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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Solifenacin succinate group (combined with standard urotherapy) | Active Comparator | These patients will receive solifenacin (5-10 mg daily) and behavioral therapy for 8 weeks |
|
| standard urotherapy group | Active Comparator | These patients will receive behavioral therapy alone for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solifenacin Succinate 5 MG Oral Tablet [Vesicare] | Drug | These patients will receive solifenacin 5-10 MG daily (combined with standard urotherapy) for 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in voiding frequency | Change in voiding frequency as documented in the bladder diaries (voids/d) from baseline to the followup | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xing Liu, Doctor | Children's Hospital of Chongqing Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24508614 | Background | 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. | |
| 27530266 |
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Apart from the participant's personal information.
8 weeks
Apart from the participant's personal information
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 20, 2020 | May 12, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000069464 | Solifenacin Succinate |
| D013607 | Tablets |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
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The 3 groups will be treated at the same time
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outcome evaluators, and statisticians were blinded.
|
| Vitamin D3 | Drug | These patients will receive high dose vitamin D supplementation (more than 2000IU daily) (combined with standard urotherapy) for 8 weeks. |
|
|
| Standard urotherapy | Behavioral | These patients will receive standard urotherapyfor 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 | 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. | 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. | 8 weeks |
| Change in mean nocturia frequency, episodes/night | Change in mean nocturia frequency from baseline to the followup | 8 weeks |
| Change in vitamin D level | Change in vitamin D level from baseline to the followup | 8 weeks |
| Global perception of improvement | Global perception of improvement (much better; better; about the same; worse) | 8 weeks |
| Wish to receive another form of treatment? | Wish to receive another form of treatment? (YES; No) | 8 weeks |
| Background |
| Franco I. Overactive bladder in children. Nat Rev Urol. 2016 Sep;13(9):520-32. doi: 10.1038/nrurol.2016.152. Epub 2016 Aug 17. |
| 16005564 | Background | Abrams 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. |
| 33207134 | Background | Yuan 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. |
| 36067369 | Background | Markland 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. |
| 35420658 | Background | Brustad 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. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |