Urinary Incontinence (UI)NCT07813702
URINARY INCONTINENCE AND GERIATRIC SYNDROMES
An observational study of Urinary Incontinence (UI) and Urinary Incontinence, run by MERT UYSAL at 1 site in Turkey (Türkiye).
Trial summary
The aim of this cross-sectional observational study is to examine the independent associations of urinary incontinence severity and post-void residual urine volume with frailty and other geriatric outcomes in older adults presenting to a urology outpatient clinic with urinary incontinence. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Urinary Incontinence (UI), Urinary Incontinence, Urinary Incontinence in Old Age
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Apr 2026to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The study population will consist of women and men aged 65 years or older presenting to the Urology Outpatient Clinic of Karabuk Training and Research Hospital with urinary incontinence. Individuals who meet the eligibility criteria, are able to mobilize independently, and provide written informed consent will be enrolled consecutively during the study period. All participants will have experienced at least one urinary leakage episode during the previous four weeks and will have an ICIQ-UI SF score of ≥1. No healthy control group will be included.
Who may be able to join
- Age 65 years or older,
- Presence of involuntary urinary leakage according to the International Continence Society definition,
- At least one urinary leakage episode during the previous four weeks and an ICIQ-UI SF score of ≥1,
- General health status adequate to tolerate the outpatient assessment protocol,
- Ability to mobilize independently,
- Ability to understand instructions in Turkish and complete the study questionnaires,
- Willingness to participate and provision of written informed consent.
Who cannot join
- Acute urinary tract infection or acute lower urinary tract symptoms,
- History of major pelvic or orthopedic surgery within the previous six months,
- Acute musculoskeletal condition that may affect performance during the assessments,
- Neurological disease causing severe mobility limitations, including Parkinson's disease or stroke,
- Diabetic neuropathy,
- Severe cardiopulmonary disease, including New York Heart Association class III-IV heart failure or forced expiratory volume in one second below 30% of the predicted value,
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- Dementia or severe cognitive impairment, defined as Global Deterioration Scale stage 4 or higher,
- Severe visual or hearing impairment that may prevent completion of the assessments,
- Terminal illness or active malignancy,
- Inability or unwillingness to provide informed consent,
- Unwillingness or inability to complete the assessment protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Karabuk Training and Research Hospital
Karabük, Merkez, 78050
About this study
Official title: THE IMPACT OF URINARY INCONTINENCE ON GERIATRIC SYNDROMES IN ELDERLY INDIVIDUALS
The aim of this cross-sectional observational study is to examine the independent associations of urinary incontinence severity and post-void residual urine volume with frailty and other geriatric outcomes in older adults presenting to a urology outpatient clinic with urinary incontinence.
- Conditions
- Urinary Incontinence (UI), Urinary Incontinence, Urinary Incontinence in Old Age, Urinary Incontinence in Geriatric Population, Geriatric Syndromes, Geriatric Syndrome
- Keywords
- Urinary incontinence, Geriatric syndrome, Elderly individuals, Post-void residual urine volume, PVR, PHYSIOTHERAPY, Muscle strength, Physical parameters, Frailty, Sarcopenia, Physical performance, Falls
- Medical subject headings
- Urinary Incontinence, Frailty, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Older Adults with Urinary Incontinence | Adults aged 65 years or older with urinary incontinence, defined as at least one episode of urinary leakage during the previous four weeks and an ICIQ-UI SF score of ≥1, will be included. Participants will undergo a single-visit observational assessment of urinary incontinence severity and type, post-void residual urine volume, frailty, sarcopenia risk, cognitive function, physical performance, balance, falls, fear of falling, sleep, nutritional status, depressive symptoms, and quality of life. No intervention will be administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty Level Assessed Using the FRAIL Scale
The primary outcome is frailty level, assessed using the five-item FRAIL Scale. The total score ranges from 0 to 5, with higher scores indicating greater frailty. Participants will be classified as robust (0 points), prefrail (1-2 points), or frail (≥3 points). The primary exposures are urinary incontinence severity, assessed using the ICIQ-UI SF total score (range: 0-21), and post-void residual urine volume, recorded in milliliters as the mean of two consecutive bladder scanner measurements performed within 10 minutes after voiding. The independent associations of ICIQ-UI SF score and post-void residual urine volume with frailty level will be examined in the same multivariable regression model after adjustment for prespecified covariates.
