## Protocol Section
### Identification Module
**NCT ID:** NCT06425211

**Brief Title:** Effectiveness of Pelvic Floor Therapy for the Management of Erectile Dysfunction and Premature Ejaculation.

**Official Title:** Effectiveness of Pelvic Floor Therapy for the Management of Erectile Dysfunction and Premature Ejaculation.

#### Organization Study ID Info
**ID:** BMGC-6
#### Organization
**Class:** INDUSTRY
**Full Name:** Boston Medical Group
### Status Module
#### Completion Date
**Date:** 2024-12

**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:** 2024-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-10-30

**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:** False

**Is FDA Regulated Drug:** False

**Is US Export:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The objective of this clinical trial is to evaluate the effectiveness of pelvic floor therapy for the management of erectile dysfunction and premature ejaculation in patients with erectile dysfunction and premature ejaculation. The main question to answer is:

What is the effectiveness of pelvic floor therapy (electrostimulation, biofeedback, and therapeutic exercise) for the treatment of patients with erectile dysfunction and or premature ejaculation?

Patients will:

* Have an initial consultation of pelvic floor rehabilitation before therapy.
* Be given pelvic floor therapy.
* Have a secondary consultation of pelvic floor rehabilitation after therapy.

Three intervention groups will be included: Group 1: Patients with premature ejaculation Group 2: Patients with erectile dysfunction Group 3: Patients with erectile dysfunction and premature ejaculation.

**Detailed Description:** The objective of this clinical trial is to evaluate the effectiveness of pelvic floor therapy for the management of erectile dysfunction and premature ejaculation in patients with erectile dysfunction and premature ejaculation.

Methodology: Pre-post study. Erectile function or intravaginal latency time will be evaluated before and after pelvic floor therapy, in three groups of patients, independently:

* Group 1: Patients with premature ejaculation
* Group 2: Patients with erectile dysfunction
* Group 3: Patients with erectile dysfunction and premature ejaculation

  66 patients will be included and will receive 24 sessions of pelvic floor therapy during 12 weeks. Outcomes will be evaluated at the end of therapy (12 weeks), 3 and 6 months follow-up.

### Conditions Module

**Conditions:**

- Erectile Dysfunction

- Premature (Early) Ejaculation

- Premature Ejaculation

- Pelvic Floor; Weak

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 66

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The therapy depends if patient is classified within muscular hyperactivity or muscular hypoactivity.

For muscular hypoactivity:

Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-7 Muscle workout: sessions 8-15 Functional training: sessions 16-23 Final evaluation: Session 24

For muscular hyperactivity they will be given:

Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-7 Muscle workout: sessions 8-15 Functional training: sessions 16-23 Final evaluation: session 24

These interventions include: Therapeutic exercises, Perineal electromyographic biofeedback, and Electrical stimulation

**Intervention Names:**

- Behavioral: Therapeutic exercises

- Device: Perineal electromyographic biofeedback

- Device: Electrical stimulation

**Label:** Erectile Dysfunction

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-15 Muscle workout: sessions 16-19 Functional training: sessions 20-23 Final evaluation: session 24

These interventions include: Therapeutic exercises, Perineal electromyographic biofeedback, and Electrical stimulation

**Intervention Names:**

- Behavioral: Therapeutic exercises

- Device: Perineal electromyographic biofeedback

- Device: Electrical stimulation

**Label:** Premature Ejaculation

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Pelvic Floor Physiotherapy assessment: session 1 Proprioceptive and Coordination Work: sessions 2-12 Muscle workout: sessions 13-20 Functional training: sessions 20-23 Final evaluation: session 24

These interventions include: Therapeutic exercises, Perineal electromyographic biofeedback, and Electrical stimulation

**Intervention Names:**

- Behavioral: Therapeutic exercises

- Device: Perineal electromyographic biofeedback

- Device: Electrical stimulation

**Label:** Premature Ejaculation + Erectile Dysfunction

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Erectile Dysfunction

- Premature Ejaculation

- Premature Ejaculation + Erectile Dysfunction

**Description:** Recognition of the pelvic area, respiratory management, lumbo-pelvic mobilization, discrimination of abdomino-pelvic contraction and myofascial release techniques.

