A Confirmatory, Multi-centre, Randomized, Open Label, Controlled Study Confirming Performance of a Single-use Intermittent Micro-holes Zone Catheter in a Population of Adult Male Intermittent Catheter Users.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 10
- 主要终点
- Residual Urine at 1st Flow Stop (HCP-led Catheterization) i.e., Total Catheterisation Volume Minus Volume at 1st Flow-stop, Both Derived From a Catheterisation Profile
研究概览
简要总结
A multi-centre, randomized, controlled crossover design. The total study duration for the individual subject was approximately 9 weeks. The study consisted of four study visits (V0-V3) and two 4-week test periods at home (T1 and T2). Visit 0 and 1 was performed on the same day if subjects allowed.
One population included all enrolled subjects who took part in the two test periods in a home setting only (T1 and T2). This constituted the Full Analysis Set (FAS) 1 (N=73)where only endpoints related to dipstick hematuria, catheter perception and quality of life were assessed.
A subset of subjects from the FAS1 also took part in two clinic visits (V2 and V3) where endpoints related to bladder emptying and discomfort were assessed. One visit took place in between the two test periods at home (V2) and the other visit took place after the last test period at home (V3) which was also the termination visit. This subset is termed the FAS 2 (N=49).
详细描述
This investigation was a multi-centre, randomized, controlled crossover study including 73 male clean intermittent catheterization (CIC) users.
The study consisted of four study visits (V0-V3) and two 4-week test periods at home (T1 and T2). Visit 0 and 1 were performed on the same day if participants allowed. Visit 0 included the screening-, inclusion-, and randomization phase of participants and at visit 1, participants performed a self-catheterization with the device according to their respective randomization scheme. This was followed by a dipstick test for hematuria. This constituted the Full Analysis Set (FAS) 1, consisting of 73 participants.
In the two 4-week test periods (T1 and T2, respectively) the participants catheterized at home with the specified catheter according to their randomization scheme. Both 4-week periods started with a 2-week run-in period followed by a 2-week period during which a dipstick test for hematuria was performed daily.
For Visit 2 and 3, a sub-group of participants was invited for a clinical test visit during which participants were catheterized with the same device applied during the preceding home-test period. First a healthcare professional (HCP)-led catheterization was performed followed by a self-catheterization, and endpoints related to bladder emptying (residual urine and number of urinary flow-stop episodes) were measured. After each catheterization, any residual urine left in the bladder was measured with a bladder scanner and hematuria was assessed with a dip-stick test. After the self-catheterization process, subjects at clinic visit V2 and V3 completed a questionnaire related to discomfort.This constituted the Full Analysis Set (FAS) 2, consisting of 49 participants.
All participants completed a perception questionnaire and a HRQoL questionnaire associated with the catheter during the last two weeks of the home test period. For participants not part of clinic visits V2 and V3, a nurse assisted with the questionnaires after each home-test period during a remote home visit. Thereafter, all participants were introduced to the second device to be tested for the next home-test period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Was at least 18 years of age and had full legal capacity
- •Had given written informed consent
- •Had signed letter of authority (only DK)
- •Had used clean intermittent self-catheterization (CISC) for at least the last 3 months
- •Had used intermittent catheterization as the only bladder emptying method for at least the last 3 months
- •Self-catheterized using Coloplast SpeediCath Flex or Hollister VaPro catheters, CH12 or CH14, for at least 3 months prior to inclusion
- •Had the ability (assessed by investigator) and willingness to adhere to a 2-month study period
- •Exclusion Criteria
- •Participation in any other clinical study during this investigation
- •Previous participation in the study
- •Symptoms of urinary tract infection as judged by the investigator (rescheduling allowed within recruitment period for LPI)
- •Individuals with history, suspected or showing signs of producing urine with excessive amount of mucus or large/clustered sediments or debris
- •Any known allergies towards ingredients in the investigational device
排除标准
- 未提供
结局指标
主要结局
Residual Urine at 1st Flow Stop (HCP-led Catheterization) i.e., Total Catheterisation Volume Minus Volume at 1st Flow-stop, Both Derived From a Catheterisation Profile
时间窗: Immediately after the procedure/catheterization, at second and third clinic visit following 4 weeks of home catheterization
The residual urine at 1st flow-stop during catheterization (performed by a HCP) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying. Hence, the residual volume at 1st flow-stop was calculated as the total volume post catheterisation minus the volume at 1st flow-stop, derived from a catheterisation profile which was connected to a time-logged weighing \[g\].
Number of Flow-stop Episodes (HCP-led Catheterization)
时间窗: Immediately after catheterisation, at second and third clinic visit following 4 weeks of home catheterization
Number of flow-stop episodes were determined as instances where the flow rate decreased to less than 0.8 mL/s for a period of at least two seconds. All episodes were detected by automatic thresholding, followed by manual inspection, where the intra-catheter pressure readings were used to support the assessment of a flow stop.
次要结局
- Number of Flow-stop Episodes (Self-led Catheterization)(Immediately after the procedure/catheterization, at second and third clinic visit following 4 weeks of home catheterization)
- Positive Hematuria Event Post-catheterisation(week 3 and 4 (1st home-period) and in week 7 and 8 (2nd home-period).)
- Residual Urine at 1st Flow Stop (Self-led Catheterization)(Immediately after the procedure/catheterization, at second and third clinic visit following 4 weeks of home catheterization)
- Mean Red Blood Cell Concentration(Dipstick test for haematuria was performed daily were performed in week 3 and 4 (1st home-period) and in week 7 and 8 (2nd home-period).)