Clinical trial NCT06719232: Evaluating the Efficacy and Patient Experience of Catheter-Free Intravesical Instillation
Official title: Evaluating the Efficacy and Patient Experience of Catheter-Free Intravesical Instillation: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Interstitial Cystitis
Recurrent Cystitis
Haemorrhagic Cystitis
Bladder Cancer
Bladder Disease
Intravesical Instillation
Bladder Pain Syndrome
Recurrent Urinary Tract Infections
Keywords: intravesical therapy
catheterization
recurrent urinary tract infection
IC/BPS
Interstitial Cystitis/Bladder Pain syndrome
Post-chemotherapy Cystitis
Post-Irradiation Cystitis
Intravesical instillation
UroDapter
Lead sponsor: Jahn Ferenc South Pest Teaching Hospital
Sponsor class: OTHER_GOV
First posted: 2024-12-05
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of patients attending the participating centers. Study participants are individuals referred by their treating physicians for catheter-free intravesical instillation therapy based on their clinical needs.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Patient Discomfort During Catheter-Free Intravesical Instillation
timeFrame: Up to two weeks.
Secondary outcomes:
measure: Success Rate of Catheter-Free Instillation
timeFrame: During each instillation visit.
measure: Incidence of Post-Treatment Urinary Tract Infections
timeFrame: Within 1-2 weeks following the last instillation.
measure: Incidence of Urethral Bleeding
timeFrame: Within 2 weeks following the last instillation.
measure: Patient Preference for Catheter-Free Instillation
timeFrame: Within 2 weeks following the last instillation.
measure: Incidence of Other Post-Treatment Complications
timeFrame: Within 2 weeks following the last instillation.
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Military Hospital Medical Centre, Hungarian Defense Forces
city: Budapest
country: Hungary
facility: Jahn Ferenc South-Pest Hospital
Study officials:
affiliation: South Pest Teaching Hospital
name: Peter Tenke, Professor of Urology
role: STUDY_CHAIR
References: