Overactive BladderNCT05709990
Efficacy and Safety of High Dose Vitamin D Supplementation for Overactive Bladder Dry in Children
A study testing Solifenacin Succinate 5 MG Oral Tablet [Vesicare], Vitamin D3 and Standard urotherapy in people with Overactive Bladder, run by Xing Liu at 1 site in China.
Trial summary
This prospective, randomized, 3-arms, parallel-design, controlled clinical trial is conducted to determine whether high dose vitamin D supplementation (combined with standard urotherapy ) improves outcomes, compared with solifenacin (combined with standard urotherapy ) ,and standard urotherapy alone in children with… Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Solifenacin Succinate 5 MG Oral Tablet [Vesicare], Vitamin D3 and Standard urotherapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2023to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children older than 5 years of age with a diagnosis of OAB dry (do not experience incontinence yet suffer from symptoms of urgency, frequency, and nocturia) seen at the outpatient urology clinics (diagnosis follows the latest International Children's Continence Society recommendations).
- Children with a serum vitamin D level of less than 35 ng/ml as indicated by the laboratory result.
- Written informed consent was obtained from participants and their parents. -
Who cannot join
- Those with a comorbidity of other urological abnormalities or serious diseases (e.g. hypospadias, cryptorchidism, posterior urethral valves, vesicoureteral reflux, neurogenic bladder, urological tumours, urinary stones, bladder and urethral injuries, etc.).
- Those with a comorbidity of neurological disorders (e.g. epilepsy, spinal cord injury, spinal cord dysplasia, spinal cord embolism syndrome, multiple sclerosis, autism spectrum disorder, etc.) .
- Those with acomorbidity of severe heart disease, abnormal liver or kidney function, lung disease, skeletal deformities, severe gastrointestinal disease, or inherited metabolic disorders.
- Those with a history of gastrointestinal surgery and urinary tract surgery.
- Those with chronic constipation.
- Those taking anticonvulsant and antiepileptic drugs, hormones, anti-tuberculosis drugs.
Show all 12Show fewer
- Those have a previous history of hypercalcemia, hyperphosphatemia with renal rickets.
- Those have a history of haematuria and urinary tract infection within the last 1 year.
- Those have a history of allergy or allergic disease to vitamin D preparations.
- Those Participate in other clinical studies at the time of consultation or during the follow-up of other clinical studies.
- Any condition that could cause urinary symptoms or interfere with assessment of efficacy parameters.
- Those unwilling to participate in this study. -
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000
About this study
Official title: Efficacy and Safety of High Dose Vitamin D Supplementation for Overactive Bladder Dry in Children: A Randomized Clinical Trial
This prospective, randomized, 3-arms, parallel-design, controlled clinical trial is conducted to determine whether high dose vitamin D supplementation (combined with standard urotherapy ) improves outcomes, compared with solifenacin (combined with standard urotherapy ) ,and standard urotherapy alone in children with OAB dry.
Read the detailed description
Overactive bladder(OAB), characterized as urinary urgency accompanied in many instances by frequency and sometimes nocturia, with or without urinary incontinence, in the absence of urinary tract infection or other documented pathology, is a common clinical entity in pediatric urology. The majority of patients with OAB do not experience incontinence yet suffer from symptoms of urgency, frequency, and nocturia, which has been termed OAB dry. Currently, standard urotherapy is proposed as the first-line therapeutic options and adjunctive anticholinergics are usually used when urotherapy alone failed. Behavioral therapy often fail to achieve satisfied symptom control as children's poor compliance. In addition,adverse side effects such as dry mouth, constipation, gastro-oesophageal reflux result in early pharmacologic treatment discontinuation.
It was informed that patients with OAB are more likely to suffer from vitamin D deficiency. The aim of the study is to determine the effect of vitamin D supplementation as an adjunctive therapy to behavioral therapy in the treatment of OAB dry. Eligible patients aged 5-18 years with a diagnosis of OAB dry will be randomly assigned into three groups to receive high dose vitamin D supplementation (combined with standard urotherapy ) , solifenacin (combined with standard urotherapy ) or standard urotherapy alone. Serum levels of 25(OH)D will be measured at baseline. Symptoms severity will be assessed at baseline and followup. All the other sociodemographic data will be also assessed. The study will give more information on the application of vitamin D supplementation in the management of OAB dry.
