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

Gaziantep Islam Science and Technology University

Status: Completed

Conditions: Lower Urinary Tract Symptoms; Diabetes Mellitus, Type 2

Treatments: Behavioral: Behavioral Treatment Program; Other: Aerobic Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06249399

GİBTU-FP-BT-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: Female

Ages: 35 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Aerobic Exercise Group

Experimental group

Description:

A behavioral treatment program will be applied to the patients. In addition, patients will be given submaximal aerobic exercise.

Treatment:

Behavioral: Behavioral Treatment Program

Other: Aerobic Exercise

Control group

Active Comparator group

Description:

A behavioral treatment program will be applied to the patients.

Treatment:

Behavioral: Behavioral Treatment Program