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临床试验/NCT06546189
NCT06546189招募中不适用

Oral Lactobacillus Supplementation as Treatment for Overactive Bladder Syndrome: A Randomised Controlled Trial

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
symptom reduction

研究概览

简要总结

Background: Overactive bladder describes a syndrome characterized by frequent urges to urinate and increased urination with or without nocturia and with or without urinary incontinence. Overactive bladder affects approximately 13% of older women and thus represents a condition with high prevalence. Affected women report significant limitations in daily life, as well as social isolation. Despite the high occurrence of this condition, therapeutic options are limited, partly because the etiology of this condition is not fully understood. Increasingly, studies suggest an imbalance in the urogenital microbiome as a possible cause of the development of the condition. Therefore, the aim of this study is to test, whether the oral administration of a lactobacillus preparation can lead to a reduction in symptoms.

Design: Randomized controlled study

Methods: Intake of OMNi BiOTiC® 41167 or placebo twice daily for 6 months; swabs (vaginal and urethral) and urine samples from a single-use catheter for microbiome determination at 0, 3, and 7 months.

Outcome: Reduction of subjective symptoms (yes/no) after 3 and 7 months; reduction of Overactive Bladder Symptom Score after 3 and 7 months; change in the urogenital microbiome after 3 and 7 months (comparison of intervention vs. placebo).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • diagnosis of overactive bladder syndrome or mixed urinary incontinence with predominance of overactive bladder symptoms

排除标准

  • under age 18
  • neurogenic overactive bladder

结局指标

主要结局

symptom reduction

时间窗: 6 months

yes/no

ICIQ-OAB symptom score reduction

时间窗: 6 months

次要结局

  • change in vaginal/urethral/bladder microbiom(3 months and 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marianne Koch

Priv.-Doz.Dr.med.univ., PhD

Medical University of Vienna

研究点 (2)

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