A Randomized Interventional Parallel Study to Evaluate the Effect of Pelvic Floor Muscle Training With Stabilization Exercises of High and Low Intensity in Women With Stress Urinary Incontinence - the PELSTAB Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Change in incontinence episode frequency (IEF) over one week.
研究概览
简要总结
This study will evaluate the safety, tolerability and efficacy of high- and low-intensity PFMT with stabilization exercises in women with SUI
详细描述
This is a randomized interventional parallel study to evaluate the effect of PFMT with stabilization exercises of high and low intensity in women with SUI
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Willing to provide written informed consent
- •Over 18 years old and experiencing uncomplicated SUI
- •Score on the International Consultation on Urinary Incontinence Questionnaire of ≥ 6 points
- •Symptoms of urinary incontinence for at least three consecutive months
- •Degree of pelvic organ prolapse, stage ≤ 2
- •Willingness to accept the randomization process and fully participate in tests
排除标准
- •History of anti-incontinence surgery in the past 12 months
- •History of pelvic prolapse repair or urethral surgery in the past 12 months
- •History of PFMT in the past 12 months
- •History of interstitial cystitis or bladder-related pain
- •Chronic severe constipation
- •Clinically significant renal or hepatic impairment
- •Clinically significant heart impairment
- •Pregnant, lactating or actively trying to become pregnant
- •Positive urinary tract infection
- •Use of rehabilitation aids (pessaries, urethral plugs, vaginal beads, etc.)
- •Insufficient understanding of pelvic floor exercises and/or omitting exercises
- •Incomplete questionnaire
- •Refusal to participate in the study
研究组 & 干预措施
Group A-intensive exercise group
Dosage of intensive exercise group - 12 weeks, five times a week for 30 minutes per day; five times with education by a physiotherapist, followed by continuation at home.
PFMT with lumbopelvic stabilization. Exercise up to five times a week for up to 30 minutes per day, after initial training with a physiotherapist.
- Educating probands about anatomy, physiology and pelvic floor muscle function.
- Training of pelvic floor muscles in different positions.
- Training of pelvic floor muscles with six stabilization exercises - activation of deep trunk muscles.
干预措施: Pelvic Floor Muscle Training (PFMT) (Other)
Group B-low-intensity exercise group
Dosage of low-intensity exercise group - 12 weeks, twice a week for 15 minutes per day; five times with physiotherapist education, followed by continuation at home.
PFMT with lumbopelvic stabilization. Exercise up to five times a week for up to 30 minutes per day, after initial training with a physiotherapist.
- Educating probands about anatomy, physiology and pelvic floor muscle function.
- Training of pelvic floor muscles in different positions.
- Training of pelvic floor muscles with six stabilization exercises - activation of deep trunk muscles.
干预措施: Pelvic Floor Muscle Training (PFMT) (Other)
结局指标
主要结局
Change in incontinence episode frequency (IEF) over one week.
时间窗: change in incontinence episode frequency over 12 weeks of treatment
Change in the number of urinary leakages during the day, measured by the voiding diary.
次要结局
- Change in incontinence quality of life(Change in incontinence quality of life over 12 weeks of treatment)
- Change in patient global impression(Change in patient global impression over 12 weeks of treatment)
- Change in performance and endurance of pelvic floor muscles(Change in performance and endurance of pelvic floor muscles over 12 weeks of treatment)
- Change in hiatal area (HA, in cm2) during the Valsalva manoeuvre, assessed by 3D ultrasound(Change in hiatal area (HA, in cm2) during the Valsalva manoeuvre, assessed by 3D ultrasound over 12 weeks of treatment)
研究者
Peter Urdzik
Faculty of Medicine
Pavol Jozef Safarik University