ISRCTN11705129终止未知
A new urinary catheter designed to improve bladder drainage: first-in-human testing of the FLUME catheter. Version 1.0
orth Bristol NHS Trust0 个研究点目标入组 15 人开始时间: 2022年2月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 终止
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Adults (>=18 years) of either gender, who are willing to participate in the study and give their written informed consent.
- •2. Subjects who are due to undergo planned general anaesthetic cystoscopy (routine endoscopic bladder inspection) – stage 1a only.
- •3. Subjects who are due to undergo a urological operation for which an indwelling catheter is routinely used – stage 1b only.
- •1. Adults (>= 8 years) of either gender.
- •2. Patients who need an indwelling urinary catheter as a method of bladder drainage for at least one month.
- •3. Patients who are willing and able to participate in the study and give their written informed consent.
- •4. Established catheter users. (Defined as had a Foley catheter for at least the last 6 months and anticipate continuing to use one for at least the next 3 months”).
排除标准
- •1. Catheter-associated UTI at time of assessment, according to National Healthcare Safety Network (NHSN) surveillance and clinical criteria. One re-screen per subject is allowed, once the infection has been treated, the patient is eligible for the study. (https://www.cdc.gov/nhsn/index.html)
- •2. Participants who are on systemic antibiotics within 48 hours prior to enrolment.
- •3. Patient with a known allergy to any of the materials used in the FLUME catheter.
- •4. Patient has urinary tract anatomic abnormality that would prevent placement of a standard Foley catheter.
- •5. Informed consent cannot be obtained (See Section 12 for assessment of capacity).
- •6. Patient is breast feeding or pregnant, confirmation that the women is not pregnant will be determined by [1] clear indication of menopause, [2] time since last menstruation or [3] confirmation of abstinence. Women of child-bearing age will be asked to perform a pregnancy test if applicable after obtaining their consent.
- •7. Patients who have undergone a TURP (Transurethral resection of the prostate) within the last 3 months.
- •8. Patients for whom a Fr14 sized dual lumen catheter would be inappropriate.
- •1. Catheter-associated UTI at time of assessment, according to National Healthcare Safety Network (NHSN) surveillance and clinical criteria. One re-screen per subject is allowed, once the infection has been treated, the patient is eligible for study. This will be recorded through self reporting of symptoms and/or prescribed antibiotics.
- •2. Participants who are on systemic antibiotics within 48 hours prior to enrolment.
- •3. Patient currently taking (or expected to take) more than a single dose of antibiotics for prevention of other infections during the catheter indwell period.
- •4. Suprapubic catheter user.
- •5. Patient with a known allergy to polyurethane or silicone used in the FLUME or comparator catheter.
- •6. Patient has urinary tract anatomical abnormality that would prevent placement of a standard Foley catheter.
- •7. Informed consent cannot be obtained.
- •8. Patient is unable or unwilling to comply with the study follow-up schedule.
- •9. Patient is breastfeeding woman or pregnant (confirmation that the woman is not pregnant will be determined by [1] clear indication of menopause, [2] time since last menstruation or [3] confirmation of abstinence. Women of child-bearing age will be asked to perform a pregnancy test if applicable (after obtaining their consent).
- •10. New catheter users.
- •11. Patients for whom scheduled catheter changes are more frequent than monthly.
- •12. Cognitive impairment affecting ability to complete outcome assessments (in the opinion of the investigator).
- •13. Patients who have undergone a TURP (Transurethral resection of the prostate) within the last 3 months.
- •14. Patients for whom a Fr14 sized dual lumen catheter would not be appropriate.
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