Consumer Evaluation of an Investigational Intermittent Catheter

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство An intermittent urethral urinary catheter with a tip, tube and drainage eyelets
  An intermittent urethral urinary catheter with a tip, tube and drainage eyelets

Первичные конечные точки

• Incidence of Health Changes and Adverse Events During Usual-Catheter and Investigational-Catheter Use [Срок оценки: Through completion of both catheter-use periods, approximately 6 to 20 days]
• Participant-Reported Overall Ease of Use of the Catheter [Срок оценки: Through completion of both catheter-use periods, approximately 6 to 20 days]

Вторичные конечные точки (12)

• Participant-Reported Ease of Inserting the Protective Tip Into the Urethral Opening [Срок оценки: Through completion of both catheter-use periods, approximately 6 to 20 days]
• Participant-Reported Ease of Inserting the Catheter Into the Urethral Opening [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Through completion of both catheter-use periods, approximately 6 to 20 days]
• Participant-Reported Bladder Drainage and Bladder Emptying [Срок оценки: Through completion of both catheter-use periods, approximately 6 to 20 days]
• Participant-Reported Worry That the Catheter Does Not Fully Empty the Bladder [Срок оценки: Through completion of both catheter-use periods, approximately 6 to 20 days]
• Occurrence of Urine Flow Restarting Before Complete Catheter Removal [Срок оценки: Through completion of both catheter-use periods, approximately 6 to 20 days]
• Occurrence of Pausing to Allow Remaining Urine to Drain Through the Catheter [Срок оценки: Through completion of both catheter-use periods, approximately 6 to 20 days]
• Participant-Reported Actions Taken to Help Remaining Urine Drain Through the Catheter [Срок оценки: Through completion of both catheter-use periods, approximately 6 to 20 days]
• Participant-Reported Ease of Withdrawing the Catheter From the Urethra [Срок оценки: 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 [Срок оценки: Through completion of both catheter-use periods, approximately 6 to 20 days]
• Participant-Reported Ability of the Catheter to Support the Recommended Catheterization Schedule [Срок оценки: Through completion of both catheter-use periods, approximately 6 to 20 days]

Критерии участия

Критерии включения

• is living in the USA
• is male
• 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.

Критерии исключения

• 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:

• Acthar Gel
• corticotropin
• Agamree
• vamorolone
• budesonide
• Cortef
• hydrocortisone
• Cortrophin Gel
• corticotrophin
• dexamethasone
• deflazacort
• prednisone
• Emflaza
• Eohilia
• fludrocortisone
• Jaythari
• Orapred ODT
• prednisolone
• Pyquvi
• Rayos
• Tarpeyo
• Uceris
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Hollister Incorporated — Libertyville

Идентификаторы

NCT: NCT07714694 · 6049-CONT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