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

NCT06249399 | Completed

• 1 other identifier: GİBTU-FP-BT-01
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lower Urinary Tract Symptoms; Diabetes Mellitus, Type 2

Keywords

Lower urinary tract symptoms; Diabetes Mellitus, Type 2; bladder; aerobic exercise; quality of life

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (11)

• Voiding Volume

  10 minutes (Change from Baseline at 12 weeks)

• Voiding Time

  10 minutes (Change from Baseline at 12 weeks)

• Maximum Bladder Capacity

  10 minutes (Change from Baseline at 12 weeks)

• Urine Maximum Flow Rate

  10 minutes (Change from Baseline at 12 weeks)

• Bladder Residual Volume

  10 minutes (Change from Baseline at 12 weeks)

Study Arms (2)

Aerobic Exercise Group

EXPERIMENTAL

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

Other: Aerobic Exercise; Behavioral: Behavioral Treatment Program

Control group

ACTIVE COMPARATOR

A behavioral treatment program will be applied to the patients.

Behavioral: Behavioral Treatment Program

Interventions

Aerobic Exercise OTHER

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.

Aerobic Exercise Group

Behavioral Treatment Program BEHAVIORAL

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.

Aerobic Exercise Group; Control group

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gaziantep Islam Science and Technology University: lead
• University of Gaziantep: collaborator
• Hasan Kalyoncu University: collaborator

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, 27000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Diabetes Mellitus, Type 2

Interventions

Exercise

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Bengisu TÜFEKÇİ

  Hasan Kalyoncu University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two groups: aerobic exercise group and control group.

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: February 8, 2024
• Study Start: May 3, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)