NCT07714694招募中不适用
Consumer Evaluation of an Investigational Intermittent Catheter
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence of Health Changes and Adverse Events During Usual-Catheter and Investigational-Catheter Use
研究概览
简要总结
This clinical study is designed to evaluate the initial safety and performance of an investigational intermittent urinary catheter in people who use intermittent catheterization. Participants will use the study catheter and provide feedback on their experience, including ease of insertion, advancement through the urethra, bladder drainage, withdrawal, comfort, confidence, satisfaction, and overall ease of use.
Safety will be evaluated through reported health changes and adverse events. Device performance and user experience will be assessed using participant questionnaires and comparisons with the participant's current intermittent catheter, including questions related to catheter handling, comfort during catheterization, perceived ability to empty the bladder, likelihood of future use, and product preference.
The study is intended to generate descriptive information on the initial clinical use of the investigational catheter and to help characterize its safety, usability, comfort, satisfaction, and performance relative to participants' current intermittent catheter products.
详细描述
This is a prospective, single-arm, fixed-sequence, within-participant clinical evaluation of an investigational intermittent catheter. Eligible adult male participants in the United States who currently use hydrophilic intermittent catheters will first use 30 of their usual catheters and then 30 study catheters. During both catheter-use periods, participants will complete daily questionnaires regarding catheter use and health changes and will complete evaluation forms assessing ease of use, catheter performance, comfort, confidence, satisfaction, and comparative preference. Safety will be evaluated through reported health changes and adverse events. The study is intended to provide descriptive information regarding the initial safety, usability, and performance of the investigational catheter relative to participants' current intermittent catheter products.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •is living in the USA
- •is at least 22 years of age
- •can speak, read, and write in English
- •is self-catheterizing 3 or more times a day
- •has been performing unassisted, self-catheterizations, with a Hydrophilic IC, for at least 1 month
- •currently uses one of the hydrophilic ICs (length=40cm; size=Ch. 14) listed below:
- •Hollister Incorporated VaPro Pocket Nelaton Tip (clear protective tip) (SKU 70144)
- •Hollister Incorporated VaPro Pocket Coude (blue protective tip) (SKU 77144)
- •Hollister Incorporated VaPro Coude (blue protective tip) (SKU 73144)
- •Hollister Incorporated VaPro Plus Nelaton (clear protective tip) (SKU 74144)
- •Hollister Incorporated VaPro Plus Pocket Nelaton (clear protective tip) (SKU 71144)
- •Hollister Incorporated Onli Nelaton (SKU: 82144-30)
- •Hollister Incorporated Onli Coudé (SKU: 85144)
- •Wellspect LoFric Origo Nelaton (SKU: 443 14 40)
- •Wellspect LoFric Origo Tiemann/Coudé (SKU: 444 14 40)
- •Wellspect LoFric Origo Flexible Coudé with protective sleeve (SKU: 449 14 40)
- •Wellspect LoFric Origo Flexible Coudé with insertion grip (SKU: 447 14 40)
- •Coloplast SpeediCath Standard Male (SKU: 28414)
- •Coloplast SpeediCath Male Coudé Tip (SKU: 28494)
- •Coloplast SpeediCath Flex Coudé Pro (SKU: 20014)
- •Convatec GentleCath Glide Male Straight Tip (SKU: 421567)
- •Convatec GentleCath Glide Male Tiemann Tip (SKU: 421910)
- •Convatec GentleCath Air Male Straight Tip (SKU:510690)
- •Convatec GentleCath Air Male Coude Tip (SKU:510696)
- •Convatec GentleCath Hydrophilic, 14FR, Straight (SKU: 508996)
- •Convatec GentleCath Hydrophilic, 14FR, Coude (SKU: 509001)
- •Convatec Cure - Hydrophilic Cure Catheter Straight Tip (SKU: HM14)
- •Convatec Cure - Hydrophilic Cure Catheter Coudé Tip (SKU: HM14C)
- •Bard - Magic3® Go Male, 14FR, Straight (SKU:53814G)
- •Bard - Magic3® Go Male, 14FR, Coude (SKU:50814G)
- •Bard - Magic3®, 14FR, Straight (SKU: 53614G)
- •Bard - Magic3®, 14FR, Straight (SKU: 53614) aa. Bard - Magic3®, 14FR, Coude (SKU: 50614)
- •is willing and able to follow the study protocol procedures including completing online questionnaires as demonstrated by signing the Informed Consent
- •is willing to switch from their current, typical intermittent catheter to the study-provided study products (e.g., study catheters) during the latter portion of the study
- •is willing to provide permission via the study informed consent and HIPAA Authorization Form for study staff to contact prescribing healthcare provider for a copy of their active prescription. Alternatively subject can opt to provide study staff with their active prescription.
