Effect of Bladder Training and Pelvic Floor Exercise Training on Urinary Symptoms and Quality of Life in Patients With Overactive Bladder Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- International Incontinence Consultation Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)
研究概览
简要总结
The aim of this study was to examine the effects of bladder training and pelvic floor exercise training programs given in addition to Botulinum Toxin-A (BTx-A) application on urinary symptoms and quality of life in patients with Overactive Bladder Syndrome (AAMS) who do not respond to conservative treatments.
Individuals who meet the criteria for inclusion in the study and agree to participate in the study will be divided into 2 separate research branches.The patients to be included in the study will be divided into two groups as "Group 1=Botox + physiotherapy " or "Group 2=Botox group ". In addition to the BTx-A application, bladder training and pelvic floor exercise training will be applied to patients in the first group, while standard patient training will be provided to patients in the second group.
Severity of urinary symptoms, quality of life and subjective perception of improvement Before BTx-A application, 2 weeks and 12 weeks after BTX-A application, International Incontinence Consultation Questionnaire - Women's Lower Urinary Tract Symptoms (ICIQ-FLUTS), 1-hour ped test, International Incontinence Consultation- Lower Urinary Tract Symptoms Quality of Life Scale (ICIQ-LUTS) and Global Perception of Improvement will be evaluated.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •over the age of 18 (those with a Mini Mental Test score of 24 and above for individuals over the age of 65),
- •Who has Non-Neurogenic Overactive Bladder Syndrome,
- •Patients who received Routine Botulinum Toxin-A administration because they did not respond to conservative treatment,
- •Patients who volunteer to participate in the study will be included.
排除标准
- •Patients with Neurogenic Overactive Bladder Syndrome,
- •Pregnant Women,
- •Lack of cooperation in evaluation and/or treatment and lack of literacy status,
- •Patients with urogynocological/anatomical abnormalities,
- •Patients receiving pelvic radiation therapy,
- •Patients with psychiatric or neurogenic disorders and
- •Patients who have not given consent to the study and do not have an informed consent form (BGOF).
结局指标
主要结局
International Incontinence Consultation Questionnaire - Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)
时间窗: the change in the symptoms of the lower urinary tract from the beginning to the end of 12 weeks and the effects of symptoms on quality of life
Storage symptoms are scored as 0-16 points, urination symptoms are scored as 0-12, incontinence symptoms are scored as 0-20 points. The effect of the patient's symptoms on their daily activities has 5 options, including "0-Never", "4-Always".The highest possible score is 48. A higher score means a worse outcome.
International Incontinence Consultation Questionnaire - Male Lower Urinary Tract Symptoms (ICIQ-MLUTS)
时间窗: the change in the symptoms of the lower urinary tract from the beginning to the end of 12 weeks and the effects of symptoms on quality of life
This scale aims to evaluate male lower urinary tract symptoms in the last 4 weeks and the effects of symptoms on quality of life with 13 questions. The effect of the patient's symptoms on their daily activities has 5 options, including "0-Never", "4-Always".The highest possible score is 52. A higher score means a worse outcome.
次要结局
- Global Perception of Improvement Scale(Change from baseline patient global change at 12 weeks)
- Compliance with Bladder Training(Compliance with Bladder Training at the end of 12 weeks)
- International Incontinence Consultation Bladder Diary (ICIQ-Bladder Diary):(change in the severity of urinary incontinence from the beginning to the end of 12 weeks)
- 1-Hour Ped Test(change in the severity of urinary incontinence from the beginning to the end of 12 weeks)
- International Incontinence Consultation- Lower Urinary Tract Symptoms Quality of Life Scale (ICIQ-LUTS):(Change in quality of life from baseline at 12 weeks)
- Compliance with Standard Patient Education(compliance with Standard Patient Education at the end of 12 weeks)
- Compliance with Pelvic Floor Exercise Training(Compliance with Pelvic Floor Exercise Training at the end of 12 weeks)
研究者
Ceren Gursen
Associate professor
Hacettepe University