Effects of Hypopressive Exercises on Urinary Incontinence and Erectile Dysfunction After Radical Prostatectomy

Официальное название

The Effects of Hypopressive Exercises on Urinary Incontinence and Erectile Dysfunction After Radical Prostatectomy: A Randomized Controlled Trial

Обзор

This randomized controlled trial investigates the effects of hypopressive exercises on urinary incontinence and erectile dysfunction in men following radical prostatectomy. Participants will be randomly assigned to one of two groups: a control group receiving home-based pelvic floor muscle exercises and an experimental group receiving both pelvic floor muscle exercises and supervised hypopressive exercises twice per week. The study aims to determine whether the addition of hypopressive techniques, which target coordinated activation of the pelvic floor and abdominal muscles without increasing intra-abdominal pressure, offers greater improvements in urinary and sexual function. Primary outcomes include pelvic floor muscle strength and endurance, while secondary outcomes include urinary incontinence severity, erectile function, and quality of life.

Подробное описание

Prostate cancer is one of the most common malignancies among men, with radical prostatectomy being a widely used treatment option. However, post-surgical complications such as urinary incontinence and erectile dysfunction significantly affect the quality of life of these patients. Pelvic floor muscle training (PFMT) is frequently recommended to manage these complications, yet its standalone effectiveness remains debatable.

Recent literature highlights that optimal pelvic floor function is achieved through coordinated activation with abdominal and respiratory muscles, such as the transversus abdominis, rectus abdominis, and diaphragm. Despite this, conventional PFMT protocols for post-prostatectomy patients often neglect this integrated muscle synergy. Hypopressive exercises, which involve postural techniques with apnea and breathing control, have been shown to activate both pelvic floor and abdominal muscles without increasing intra-abdominal pressure.

This study aims to evaluate the effects of hypopressive exercises, in addition to standard pelvic floor exercises, on pelvic floor muscle strength, urinary incontinence severity, and erectile function in post-prostatectomy men. The study will be conducted with two arms: a control group performing home-based pelvic floor exercises and an experimental group performing the same PFMT along with supervised hypopressive exercises twice weekly for 8 weeks. Outcomes will be assessed pre- and post-intervention, focusing on both physical performance and patient-reported measures.

Вмешательства

• Поведенческое Pelvic Floor Muscle Training (PFMT)
  Participants in the control group will receive an individualized home-based pelvic floor muscle exercise program. Exercises will be performed once daily for 8 weeks, focusing on voluntary pelvic floor contractions in various positions (supine, sitting, standing). Participants will receive initial training and written instructions from a physiotherapist, and will be contacted weekly to monitor adherence.
• Поведенческое Hypopressive Exercises
  Participants in the experimental group will attend supervised hypopressive exercise sessions twice per week for 8 weeks. These sessions involve specific postural sequences combined with breathing and apnea techniques aimed at reducing intra-abdominal pressure while activating pelvic floor and abdominal muscles. Sessions will be led by a physiotherapist and adapted based on individual performance and posture tolerance.

Первичные конечные точки

• Change in urinary incontinence severity measured by 1-hour Pad Test [Срок оценки: Baseline and 8 weeks]
• Change in pelvic floor muscle strength measured by Modified Oxford Scale [Срок оценки: Baseline and 8 weeks]
• Change in pelvic floor muscle endurance measured in seconds [Срок оценки: Baseline and Week 8]

Вторичные конечные точки (6)

• Change in erectile function measured by IIEF-5 [Срок оценки: Baseline and 8 weeks]
• Change in urinary incontinence severity and impact measured by ICIQ-SF [Срок оценки: Baseline and 8 weeks]
• Change in quality of life measured by King's Health Questionnaire [Срок оценки: Baseline and 8 weeks]
• Change in urinary frequency and incontinence episodes measured by 3-day bladder diary [Срок оценки: Baseline and 8 weeks]
• Change in perceived urinary symptom severity measured by Patient Global Impression of Severity (PGI-S) [Срок оценки: Baseline and 8 weeks]
• Perceived improvement in urinary symptoms measured by Patient Global Impression of Improvement (PGI-I) [Срок оценки: Week 8]

Критерии участия

Критерии включения

• Male individuals diagnosed with prostate cancer who have undergone radical prostatectomy
• Experiencing both urinary incontinence and erectile dysfunction
• Age > 55 years
• A score of 24 or higher on the Mini-Mental State Examination (MMSE)
• Literate (able to read and write)
• Willingness to participate in the study (signed informed consent)
• Ability to voluntarily contract pelvic floor muscles
• Ability to cooperate with the assessments and interventions used in the study

Критерии исключения

• History of urinary incontinence before surgery
• Congenital abnormalities of the urinary system
• Presence of neurological disorders
• History of transurethral resection of the prostate (TURP)
• Diagnosis of chronic obstructive pulmonary disease (COPD) and/or chronic restrictive pulmonary disease
• History of inguinal hernia
• Previous or current history of radiation therapy
• Surgical or postoperative complications that prevent early physiotherapy intervention (e.g., urinary tract infection, bladder neck stenosis)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• University of Health Sciences, Gülhane Training and Research Hospital — Ankara

Идентификаторы

NCT: NCT07101731 · SBU-RPHEE-2025-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