UROtainer for Bladder Catheter Maintenance, Infection Prevention and Quality of Life

Официальное название

Study of Uro-Tainer® Polihexanide and Uro-Tainer® With Citric Acid on Catheter Blockage, Infection Prevention, Cost-effectiveness and Quality of Life (UROBIQ): a Prospective Randomized Single-blinded Clinical Study

Обзор

The purpose of the current study is to investigate whether catheter flushing with Uro-Tainer® with citric acid and Uro-Tainer® Polihexanide can: Reduce catheter changes due to incrustation and blockage. In addition, a list of secondary aims inclusive of cost-effectiveness analysis in collaboration with the Centre for Innovative Medical Technology (CIMT) at OUH.

Подробное описание

The purpose of the current study is to investigate whether catheter flushing with Uro-Tainer® with citric acid and Uro-Tainer® Polihexanide can: Reduce catheter changes due to incrustation and blockage.

In addition, a list of secondary aims inclusive of cost-effectiveness analysis in collaboration with the Centre for Innovative Medical Technology (CIMT) at OUH.

There is a need for a randomised study to justify if Uro-Tainer® flushing will have an advantage over the cheaper and normally used Saline flushing.

Standard therapies vary depending on the blockage type and severity. Saline Solution can be used daily for a shorter period and 1-2 times a week for long-term catheter maintenance.

Study:

* Uro-Tainer® Polihexanide two weekly rinses compared to two weekly rinses with saline for 3 months. * Uro-Tainer® with citric acid: Two weekly rinses compared to two weekly rinses with saline for 3 months.

Clinical benefits:

* Less catheter blockage -\> less need for catheter replacement outside the regular schedule -\> Fewer infections and better QoL * It is expected that cost-effectiveness analysis will show a better economic outcome for the society * No unknown adverse effects are expected * The risk of participation in this study is very small compared to the expected effect of fewer catheter replacements, fewer infections and better QoL which justifies the selection of clinical endpoints.

Вмешательства

• Устройство UroTainer®
  Clinical effect of preventive treatment - catheter flushing with UroTainer®
• Устройство Saline
  Clinical effect of preventive treatment - catheter flushing with saline solution

Первичные конечные точки

• Number of catheter changes during the treatment and follow-up period. [Срок оценки: 1 year]

Вторичные конечные точки (8)

• UTI events (Urinary tract infection event) [Срок оценки: 1 year]
• Urine culture [Срок оценки: 1 year]
• Odour [Срок оценки: 1 year]
• Quality of life by SF-36 [Срок оценки: 1 year]
• Quality of life by ICIQ-LTCqol [Срок оценки: 1 year]
• Cost effectiveness analyses 1 [Срок оценки: 1 year]
• Cost effectiveness analyses 2 [Срок оценки: 1 year]
• Cost effectiveness analyses 3 [Срок оценки: 1 year]

Критерии участия

Критерии включения

Citizen not previously flushed

• A permanent catheter (suprapubic and urethral)
• Male and female > 18 years of age
• Acute or previous catheter stop because of blocking or incrustations.
• The pilot project does not include clogging due to incrustations
• Voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Ethics Committee (EC) before all evaluations.

Citizen previously flushed with NaCl or UroTainer®

• A permanent catheter (suprapubic and urethral)
• Male and female > 18 years of age
• Willingness to take a rinse break for a minimum of 4 weeks. In the event of 2 catheter stops during the flushing break, assessed on the basis of an urgent need for catheter flushing with NaCl or catheter change, the citizen can be included.
• The pilot project does not include clogging due to incrustations
• If there is no catheter stop during the rinsing break, the citizen will continue without rinsing until a possible catheter stop.
• Voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Ethics Committee (EC) before all evaluations.

Критерии исключения

• Urothelial cancer
• Bladder and kidney stones requiring treatment
• Age < 18 years of age
• Pregnant and / or breastfeeding women
• Not able to understand Danish
• Dementia, where relatives can / will not give consent
• Simultaneous participation in another interventional clinical trial (drugs or medical devices studies)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Дания · 1 центр

• Odense University Hospital — Odense

Идентификаторы

NCT: NCT05775614 · UROBIQ

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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