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Development and Application of an Intelligent Management and Assessment System for Urinary and Fecal Incontinence in the Elderly - A Prospective Randomized Controlled Study Investigating the Safety and Efficacy of Digital Therapy in Patients with Lower Urinary Tract Symptoms/Fecal Incontinence

Development and Application of an Intelligent Management and Assessment System for Urinary and Fecal Incontinence in the Elderly - A Prospective Randomized Controlled Study Investigating the Safety and Efficacy of Digital Therapy in Patients with Lower Urinary Tract Symptoms/Fecal Incontinence

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112506
Enrollment
Unknown
Registered
2025-11-14
Start date
2025-11-20
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diseases of the urogenital system

Interventions

Control group:The subjects in the control group received conventional behavioral therapy (including behavioral therapy, drug therapy and regular follow-up), and were also required to use the Xiaoyu Bl
Experimental group:In addition to continuing to receive conventional treatment and care, the subjects in the experimental group will also receive personalized intervention measures - digital full-proc

Sponsors

Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
19 Years to 89 Years

Inclusion criteria

Inclusion criteria: 1. Lower urinary tract symptoms occur( Frequent urination: urinary frequency >= 8 times/day, the average urine output per visit is less than 200ml;Increased nocturia: nocturia >=2 times/day; urinary incontinence; fecal incontinence); 2. The patient is over 18 years old; 3. The patient is proficient in using smartphones and is willing to accept digital bladder management/electronic urination diary; 4. After enrollment, agree to follow doctor's orders for follow-up visits/medication during the trial period; 5. Voluntarily participate in this clinical study and be able to sign the informed consent form

Exclusion criteria

Exclusion criteria: 1. Patients with poor compliance and missing follow-up data; 2. There are other specialized diseases that need to be treated in the pelvic cavity and related areas, such as bladder cancer, prostate cancer, cervical cancer, and other tumors of the urogenital system, tumors/injuries of the nervous system, uncontrolled urinary tract infections, etc; 3. Pregnant and lactating women, as well as women of childbearing age who plan to conceive during the study period; 4. Those with mental or cognitive impairments who are unable to complete this study; 5. There are contraindications related to the administration of the trial drug; 6. Other health conditions that the researchers consider unsuitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
Change in lower urinary tract symptom score;

Secondary

MeasureTime frame
Frequency of urination;Nocturia frequency;scores of ICIQ-MLUTS, ICIQ-FLUTS;Bristol stool classification;scores of ICIQ-LUTSQoL;

Countries

China

Contacts

Public ContactHuang Hao

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

1019056315@qq.com+86 150 1322 8615

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026