Urinary Incontinence Clinical Trials

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Efficacy, Neural Repair Mechanism, and Health Economics of a Multimodal Treat-to-Target Strategy Incorporating Vitamin D for Pediatric Overactive Bladder-Wet: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this clinical trial is to investigate whether adding high-dose vitamin D (2,400 IU daily) to standard medical treatment (solifenacin combined with behavioral therapy) is more effective than standard treatment alone for children with overactive bladder-wet (OAB-wet). OAB-wet causes sudden urinary urges and frequent daytime or incontinence, which significantly impacts a child's quality of life and increases the family's caregiving burden. While solifenacin is a standard medication used to calm the bladder, many children do not achieve complete dryness. This study introduces the Treat-to-Target (T2T) approach, where clinicians and families set personalized functional goals (such as zero leakage) and monitor progress closely to adjust care. The study aims to answer the following questions: Does adding vitamin D help more children achieve their goal of zero leakage compared to standard treatment? Does vitamin D help repair bladder-related nerves, as measured by a specific marker in the urine? Does this combined approach reduce the family's expenses (like laundry costs and diaper use) and improve the child's self-esteem? Participants will be randomly assigned to one of two groups for 12 weeks: Intervention Group: Standard care (solifenacin + behavioral therapy) plus daily vitamin D (2,400 IU). Control Group: Standard care (solifenacin + behavioral therapy) alone. Researchers will evaluate symptoms, vitamin D levels, and nerve repair markers at 6 and 12 weeks to determine the best treatment strategy for these children.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 18
Healthy Volunteers: f
View:

• Children older than or equal to 5 years of age with a diagnosis of wet OAB (the diagnosis followed the latest guidelines of ICCS) attending the outpatient clinic of the Department of Urology of the Affiliated Children's Hospital of Chongqing Medical University,

• children with serum vitamin D levels below 35 ng/ml as indicated by the tests conducted by the hospital

• children whose guardians have given their informed consent, are able to ensure compliance and have signed a paper-based informed consent form.

Locations
Other Locations
China
Children's Hospital of Chongqing Medical University
RECRUITING
Chongqing
Contact Information
Primary
Xing Liu
CHS_1900@163.com
18725665020
Time Frame
Start Date: 2026-04-20
Estimated Completion Date: 2027-04-15
Participants
Target number of participants: 180
Treatments
Active_comparator: Standard-of-care
Standard Urotherapy plus Solinasine succinate 5mg once daily with a maximum dose of 10mg/day
Experimental: Multimodal strategy
A multimodal start consisting of solifenacin, standard behavioral therapy (SU), and 2,400 IU/day of vitamin D3
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital of Chongqing Medical University

This content was sourced from clinicaltrials.gov