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New treatment option for Urinary Bladder, Overactive
Official title Vitamin D Treat-to-Target Strategy for Children With Overactive Bladder-Wet
ClinicalTrials.gov ID: NCT06201013
What this study is testing
What is Solifenacin Succinate?
Solifenacin Succinate is an investigational medicine, given as an once-daily, being studied as a potential treatment for urinary bladder, overactive.
Also referred to as andard Urotherapy Combined with Solifenacin Drug Treatment.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 18
You may be able to join 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...
- 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 likely can't join if
- Those with urinary malformations or serious diseases (e.g., hypospadias, cryptorchidism, posterior urethral valvulae, vesicoureteral reflux...
- Those with neurological disorders (e.g., epilepsy, spinal cord injuries, spinal dysplasia, spinal embolism syndrome, multiple sclerosis, and autism...
- People with serious heart disease, abnormal liver and kidney function, lung disease, bone deformity, serious digestive tract disease, genetic...
- 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
See the full eligibility criteria
- 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...
- 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Chongqing, Chongqing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chongqing, Chongqing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.