Effectiveness and Safety of TENS Therapy for Premature Ejaculation

NCT06425224 | Recruiting Phase 3 DMC FDA Drug FDA Device

• 1 other identifier: BMGC-M1
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Premature Ejaculation; Sex Disorder; TEN

Outcome Measures

Primary Outcomes (1)

• Change in intravaginal latency time

  Average change in intravaginal latency time, measured with a stopwatch by the couple.

  12 weeks

Secondary Outcomes (6)

• Change in intravaginal latency time

  24 weeks

• Clinical improvement in premature ejaculation

  At weeks 12 (end of therapy) and 24 (three months of follow-up).

• Change in the diagnosis of premature ejaculation

  At weeks 12 and 24 (greater than 12 to less than 12).

• Global Impression of Change Scale

  Weeks 12 and 24.

• PEP (Premature Ejaculation Profile) questionnaire score

  At weeks 12 and 24

Study Arms (3)

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.

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.

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.

Device: Tens therapy; Drug: Standard treatment (dapoxetine 30 mg as needed)

Interventions

Tens therapy DEVICE

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.

Group 1: Tens therapy + dapoxetine placebo on demand.; Group 3: Tens therapy + standard treatment (dapoxetine 30 mg as needed).

Dapoxetine placebo DRUG

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.

Group 1: Tens therapy + dapoxetine placebo on demand.

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

Group 2: Standard treatment (dapoxetine 30 mg as needed) + placebo therapy.; Group 3: Tens therapy + standard treatment (dapoxetine 30 mg as needed).

Placebo therapy DEVICE

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 2: Standard treatment (dapoxetine 30 mg as needed) + placebo therapy.

Eligibility Criteria

• Age: 18 Years - 62 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Medical Group: lead

Study Sites (1)

Boston Medical Group

Mexico City, 01000, Mexico

RECRUITING

MeSH Terms

Conditions

Premature Ejaculation; Sexual Dysfunction, Physiological

Interventions

dapoxetine; Health Services Needs and Demand

Condition Hierarchy (Ancestors)

Ejaculatory Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Health Services Research; Health Planning; Health Care Economics and Organizations; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Jorge Barba, MD

  Boston Medical Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolina Sandoval, Master

CONTACT

+573133920816; csandoval@bostonmedical.com.co

Héctor Corredor, MD

CONTACT

+573174317162; hcorredor@bostonmedical.com.co

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 22, 2024
• Study Start: June 15, 2022
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)