 12 weeks
Average change in intravaginal latency time, measured with a stopwatch by the couple.
6 secondary outcomes
Change in intravaginal latency time
Time frame: 24 weeks
Clinical improvement in premature ejaculation
Time frame: At weeks 12 (end of therapy) and 24 (three months of follow-up).
Change in the diagnosis of premature ejaculation
Time frame: At weeks 12 and 24 (greater than 12 to less than 12).
Global Impression of Change Scale
Time frame: Weeks 12 and 24.
PEP (Premature Ejaculation Profile) questionnaire score
Time frame: At weeks 12 and 24
Adverse events
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Individual participant dataSharing planned: No
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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.
Jorge Barba, 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 Phase 3 study testing Tens therapy and Standard treatment (dapoxetine 30 mg as needed) in people with Premature Ejaculation and Sex Disorder, run by Boston Medical Group at 1 site in Mexico.
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 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: looking for participants now, as of the sponsor's last update on 22 May 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 Mexico. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carolina Sandoval, Master (+573133920816, csandoval@bostonmedical.com.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in intravaginal latency time (time frame: 12 weeks). 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 22 May 2024.