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

Launched by XING LIU · Jun 28, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring new treatment options for children with a condition called dry overactive bladder (OAB), which causes frequent urges to urinate without actually passing much urine. The study aims to compare two different approaches: one group of children will receive standard behavioral therapy along with a traditional medication called Solinaxine, while another group will receive the same behavioral therapy paired with high doses of vitamin D for a short period. Researchers hope to find out if the combination of vitamin D and therapy can effectively improve bladder symptoms in these children.

To be eligible for the trial, children must be older than 5 years and have been diagnosed with dry OAB, as well as have low levels of vitamin D in their blood. However, children with certain medical conditions, such as severe heart disease, neurological disorders, or specific urinary system problems, cannot participate. If enrolled, participants can expect regular follow-ups to monitor their symptoms and overall health during the study. This trial aims to provide valuable insights into potential new treatments for managing dry OAB in children, which could help improve their quality of life.

Gender

ALL

Eligibility criteria

• 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 with dry OAB.
• • 2. The results of our laboratory indicated that the serum vitamin D level was lower than 35ng/mL.
• • 3. The child (guardian) has been informed of the nature of the study, understands the provisions in the protocol, is able to guarantee compliance, and signs the informed consent.
• Exclusion Criteria:
• • 1. Patients with other urinary system malformations or serious diseases (such as hypospadias, cryptorchidism, posterior urethral valvular disease, vesicoureteral reflux, neurogenic bladder, urinary system tumors, urinary calculi, bladder and urethral injuries, etc.);
• • 2. complicated with neurological diseases (such as epilepsy, spinal cord injury, spinal cord dysplasia, tethered cord syndrome, multiple sclerosis, autism spectrum disorder, etc.);
• • 3. Patients with severe heart disease, abnormal liver and kidney function, lung disease, bone malformation, severe digestive tract disease, and genetic metabolic disease;
• • 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-up of another clinical study;
• • 11. Those who did not want to participate in the study or had poor follow-up compliance