**Name:** Therapeutic exercises

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Erectile Dysfunction

- Premature Ejaculation

- Premature Ejaculation + Erectile Dysfunction

**Description:** Free muscle work and gross motor coordination:

**Name:** Perineal electromyographic biofeedback

**Type:** DEVICE

#### Intervention 3

**Arm Group Labels:**

- Erectile Dysfunction

- Premature Ejaculation

- Premature Ejaculation + Erectile Dysfunction

**Description:** Muscular proprioceptive work: 50 Hz 300 µs

**Name:** Electrical stimulation

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Change in baseline intravaginal latency time (IVLT) at the end of therapy. (Groups 1,3)

**Measure:** Change in baseline intravaginal latency time (IVLT)

**Time Frame:** 12 weeks

**Description:** International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score change at the end of therapy. (Groups 2,3)

**Measure:** Change in International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score

**Time Frame:** 12 weeks

#### Secondary Outcomes

**Description:** Change in IVLT at 3 and 6 months of follow-up. (Groups 1,3)

**Measure:** Change in baseline intravaginal latency time (IVLT) at follow-up

**Time Frame:** 3 and 6 months of follow-up.

**Description:** Change in baseline PEP score at the end of therapy, 3 and 6 months of follow-up. (Groups 1,3)

**Measure:** Change Premature Ejaculation Perfil (PEP) score

**Time Frame:** 12 weeks, 3 and 6 months follow-up.

**Description:** Change in baseline PEDT questionnaire score at the end of therapy, 3 and 6 months follow-up. (Groups 1,3)

**Measure:** Change in Premature Ejaculation Diagnosis Tool (PEDT) questionnnaire score

**Time Frame:** 12 weeks, 3 and 6 months follow-up.

**Description:** Change in the parameters of the baseline Intracavity Assessment at the end of therapy, 3 and 6 months follow-up.

**Measure:** Change Intracavity Assessment

**Time Frame:** 12 weeks, 3 and 6 months follow-up.

**Description:** Incidente of side effects related to therapy.

**Measure:** Side Effects

**Time Frame:** 12 weeks, 3 and 6 months follow-up.

**Description:** International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score change at the 3 and 6 months of follow-up. (Groups 2,3)

**Measure:** Change in International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score at follow-up

**Time Frame:** 3 and 6 months of follow-up.

**Description:** Increase of 1 point in the baseline EHS at the end of therapy, 3 and 6 months of follow-up. (Groups 2,3)

**Measure:** Change in Erection Hardness Score (EHS)

**Time Frame:** 12 weeks, 3 and 6 months of follow-up.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

Overall:

* Men over 18 years of age
* Erectile dysfunction or premature ejaculation for at least 6 months
* Sexual activity with a heterosexual partner at least once a week
* Signing of informed consent before the start of the study

For the premature ejaculation group:

* Premature ejaculation according to the International Society of Sexual Medicine (ISSM) criteria
* Premature Ejaculation Diagnosis Tool (PEDT) questionnaire score greater than 11

For the erectile dysfunction group:

* Clinical diagnosis of primary erectile dysfunction
* International Index Erectile Function - Erectile Function domain (IIEF-EF) score less than 26

Exclusion Criteria:

* Pharmacological treatment for erectile dysfunction or premature ejaculation in the last 3 months
* Erection Hardness Score (EHS) greater than 3 for patients with erectile dysfunction
* History of hypogonadism or suspected hypogonadism due to Aging Males Symptoms (AMS) score greater than 36 for patients with erectile dysfunction
* History of pelvic radiotherapy
* Pacemaker or cardiac arrhythmia, epilepsy
* History of spinal cord trauma or spinal surgeries.
* Inability to attend therapies or controls
* Illiteracy or cognitive disability that prevents you from completing the questionnaires
* Psychiatric, psychological disorders, or cognitive deficiencies
* Injuries in the area of application of the therapy
* Active pelvic organ cancer

**Maximum Age:** 100 Years

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_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:** Bogotá

**Contacts:**

***Contact 1:***

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

- **Name:** Carolina Sandoval, Master

- **Phone:** 57 3208899777

- **Role:** CONTACT

***Contact 2:***

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

- **Name:** Héctor Corredor, MD

- **Phone:** +57 3174317162

- **Role:** CONTACT

**Country:** Colombia

**Facility:** Boston Medical Group Colombia

**State:** Cundinamarca

**Status:** RECRUITING

**Zip:** 11022

#### Overall Officials

**Official 1:**

**Affiliation:** Boston Medical Group

**Name:** Cristina Amaya

**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: D000005832

- Term: Genital Diseases, Male

- ID: D000091662

- Term: Genital Diseases

- ID: D000012735

- Term: Sexual Dysfunction, Physiological

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000020018

- Term: Sexual Dysfunctions, Psychological

- ID: D000001523

- Term: Mental Disorders

- ID: D000097910

- Term: Ejaculatory Dysfunction

### 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: M10217

- Name: Erectile Dysfunction

- Relevance: HIGH

- As Found: Erectile Dysfunction

- ID: M29853

- Name: Premature Ejaculation

- Relevance: HIGH

- As Found: Premature Ejaculation

- 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: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8944

- Name: Genital Diseases, Male

- Relevance: LOW

- As Found: Unknown

- ID: M15546

- Name: Sexual Dysfunction, Physiological

- 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

- ID: M3452

- Name: Ejaculatory Dysfunction

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000047928

- Term: Premature Birth

- ID: D000007172

- Term: Erectile Dysfunction

- ID: D000061686

- Term: Premature Ejaculation

### Misc Info Module

- Version Holder: 2024-05-31
