RecruitingNot ApplicableNCT06425211

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


Sponsor

Boston Medical Group

Enrollment

66 participants

Start Date

Oct 30, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 100 Years

Inclusion Criteria11

  • 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 Criteria11

  • 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

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Interventions

BEHAVIORALTherapeutic exercises

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

DEVICEPerineal electromyographic biofeedback

Free muscle work and gross motor coordination:

DEVICEElectrical stimulation

Muscular proprioceptive work: 50 Hz 300 µs


Locations(1)

Boston Medical Group Colombia

Bogotá, Cundinamarca, Colombia

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NCT06425211


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