jRCTs031240134招募中不适用
ADVISR trial: ADd-on or switch to Vibegron in patients with overactive bladder InSufficiently responding to initial 4-Week antimuscarinics: A Randomized, parallel-group, multicenter study (ADVISR trial)
未提供0 个研究点目标入组 110 人开始时间: 2024年6月14日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 主要终点
- Comparison of changes in daily urination frequency
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients aged 18 years or older at time of registration
- •Patients who have been diagnosed with overactive bladder (OAB) based on the Over Active Bladder Symptom Score (OABSS) (*) and who continue to have OAB symptoms (*) even after treatment with one of the following anticholinergic drugs for 4 weeks or more
- •OABSS urinary urgency score of 2 points or more and OABSS total score of 3 points or more
- •Propiverine hydrochloride 20mg (orally administered once a day after meals)
- •Imidafenacin 0.1mg (administered twice a day, after breakfast and dinner)
- •Solifenacin succinate 5mg (oral administration once a day)
- •Fesoterodine fumarate 4mg (oral administration once a day)
- •Oxybutynin hydrochloride transdermal preparation 73.5mg (applied once a day to either the lower leg, lower back, or thigh)
- •Patients who are willing and able to accurately fill out a urinary diary/questionnaire, including measuring urine volume for 3 days.
- •Patients who are willing and able to follow the study protocol, including study visits and tests.
- •Patients who have fully understood the content of this study and have given their written consent.
排除标准
- •Patients with clinically significant bladder outlet obstruction
- •Patients with residual urine volume (> 150ml)
- •Patients with severe stress urinary incontinence or patients with mixed urinary incontinence
- •Patients with a continuously indwelling urinary catheter or patients who perform intermittent self-catheterization
- •Patients receiving non-drug treatment for urinary incontinence, including sacral nerve stimulation therapy. However, bladder training programs or pelvic floor muscle exercises that have been started within 30 days prior to registration is allowed.
- •Patients who are judged by the research physician to have a history of disease or surgery that may affect urinary evaluation due to OAB (such as patients who received botulinum toxin intravesical injection therapy)
- •Patients with chronic inflammatory disease or malignant disease (*) in the pelvis. *Patients who have undergone intravesical treatment for bladder malignancy within the past 12 months, or patients who have a history of bladder cancer, prostate cancer, or uterine cancer within 5 years before enrollment. However, patients with a history of bladder, prostate, or uterine cancer may be eligible for registration if they have undergone treatment, are cancer-free, and have not experienced recurrence for five years.
- •Patients with uncontrolled narrow-angle glaucoma, urinary retention or pyloric stenosis, severe ulcerative colitis, toxic megacolon, myasthenia gravis, or other patients for whom anticholinergic drugs are contraindicated by the principal investigator.
- •Patients with a history of hypersensitivity to the components of vibegron.
- •Patients who are or may be pregnant, or who are breastfeeding.
- •Patients who are deemed ineligible by the research physician for other medical, psychological, or other reasons.
结局指标
主要结局
Comparison of changes in daily urination frequency
时间窗: 12 weeks after the start of protocol treatment
Comparison of changes in daily urination frequency at 12 weeks after the start of protocol treatment between the combination group and the switching group
次要结局
- Intergroup comparison of changes in daily urination frequency(4 and 8 weeks)
- Intergroup comparison of changes in nighttime urination frequency(4, 8, and 12 weeks)
- Intra-group comparison of changes in nighttime urination frequency(4, 8, and 12 weeks)
- Intra-group comparison of changes in daily urinary incontinence frequency(4, 8, and 12 weeks)
- Intergroup comparison of changes in daytime urination frequency(4, 8, and 12 weeks)
- Intergroup comparison of changes in each OABSS score and total score(4, 8, and 12 weeks)
- Intergroup comparison of changes in each IPSS/QOL score and total score(4, 8, and 12 weeks)
- Intra-group comparison of changes in daily urination frequency(4, 8, and 12 weeks)
- Intergroup comparison of changes in daily urinary incontinence frequency(4, 8, and 12 weeks)
- Intra-group comparison of changes in daytime urination frequency(4, 8, and 12 weeks)
- Intra-group comparison of changes in each OABSS score and total score(4, 8, and 12 weeks)
- Intra-group comparison of changes in each IPSS/QOL score and total score(4, 8, and 12 weeks)
研究者
相似试验
已完成
3 期
A randomised, controlled clinical trial assessing the efficacy of;Lanreotide to halt disease progression in ADPKDpolycystic kidney disease100383601001965410029149Autosomal Dominant Polycystic Kidney DiseaseNL-OMON39497niversitair Medisch Centrum Groningen300
进行中（未招募）
不适用
To investigate the effect of Lanreotide on renal function decline in ADPKD patientsFirst, to demonstrate whether Lanreotide attenuates progression of the renal phenotype in ADPKD patients as measuredby change in rate of renal function decline and change in renal volume. Second, to demonstrate whether Lanreotidemodifies progression of the liver phenotype in the subset of ADPKD patients with moderate to severe polycystic liverdisease as measured by change in liver volume.MedDRA version: 14.1Level: LLTClassification code 10023433Term: Kidney polycysticSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2011-005017-37-NLDIPAK Consortium
进行中（未招募）
1 期
prospective, randomized, controlled study evaluating the effect of conversion from tacrolimus treatment to mTor inhibitor-based immunosuppression + tacrolimus to boost conversion to positive SARS-CoV-2 serology after a fourth dose of the vaccine of SARS-CoV-2 mRNA in solid organ transplant recipients who have not previously responded.Seroconversion is evaluated after changing treatment from tacrolimus to tacrolimus + mTOR inhibitor in solid organ transplant patients who have not responded to the first three doses of the vaccineMedDRA version: 21.0Level: PTClassification code 10080575Term: Solid organ transplantSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2022-000617-13-ESFundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)50
已完成
3 期
R-Anti-D immunoglobulin to prevent Rh-D sensitisation of Rh-negative pregnant womeCTRI/2017/03/008101Bharat Serums and Vaccines Ltd215
已完成
不适用
A prospective, randomized controlled trial assessing the efficacy and safety of cilostazol and aspirin therapy versus aspirin therapy for the prevention of vascular events in patietns undergoing coronary stent implantatioJPRN-UMIN000012541Koseikai Takai Hospital700