Clinical trial NCT06249399: The Effect of Aerobic Exercise on Lower Urinary System Symptoms in Women With Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Urinary Tract Symptoms
Diabetes Mellitus, Type 2
Keywords: Lower urinary tract symptoms
Diabetes Mellitus, Type 2
bladder
aerobic exercise
quality of life
Lead sponsor: Gaziantep Islam Science and Technology University
Sponsor class: OTHER
Collaborators: name: University of Gaziantep
name: Hasan Kalyoncu University
First posted: 2024-02-08
Enrollment: 44
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups: aerobic exercise group and control group.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bladder Compliance
timeFrame: 10 minutes (Change from Baseline at 12 weeks)
measure: Bladder Sensation
timeFrame: 10 minutes (Change from Baseline at 12 weeks)
Secondary outcomes:
measure: Voiding Volume
timeFrame: 10 minutes (Change from Baseline at 12 weeks)
measure: Voiding Time
timeFrame: 10 minutes (Change from Baseline at 12 weeks)
measure: Maximum Bladder Capacity
timeFrame: 10 minutes (Change from Baseline at 12 weeks)
measure: Urine Maximum Flow Rate
timeFrame: 10 minutes (Change from Baseline at 12 weeks)
measure: Bladder Residual Volume
timeFrame: 10 minutes (Change from Baseline at 12 weeks)
measure: Ultrasonography (USG) evaluation
timeFrame: 10 minutes (Change from Baseline at 12 weeks)
measure: Bladder Diary
timeFrame: Change from Baseline at 12 weeks
measure: King's Health Questionnaire (KHQ)
timeFrame: Change from Baseline at 12 weeks
measure: Bristol Female Lower Urinary System Symptom Index (BFLUSSI)
timeFrame: Change from Baseline at 12 weeks
measure: HbA1c
timeFrame: Change from Baseline at 12 weeks
measure: Patient Information Form
timeFrame: Change from Baseline at 12 weeks
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Hasan Kalyoncu University
Study officials:
affiliation: Hasan Kalyoncu University
name: Bengisu TÜFEKÇİ
role: PRINCIPAL_INVESTIGATOR
References: