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NCT Number: NCT06425211

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

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.

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Key information

Conditions

Erectile Dysfunction Asthenia Ejaculatory Dysfunction Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Obstetric Labor Complications Obstetric Labor, Premature Pathological Conditions, Signs and Symptoms Pelvic Floor; Weak Pregnancy Complications Premature (Early) Ejaculation Premature Birth Premature Ejaculation Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Signs and Symptoms Urogenital Diseases

Age range

18 year–100 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Therapeutic Exercises

Behavioral

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

Perineal electromyographic biofeedback

Device

Free muscle work and gross motor coordination:

Electrical Stimulation

Device

Muscular proprioceptive work: 50 Hz 300 µs

Primary outcomes

  1. Change in baseline intravaginal latency time (IVLT)

    Time frame: 12 weeks

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

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

    Time frame: 12 weeks

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

Secondary outcomes

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

    Time frame: 3 and 6 months of follow-up.

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

  2. Change Premature Ejaculation Perfil (PEP) score

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

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

  3. Change in Premature Ejaculation Diagnosis Tool (PEDT) questionnnaire score

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

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

  4. Change Intracavity Assessment

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

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

  5. Side Effects

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

    Incidente of side effects related to therapy.

  6. 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.

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

  7. Change in Erection Hardness Score (EHS)

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Carolina Sandoval, Master

CONTACT

[email protected]

+573133920816

Héctor Corredor, MD

CONTACT

[email protected]

+573174317162

Sponsors and collaborators

Lead sponsor

Boston Medical Group

Industry

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
May 22, 2024
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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