The Effect of Aerobic Exercise on Lower Urinary System Symptoms in Women With Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

The Effect Of Aerobic Exercise On Bladder Function And Lower Urinary Tract Symptoms In Women Who Has Diabetes Mellitus With Lower Urinary Tract Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06249399
• Other study ID #: GIBTU-FP-BT-01
• Status: Completed
• Phase: N/A
• Start date: May 3, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: March 2024
• Source: Gaziantep Islam Science and Technology University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Lower Urinary Tract Symptoms

Intervention

Other:
• Aerobic Exercise
Aerobic Exercise training will be provided three days a week, 45 minutes a day, for 12 weeks. Patients will be subjected to submaximal aerobic exercise with rhythmic movements without equipment via video conference accompanied by a physiotherapist.

Behavioral:
• Behavioral Treatment Program
Behavioral Treatment Program will be completed with an initial training period of 40 minutes, and subsequent control interviews of 20 minutes at four-week intervals.

Locations

Country	Name	City	State
Turkey	Hasan Kalyoncu University	Gaziantep

Sponsors (3)

Lead Sponsor	Collaborator
Gaziantep Islam Science and Technology University	Hasan Kalyoncu University, University of Gaziantep

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bladder Compliance	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.	10 minutes (Change from Baseline at 12 weeks)
Primary	Bladder Sensation	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.	10 minutes (Change from Baseline at 12 weeks)
Secondary	Voiding Volume	Voiding volume will be evaluated by urodynamics. 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 Voiding volume (ml) will be recorded.	10 minutes (Change from Baseline at 12 weeks)
Secondary	Voiding Time	Voiding time will be evaluated by urodynamics. 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 Voiding time (sec) will be recorded.	10 minutes (Change from Baseline at 12 weeks)
Secondary	Maximum Bladder Capacity	Maximum bladder capacity will be evaluated by urodynamics. 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 Maximum bladder capacity (ml) will be recorded.	10 minutes (Change from Baseline at 12 weeks)
Secondary	Urine Maximum Flow Rate	Urine maximum flow rate will be evaluated by urodynamics. 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 Maximum flow rate (ml/s) will be recorded.	10 minutes (Change from Baseline at 12 weeks)
Secondary	Bladder Residual Volume	Bladder residual volume rate will be evaluated by urodynamics. 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 Residual volume (cc) will be recorded.	10 minutes (Change from Baseline at 12 weeks)
Secondary	Ultrasonography (USG) evaluation	Ultrasonography will be performed by the doctor using the measured thickest part of the bladder wall as reference. The wall thickness of the bladder (mm) will be noted when the bladder is empty and full. USG is a non-invasive imaging method that physicians routinely use to evaluate the urinary system.	10 minutes (Change from Baseline at 12 weeks)
Secondary	Bladder Diary	48-hour bladder diary will be taken. The average of daily urination frequency numbers and daily fluid consumption amounts will be taken.	Change from Baseline at 12 weeks
Secondary	King's Health Questionnaire (KHQ)	It will be used to evaluate urinary system symptom severity and quality of life related to urinary system symptoms.The KHQ scale consists of two parts and 32 items. In the first part, there are two single-item questions about general health and quality of life. Again, in the first part, it consists of seven subheadings consisting of multiple items, including the individual's roles in daily life, physical condition, social situation, personal relationships, emotional problems, sleep/energy disorders, and violence measurements, and consists of 21 questions. The second part is a scale consisting of 11 questions that questions the presence of lower urinary tract symptoms and the severity of symptoms.Scoring on the Symptom Severity Scale ranges from 0 points (best) to 30 points (worst). In other KHQ subheadings, the scale scoring is 0 points (best) -100 points (worst). An increase in the score obtained from KHQ indicates a decrease in the quality of life.	Change from Baseline at 12 weeks
Secondary	Bristol Female Lower Urinary System Symptom Index (BFLUSSI)	It will be used to evaluate the Quality of Life Due to Lower Urinary System Symptoms.This scale includes storage functions (questions 1-4), excretory functions (questions 5-7), urinary incontinence (questions 8-12), sexual life (questions 13-14) and quality of life (questions 15-19). It consists of five sections with subheadings.; The highest score that can be obtained from the survey is 71, while the lowest score is 0. A high score from the survey indicates that the severity of LUTS is high and sexual functions and quality of life are negatively affected.	Change from Baseline at 12 weeks
Secondary	HbA1c	HbA1c (blood glucose level) will be noted as a result of the blood evaluations taken by the clinician.	Change from Baseline at 12 weeks
Secondary	Patient Information Form	Patient information such as sociodemographic (age (year), occupation (employed/unemployed), education (literate/primary school/high school/university/graduate school), marital status (married/single), number of births (n), type of delivery (vaginal/caesarean section) and physical (height (m), weight (kg), BMI (kg/m2),constipation (, type 2 DM duration (year)) will be noted. Personal habits (liquid consumption habits (ml), number of urinations per day (n)) will be noted.	Change from Baseline at 12 weeks