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Идёт набор NCT06425211

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

Без фазы С лечением Erectile Dysfunction Premature (Early) Ejaculation Premature Ejaculation Pelvic Floor; Weak

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Therapeutic exercises, Perineal electromyographic biofeedback, Electrical stimulation.
Кому может быть актуально
Состояния в реестре: Erectile Dysfunction, Premature (Early) Ejaculation, Premature Ejaculation, Pelvic Floor; Weak. Базовые параметры: 18 лет — 100 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Колумбия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое Therapeutic exercises
    Recognition of the pelvic area, respiratory management, lumbo-pelvic mobilization, discrimination of abdomino-pelvic contraction and myofascial release techniques.
  • Устройство Perineal electromyographic biofeedback
    Free muscle work and gross motor coordination:
  • Устройство Electrical stimulation
    Muscular proprioceptive work: 50 Hz 300 µs

Первичные конечные точки

  • Change in baseline intravaginal latency time (IVLT) [Срок оценки: 12 weeks]
  • Change in International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score [Срок оценки: 12 weeks]
Вторичные конечные точки (7)
  • Change in baseline intravaginal latency time (IVLT) at follow-up [Срок оценки: 3 and 6 months of follow-up.]
  • Change Premature Ejaculation Perfil (PEP) score [Срок оценки: 12 weeks, 3 and 6 months follow-up.]
  • Change in Premature Ejaculation Diagnosis Tool (PEDT) questionnnaire score [Срок оценки: 12 weeks, 3 and 6 months follow-up.]
  • Change Intracavity Assessment [Срок оценки: 12 weeks, 3 and 6 months follow-up.]
  • Side Effects [Срок оценки: 12 weeks, 3 and 6 months follow-up.]
  • Change in International Index of Erectile Dysfuntion - Erectile Dysfunction domain (IIEF-EF) score at follow-up [Срок оценки: 3 and 6 months of follow-up.]
  • Change in Erection Hardness Score (EHS) [Срок оценки: 12 weeks, 3 and 6 months of follow-up.]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Колумбия · 1 центр
  • Boston Medical Group Colombia — Bogotá

Идентификаторы

NCT: NCT06425211 · BMGC-6

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