- Conditions
- Overactive Bladder
- Being tested
- Solifenacin Succinate 5 MG Oral Tablet [Vesicare], Vitamin D3, Standard urotherapy
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solifenacin Succinate 5 MG Oral Tablet [Vesicare]Drug
Also called standard urotherapy
These patients will receive solifenacin 5-10 MG daily (combined with standard urotherapy) for 8 weeks.
Vitamin D3Drug
Also called standard urotherapy
These patients will receive high dose vitamin D supplementation (more than 2000IU daily) (combined with standard urotherapy) for 8 weeks.
Standard urotherapyBehavioural
These patients will receive standard urotherapyfor 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| High dose vitamin D supplementation (combined with standard urotherapy) | Experimental | These patients will receive high dose vitamin D supplementation (more than 2000IU daily) and behavioral therapy for 8 weeks Receives: Drug: Vitamin D3 |
| Solifenacin succinate group (combined with standard urotherapy) | Active comparator | These patients will receive solifenacin (5-10 mg daily) and behavioral therapy for 8 weeks Receives: Drug: Solifenacin Succinate 5 MG Oral Tablet [Vesicare] |
| standard urotherapy group | Active comparator | These patients will receive behavioral therapy alone for 8 weeks. Receives: Behavioral: Standard urotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in voiding frequency
Change in voiding frequency as documented in the bladder diaries (voids/d) from baseline to the followup
Measured: 8 weeks
Secondary outcomes (8)
Change in mean urgency score
Change in mean urgency score as documented from baseline to the followup，0 indicated no urgency, 1 indicated mild awareness of urgency that iseasily tolerated, 2 indicated moderate urgency discomfort that interferes with or shortens usual activity, and 3 indicated severe urgency discomfort that abruptly stops all activities or tasks
Measured: 8 weeks
Change in max urgency score
Change in max urgency score as documented from baseline to the followup，0 indicated no urgency, 1 indicated mild awareness of urgency that iseasily tolerated, 2 indicated moderate urgency discomfort that interferes with or shortens usual activity, and 3 indicated severe urgency discomfort that abruptly stops all activities or tasks
Measured: 8 weeks
Change in pediatric lower urinary tract symptom score
Change in pediatric lower urinary tract symptom score from baseline to the followup， score ranged from 0 to 21 and higher scores indicated a more frequent and severe occurrence of lower urinary tract symptoms.
Measured: 8 weeks
Change in quality of life score
The quality of life was assessed using a scale ranging from 0 to 3, where a score of 0 indicated no impact on family, social, or academic life, a score of 1 indicated occasional impact, a score of 2 indicated significant impact, and a score of 3 indicated severe impact on family, social, or academic life.
Measured: 8 weeks
Change in mean nocturia frequency, episodes/night
Change in mean nocturia frequency from baseline to the followup
Measured: 8 weeks
Change in vitamin D level
Change in vitamin D level from baseline to the followup
Measured: 8 weeks
Global perception of improvement
Global perception of improvement (much better; better; about the same; worse)
Measured: 8 weeks
Wish to receive another form of treatment?
Wish to receive another form of treatment? (YES; No)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start15 Jan 2023
- Primary completion3 Jun 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The 3 groups will be treated at the same time
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xing Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xing Liu, Children's Hospital of Chongqing Medical University
- Investigators
- Xing Liu, Doctor, Study director, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709990
- Sponsor's protocol ID
- 2022515
- Status last verified
- Feb 2024
- First submitted
- 18 Jan 2023
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Apart from the participant's personal information.
Publications
Austin PF, Bauer SB, Bower W, Chase J, Franco I, Hoebeke P, Rittig S, Vande Walle J, von Gontard A, Wright A, Yang SS, Neveus T. The standardization of terminology of lower urinary tract function in children and adolescents: update report from the Standardization Committee of the International Children's Continence Society. J Urol. 2014 Jun;191(6):1863-1865.e13. doi: 10.1016/j.juro.2014.01.110. Epub 2014 Feb 4.
PubMed 24508614Franco I. Overactive bladder in children. Nat Rev Urol. 2016 Sep;13(9):520-32. doi: 10.1038/nrurol.2016.152. Epub 2016 Aug 17.
PubMed 27530266Abrams P, Swift S. Solifenacin is effective for the treatment of OAB dry patients: a pooled analysis. Eur Urol. 2005 Sep;48(3):483-7. doi: 10.1016/j.eururo.2005.06.007.
