Helping older adults with an overactive bladder protect their brain health by improving sleep

ISRCTN	ISRCTN98707807
DOI	https://doi.org/10.1186/ISRCTN98707807
Sponsor	Wuxi No.2 People's Hospital
Funder	National Natural Science Foundation of China

Submission date: 10/04/2026
Registration date: 13/04/2026
Last edited: 13/04/2026

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Ninghan Feng
Principal investigator

Wuxi No.2 People's Hospital, Jiangnan University Medical Center, No.68 Zhongshan Road, Liangxi District, Wuxi City, Jiangsu Province
Wuxi
214000
China

ORCID ID	0000-0002-0892-6102
Phone	+86 13861892528
Email	n.feng@njmu.edu.cn

Mrs Ye Hua
Scientific

Wuxi No.2 People's Hospital, Jiangnan University Medical Center, No.68 Zhongshan Road, Liangxi District, Wuxi City, Jiangsu Province
Wuxi
214000
China

Phone	+86 18762806797
Email	77819869@qq.com

Miss Siyi Fu
Public

Wuxi No.2 People's Hospital, Jiangnan University Medical Center, No.68 Zhongshan Road, Liangxi District, Wuxi City, Jiangsu Province
Wuxi
214000
China

Phone	+86 18967215772
Email	fusiyi0210@163.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Active
Assignment	Parallel
Purpose	Treatment
Scientific title	A comprehensive intervention study plan for cognitive vulnerability in elderly patients with overactive bladder based on sleep-lymphoid pathway
Study objectives
Ethics approval(s)	Approved 22/04/2024, Medical Ethics Committee of the Wuxi No.2 People’s Hospital, Jiangnan University Medical Center (No.68 Zhongshan Road, Liangxi District, Wuxi City, Jiangsu Province, Wuxi, 214000, China; +86 15152220089; 9862022074@jiangnan.edu.cn), ref: 2024 Y-26
Health condition(s) or problem(s) studied	Overactive bladder syndrome
Intervention	Participants will be randomized in a 1:1 ratio to either the control group (standard behavioral management) or the intervention group (standard behavioral management plus a comprehensive mechanism-targeted intervention) using a centralized, computer-generated block randomization scheme stratified by study center, sex, baseline Overactive Bladder Symptom Score (OABSS), and baseline Montreal Cognitive Assessment (MoCA). Control Group: Standard Behavioral Management 1. Bladder training. 2. Delayed voiding and urgency suppression techniques. 3. Fluid intake and caffeine management. 4. Nocturnal fluid management. 5. Voiding diary–based feedback. 6. Basic pelvic floor and lifestyle education. Intervention Group: Integrated Mechanism-Targeted Intervention 1. Structured Aerobic Exercise Module Five sessions per week, 30–40 minutes per session, at moderate intensity, for 24 weeks. Recommended activities include brisk walking, stationary cycling, or elliptical training. Exercise intensity is prescribed at 50%–70% of heart rate reserve (HRR) or a Borg Rating of Perceived Exertion (RPE) of 11–13. 2. Sleep Optimization Module Standardized management targeting nocturia-related sleep disruption, including fixed sleep–wake schedules, pre-sleep fluid restriction, stimulus control before bedtime, sleep hygiene education, and strategies for managing nocturnal awakenings. 3. Adherence Enhancement Module Adherence is reinforced through mobile app or paper-based check-ins, biweekly follow-up visits, and wearable device monitoring of step counts and exercise duration, with adherence supervision provided by research nurses.
Intervention type	Behavioural
Primary outcome measure(s)	Health-related quality of life associated with overactive bladder measured using Overactive Bladder Questionnaire Health-Related Quality of Life (OAB-q HRQoL) total score at Baseline and 24 weeks post-randomization
Key secondary outcome measure(s)	Overactive bladder symptoms, nocturia, and sleep quality measured using composite assessment including: Overactive Bladder Symptom Score (OABSS), Pittsburgh Sleep Quality Index (PSQI) total score, mean number of nocturnal voids per night (bladder diary) at baseline, 24 weeks, and 52 weeks Global cognitive function measured using composite z-score derived from a standardized neuropsychological test battery assessing memory, attention, and executive function at baseline, 24 weeks, and 52 weeks Glymphatic system function measured using diffusion MRI–derived biomarkers, including: Free water (FW) fraction and ALPS (Analysis along the Perivascular Space) index at baseline and 24 weeks Sustained effects of the intervention on clinical and cognitive outcomes measured using maintenance of improvements in OAB-q HRQoL, symptom measures, sleep quality, and cognitive composite scores at 52 weeks post-randomization Mediation effects of sleep and glymphatic function on cognitive outcomes measured using longitudinal mediation analysis evaluating indirect effects of changes in sleep quality (PSQI) and diffusion MRI–derived glymphatic biomarkers (FW and ALPS index) on cognitive composite scores at baseline to 24 weeks, with extension to 52 weeks Incidence of adverse events measured using number and proportion of participants experiencing adverse events, including falls and musculoskeletal injuries, classified by severity and relatedness at baseline to 52 weeks
Completion date	30/04/2026

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	60 Years
Upper age limit	90 Years
Sex	All
Target sample size at registration	130
Total final enrolment	110
Key inclusion criteria	1. Age ≥60 years old 2. Idiopathic OAB that meets ICS/ guidelines definitions 3. OAB symptoms persist for ≥3 months 4. OABSS ≥6 5. Nocturia ≥2 times per night 6. PSQI ≥6 7. For people with cognitive fragility but not dementia, MoCA 20 - 27 is recommended 8. Willing to complete the 24-week intervention and follow-up and sign informed consent
Key exclusion criteria	1. Lower urinary tract symptoms (LUTS) clearly caused by neurological disorders 2. Previous diagnosis of dementia or significant functional dependence 3. Significant bladder outlet obstruction or significant residual urine 4. Organic diseases such as acute urinary infections, bladder tumors, and bladder stones 5. Uncontrolled severe depression/anxiety 6. Confirmed moderate-to-severe obstructive sleep apnea that is untreated 7. Recent use of medications that may significantly affect cognition or sleep and cannot be stabilized 8. Contraindications to MRI or inability to complete the exercise intervention
Date of first enrolment	22/04/2024
Date of final enrolment	31/10/2025

Locations

Countries of recruitment

China

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request

Editorial Notes

10/04/2026: Trial's existence confirmed by Medical Ethics Committee of the Wuxi No.2 People’s Hospital, Jiangnan University Medical Center.