A Comparison of the Effect on Stress Urinary Incontinence of Lumbopelvic Stabilisation Exercises and Pelvic Floor Exercises: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- The primer outcome of the study was to investigate the effects of lumbopelvic stabilisation exercises and pelvic floor exercises on the severity of incontinence in women with a diagnosis of stress urinary incontinence
研究概览
简要总结
The patients diagnosed with stress urinary incontinence and included in the study. According to randomisation plan one group will be instructed by a physiotherapist to perform pelvic flor exercises and the other group will be instructed by the same physiotherapist to perform dynamic lumbopelvic stabilisation exercises.Throughout the study, the women will be followed up to ensure the exercises are performed. The exercises will be applied for approximately 30 mins once a day for a period of 10 weeks.
详细描述
The females included in the study will be separated into 2 groups in the randomisation plan. One group will be instructed by a physiotherapist to perform pelvic flor exercises, and the other group will be instructed by the same physiotherapist to perform dynamic lumbopelvic stabilisation exercises. After a demonstration by the physiotherapist of how both exercises should be performed, the women will be requested to perform the exercises under the supervision of the physiotherapist. The pelvic flor exercise will be in the form of contraction-release for rapidly contracting muscle fibres, and for slowly contracting muscle fibres, slow contraction by counting to ten, hold for a count of ten, then gradually relax by counting to ten. The exercises will start as 5 sets of 10 repetitions per day, then each week the number of sets will be increased by 5 to reach 30 sets per day, and the exercises will be continued at this rate of 30 sets per day.
The women who will perform the dynamic lumbopelvic stabilisation exercises will be taught the basic movement, starting with co-contraction of the transversus abdominis (TA) muscle and other muscles together with diaphragm breathing, and continuing the exercises with upper and lower extremity movements together with TA and multifidus contraction. Initially the exercise position is held for 5-10 secs with 10 repetitions, and as the program advances the time of holding the position will be extended to 30-45 secs. Throughout the study, the women will be followed up to ensure the exercises are performed. The exercises will be applied for approximately 30 mins once a day for a period of 10 weeks.
The Q-Tip test will be used in the evaluation of uretero vesical junction (UVJ) mobility. A cotton swab lubricated with lidocaine gel will be used in the test. The cotton swab will be placed from the external urethral meatus and will be slowly pushed towards the bladder until resistance is felt. This point where resistance is met will be accepted as the UVJ. During the test, the angle will be measured during maximal strain by drawing the labia to the sides.
The patients diagnosed with stress urinary incontinence and included in the study will be taught the lumbopelvic stabilisation and pelvic floor exercises in the clinic under the guidance of the physiotherapist.
Study procedure:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged ≥ 35 years
- •BMI <29 kg/m2
- •Are willing to participate in the research
- •Premenopausal
- •Able to self-report urine loss
- •Educational level of at least primary school
- •Positive cough provocation test (stress test)
- •Positive Q-tip test,
- •No complaints of constipation
排除标准
- •Musculoskeletal system disorder
- •Neurological dysfunction
- •Genital prolapse more then second stage
- •Hormone replacement therapy use
- •Postmenopausal
- •Anticholinergic drug use
- •Urge and mixed incontinence
- •Diuretic drug use
- •Antidepressant drugs use
- •Caffeine intake of >4 cups/day
- •Diabetes insipidus
- •Urinary infection
- •Vaginal infection
- •History of urinary or genital surgery
- •Malignancy
- •Pelvic Floor Trauma
- •Lumbar disc hernia
- •Pregnancy
- •Breast-feeding
- •Diabetes mellitus
- •Hypertension
- •BMI>30 kg/m2
- •Chronic obstructive sleep apnea
- •Chronic lung disease
研究组 & 干预措施
Lumbopelvic Stabilisation Exercises
Starting with co-contraction of the transversus abdominis (TA) muscle and other muscles together with diaphragm breathing, and continuing the exercises with upper and lower extremity movements together with TA and multifidus contraction
干预措施: Lumbopelvic Stabilisation Exercises Group (Behavioral)
Pelvic Floor Exercises
The pelvic flor exercise will be in the form of contraction-release for rapidly contracting muscle fibres and for slowly contracting muscle fibres,slow contraction by counting to ten hold for a count of ten, then gradually relax by counting to ten.
干预措施: Pelvic Floor Exercises Group (Behavioral)
结局指标
主要结局
The primer outcome of the study was to investigate the effects of lumbopelvic stabilisation exercises and pelvic floor exercises on the severity of incontinence in women with a diagnosis of stress urinary incontinence
时间窗: six month
The severity of incontinence at before and after the exercises (total exercise duration is 10 weeks) will measure with Urogenital Distress Inventory. The change from baseline in Urogenital Distress Inventory after the exercises intervention will be measured by decrease on the severity of incontinence.
The other primer outcome of the study was to lumbopelvic stabilisation exercises and pelvic floor exercises on the severity of incontinence in women with a diagnosis of stress urinary incontinence
时间窗: six month
The severity of incontinence at before and after the exercises (total exercise duration is 10 weeks) will measure with Incontinence Impact Questionnaire. The change from baseline in Incontinence Impact Questionnaire after the exercises intervention will be measured by decrease on the severity of incontinence.
The another primer outcome of the study was to investigate the effects of lumbopelvic stabilisation exercises and pelvic floor exercises on the amount of urinary output in women with a diagnosis of stress urinary incontinence
时间窗: six month
The amount of urinary output and urine leakage in women during five days before exercises and five days after exercises (total exercise duration is 10 weeks) will Bladder Diary with measure. The amount of urinary output and urine leakage before and after exercises will be measured by decrease in urination of frequency and urine leakage at Bladder Diary.
次要结局
- The seconder outcome of the study was to investigate the effects of lumbopelvic stabilisation exercise and pelvic floor exercise on the degree of quality of life in women with a diagnosis of stress urinary incontinence(six month)
研究者
Meryem Kurek eken
Associated Professor
Aydin Adnan Menderes University