Toileting-Related FallsNCT07738354
Integrated Prevention, Treatment, and Rehabilitation for Toileting-Related Falls
A study testing Individualized Multidimensional Management Program for Toileting-Related Fall Prevention in people with Toileting-Related Falls and Fall Risk, run by Qing Yuan at 1 site in China.
Trial summary
Toileting-related falls may result from a combination of urinary symptoms, impaired gait and balance, reduced muscle strength, cognitive or emotional problems, and unsafe environmental conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Toileting-Related Falls, Fall Risk
- What is being tested?
- Individualized Multidimensional Management Program for Toileting-Related Fall Prevention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Aug 2026to Dec 2028
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older, with no upper age limit.
- Presence of physical disability, functional limitation, loss of independence, or a need for assistance with daily activities.
- Presence of at least one risk factor for toileting-related falls, including but not limited to urinary frequency, urinary urgency, nocturia, urinary incontinence, voiding difficulty, overactive bladder, underactive bladder, impaired gait or balance, reduced muscle strength, fear of falling, cognitive or emotional problems, a history of falls, unsafe nighttime toileting, or environmental hazards associated with toileting.
- Able and willing to participate in the study assessments and follow-up procedures, with assistance from a caregiver when necessary.
- Written informed consent provided by the participant or, when applicable, by a legally authorized representative.
Who cannot join
- Acute infection or other acute medical condition requiring immediate treatment that would prevent participation in study assessments or interventions.
- Severe or unstable medical condition that, in the investigator's judgment, would make participation unsafe or interfere with study procedures or follow-up.
- Severe disturbance of consciousness or other condition that prevents completion of the required assessments and study procedures, even with appropriate assistance.
- Inability to participate in the planned follow-up or provide sufficient study-related information.
- Any other condition that, in the investigator's judgment, makes the individual unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100039
Qing Yuan, MD, PhD, +8618910980422
About this study
Official title: Construction, Validation, and Demonstration of a Comprehensive Prevention, Treatment, and Rehabilitation System for Toileting-Related Falls in Older Adults and People With Disabilities
Toileting-related falls may result from a combination of urinary symptoms, impaired gait and balance, reduced muscle strength, cognitive or emotional problems, and unsafe environmental conditions. Older adults and people with disabilities may be especially vulnerable because they frequently require assistance or must move quickly, particularly during nighttime toileting.
This multicenter prospective study will evaluate a comprehensive prevention, treatment, and rehabilitation program for older adults and people with disabilities who are at risk of toileting-related falls. Participants will receive a standardized multidimensional assessment covering urinary function, gait and balance, physical function, psychological and cognitive factors, activities of daily living, previous falls, and environmental risks.
Read more
Based on the risks identified, each participant will receive an individualized combination of interventions. These may include urinary symptom management, gait and balance rehabilitation, strength and mobility training, psychological or cognitive support, caregiver education, and modification of the toileting environment. Participants will be followed and reassessed, and their management plans may be adjusted according to changes in risk and clinical condition.
The study will evaluate the feasibility, implementation, and safety of this integrated care program, as well as changes in toileting-related falls, nighttime falls, urinary symptoms, mobility and balance, activities of daily living, and fear of falling.
Read the detailed description
Toileting-related falls are clinically important events that may occur through the interaction of urinary urgency, nocturia, urinary incontinence, impaired mobility, gait and balance dysfunction, reduced muscle strength, cognitive or psychological problems, inadequate caregiver support, and environmental hazards. Conventional fall-prevention programs often focus mainly on mobility or environmental risks, whereas urinary symptoms and toileting-related exposure may not be addressed within the same care pathway.
This study is a multicenter, prospective, single-group interventional study designed to construct, validate, and demonstrate a comprehensive prevention, treatment, and rehabilitation system for toileting-related falls in older adults and people with disabilities. The study integrates urological care, rehabilitation, nursing, psychological support, caregiver involvement, environmental risk management, and longitudinal follow-up within a standardized dynamic management pathway.
The study pathway consists of the following stages:
- Participant screening and enrollment;
- Standardized multidimensional baseline assessment;
- Identification and stratification of modifiable risk factors;
- Development and delivery of an individualized multicomponent intervention plan;
- Follow-up and repeat assessment;
- Adjustment of the intervention plan based on clinical response, adherence, safety, and changes in risk;
- Feedback and continuous improvement of the implementation process.