PubMed 16005564Yuan P, Wang T, Li H, Lan R, Li M, Liu J. Systematic Review and Meta-Analysis of the Association between Vitamin D Status and Lower Urinary Tract Symptoms. J Urol. 2021 Jun;205(6):1584-1594. doi: 10.1097/JU.0000000000001441. Epub 2020 Nov 18.
PubMed 33207134Markland AD, Vaughan CP, Huang AJ, Kim E, Bubes VY, Tangpricha V, Buring JR, Lee IM, Cook NR, Manson JE, Grodstein F. Effect of Vitamin D Supplementation on Overactive Bladder and Urinary Incontinence Symptoms in Older Men: Ancillary Findings From a Randomized Trial. J Urol. 2023 Jan;209(1):243-252. doi: 10.1097/JU.0000000000002942. Epub 2022 Sep 6.
PubMed 36067369Brustad N, Yousef S, Stokholm J, Bonnelykke K, Bisgaard H, Chawes BL. Safety of High-Dose Vitamin D Supplementation Among Children Aged 0 to 6 Years: A Systematic Review and Meta-analysis. JAMA Netw Open. 2022 Apr 1;5(4):e227410. doi: 10.1001/jamanetworkopen.2022.7410.
PubMed 35420658
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of High Dose Vitamin D Supplementation for Overactive Bladder Dry in Children: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05709990
- Acronym / sponsor ID
- 2022515
- Conditions
- Overactive Bladder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Xing LiuUniversity, hospital or other
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 3 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, randomized, 3-arms, parallel-design, controlled clinical trial is conducted to determine whether high dose vitamin D supplementation (combined with standard urotherapy ) improves outcomes, compared with solifenacin (combined with standard urotherapy ) ,and standard urotherapy alone in children with OAB dry.
Detailed description
Overactive bladder(OAB), characterized as urinary urgency accompanied in many instances by frequency and sometimes nocturia, with or without urinary incontinence, in the absence of urinary tract infection or other documented pathology, is a common clinical entity in pediatric urology. The majority of patients with OAB do not experience incontinence yet suffer from symptoms of urgency, frequency, and nocturia, which has been termed OAB dry. Currently, standard urotherapy is proposed as the first-line therapeutic options and adjunctive anticholinergics are usually used when urotherapy alone failed. Behavioral therapy often fail to achieve satisfied symptom control as children's poor compliance. In addition,adverse side effects such as dry mouth, constipation, gastro-oesophageal reflux result in early pharmacologic treatment discontinuation.
It was informed that patients with OAB are more likely to suffer from vitamin D deficiency. The aim of the study is to determine the effect of vitamin D supplementation as an adjunctive therapy to behavioral therapy in the treatment of OAB dry. Eligible patients aged 5-18 years with a diagnosis of OAB dry will be randomly assigned into three groups to receive high dose vitamin D supplementation (combined with standard urotherapy ) , solifenacin (combined with standard urotherapy ) or standard urotherapy alone. Serum levels of 25(OH)D will be measured at baseline. Symptoms severity will be assessed at baseline and followup. All the other sociodemographic data will be also assessed. The study will give more information on the application of vitamin D supplementation in the management of OAB dry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The 3 groups will be treated at the same time
| Arm | Type | Receives |
|---|---|---|
| High dose vitamin D supplementation (combined with standard urotherapy) | Experimental | Drug: Vitamin D3These patients will receive high dose vitamin D supplementation (more than 2000IU daily) and behavioral therapy for 8 weeks |
| Solifenacin succinate group (combined with standard urotherapy) | Active comparator | Drug: Solifenacin Succinate 5 MG Oral Tablet [Vesicare]These patients will receive solifenacin (5-10 mg daily) and behavioral therapy for 8 weeks |
| standard urotherapy group | Active comparator | Behavioral: Standard urotherapyThese patients will receive behavioral therapy alone for 8 weeks. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children older than 5 years of age with a diagnosis of OAB dry (do not experience incontinence yet suffer from symptoms of urgency, frequency, and nocturia) seen at the outpatient urology clinics (diagnosis follows the latest International Children's Continence Society recommendations).
- Children with a serum vitamin D level of less than 35 ng/ml as indicated by the laboratory result.
- Written informed consent was obtained from participants and their parents. -
Key exclusion criteria (12 listed)
- Those with a comorbidity of other urological abnormalities or serious diseases (e.g. hypospadias, cryptorchidism, posterior urethral valves, vesicoureteral reflux, neurogenic bladder, urological tumours, urinary stones, bladder and urethral injuries, etc.).
