Vitamin D Treat-to-Target Strategy for Children With Overactive Bladder-Wet

NCT06201013 | Recruiting DMC

• 1 other identifier: 2023922
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urinary Bladder, Overactive; Overactive Bladder; Urinary Incontinence, Urge

Keywords

Urinary Bladder, Overactive; Urinary Incontinence, Urge; Vitamin D

Outcome Measures

Primary Outcomes (1)

• Clinical Target Achievement Rate at 12 Weeks

  Percentage of participants who achieve their pre-defined personalized clinical goal set at Week 0.

  week 12

Secondary Outcomes (5)

• Change in Weekly Urinary Incontinence (UI) Frequency

  Baseline, 6 weeks, 12 weeks.

• Change in Pediatric Incontinence Questionnaire (PIN-Q) Score

  Baseline, 12 weeks.

• Change in Pediatric Lower Urinary Tract Symptom (PLUTS) Score

  Baseline, 6 weeks, 12 weeks.

• Health Economics: Total Household Burden Cost

  12 weeks

• Change in Urinary Myelin Basic Protein (uMBP)/Creatinine Ratio

  Baseline, 12 weeks.

Study Arms (2)

Standard-of-care

ACTIVE COMPARATOR

Standard Urotherapy plus Solinasine succinate 5mg once daily with a maximum dose of 10mg/day

Behavioral: urotherapy; Drug: Solifenacin Succinate

Multimodal strategy

EXPERIMENTAL

A multimodal start consisting of solifenacin, standard behavioral therapy (SU), and 2,400 IU/day of vitamin D3

Behavioral: urotherapy; Drug: Vitamin D3

Interventions

urotherapy BEHAVIORAL

Participants were asked to undergo a 30-min session every 6 weeks at follow-up, including (1) education about the disease to dispel doubts about it and to understand the benefits of curing the dysfunction in order for the child to have a better therapeutic outcome, (2) urination at regular intervals and the establishment of good urination habits, (3) dietary instructions to avoid constipation, (4) accurate recording of symptoms of OAB, and (5) communication with the research team every 2 weeks.

Multimodal strategy; Standard-of-care

Solifenacin Succinate DRUG

In addition to urotherapy, take Solifenacin succinate 5mg once daily, maximum dose 10 mg/day

Also known as: andard Urotherapy Combined with Solifenacin Drug Treatment

Standard-of-care

Vitamin D3 DRUG

In addition to urologic therapy, vitamin D drops containing 400 IU of vitamin D3 per capsule, 1,200 iu per oral dose, twice daily, for a total of 2,400 iu/d; serum vitamin D levels need to be rechecked at every 6-week follow-up visit

Also known as: Standard Urotherapy Combined with Vitamin D supplementation

Multimodal strategy

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Those with urinary malformations or serious diseases (e.g., hypospadias, cryptorchidism, posterior urethral valvulae, vesicoureteral reflux, neurogenic bladder, urinary tumors, urinary stones, bladder and urethral injuries, etc.)
• Those with neurological disorders (e.g., epilepsy, spinal cord injuries, spinal dysplasia, spinal embolism syndrome, multiple sclerosis, and autism spectrum disorders, etc.)
• People with serious heart disease, abnormal liver and kidney function, lung disease, bone deformity, serious digestive tract disease, genetic metabolic disease
• People with history of gastrointestinal surgery and urological surgery
• People with dry stools and long-term constipation
• People who are taking anticonvulsant and antiepileptic drugs, hormones, and anti-tuberculosis drugs
• People with history of hypercalcemia, hyperphosphatemia with renal rickets
• People who have had unexplained hematuria and hematuria with renal rickets within the last year
• People who have been suffering from severe heart disease or chronic diabetes.
• participation in other clinical studies at the time of consultation or during the follow-up period of other clinical studies
• unwillingness to participate in this study

Sponsors & Collaborators

• Children's Hospital of Chongqing Medical University: lead

Study Sites (1)

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge

Interventions

Solifenacin Succinate; Cholecalciferol

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Central Study Contacts

Xing Liu

CONTACT

18725665020; CHS_1900@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Doctor

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: January 11, 2024
• Study Start: April 20, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): April 15, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-03

Locations

CN (1)