The multidimensional assessment will cover the following major domains:
Urinary function: urinary frequency, urgency, nocturia, urinary incontinence, voiding difficulty, bladder-related symptoms, voiding diaries, and other clinically indicated urinary function measurements.
Gait, balance, and physical function: muscle strength, muscle tone, joint mobility, transfer ability, sit-to-stand performance, gait, balance, use of mobility aids, and fall risk.
Psychological and cognitive factors: fear of falling, anxiety, depressive symptoms, fall-related psychological responses, cognition, treatment cooperation, and caregiver support.
Activities of daily living and environmental risks: independence in toileting and other daily activities, nighttime lighting, the route from the bed to the toilet, slippery surfaces, handrails, toilet height, thresholds, availability of assistive devices, and caregiver response.
Interventions will be individualized according to the participant's predominant and modifiable risk factors. The intervention package may include behavioral and clinical management of urinary symptoms, bladder training, medication optimization when clinically appropriate, neuromodulation or electrical stimulation when indicated, gait and balance rehabilitation, muscle-strengthening and mobility training, transfer training, assistive-device adaptation, psychological or cognitive support, caregiver education, scheduled or assisted toileting, and modification of environmental hazards.
Not every participant will receive every intervention. The specific intervention combination will be selected according to the standardized assessment, clinical indications, participant needs, safety considerations, and available resources at each participating center.
Participants will undergo longitudinal follow-up to document intervention delivery, adherence, adverse events, repeat assessments, falls, toileting-related falls, nighttime falls, urinary symptoms, physical function, activities of daily living, and fear of falling. Intervention plans may be modified during follow-up when clinically indicated.
The study will assess both implementation outcomes and clinical outcomes. Implementation evaluation will include participant reach, institutional adoption, completion of standardized assessments, delivery of individualized interventions, protocol adherence, staff training, data completeness, follow-up completion, safety, and sustainability of the care pathway. Clinical evaluation will examine changes in toileting-related falls and related risk factors, including urinary symptoms, nocturia, gait and balance, functional independence, and fear of falling.
The overall aim is to determine whether this integrated and dynamically adjusted care pathway can be implemented safely and consistently across different clinical and rehabilitation settings and provide a reproducible model for the prevention and management of toileting-related falls.
- Conditions
- Toileting-Related Falls, Fall Risk
- Being tested
- Individualized Multidimensional Management Program for Toileting-Related Fall Prevention
- Keywords
- Toileting-Related Falls, Fall Prevention, Older Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Multidimensional Management Program for Toileting-Related Fall PreventionOther
Participants will receive an individualized, multicomponent management program based on standardized multidimensional assessment and risk stratification. The assessment covers urinary function, gait and balance, physical function, psychological and cognitive factors, activities of daily living, caregiver support, and environmental risks related to toileting.
The intervention plan will be tailored to each participant's identified modifiable risk factors and clinical indications. Components may include management of urinary symptoms and nocturia, bladder and behavioral training, clinically indicated treatment optimization, neuromodulation or electrical stimulation when appropriate, gait and balance rehabilitation, muscle-strengthening and mobility training, assistive-device adaptation, psychological or cognitive support, caregiver education, scheduled or assisted toileting, and environmental modification.
Not all participants will receive every component. Intervention plans may be adju
| Study group | Role | What they receive |
|---|---|---|
| Integrated Multidimensional Management Program | Experimental | Participants will receive a comprehensive, individualized, multidimensional management program for the prevention of toileting-related falls. Following standardized assessment of urinary function, gait and balance, physical function, psychological and cognitive factors, activities of daily living, and environmental risks, participants will receive a tailored combination of interventions according to their identified risk factors and clinical indications. Interventions may include urinary symptom management, bladder training, medication optimization, neuromodulation or electrical stimulation when indicated, gait and balance rehabilitation, strength and mobility training, psychological or cognitive support, caregiver education, assisted or scheduled toileting, and environmental modification. Intervention plans may be adjusted during follow-up based on reassessment, clinical response, adherence, and safety. Receives: Other: Individualized Multidimensional Management Program for Toileting-Related Fall Prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Experiencing at Least One Toileting-Related Fall During Follow-up
The proportion of participants who experience at least one toileting-related fall during the follow-up period. A toileting-related fall is defined as a fall occurring in association with going to the toilet, using the toilet, transferring on or off the toilet, or returning from the toilet. The proportion will be calculated as the number of participants with at least one toileting-related fall divided by the total number of participants included in the follow-up analysis.
Measured: 6 months
Secondary outcomes (7)
Number of Nighttime Toileting-Related Falls During the 6-Month Follow-up
The total number of nighttime toileting-related falls experienced by each participant during the 6-month follow-up period. A nighttime toileting-related fall is defined as a fall occurring during nighttime in association with going to the toilet, using the toilet, transferring on or off the toilet, or returning from the toilet.
Measured: 6 months
Total Number of Falls During the 6-Month Follow-up
The total number of falls experienced by each participant during the 6-month follow-up period, regardless of whether the fall is related to toileting.
Measured: 6 months
Change in Overactive Bladder Symptom Score From Baseline to 6 Months
Change in the Overactive Bladder Symptom Score (OABSS) from baseline to 6 months. The OABSS evaluates daytime urinary frequency, nocturia, urinary urgency, and urgency urinary incontinence. Total scores range from 0 to 15, with higher scores indicating more severe overactive bladder symptoms.
Measured: Baseline and 6 months
Change in Average Number of Nocturia Episodes per Night From Baseline to 6 Months
Change in the average number of nocturnal voiding episodes per night from baseline to 6 months, assessed using participant-reported voiding records or voiding diaries. Nocturia is defined as waking from sleep to void during the nighttime period.
Measured: Baseline and 6 months
Change in Tinetti Performance-Oriented Mobility Assessment Score From Baseline to 6 Months
Change in the total Tinetti Performance-Oriented Mobility Assessment score from baseline to 6 months. The assessment evaluates balance and gait performance. Higher scores indicate better mobility and a lower risk of falls.
Measured: Baseline and 6 months
Change in Modified Barthel Index From Baseline to 6 Months
Change in the Modified Barthel Index from baseline to 6 months. The index assesses independence in activities of daily living, including personal care, toileting, mobility, transfers, and other daily activities. Higher scores indicate greater functional independence.
Measured: Baseline and 6 months
Completion Rate of the Multidimensional Baseline Assessment
The proportion of enrolled participants who complete all protocol-required and applicable baseline assessment domains, including urinary function, gait and balance, physical function, psychological and cognitive factors, activities of daily living, fall history, and toileting-related environmental risks.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Toileting-Related FallsStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qing Yuan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qing Yuan, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738354
- Sponsor's protocol ID
- PLAGH-TOILETFALL-2023-750
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eckstrom E, Parker EM, Lambert GH, Winkler G, Dowler D, Casey CM. Implementing STEADI in Academic Primary Care to Address Older Adult Fall Risk. Innov Aging. 2017 Sep;1(2):igx028. doi: 10.1093/geroni/igx028.
PubMed 29955671Szabo SM, Gooch KL, Walker DR, Johnston KM, Wagg AS. The Association Between Overactive Bladder and Falls and Fractures: A Systematic Review. Adv Ther. 2018 Nov;35(11):1831-1841. doi: 10.1007/s12325-018-0796-8. Epub 2018 Sep 25.
PubMed 30255417Vaughan CP, Brown CJ, Goode PS, Burgio KL, Allman RM, Johnson TM 2nd. The association of nocturia with incident falls in an elderly community-dwelling cohort. Int J Clin Pract. 2010 Apr;64(5):577-83. doi: 10.1111/j.1742-1241.2009.02326.x.
PubMed 20456212Zou M, Lu R, Jiang Y, Liu P, Tian B, Liang Y, Wang X, Jiang L. Association between toileting and falls in older adults admitted to the emergency department and hospitalised: a cross-sectional study. BMJ Open. 2023 Jun 1;13(6):e065544. doi: 10.1136/bmjopen-2022-065544.
PubMed 37263694Rose G, Decalf V, Everaert K, Bower WF. Toileting-related falls at night in hospitalised patients: The role of nocturia. Australas J Ageing. 2020 Mar;39(1):e70-e76. doi: 10.1111/ajag.12696. Epub 2019 Jul 18.
PubMed 31321899Montero-Odasso M, van der Velde N, Martin FC, Petrovic M, Tan MP, Ryg J, Aguilar-Navarro S, Alexander NB, Becker C, Blain H, Bourke R, Cameron ID, Camicioli R, Clemson L, Close J, Delbaere K, Duan L, Duque G, Dyer SM, Freiberger E, Ganz DA, Gomez F, Hausdorff JM, Hogan DB, Hunter SMW, Jauregui JR, Kamkar N, Kenny RA, Lamb SE, Latham NK, Lipsitz LA, Liu-Ambrose T, Logan P, Lord SR, Mallet L, Marsh D, Milisen K, Moctezuma-Gallegos R, Morris ME, Nieuwboer A, Perracini MR, Pieruccini-Faria F, Pighills A, Said C, Sejdic E, Sherrington C, Skelton DA, Dsouza S, Speechley M, Stark S, Todd C, Troen BR, van der Cammen T, Verghese J, Vlaeyen E, Watt JA, Masud T; Task Force on Global Guidelines for Falls in Older Adults. World guidelines for falls prevention and management for older adults: a global initiative. Age Ageing. 2022 Sep 2;51(9):afac205. doi: 10.1093/ageing/afac205.
PubMed 36178003
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction, Validation, and Demonstration of a Comprehensive Prevention, Treatment, and Rehabilitation System for Toileting-Related Falls in Older Adults and People With Disabilities
- ClinicalTrials.gov ID
- NCT07738354
- Acronym / sponsor ID
- PLAGH-TOILETFALL-2023-750
- Conditions
- Toileting-Related Falls, Fall Risk
- Keywords
- Toileting-Related Falls, Fall Prevention, Older Adults
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Qing YuanUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 31 Jul 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.
Toileting-related falls may result from a combination of urinary symptoms, impaired gait and balance, reduced muscle strength, cognitive or emotional problems, and unsafe environmental conditions. Older adults and people with disabilities may be especially vulnerable because they frequently require assistance or must move quickly, particularly during nighttime toileting.
This multicenter prospective study will evaluate a comprehensive prevention, treatment, and rehabilitation program for older adults and people with disabilities who are at risk of toileting-related falls. Participants will receive a standardized multidimensional assessment covering urinary function, gait and balance, physical function, psychological and cognitive factors, activities of daily living, previous falls, and environmental risks.
Based on the risks identified, each participant will receive an individualized combination of interventions. These may include urinary symptom management, gait and balance rehabilitation, strength and mobility training, psychological or cognitive support, caregiver education, and modification of the toileting environment. Participants will be followed and reassessed, and their management plans may be adjusted according to changes in risk and clinical condition.
The study will evaluate the feasibility, implementation, and safety of this integrated care program, as well as changes in toileting-related falls, nighttime falls, urinary symptoms, mobility and balance, activities of daily living, and fear of falling.
Detailed description
Toileting-related falls are clinically important events that may occur through the interaction of urinary urgency, nocturia, urinary incontinence, impaired mobility, gait and balance dysfunction, reduced muscle strength, cognitive or psychological problems, inadequate caregiver support, and environmental hazards. Conventional fall-prevention programs often focus mainly on mobility or environmental risks, whereas urinary symptoms and toileting-related exposure may not be addressed within the same care pathway.
This study is a multicenter, prospective, single-group interventional study designed to construct, validate, and demonstrate a comprehensive prevention, treatment, and rehabilitation system for toileting-related falls in older adults and people with disabilities. The study integrates urological care, rehabilitation, nursing, psychological support, caregiver involvement, environmental risk management, and longitudinal follow-up within a standardized dynamic management pathway.
The study pathway consists of the following stages:
- Participant screening and enrollment;
- Standardized multidimensional baseline assessment;
- Identification and stratification of modifiable risk factors;
- Development and delivery of an individualized multicomponent intervention plan;
- Follow-up and repeat assessment;
- Adjustment of the intervention plan based on clinical response, adherence, safety, and changes in risk;
- Feedback and continuous improvement of the implementation process.
The multidimensional assessment will cover the following major domains:
Urinary function: urinary frequency, urgency, nocturia, urinary incontinence, voiding difficulty, bladder-related symptoms, voiding diaries, and other clinically indicated urinary function measurements.
Gait, balance, and physical function: muscle strength, muscle tone, joint mobility, transfer ability, sit-to-stand performance, gait, balance, use of mobility aids, and fall risk.
Psychological and cognitive factors: fear of falling, anxiety, depressive symptoms, fall-related psychological responses, cognition, treatment cooperation, and caregiver support.
Activities of daily living and environmental risks: independence in toileting and other daily activities, nighttime lighting, the route from the bed to the toilet, slippery surfaces, handrails, toilet height, thresholds, availability of assistive devices, and caregiver response.
Interventions will be individualized according to the participant's predominant and modifiable risk factors. The intervention package may include behavioral and clinical management of urinary symptoms, bladder training, medication optimization when clinically appropriate, neuromodulation or electrical stimulation when indicated, gait and balance rehabilitation, muscle-strengthening and mobility training, transfer training, assistive-device adaptation, psychological or cognitive support, caregiver education, scheduled or assisted toileting, and modification of environmental hazards.
Not every participant will receive every intervention. The specific intervention combination will be selected according to the standardized assessment, clinical indications, participant needs, safety considerations, and available resources at each participating center.
Participants will undergo longitudinal follow-up to document intervention delivery, adherence, adverse events, repeat assessments, falls, toileting-related falls, nighttime falls, urinary symptoms, physical function, activities of daily living, and fear of falling. Intervention plans may be modified during follow-up when clinically indicated.
The study will assess both implementation outcomes and clinical outcomes. Implementation evaluation will include participant reach, institutional adoption, completion of standardized assessments, delivery of individualized interventions, protocol adherence, staff training, data completeness, follow-up completion, safety, and sustainability of the care pathway. Clinical evaluation will examine changes in toileting-related falls and related risk factors, including urinary symptoms, nocturia, gait and balance, functional independence, and fear of falling.
The overall aim is to determine whether this integrated and dynamically adjusted care pathway can be implemented safely and consistently across different clinical and rehabilitation settings and provide a reproducible model for the prevention and management of toileting-related falls.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Integrated Multidimensional Management Program | Experimental | Other: Individualized Multidimensional Management Program for Toileting-Related Fall PreventionParticipants will receive a comprehensive, individualized, multidimensional management program for the prevention of toileting-related falls. Following standardized assessment of urinary function, gait and balance, physical function, psychological and cognitive factors, activities of daily living, and environmental risks, participants will receive a tailored combination of interventions according to their identified risk factors and clinical indications. Interventions may include urinary symptom management, bladder training, medication optimization, neuromodulation or electrical stimulation when indicated, gait and balance rehabilitation, strength and mobility training, psychological or cognitive support, caregiver education, assisted or scheduled toileting, and environmental modification. Intervention plans may be adjusted during follow-up based on reassessment, clinical response, adherence, and safety. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older, with no upper age limit.
- Presence of physical disability, functional limitation, loss of independence, or a need for assistance with daily activities.
- Presence of at least one risk factor for toileting-related falls, including but not limited to urinary frequency, urinary urgency, nocturia, urinary incontinence, voiding difficulty, overactive bladder, underactive bladder, impaired gait or balance, reduced muscle strength, fear of falling, cognitive or emotional problems, a history of falls, unsafe nighttime toileting, or environmental hazards associated with toileting.
- Able and willing to participate in the study assessments and follow-up procedures, with assistance from a caregiver when necessary.
- Written informed consent provided by the participant or, when applicable, by a legally authorized representative.
Key exclusion criteria (5 listed)
- Acute infection or other acute medical condition requiring immediate treatment that would prevent participation in study assessments or interventions.
- Severe or unstable medical condition that, in the investigator's judgment, would make participation unsafe or interfere with study procedures or follow-up.
- Severe disturbance of consciousness or other condition that prevents completion of the required assessments and study procedures, even with appropriate assistance.
- Inability to participate in the planned follow-up or provide sufficient study-related information.
- Any other condition that, in the investigator's judgment, makes the individual unsuitable for participation in the study.
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 |
|---|---|---|
| Individualized Multidimensional Management Program for Toileting-Related Fall PreventionParticipants will receive an individualized, multicomponent management program based on standardized multidimensional assessment and risk stratification. The assessment covers urinary function, gait and balance, physical function, psychological and cognitive factors, activities of daily living, caregiver support, and environmental risks related to toileting. The intervention plan will be tailored to each participant's identified modifiable risk factors and clinical indications. Components may include management of urinary symptoms and nocturia, bladder and behavioral training, clinically indicated treatment optimization, neuromodulation or electrical stimulation when appropriate, gait and balance rehabilitation, muscle-strengthening and mobility training, assistive-device adaptation, psychological or cognitive support, caregiver education, scheduled or assisted toileting, and environmental modification. Not all participants will receive every component. Intervention plans may be adju | Other | Integrated Multidimensional Management Program |
Primary outcome
Proportion of Participants Experiencing at Least One Toileting-Related Fall During Follow-up
Time frame: 6 months
The proportion of participants who experience at least one toileting-related fall during the follow-up period. A toileting-related fall is defined as a fall occurring in association with going to the toilet, using the toilet, transferring on or off the toilet, or returning from the toilet. The proportion will be calculated as the number of participants with at least one toileting-related fall divided by the total number of participants included in the follow-up analysis.
7 secondary outcomes
Number of Nighttime Toileting-Related Falls During the 6-Month Follow-up
Time frame: 6 months
Total Number of Falls During the 6-Month Follow-up
Time frame: 6 months
Change in Overactive Bladder Symptom Score From Baseline to 6 Months
Time frame: Baseline and 6 months
Change in Average Number of Nocturia Episodes per Night From Baseline to 6 Months
Time frame: Baseline and 6 months
Change in Tinetti Performance-Oriented Mobility Assessment Score From Baseline to 6 Months
Time frame: Baseline and 6 months
Change in Modified Barthel Index From Baseline to 6 Months
Time frame: Baseline and 6 months
Completion Rate of the Multidimensional Baseline Assessment
Time frame: At baseline
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 31 Jul 2026.
- Results publication: PubMed 29955671Eckstrom E, Parker EM, Lambert GH, Winkler G, Dowler D, Casey CM. Implementing STEADI in Academic Primary Care to Address Older Adult Fall Risk. Innov Aging. 2017 Sep;1(2):igx028. doi: 10.1093/geroni/igx028.
- Results publication: PubMed 30255417Szabo SM, Gooch KL, Walker DR, Johnston KM, Wagg AS. The Association Between Overactive Bladder and Falls and Fractures: A Systematic Review. Adv Ther. 2018 Nov;35(11):1831-1841. doi: 10.1007/s12325-018-0796-8. Epub 2018 Sep 25.
- Results publication: PubMed 20456212Vaughan CP, Brown CJ, Goode PS, Burgio KL, Allman RM, Johnson TM 2nd. The association of nocturia with incident falls in an elderly community-dwelling cohort. Int J Clin Pract. 2010 Apr;64(5):577-83. doi: 10.1111/j.1742-1241.2009.02326.x.
- Results publication: PubMed 37263694Zou M, Lu R, Jiang Y, Liu P, Tian B, Liang Y, Wang X, Jiang L. Association between toileting and falls in older adults admitted to the emergency department and hospitalised: a cross-sectional study. BMJ Open. 2023 Jun 1;13(6):e065544. doi: 10.1136/bmjopen-2022-065544.
- Results publication: PubMed 31321899Rose G, Decalf V, Everaert K, Bower WF. Toileting-related falls at night in hospitalised patients: The role of nocturia. Australas J Ageing. 2020 Mar;39(1):e70-e76. doi: 10.1111/ajag.12696. Epub 2019 Jul 18.
- Results publication: PubMed 36178003Montero-Odasso M, van der Velde N, Martin FC, Petrovic M, Tan MP, Ryg J, Aguilar-Navarro S, Alexander NB, Becker C, Blain H, Bourke R, Cameron ID, Camicioli R, Clemson L, Close J, Delbaere K, Duan L, Duque G, Dyer SM, Freiberger E, Ganz DA, Gomez F, Hausdorff JM, Hogan DB, Hunter SMW, Jauregui JR, Kamkar N, Kenny RA, Lamb SE, Latham NK, Lipsitz LA, Liu-Ambrose T, Logan P, Lord SR, Mallet L, Marsh D, Milisen K, Moctezuma-Gallegos R, Morris ME, Nieuwboer A, Perracini MR, Pieruccini-Faria F, Pighills A, Said C, Sejdic E, Sherrington C, Skelton DA, Dsouza S, Speechley M, Stark S, Todd C, Troen BR, van der Cammen T, Verghese J, Vlaeyen E, Watt JA, Masud T; Task Force on Global Guidelines for Falls in Older Adults. World guidelines for falls prevention and management for older adults: a global initiative. Age Ageing. 2022 Sep 2;51(9):afac205. doi: 10.1093/ageing/afac205.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Multidimensional Management Program for Toileting-Related Fall Prevention in people with Toileting-Related Falls and Fall Risk, run by Qing Yuan at 1 site in China.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 31 Jul 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 China. 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 Qing Yuan, MD, PhD (+8618910980422, qyuanmd@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Experiencing at Least One Toileting-Related Fall During Follow-up (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07738354, which also lists 6 linked publications.
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 31 Jul 2026.