NCT06710899尚未招募1 期
Does Vitamin C Improve the Efficacy of Methenamine Hippurate (Hiprex®) in Prophylaxis of Recurrent Urinary Tract Infections? A Proof of Concept Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Frequency of UTIs
研究概览
简要总结
A single centre proof of concept study to assess whether Vitamin C improves the efficacy of Methenamine Hippurate (Hiprex®) in the prophylaxis of recurrent urinary tract infections (rUTIs) in women
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Recurrent proven UTI, defined as "two or more proven infections in six months or three or more infections in six months"
- •Willing and able to give fully informed consent
- •Patients suitable for prophylaxis following discussion with their clinician.
- •No contra-indications to treatment with methenamine hippurate or Vitamin C
- •All women will have undergone standard diagnostic work-up and have followed routine conservative UTI prevention measures.
- •A working email address to be used to submit urine pH results
- •Willing and able to comply with the study procedures
- •Females of childbearing potential must be willing to use a highly effective method of contraception (hormonal or barrier method of birth control; abstinence; sterilisation or vasectomised partner)
排除标准
- •Women who are pregnant or breast-feeding
- •Contraindications to methenamine hippurate as described in BNF: known allergy, gout, severe metabolic acidosis, severe dehydration, eGFR less than 10 ml/min, severe hepatic impairment
- •Currently using vitamin C containing supplement or cranberry extract tablets
- •Women using urinary alkalinisation agents, e.g potassium citrate, sodium bicarbonate
- •Currently receiving any form of bladder instillation or intradetrusor Onabotulinum Toxin A injections
- •Patients already on low-dose antibiotics or methenamine hippurate (due to delay that will be incurred by 3-month washout period)
- •Indwelling urinary catheter in situ or performing clean intermittent self-catheterisation
- •Correctable urinary tract abnormalities, e.g., urinary tract calculi, urinary retention
- •Formation of ileal conduit or augmented bladder
- •Neurogenic bladder dysfunction
- •Hyperoxaluria
研究组 & 干预措施
Treatment phase A
Experimental
Methenamine Hippurate 1g BD for 6 months
干预措施: Methenamine Hippurate 1g BD (Drug)
Treatment phase B
Experimental
Methenamine Hippurate 1g BD + Vitamin C 1g BD for 6 months
干预措施: Methenamine Hippurate 1g BD + Vitamin C 1g BD (Drug)
Treatment phase C
Experimental
Methenamine 1g BD for 6 months
干预措施: Methenamine Hippurate 1g BD (Drug)
结局指标
主要结局
Frequency of UTIs
时间窗: 24 months
The incidence of symptomatic UTI during each six-month treatment phase of either methenamine hippurate alone or methenamine hippurate plus vitamin C
次要结局
- Urine pH(24 months)
研究者
研究点 (1)
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