Measured: During the single study visit (cross-sectional baseline assessment)
Secondary outcomes (7)
Physical Performance Assessed Using the Short Physical Performance Battery
Physical performance will be assessed using the Short Physical Performance Battery (SPPB), comprising standing balance, usual-paced walking, and five-repetition chair-rise tests. Each component is scored from 0 to 4, resulting in a total score ranging from 0 to 12. Higher scores indicate better physical performance. A total score of ≤8 will be considered indicative of low physical performance.
Measured: During the single study visit (baseline assessment)
Functional Mobility Assessed Using the Timed Up and Go Test
Functional mobility will be assessed using the Timed Up and Go Test (TUG). Participants will stand up from a chair, walk three meters, turn, walk back to the chair, and sit down. Completion time will be recorded in seconds, with longer times indicating poorer functional mobility.
Measured: During the single study visit (baseline assessment)
Motor-Cognitive Mobility Assessed Using the Dual-Task Timed Up and Go Test
Motor-cognitive mobility will be assessed using the Dual-Task Timed Up and Go Test (DT-TUG). Participants will complete the TUG while simultaneously performing serial subtraction by threes from 100. Completion time will be recorded in seconds, with longer times indicating poorer motor-cognitive mobility performance.
Measured: During the single study visit (baseline assessment)
Handgrip Strength Measured Using a Hand Dynamometer
Handgrip strength will be measured in the dominant hand using a BASELINE hand dynamometer. Three trials will be performed, and the highest value, recorded in kilograms, will be used in the analysis. Values below 27 kg in men and below 16 kg in women will be classified as low muscle strength.
Measured: During the single study visit (baseline assessment)
Isometric Quadriceps Muscle Strength Measured Using a Hand-Held Dynamometer
Isometric quadriceps muscle strength will be measured using a hand-held dynamometer (BASELINE) under a standardized testing protocol. Participants will perform two maximal voluntary isometric contractions with standardized verbal encouragement. The highest force value obtained from the two trials will be used in the analysis, with higher values indicating greater quadriceps muscle strength.
Measured: During the single study visit (baseline assessment)
Concern About Falling Assessed Using the Falls Efficacy Scale-International
Concern about falling will be assessed using the 16-item Falls Efficacy Scale-International (FES-I). Each item is scored from 1 to 4, producing a total score ranging from 16 to 64. Higher scores indicate greater concern about falling. Scores of 16-19, 20-27, and 28-64 will be classified as low, moderate, and high concern about falling, respectively.
Measured: During the single study visit (baseline assessment)
Sleep Quality Assessed Using the Pittsburgh Sleep Quality Index
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which evaluates subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality. A total score greater than 5 will be considered indicative of poor sleep quality.
Measured: During the single study visit, reflecting sleep during the previous month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start8 Apr 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence (UI)Studies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MERT UYSAL
- Sponsor type
- University, hospital or other
- Collaborators
- Karabuk Training and Research Hospital, Karabuk University, Abant Izzet Baysal University
- Responsible party
- Sponsor-investigator, MERT UYSAL, Karabuk University
- Investigators
- Eylem Tutun Yumin, Professor, Study chair, Abant Izzet Baysal UniversityMeral Sertel, Professor, Study director, Uludag UniversityFahrettin Samil Uysal, Assistant Professor, Study director, Karabuk UniversityMert Uysal, Lecturer, Principal investigator, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813702
- Sponsor's protocol ID
- KBU-FTR-MU-02
- Status last verified
- Apr 2026
- First submitted
- 4 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the informed consent and ethics approval do not include external sharing or secondary use of individual-level health data. Only aggregated study results will be disseminated.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE IMPACT OF URINARY INCONTINENCE ON GERIATRIC SYNDROMES IN ELDERLY INDIVIDUALS
- ClinicalTrials.gov ID
- NCT07813702
- Acronym / sponsor ID
- KBU-FTR-MU-02
- Conditions
- Urinary Incontinence (UI), Urinary Incontinence, Urinary Incontinence in Old Age, Urinary Incontinence in Geriatric Population, Geriatric Syndromes, Geriatric Syndrome
- Keywords
- Urinary incontinence, Geriatric syndrome, Elderly individuals, Post-void residual urine volume, PVR, PHYSIOTHERAPY, Muscle strength, Physical parameters
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- MERT UYSALUniversity, hospital or other
- Collaborators
- Karabuk Training and Research Hospital, Karabuk University, Abant Izzet Baysal University
