Efficacy and Safety of VDS+SU in the Treatment of OAB-dry in Children

Last updated: April 9, 2025
Sponsor: Xing Liu
Overall Status: Active - Recruiting

Phase

N/A

Condition

Overactive Bladder

Enuresis

Treatment

vitamin D

Solifenacin

Standard behavioral therapy

Clinical Study ID

NCT06489951
202453
  • Ages 5-18
  • All Genders

Study Summary

The aim of this study is to give children with dry OAB: (1) Standard behavioral therapy combined with classical anticholinergic drugs (Solinaxine), or (2) standard behavioral therapy combined with short-term high-dose exogenous vitamin D supplementation are used to compare the outcomes of lower urinary tract symptoms in children with dry OAB during follow-up. To provide more robust supporting evidence for the broader promotion of short-term high-dose exogenous vitamin D supplements in combination with standard behavioral therapy as an effective treatment for dry OAB treatment in children.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Children older than 5 years who were admitted to the Department of Urology,Children's Hospital Affiliated to Chongqing Medical University and diagnosed withdry OAB.

  2. The results of our laboratory indicated that the serum vitamin D level was lowerthan 35ng/mL.

  3. The child (guardian) has been informed of the nature of the study, understands theprovisions in the protocol, is able to guarantee compliance, and signs the informedconsent.

Exclusion

Exclusion Criteria:

  1. Patients with other urinary system malformations or serious diseases (such ashypospadias, cryptorchidism, posterior urethral valvular disease, vesicoureteralreflux, neurogenic bladder, urinary system tumors, urinary calculi, bladder andurethral injuries, etc.);

  2. complicated with neurological diseases (such as epilepsy, spinal cord injury, spinalcord dysplasia, tethered cord syndrome, multiple sclerosis, autism spectrumdisorder, etc.);

  3. Patients with severe heart disease, abnormal liver and kidney function, lungdisease, bone malformation, severe digestive tract disease, and genetic metabolicdisease;

  4. History of gastrointestinal surgery and urinary system surgery;

  5. Dry stool, long-term constipation;

  6. are taking anticonvulsant and antiepileptic drugs, hormones, antituberculosis drugs;

  7. Previous history of hypercalcemia, hyperphosphatemia with renal rickets;

  8. History of unexplained hematuria and urinary tract infection in the past 1 year;

  9. Have a history of allergy or allergic reaction to vitamin D preparations;

  10. Participating in another clinical study at the time of visit or during the follow-upof another clinical study;

  11. Those who did not want to participate in the study or had poor follow-up compliance

Study Design

Total Participants: 180
Treatment Group(s): 3
Primary Treatment: vitamin D
Phase:
Study Start date:
December 26, 2024
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Children's Hospital of Chongqing Medical University

    Chongqing, Chongqing 400000
    China

    Active - Recruiting

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