The Effect Of Aerobic Exercise On Bladder Function And Lower Urinary Tract Symptoms In Women Who Has Diabetes Mellitus With Lower Urinary Tract Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Bladder Sensation
研究概览
简要总结
The goal of this clinical trial is to investigate the effect of aerobic exercise (AE) on bladder functions and urinary system symptoms in women diagnosed with Diabetes Mellitus (DM) and suffered from Lower Urinary Tract Symptoms (LUTS). In the study, 44 individuals (35-55 age) were divided into two groups: Aerobic Exercise (AE) (n=22) and Control Group (n=22) by simple random method.
The main questions it aims to answer are:
- Is aerobic exercise effective on bladder functions in women diagnosed with Diabetes Mellitus and suffered from Lower Urinary Tract Symptoms?
- Is aerobic exercise effective on urinary tract symptoms in women diagnosed with Diabetes Mellitus and suffered from Lower Urinary Tract Symptoms?
- Is aerobic exercise effective on quality of life in women diagnosed with Diabetes Mellitus and suffered from Lower Urinary Tract Symptoms?
Intervention/treatment
- Control group individuals will be given a behavioral treatment program.
- Submaximal aerobic exercise training will be given to the AE group in addition to the behavioral treatment program.
详细描述
The goal of this clinical trial is to investigate the effect of aerobic exercise (AE) on bladder functions and urinary system symptoms in women diagnosed with Diabetes Mellitus (DM) and suffered from Lower Urinary Tract Symptoms (LUTS). In the study, 44 individuals (35-55 age) were divided into two groups: Aerobic Exercise (AE) (n=22) and Control Group (n=22) by simple random method. Bladder sensation (first sensation) and compliance from urodynamic evaluations will be taken as reference as the primary outcome measurement in treatment effectiveness.
- Control group individuals will be given a behavioral treatment program.
- Submaximal aerobic exercise training will be given to the AE group in addition to the behavioral treatment program.
AE training was provided three days a week, 45 minutes a day, for 12 weeks. The behavioral treatment protocol was completed with an initial training period of 40 minutes, and subsequent control interviews of 20 minutes at four-week intervals.
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
- 35 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between the ages of 35-55,
- •Individuals who volunteer to participate in the study,
- •Those diagnosed with Type II diabetes for 5 years or more and those diagnosed with LUTS
排除标准
- •Stage 2 and more advanced pelvic organ prolapse,
- •Urinary tract infection,
- •Has had previous surgery for urinary incontinence and pelvic organ prolapse,
- •Diagnosis of Cerebro Vascular Event (CVE) and dementia,
- •Using A-blockers, antimuscarinics, antidepressants, diuretics and antihistamines,
- •Individuals in menopause.
研究组 & 干预措施
Control group
A behavioral treatment program will be applied to the patients.
干预措施: Behavioral Treatment Program (Behavioral)
Aerobic Exercise Group
A behavioral treatment program will be applied to the patients. In addition, patients will be given submaximal aerobic exercise.
干预措施: Aerobic Exercise (Other)
Aerobic Exercise Group
A behavioral treatment program will be applied to the patients. In addition, patients will be given submaximal aerobic exercise.
干预措施: Behavioral Treatment Program (Behavioral)
结局指标
主要结局
Bladder Sensation
时间窗: 10 minutes (Change from Baseline at 12 weeks)
Bladder sensation will be evaluated by urodynamics. With urodynamic evaluations, pathologies of the lower urinary system can be diagnosed and classified. Urodynamic examinations are performed in a suitable laboratory environment. First of all, a suitable sterile catheter is placed in the bladder and isotonic fluid is filled into it at a certain speed. In this way, the behavior of the bladder and its muscles during urine filling, pressure measurements and behavior during urination are examined. Bladder functions are evaluated with urodynamic evaluations. With the urodynamic evaluation will be performed by the clinician in the urology outpatient clinic sensation (ml) will be recorded.
Bladder Compliance
时间窗: 10 minutes (Change from Baseline at 12 weeks)
Bladder compliance will be evaluated by urodynamics. With urodynamic evaluations, pathologies of the lower urinary system can be diagnosed and classified. Urodynamic examinations are performed in a suitable laboratory environment. First of all, a suitable sterile catheter is placed in the bladder and isotonic fluid is filled into it at a certain speed. In this way, the behavior of the bladder and its muscles during urine filling, pressure measurements and behavior during urination are examined. Bladder functions are evaluated with urodynamic evaluations. With the urodynamic evaluation will be performed by the clinician in the urology outpatient clinic compliance (ml/cmH2O) will be recorded.
次要结局
- Maximum Bladder Capacity(10 minutes (Change from Baseline at 12 weeks))
- Bladder Residual Volume(10 minutes (Change from Baseline at 12 weeks))
- Voiding Volume(10 minutes (Change from Baseline at 12 weeks))
- Ultrasonography (USG) evaluation(10 minutes (Change from Baseline at 12 weeks))
- Patient Information Form(Change from Baseline at 12 weeks)
- Voiding Time(10 minutes (Change from Baseline at 12 weeks))
- King's Health Questionnaire (KHQ)(Change from Baseline at 12 weeks)
- Bristol Female Lower Urinary System Symptom Index (BFLUSSI)(Change from Baseline at 12 weeks)
- Urine Maximum Flow Rate(10 minutes (Change from Baseline at 12 weeks))
- Bladder Diary(Change from Baseline at 12 weeks)
- HbA1c(Change from Baseline at 12 weeks)
研究者
Bengisu Tüfekçi
Principal Investigator
Gaziantep Islam Science and Technology University