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 10 Sep 2026 (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 aim of this cross-sectional observational study is to examine the independent associations of urinary incontinence severity and post-void residual urine volume with frailty and other geriatric outcomes in older adults presenting to a urology outpatient clinic with urinary incontinence.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older Adults with Urinary Incontinence | – | –Adults aged 65 years or older with urinary incontinence, defined as at least one episode of urinary leakage during the previous four weeks and an ICIQ-UI SF score of ≥1, will be included. Participants will undergo a single-visit observational assessment of urinary incontinence severity and type, post-void residual urine volume, frailty, sarcopenia risk, cognitive function, physical performance, balance, falls, fear of falling, sleep, nutritional status, depressive symptoms, and quality of life. No intervention will be administered. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study population will consist of women and men aged 65 years or older presenting to the Urology Outpatient Clinic of Karabuk Training and Research Hospital with urinary incontinence. Individuals who meet the eligibility criteria, are able to mobilize independently, and provide written informed consent will be enrolled consecutively during the study period. All participants will have experienced at least one urinary leakage episode during the previous four weeks and will have an ICIQ-UI SF score of ≥1. No healthy control group will be included.
Key inclusion criteria (7 listed)
- Age 65 years or older,
- Presence of involuntary urinary leakage according to the International Continence Society definition,
- At least one urinary leakage episode during the previous four weeks and an ICIQ-UI SF score of ≥1,
- General health status adequate to tolerate the outpatient assessment protocol,
- Ability to mobilize independently,
Key exclusion criteria (11 listed)
- Acute urinary tract infection or acute lower urinary tract symptoms,
- History of major pelvic or orthopedic surgery within the previous six months,
- Acute musculoskeletal condition that may affect performance during the assessments,
- Neurological disease causing severe mobility limitations, including Parkinson's disease or stroke,
- Diabetic neuropathy,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frailty Level Assessed Using the FRAIL Scale
Time frame: During the single study visit (cross-sectional baseline assessment)
The primary outcome is frailty level, assessed using the five-item FRAIL Scale. The total score ranges from 0 to 5, with higher scores indicating greater frailty. Participants will be classified as robust (0 points), prefrail (1-2 points), or frail (≥3 points). The primary exposures are urinary incontinence severity, assessed using the ICIQ-UI SF total score (range: 0-21), and post-void residual urine volume, recorded in milliliters as the mean of two consecutive bladder scanner measurements performed within 10 minutes after voiding. The independent associations of ICIQ-UI SF score and post-void residual urine volume with frailty level will be examined in the same multivariable regression model after adjustment for prespecified covariates.
7 secondary outcomes
Physical Performance Assessed Using the Short Physical Performance Battery
Time frame: During the single study visit (baseline assessment)
Functional Mobility Assessed Using the Timed Up and Go Test
Time frame: During the single study visit (baseline assessment)
Motor-Cognitive Mobility Assessed Using the Dual-Task Timed Up and Go Test
Time frame: During the single study visit (baseline assessment)
Handgrip Strength Measured Using a Hand Dynamometer
Time frame: During the single study visit (baseline assessment)
Isometric Quadriceps Muscle Strength Measured Using a Hand-Held Dynamometer
Time frame: During the single study visit (baseline assessment)
Concern About Falling Assessed Using the Falls Efficacy Scale-International
Time frame: During the single study visit (baseline assessment)
Sleep Quality Assessed Using the Pittsburgh Sleep Quality Index
Time frame: During the single study visit, reflecting sleep during the previous month.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the informed consent and ethics approval do not include external sharing or secondary use of individual-level health data. Only aggregated study results will be disseminated.
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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.
Eylem Tutun Yumin, Professor study chair
Abant Izzet Baysal University
Meral Sertel, Professor study director
Uludag University
Fahrettin Samil Uysal, Assistant Professor study director
Karabuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence (UI) and Urinary Incontinence, run by MERT UYSAL 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 7 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 10 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mert Uysal, Lecturer (0 (370) 418 8704, mertuysal@karabuk.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty Level Assessed Using the FRAIL Scale (time frame: During the single study visit (cross-sectional baseline assessment)). 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 10 Sep 2026.