Effectiveness and Safety of TENS Therapy for Premature Ejaculation

Premature Ejaculation Clinical Trial

— TENSPE2  

Official title:

Effectiveness and Safety of Transcutaneous Posterior Tibial Nerve Stimulation Therapy for the Management of Patients With Premature Ejaculation. Phase III Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06425224
• Other study ID #: BMGC-M1
• Status: Recruiting
• Phase: Phase 3
• Start date: June 15, 2022
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: Boston Medical Group
• Contact: Carolina Sandoval, Master
• Phone: +573133920816
• Email: csandoval[@]bostonmedical.com.co
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 129
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 62 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• 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.

Related Conditions & MeSH terms

• Premature Birth
• Premature Ejaculation
• Sex Disorder
• Sexual Dysfunction, Physiological
• TEN

Intervention

Device:
• Tens therapy
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 (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.

Drug:
• Dapoxetine placebo
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)
Patients in this group will receive dapoxetine 30 mg, taken 3 to 4 hours before sexual intercourse, for the 12 weeks of the study

Device:
• Placebo therapy
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.

Locations

Country	Name	City	State
Mexico	Boston Medical Group	Ciudad de México

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Group

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in intravaginal latency time	Average change in intravaginal latency time, measured with a stopwatch by the couple.	12 weeks
Secondary	Change in intravaginal latency time	Average change in intravaginal latency time, measured with a stopwatch by the couple.	24 weeks
Secondary	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.	At weeks 12 (end of therapy) and 24 (three months of follow-up).
Secondary	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	At weeks 12 and 24 (greater than 12 to less than 12).
Secondary	Global Impression of Change Scale	Global Impression of Change Scale score	Weeks 12 and 24.
Secondary	PEP (Premature Ejaculation Profile) questionnaire score	Change in the PEP (Premature Ejaculation Profile) questionnaire score	At weeks 12 and 24
Secondary	Adverse events	Type, frequency and severity of adverse events during therapy.	24 weeks