排除标准
- •is currently receiving chemotherapy, has received chemotherapy within the past 30 days, or is scheduled to receive chemotherapy during the study (i.e., in the next 34 days)
- •is currently undergoing, has previously underwent, or is planning to undergo radiation therapy to the bladder, prostate, or rectum during the study (i.e., in the next 34 days)
- •is currently using one or more of the following oral or injectable steroid therapies for 30 days or more:
- •corticotropin
- •hydrocortisone
- •Cortrophin Gel
- •corticotrophin
- •dexamethasone
- •deflazacort
- •fludrocortisone
- •Orapred ODT
- •prednisolone
- •currently has urinary tract infection (UTI) symptoms or has been diagnosed with a UTI by a healthcare provider in the last 2 weeks
- •has a retracted penis
- •has skin irritation or lesions (sores) on the penis
- •Performs non-urethral catheterization
- •Has participated in a study involving actual use of a study urethral IC (i.e. inserting/removing) within the last 30 days
- •Is currently an employee of Hollister Incorporated or any other intermittent catheter manufacturer.
结局指标
主要结局
Incidence of Health Changes and Adverse Events During Usual-Catheter and Investigational-Catheter Use
时间窗: Through completion of both catheter-use periods, approximately 6 to 20 days
Number and nature of participant-reported health changes and adverse events collected during both the control-catheter period and the study-catheter period. Safety events will be categorized by incidence, severity, and relatedness.
Participant-Reported Overall Ease of Use of the Catheter
时间窗: Through completion of both catheter-use periods, approximately 6 to 20 days
Participant-reported overall ease of use of the catheter, assessed on a 5-point ordinal scale coded 1 to 5: 1 = Very Easy, 2 = Easy, 3 = Neither Easy nor Difficult, 4 = Difficult, and 5 = Very Difficult. Lower scores indicate easier overall use.
次要结局
- Participant-Reported Ease of Inserting the Protective Tip Into the Urethral Opening(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Participant-Reported Ease of Inserting the Catheter Into the Urethral Opening(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Participant-Reported Ease of Advancing the Catheter Through the Protective Tip Into the Urethra(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Participant-Reported Ease of Advancing the Catheter Through the Urethra to the Bladder(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Participant-Reported Bladder Drainage and Bladder Emptying(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Participant-Reported Worry That the Catheter Does Not Fully Empty the Bladder(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Occurrence of Urine Flow Restarting Before Complete Catheter Removal(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Occurrence of Pausing to Allow Remaining Urine to Drain Through the Catheter(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Participant-Reported Actions Taken to Help Remaining Urine Drain Through the Catheter(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Participant-Reported Ease of Withdrawing the Catheter From the Urethra(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Participant-Reported Ability to Insert the Catheter Without Contaminating or Touching the Portion That Enters the Body(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Participant-Reported Ability of the Catheter to Support the Recommended Catheterization Schedule(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Occurrence of Discomfort During Catheter Insertion(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Participant-Reported Type of Discomfort During Catheter Insertion(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Frequency of Discomfort During Catheter Insertion(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Occurrence of Coughing or Deep Breathing to Assist Catheter Insertion Into the Bladder(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Occurrence of Turning or Twisting the Catheter During Advancement Through the Urethra(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Participant-Reported Actions Taken During Catheter Insertion(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Correct Orientation of the Funnel Notch Before Insertion Among Participants Using a Curved-Tip Catheter(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Occurrence of Turning the Curved-Tip Catheter During Advancement Into the Bladder(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Participant-Reported Burden Associated With Orienting or Turning a Curved-Tip Catheter(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Participant-Reported Difficulty Pushing the Catheter Through the Urethra Into the Bladder(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Occurrence of Discomfort During Bladder Drainage(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Frequency of Discomfort During Bladder Drainage(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Participant-Reported Discomfort Symptoms During Bladder Drainage(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Occurrence of Discomfort During Catheter Removal(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Frequency of Discomfort During Catheter Removal(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Participant-Reported Discomfort Symptoms During Catheter Removal(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Participant-Reported Comfort Using the Catheter(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Participant-Reported Confidence That the Catheter Will Slide in Comfortably With Each Use(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Participant-Reported Confidence That the Catheter Will Slide in Easily With Each Use(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Participant-Reported Confidence That the Catheter Allows the Bladder to Empty Fully(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Participant-Reported Confidence in Successfully Using the Catheter(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Time to Participant-Reported Confidence in Using the Catheter(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Participant-Reported Ability of the Catheter to Support Confidence During Use(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Participant-Reported Confidence When the Catheter Was Inserted(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Participant-Reported Ability of the Catheter to Help the Participant Feel Confident When Used(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Participant-Reported Overall Satisfaction With the Catheter(Through completion of both catheter-use periods, approximately 6 to 20 days)
- Participant-Reported Bladder Emptying Time With the Investigational Catheter Compared With the Participant's Current Intermittent Catheter(At completion of the study-catheter period, approximately 6 to 20 days after starting the control-catheter period)
- Participant-Reported Advancement Performance of the Investigational Catheter Compared With the Participant's Current Intermittent Catheter(At completion of the study-catheter period, approximately 6 to 20 days after starting the control-catheter period)
- Participant-Reported Likelihood of Using the Investigational Catheter if Commercially Available in the Participant's Usual Type and Package(At completion of the study-catheter period, approximately 6 to 20 days after starting the control-catheter period)
- Participant-Reported Overall Catheter Preference Between the Investigational Catheter and the Participant's Current Intermittent Catheter(At completion of the study-catheter period, approximately 6 to 20 days after starting the control-catheter period)
研究者
研究点 (1)
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