## Protocol Section
### Identification Module
**NCT ID:** NCT06425224

**Acronym:** TENSPE2

**Brief Title:** Effectiveness and Safety of TENS Therapy for Premature Ejaculation

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

#### Organization Study ID Info
**ID:** BMGC-M1
#### Organization
**Class:** INDUSTRY
**Full Name:** Boston Medical Group
### Status Module
#### Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-06-15

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Boston Medical Group

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** True

**Is US Export:** True

**Oversight Has DMC:** True

### Description Module

**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 Module

**Conditions:**

- Premature Ejaculation

- Sex Disorder

- TEN

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 129

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Device: Tens therapy

- Drug: Dapoxetine placebo

**Label:** Group 1: Tens therapy + dapoxetine placebo on demand.

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Drug: Standard treatment (dapoxetine 30 mg as needed)

- Device: Placebo therapy

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

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Description:** 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.

**Intervention Names:**

- Device: Tens therapy

- Drug: Standard treatment (dapoxetine 30 mg as needed)

**Label:** Group 3: Tens therapy + standard treatment (dapoxetine 30 mg as needed).

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group 1: Tens therapy + dapoxetine placebo on demand.

- Group 3: Tens therapy + standard treatment (dapoxetine 30 mg as needed).

**Description:** 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.

**Name:** Tens therapy

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Group 1: Tens therapy + dapoxetine placebo on demand.

**Description:** 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.

**Name:** Dapoxetine placebo

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

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

- Group 3: Tens therapy + standard treatment (dapoxetine 30 mg as needed).

**Description:** Patients in this group will receive dapoxetine 30 mg, taken 3 to 4 hours before sexual intercourse, for the 12 weeks of the study

**Name:** Standard treatment (dapoxetine 30 mg as needed)

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

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

**Description:** 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.

**Name:** Placebo therapy

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Change in intravaginal latency time

**Time Frame:** 12 weeks

#### Secondary Outcomes

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

**Measure:** Change in intravaginal latency time

**Time Frame:** 24 weeks

**Description:** Proportion of patients with clinical improvement in premature ejaculation, defined as a three-fold increase in the intravaginal ejaculatory latency time.

**Measure:** Clinical improvement in premature ejaculation

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

**Description:** 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

**Measure:** Change in the diagnosis of premature ejaculation

**Time Frame:** At weeks 12 and 24 (greater than 12 to less than 12).

**Description:** Global Impression of Change Scale score

**Measure:** Global Impression of Change Scale

**Time Frame:** Weeks 12 and 24.

**Description:** Change in the PEP (Premature Ejaculation Profile) questionnaire score

**Measure:** PEP (Premature Ejaculation Profile) questionnaire score

**Time Frame:** At weeks 12 and 24

**Description:** Type, frequency and severity of adverse events during therapy.

**Measure:** Adverse events

**Time Frame:** 24 weeks

### Eligibility Module

**Eligibility Criteria:** 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.

**Maximum Age:** 62 Years

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** csandoval@bostonmedical.com.co

**Name:** Carolina Sandoval, Master

**Phone:** +573133920816

**Role:** CONTACT

**Contact 2:**

**Email:** hcorredor@bostonmedical.com.co

**Name:** Héctor Corredor, MD

**Phone:** +573174317162

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Ciudad de México

**Contacts:**

***Contact 1:***

- **Email:** csandoval@bostonmedical.com.co

- **Name:** Carolina Sandoval, MSc

- **Phone:** +573133920816

- **Role:** CONTACT

***Contact 2:***

- **Email:** hcorredor@bostonmedical.com.co

- **Name:** Héctor Corredor, Md

- **Phone:** +573174317162

- **Role:** CONTACT

**Country:** Mexico

**Facility:** Boston Medical Group

**Status:** RECRUITING

**Zip:** 01000

#### Overall Officials

**Official 1:**

**Affiliation:** Boston Medical Group

**Name:** Jorge Barba, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007752

- Term: Obstetric Labor, Premature

- ID: D000007744

- Term: Obstetric Labor Complications

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000097910

- Term: Ejaculatory Dysfunction

- ID: D000005832

- Term: Genital Diseases, Male

- ID: D000091662

- Term: Genital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000020018

- Term: Sexual Dysfunctions, Psychological

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M25869

- Name: Premature Birth

- Relevance: HIGH

- As Found: Premature

- ID: M29853

- Name: Premature Ejaculation

- Relevance: HIGH

- As Found: Premature Ejaculation

- ID: M15546

- Name: Sexual Dysfunction, Physiological

- Relevance: HIGH

- As Found: Sex Disorder

- ID: M10772

- Name: Obstetric Labor, Premature

- Relevance: LOW

- As Found: Unknown

- ID: M10764

- Name: Obstetric Labor Complications

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M3452

- Name: Ejaculatory Dysfunction

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8944

- Name: Genital Diseases, Male

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M21873

- Name: Sexual Dysfunctions, Psychological

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000047928

- Term: Premature Birth

- ID: D000061686

- Term: Premature Ejaculation

- ID: D000012735

- Term: Sexual Dysfunction, Physiological

### Misc Info Module

- Version Holder: 2024-05-31
