Идёт набор NCT06719232

Evaluating the Efficacy and Patient Experience of Catheter-Free Intravesical Instillation

— Наблюдательное Interstitial Cystitis Recurrent Cystitis Haemorrhagic Cystitis Bladder Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Catheter-Free Intravesical Instillation with a special syringe adapter.
Кому может быть актуально: Состояния в реестре: Interstitial Cystitis, Recurrent Cystitis, Haemorrhagic Cystitis, Bladder Cancer. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Венгрия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Evaluating the Efficacy and Patient Experience of Catheter-Free Intravesical Instillation: a Prospective Observational Study

Обзор

This study aims to evaluate a catheter-free method for delivering medications directly into the bladder, known as intravesical instillation, which is commonly used to treat conditions such as interstitial cystitis/bladder pain syndrome (IC/BPS), recurrent urinary tract infections, bladder cancer, and post-chemotherapy or post-radiation cystitis. The study investigates whether this method, which eliminates the need for catheterization, reduces discomfort and complications while maintaining treatment effectiveness. By collecting data on patient experiences and outcomes, the study seeks to determine if this approach provides a safer and more comfortable alternative to traditional catheter-based treatments.

Подробное описание

Intravesical instillation, a method involving the direct administration of therapeutic agents into the bladder via a catheter, is widely used in the treatment of various urological conditions, including interstitial cystitis/bladder pain syndrome (IC/BPS), recurrent urinary tract infections (UTIs), post-chemotherapy and post-radiation cystitis, and non-muscle invasive bladder cancer. This approach allows high concentrations of medication to be delivered directly to the bladder without systemic exposure, thereby enhancing treatment efficacy while reducing the risk of systemic side effects.

A notable drawback of traditional intravesical treatments is the need for catheterization. However, catheter-free intravesical instillations have become possible with the use of a specialized urological adapter that requires only 6-8 mm insertion into the urethral opening (UroDapter). By relaxing the urethral sphincter, patients can facilitate the delivery of the instillation fluid into the bladder without a catheter. This method is painless, causes minimal discomfort, and significantly reduces the risk of urinary tract infections, urethral bleeding, and urethral strictures compared to catheter-based approaches. Catheter-free intravesical instillations have been performed in Hungarian outpatient urology settings since 2018.

This prospective observational study includes patients whose physicians recommended catheter-free bladder instillation therapy. The study aims to anonymously collect data on the treatment's effectiveness, patient experience and incidence of complications associated with the caheter-free approach, focusing on its application for IC/BPS, recurrent UTIs, post-chemotherapy and post-radiation cystitis, and bladder cancer. Findings will be instrumental in refining protocols for intravesical treatments and enhancing patient compliance and satisfaction.

Вмешательства

Устройство Catheter-Free Intravesical Instillation with a special syringe adapter
The intervention involves catheter-free intravesical instillation using a specialized urological adapter. This device is attached to a syringe and inserted approximately 6-8 mm into the urethral opening, allowing the instillation solution to reach the bladder without the need for catheterization.

Первичные конечные точки

Patient Discomfort During Catheter-Free Intravesical Instillation [Срок оценки: Up to two weeks.]

Вторичные конечные точки (5)

Success Rate of Catheter-Free Instillation [Срок оценки: During each instillation visit.]
Incidence of Post-Treatment Urinary Tract Infections [Срок оценки: Within 1-2 weeks following the last instillation.]
Incidence of Urethral Bleeding [Срок оценки: Within 2 weeks following the last instillation.]
Patient Preference for Catheter-Free Instillation [Срок оценки: Within 2 weeks following the last instillation.]
Incidence of Other Post-Treatment Complications [Срок оценки: Within 2 weeks following the last instillation.]

Критерии участия

Критерии включения

Male and female patients aged between 18 and 80 years.
Patients for whom the treating physician has determined that intravesical instillation is necessary due to one of the following conditions:
Interstitial cystitis/bladder pain syndrome (IC/BPS).
Recurrent urinary tract infections (UTIs).
Non-muscle invasive bladder cancer.
Post-radiation cystitis.
Post-chemotherapy cystitis.
Negative urine culture within the last two weeks.
Patients who provide verbal and written informed consent to participate in the study.