- Those with a comorbidity of neurological disorders (e.g. epilepsy, spinal cord injury, spinal cord dysplasia, spinal cord embolism syndrome, multiple sclerosis, autism spectrum disorder, etc.) .
- Those with acomorbidity of severe heart disease, abnormal liver or kidney function, lung disease, skeletal deformities, severe gastrointestinal disease, or inherited metabolic disorders.
- Those with a history of gastrointestinal surgery and urinary tract surgery.
- Those with chronic constipation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solifenacin Succinate 5 MG Oral Tablet [Vesicare]Also: standard urotherapyThese patients will receive solifenacin 5-10 MG daily (combined with standard urotherapy) for 8 weeks. | Drug | Solifenacin succinate group (combined with standard urotherapy) |
| Vitamin D3Also: standard urotherapyThese patients will receive high dose vitamin D supplementation (more than 2000IU daily) (combined with standard urotherapy) for 8 weeks. | Drug | High dose vitamin D supplementation (combined with standard urotherapy) |
| Standard urotherapyThese patients will receive standard urotherapyfor 8 weeks. | Behavioural | standard urotherapy group |
Primary outcome
Change in voiding frequency
Time frame: 8 weeks
Change in voiding frequency as documented in the bladder diaries (voids/d) from baseline to the followup
8 secondary outcomes
Change in mean urgency score
Time frame: 8 weeks
Change in max urgency score
Time frame: 8 weeks
Change in pediatric lower urinary tract symptom score
Time frame: 8 weeks
Change in quality of life score
Time frame: 8 weeks
Change in mean nocturia frequency, episodes/night
Time frame: 8 weeks
Change in vitamin D level
Time frame: 8 weeks
Global perception of improvement
Time frame: 8 weeks
Wish to receive another form of treatment?
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Background: PubMed 24508614Austin PF, Bauer SB, Bower W, Chase J, Franco I, Hoebeke P, Rittig S, Vande Walle J, von Gontard A, Wright A, Yang SS, Neveus T. The standardization of terminology of lower urinary tract function in children and adolescents: update report from the Standardization Committee of the International Children's Continence Society. J Urol. 2014 Jun;191(6):1863-1865.e13. doi: 10.1016/j.juro.2014.01.110. Epub 2014 Feb 4.
- Background: PubMed 27530266Franco I. Overactive bladder in children. Nat Rev Urol. 2016 Sep;13(9):520-32. doi: 10.1038/nrurol.2016.152. Epub 2016 Aug 17.
- Background: PubMed 16005564Abrams P, Swift S. Solifenacin is effective for the treatment of OAB dry patients: a pooled analysis. Eur Urol. 2005 Sep;48(3):483-7. doi: 10.1016/j.eururo.2005.06.007.
- Background: PubMed 33207134Yuan P, Wang T, Li H, Lan R, Li M, Liu J. Systematic Review and Meta-Analysis of the Association between Vitamin D Status and Lower Urinary Tract Symptoms. J Urol. 2021 Jun;205(6):1584-1594. doi: 10.1097/JU.0000000000001441. Epub 2020 Nov 18.
- Background: PubMed 36067369Markland AD, Vaughan CP, Huang AJ, Kim E, Bubes VY, Tangpricha V, Buring JR, Lee IM, Cook NR, Manson JE, Grodstein F. Effect of Vitamin D Supplementation on Overactive Bladder and Urinary Incontinence Symptoms in Older Men: Ancillary Findings From a Randomized Trial. J Urol. 2023 Jan;209(1):243-252. doi: 10.1097/JU.0000000000002942. Epub 2022 Sep 6.
- Background: PubMed 35420658Brustad N, Yousef S, Stokholm J, Bonnelykke K, Bisgaard H, Chawes BL. Safety of High-Dose Vitamin D Supplementation Among Children Aged 0 to 6 Years: A Systematic Review and Meta-analysis. JAMA Netw Open. 2022 Apr 1;5(4):e227410. doi: 10.1001/jamanetworkopen.2022.7410.
- Individual participant dataSharing planned: Yes. Apart from the participant's personal information.
Related trials for Overactive Bladder
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xing Liu, Doctor study director
Children's Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solifenacin Succinate 5 MG Oral Tablet [Vesicare], Vitamin D3 and Standard urotherapy in people with Overactive Bladder, run by Xing Liu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in voiding frequency (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05709990, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.