Evaluating the Efficacy and Patient Experience of Catheter-Free Intravesical Instillation: a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Patient Discomfort During Catheter-Free Intravesical Instillation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Urinary tract infection within the past month or currently active infection.
- •Diagnosed bleeding disorders or recurrent macroscopic hematuria.
- •Post-void residual urine volume greater than 100 ml.
- •Mental condition that prevents reliable cooperation.
结局指标
主要结局
Patient Discomfort During Catheter-Free Intravesical Instillation
时间窗: Up to two weeks.
Level of discomfort experienced by patients during catheter-free intravesical instillation treatments, measured using the Numerical Rating Scale (NRS) from 0 to 10
次要结局
- Success Rate of Catheter-Free Instillation(During each instillation visit.)
- Incidence of Post-Treatment Urinary Tract Infections(Within 1-2 weeks following the last instillation.)
- Incidence of Urethral Bleeding(Within 2 weeks following the last instillation.)
- Patient Preference for Catheter-Free Instillation(Within 2 weeks following the last instillation.)
- Incidence of Other Post-Treatment Complications(Within 2 weeks following the last instillation.)
研究者
Dr. Béla Köves
Head Physician
Jahn Ferenc South Pest Teaching Hospital