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Search / Trial NCT06425211

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

Launched by BOSTON MEDICAL GROUP · May 17, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how effective pelvic floor therapy is for men dealing with erectile dysfunction and premature ejaculation. Pelvic floor therapy includes treatments like electrostimulation, biofeedback, and exercises aimed at strengthening the pelvic area. The main goal is to find out if these therapies can help improve sexual function in men who have been experiencing these issues for at least six months.

To participate, men must be over 18 and have either erectile dysfunction or premature ejaculation. They should also be sexually active with a partner at least once a week. Eligible participants will first meet with a healthcare provider for an initial consultation, then undergo pelvic floor therapy, and finally have a follow-up consultation. The trial is currently recruiting participants, and it’s important to note that those who have recently used medications for these conditions or have certain medical histories may not be eligible. This trial could provide valuable insights into a non-pharmacological approach for managing these sexual health issues.

Gender

MALE

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

About Boston Medical Group

Boston Medical Group is a leading clinical trial sponsor dedicated to advancing medical research and improving patient outcomes in the field of men's health and sexual wellness. With a commitment to innovation and excellence, the organization collaborates with healthcare professionals and research institutions to conduct rigorous clinical studies that explore new treatments and therapies. Through its comprehensive approach, Boston Medical Group aims to enhance the understanding of various health conditions while ensuring the highest ethical standards and patient safety in all research endeavors.

Locations

Bogotá, Cundinamarca, Colombia

Patients applied

0 patients applied

Trial Officials

Cristina Amaya

Principal Investigator

Boston Medical Group

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported