Integrated Prevention, Treatment, and Rehabilitation for Toileting-Related Falls

NCT07738354 | Not Yet Recruiting DMC

• 1 other identifier: PLAGH-TOILETFALL-2023-750
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Toileting-Related Falls; Fall Risk

Keywords

Toileting-Related Falls; Fall Prevention; Older Adults

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (7)

• Number of Nighttime Toileting-Related Falls During the 6-Month Follow-up

  6 months

• Total Number of Falls During the 6-Month Follow-up

  6 months

• Change in Overactive Bladder Symptom Score From Baseline to 6 Months

  Baseline and 6 months

• Change in Average Number of Nocturia Episodes per Night From Baseline to 6 Months

  Baseline and 6 months

• Change in Tinetti Performance-Oriented Mobility Assessment Score From Baseline to 6 Months

  Baseline and 6 months

Other Outcomes (4)

• Enrollment Rate Among Eligible Screened Individuals

  At completion of recruitment, up to 12 months after recruitment initiation

• Proportion of Participants Receiving a Risk-Based Individualized Intervention

  Up to 6 months after enrollment

• Six-Month Follow-up Completion Rate

  At 6 months

Study Arms (1)

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.

Other: Individualized Multidimensional Management Program for Toileting-Related Fall Prevention

Interventions

Individualized Multidimensional Management Program for Toileting-Related Fall Prevention OTHER

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

Integrated Multidimensional Management Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qing Yuan: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100039, China

Location

Related Publications (6)

• 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.

  PMID: 29955671 RESULT

• Szabo 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.

  PMID: 30255417 RESULT

• Vaughan 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.

  PMID: 20456212 RESULT

• Zou 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.

  PMID: 37263694 RESULT

• Rose 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.

  PMID: 31321899 RESULT

• Montero-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.

  PMID: 36178003 RESULT

Central Study Contacts

Qing Yuan, MD, PhD

CONTACT

+8618910980422; qyuanmd@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chinese PLAGH

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 31, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)