The Effects of Hypopressive Exercises on Urinary Incontinence and Erectile Dysfunction After Radical Prostatectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in urinary incontinence severity measured by 1-hour Pad Test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking was performed due to the nature of the intervention. Participants and investigators were aware of the group assignments. türkçesi
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Pelvic Floor Home Exercise + Supervised Hypopressive Exercise Group
Participants will perform daily home-based pelvic floor muscle exercises and also attend supervised hypopressive exercise sessions twice a week for 8 weeks.
干预措施: Pelvic Floor Muscle Training (PFMT) (Behavioral)
Pelvic Floor Home Exercise + Supervised Hypopressive Exercise Group
Participants will perform daily home-based pelvic floor muscle exercises and also attend supervised hypopressive exercise sessions twice a week for 8 weeks.
干预措施: Hypopressive Exercises (Behavioral)
Pelvic Floor Home Exercise Only Group
Participants will be instructed to perform home-based pelvic floor muscle exercises daily for 8 weeks. No supervised exercise sessions will be provided.
干预措施: Pelvic Floor Muscle Training (PFMT) (Behavioral)
结局指标
主要结局
Change in urinary incontinence severity measured by 1-hour Pad Test
时间窗: Baseline and 8 weeks
The 1-hour Pad Test, standardized by the International Continence Society (ICS), will be used to objectively assess urinary leakage. A weight gain of \>1g indicates a positive test. Severity will be classified as mild (\<2g), moderate (2-10g), severe (10-50g), or very severe (\>50g). The difference in pad weight pre- and post-intervention will be recorded.
Change in pelvic floor muscle endurance measured in seconds
时间窗: Baseline and Week 8
Pelvic floor muscle endurance will be assessed by instructing participants to sustain a maximal voluntary pelvic floor muscle contraction for as long as possible in a side-lying position with knees flexed at 45 degrees. The duration (in seconds) for which the contraction is maintained without loss of force will be recorded. Longer durations indicate greater endurance.
Change in pelvic floor muscle strength measured by Modified Oxford Scale
时间窗: Baseline and 8 weeks
Pelvic floor muscle strength will be assessed by manual digital palpation in a side-lying position with knees flexed at 45 degrees. Strength will be scored using the Modified Oxford Scale, which ranges from 0 (no contraction) to 5 (strong contraction). Higher scores indicate better pelvic floor muscle strength.
次要结局
- Change in quality of life measured by King's Health Questionnaire(Baseline and 8 weeks)
- Change in erectile function measured by IIEF-5(Baseline and 8 weeks)
- Change in urinary incontinence severity and impact measured by ICIQ-SF(Baseline and 8 weeks)
- Change in perceived urinary symptom severity measured by Patient Global Impression of Severity (PGI-S)(Baseline and 8 weeks)
- Change in urinary frequency and incontinence episodes measured by 3-day bladder diary(Baseline and 8 weeks)
- Perceived improvement in urinary symptoms measured by Patient Global Impression of Improvement (PGI-I)(Week 8)
研究者
Betül ERBAY
Lecturer
Bartın Unıversity