Lower Urinary Tract SymptomsNCT06249399
The Effect of Aerobic Exercise on Lower Urinary System Symptoms in Women With Diabetes Mellitus
A study testing Aerobic Exercise and Behavioral Treatment Program in people with Lower Urinary Tract Symptoms and Diabetes Mellitus, Type 2, run by Gaziantep Islam Science and Technology University at 1 site in Turkey (Türkiye).
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). Read more about this study
- Who is it for?
- Ages 35 to 55 years, women only
- Conditions the study is for
- Lower Urinary Tract Symptoms, Diabetes Mellitus, Type 2
- What is being tested?
- Aerobic Exercise and Behavioral Treatment Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 May 2023to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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:
Read more
- 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.
Read the 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.
- Being tested
- Aerobic Exercise, Behavioral Treatment Program
- Keywords
- Lower urinary tract symptoms, Diabetes Mellitus, Type 2, bladder, aerobic exercise, quality of life
- Medical subject headings
- Lower Urinary Tract Symptoms, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseOther
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 Treatment ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise Group | Experimental | A behavioral treatment program will be applied to the patients. In addition, patients will be given submaximal aerobic exercise. Receives: Other: Aerobic Exercise; Behavioral: Behavioral Treatment Program |
| Control group | Active comparator | A behavioral treatment program will be applied to the patients. Receives: Behavioral: Behavioral Treatment Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 minutes (Change from Baseline at 12 weeks)
Secondary outcomes (11)
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.
Measured: 10 minutes (Change from Baseline at 12 weeks)
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.
Measured: 10 minutes (Change from Baseline at 12 weeks)
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.
Measured: 10 minutes (Change from Baseline at 12 weeks)
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.
Measured: 10 minutes (Change from Baseline at 12 weeks)
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.
Measured: 10 minutes (Change from Baseline at 12 weeks)
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.
Measured: 10 minutes (Change from Baseline at 12 weeks)
Bladder Diary
48-hour bladder diary will be taken. The average of daily urination frequency numbers and daily fluid consumption amounts will be taken.
Measured: Change from Baseline at 12 weeks
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.
Measured: Change from Baseline at 12 weeks
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.
Measured: Change from Baseline at 12 weeks
HbA1c
HbA1c (blood glucose level) will be noted as a result of the blood evaluations taken by the clinician.
Measured: Change from Baseline at 12 weeks
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.
Measured: Change from Baseline at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start3 May 2023
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups: aerobic exercise group and control group.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziantep Islam Science and Technology University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Gaziantep, Hasan Kalyoncu University
- Responsible party
- Principal investigator, Bengisu Tüfekçi, Gaziantep Islam Science and Technology University
- Investigators
- Bengisu TÜFEKÇİ, Principal investigator, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249399
- Sponsor's protocol ID
- GİBTU-FP-BT-01
- Status last verified
- Mar 2024
- First submitted
- 12 Jan 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06249399
- Acronym / sponsor ID
- GİBTU-FP-BT-01
- Keywords
- Lower urinary tract symptoms, Diabetes Mellitus, Type 2, bladder, aerobic exercise, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Gaziantep Islam Science and Technology UniversityUniversity, hospital or other
- Collaborators
- University of Gaziantep, Hasan Kalyoncu University
- Study start
- 3 May 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups: aerobic exercise group and control group.
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise Group | Experimental | Other: Aerobic Exercise, Behavioral: Behavioral Treatment ProgramA behavioral treatment program will be applied to the patients. In addition, patients will be given submaximal aerobic exercise. |
| Control group | Active comparator | Behavioral: Behavioral Treatment ProgramA behavioral treatment program will be applied to the patients. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic ExerciseAerobic 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. | Other | Aerobic Exercise Group |
| Behavioral Treatment ProgramBehavioral Treatment Program will be completed with an initial training period of 40 minutes, and subsequent control interviews of 20 minutes at four-week intervals. | Behavioural | Aerobic Exercise Group, Control group |
Primary outcome
Bladder Compliance
Time frame: 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.
Bladder Sensation
Time frame: 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.
11 secondary outcomes
Voiding Volume
Time frame: 10 minutes (Change from Baseline at 12 weeks)
Voiding Time
Time frame: 10 minutes (Change from Baseline at 12 weeks)
Maximum Bladder Capacity
Time frame: 10 minutes (Change from Baseline at 12 weeks)
Urine Maximum Flow Rate
Time frame: 10 minutes (Change from Baseline at 12 weeks)
Bladder Residual Volume
Time frame: 10 minutes (Change from Baseline at 12 weeks)
Ultrasonography (USG) evaluation
Time frame: 10 minutes (Change from Baseline at 12 weeks)
Bladder Diary
Time frame: Change from Baseline at 12 weeks
King's Health Questionnaire (KHQ)
Time frame: Change from Baseline at 12 weeks
Bristol Female Lower Urinary System Symptom Index (BFLUSSI)
Time frame: Change from Baseline at 12 weeks
HbA1c
Time frame: Change from Baseline at 12 weeks
Patient Information Form
Time frame: Change from Baseline at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bengisu TÜFEKÇİ principal investigator
Hasan Kalyoncu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise and Behavioral Treatment Program in people with Lower Urinary Tract Symptoms and Diabetes Mellitus, Type 2, run by Gaziantep Islam Science and Technology University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder Compliance (time frame: 10 minutes (Change from Baseline at 12 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.