Comparison of Training Models in Pelvic Floor Muscle Training in Healthy Adult Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean Bladder Base Displacement During Pelvic Floor Muscle Contraction
研究概览
简要总结
Pelvic floor muscle training (PFMT) is an exercise approach designed to improve the strength, endurance, power, relaxation, or coordination of the pelvic floor muscles. It is recommended as a first-line treatment for urinary incontinence (stress, urge, mixed), pelvic organ prolapse, and fecal incontinence. Evidence also suggests its potential to enhance sexual function in both men and women.
To teach proper pelvic floor contraction, individuals must first learn the anatomical location, structure, and function of these muscles. Various teaching strategies can support motor learning, such as verbal cues (commands or imagery), visual input (anatomical models or illustrations), physical guidance (tactile feedback), and environmental adjustments (comfortable positions, safe space). Yet, the choice of teaching method in clinical practice is currently based only on experience, not evidence.
This study aims to compare the effectiveness of four different PFMT teaching models-brochure-based, verbal instruction-based, visual instruction-based, and external palpation-aided-in teaching correct pelvic floor contraction and improving awareness in healthy adult women. It will be conducted as a four-arm randomized controlled trial. Participants will be evaluated before the training, immediately after, and one week later.
The findings from this study will help identify the most effective and practical approach for teaching PFMT. Although the study is conducted with healthy women without pelvic symptoms, the results will inform better training strategies for individuals with pelvic floor dysfunction, including those with urinary problems, chronic diseases, or pregnancy-related pelvic floor issues. Ultimately, this research seeks to fill a gap in the current literature and contribute to more evidence-based clinical practice.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older
- •Willingness to participate in the study
排除标准
- •Pregnancy
- •History of cesarean or vaginal delivery within the past 6 months
- •Previous pelvic floor muscle training
- •History of pelvic surgery
- •Currently receiving or having received treatment for pelvic organ prolapse
研究组 & 干预措施
Brochure-Based Pelvic Floor Muscle Training
干预措施: Brochure-Based Pelvic Floor Muscle Training (Behavioral)
Verbal Instruction-Based Pelvic Floor Muscle Training
干预措施: Verbal Instruction-Based Pelvic Floor Muscle Training (Behavioral)
Visual-Aided Pelvic Floor Muscle Training
干预措施: Visual-Aided Pelvic Floor Muscle Training (Behavioral)
External Palpation-Aided Pelvic Floor Muscle Training
干预措施: External Palpation-Aided Pelvic Floor Muscle Training (Behavioral)
结局指标
主要结局
Mean Bladder Base Displacement During Pelvic Floor Muscle Contraction
时间窗: Baseline (pre-training), immediately after training (within 1 hours of completion of training), and follow-up (7 days after training)
Pelvic floor muscle activity will be objectively assessed using transabdominal B-mode ultrasound, which allows real-time visualization of muscle movement. Participants will drink 500 ml of water and refrain from voiding before the test. While lying supine with knees flexed, a linear probe will be placed transabdominal suprapubically to visualize the bladder base. Bladder displacement during pelvic floor contraction will be measured by placing markers on the ultrasound image at rest and during contraction. The procedure will be repeated three times, and the average measurement in millimeters will be recorded.
Presence or Absence of Voluntary Pelvic Floor Muscle Contraction Assessed by Palpation
时间窗: Baseline (pre-training), immediately after training (within 1 hours of completion of training), and follow-up (7 days after training)
The participants' ability to contract their pelvic floor muscles will be assessed by a specialized physiotherapist through external palpation and categorized as no voluntary contraction, weak, moderate, or strong contraction.
Mean Bladder Base Displacement During Pelvic Floor Muscle Contraction
时间窗: Baseline (pre-training), immediately after training (within 1 hours of completion of training), and follow-up (7 days after training)
Pelvic floor muscle activity will be objectively assessed using transabdominal B-mode ultrasound, which allows real-time visualization of muscle movement. Participants will drink 500 ml of water and refrain from voiding before the test. While lying supine with knees flexed, a linear probe will be placed transabdominal suprapubically to visualize the bladder base. Bladder displacement during pelvic floor contraction will be measured by placing markers on the ultrasound image at rest and during contraction. The procedure will be repeated three times, and the average measurement in millimeters will be recorded.
Presence or Absence of Voluntary Pelvic Floor Muscle Contraction Assessed by Palpation
时间窗: Baseline (pre-training), immediately after training (within 1 hours of completion of training), and follow-up (7 days after training)
The participants' ability to contract their pelvic floor muscles will be assessed by a specialized physiotherapist through external palpation and categorized as no voluntary contraction, weak, moderate, or strong contraction.
次要结局
- Semi-Structured Form for Pelvic Floor Awareness(Baseline (pre-training), immediately after training (within 1 hours of completion of training), and follow-up (7 days after training))
- Participant Satisfaction(Immediately after training (within 1 hours of completion of training))
- Semi-Structured Form for Pelvic Floor Awareness(Baseline (pre-training), immediately after training (within 1 hours of completion of training), and follow-up (7 days after training))
- Participant Satisfaction(Immediately after training (within 1 hours of completion of training))
研究者
Ipek Yavas
PT, MSc, Lecturer
Izmir University of Economics