Effectiveness of Pelvic Floor Therapy for the Management of Erectile Dysfunction and Premature Ejaculation.

NCT06425211 | Recruiting

• 1 other identifier: BMGC-6
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Dysfunction; Pelvic Floor; Weak; Premature (Early) Ejaculation; Premature Ejaculation

Outcome Measures

Primary Outcomes (2)

• Change in baseline intravaginal latency time (IVLT)

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

  12 weeks

• Change in International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score

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

  12 weeks

Secondary Outcomes (7)

• Change in baseline intravaginal latency time (IVLT) at follow-up

  3 and 6 months of follow-up.

• Change Premature Ejaculation Perfil (PEP) score

  12 weeks, 3 and 6 months follow-up.

• Change in Premature Ejaculation Diagnosis Tool (PEDT) questionnnaire score

  12 weeks, 3 and 6 months follow-up.

• Change Intracavity Assessment

  12 weeks, 3 and 6 months follow-up.

• Side Effects

  12 weeks, 3 and 6 months follow-up.

Study Arms (3)

Erectile Dysfunction

EXPERIMENTAL

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

Behavioral: Therapeutic exercises; Device: Perineal electromyographic biofeedback; Device: Electrical stimulation

Premature Ejaculation

EXPERIMENTAL

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

Behavioral: Therapeutic exercises; Device: Perineal electromyographic biofeedback; Device: Electrical stimulation

Premature Ejaculation + Erectile Dysfunction

EXPERIMENTAL

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

Behavioral: Therapeutic exercises; Device: Perineal electromyographic biofeedback; Device: Electrical stimulation

Interventions

Perineal electromyographic biofeedback DEVICE

Free muscle work and gross motor coordination:

Erectile Dysfunction; Premature Ejaculation; Premature Ejaculation + Erectile Dysfunction

Therapeutic exercises BEHAVIORAL

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

Erectile Dysfunction; Premature Ejaculation; Premature Ejaculation + Erectile Dysfunction

Electrical stimulation DEVICE

Muscular proprioceptive work: 50 Hz 300 µs

Erectile Dysfunction; Premature Ejaculation; Premature Ejaculation + Erectile Dysfunction

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Group: lead

Study Sites (1)

Boston Medical Group Colombia

Bogotá, Cundinamarca, 11022, Colombia

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction; Premature Birth; Premature Ejaculation; Asthenia

Interventions

Exercise Therapy; Electric Stimulation

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Ejaculatory Dysfunction; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Stimulation; Investigative Techniques

Study Officials

• Cristina Amaya

  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: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• 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: October 30, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)