Lower Urinary Tract Symptoms After Intravesical Therapy (LUTSI)

Ludwig Maximilian University of Munich

Status: Enrolling

Conditions: Chemotherapy Effect; Lower Urinary Tract Symptoms; Chemotherapeutic Toxicity; Overactive Bladder

Treatments: Other: Validated questionnaires

Study type: Observational

Funder types: Other

Identifiers

NCT05844059

23-0226

Details and patient eligibility

About

With this prospective, observational study, we would like to investigate the effect of instillation therapy using BCG or mitomycin C on short- and long-term irritative and obstructive lower urinary tract symptoms using validated questionnaires. The study will objectify the lower urinary tract symptoms and thereby provide better recommendations for therapy with mitomycin C or BCG.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Urinary bladder carcinoma requiring instillation therapy
• Complete resection of the tumor
• No intravesical chemotherapy in the last 3 months

Exclusion criteria

• Patients who are unable to complete the questionnaires
• Patients who are not willing to participate
• Patients with contraindications for instillation therapy (allergic reactions, immunosuppression)

Trial design

60 participants in 2 patient groups

Patients undergoing instillation therapy with BCG

Description:

All patients that undergo therapy with BCG after diagnosis of non-muscle-invasive bladder cancer

Treatment:

Other: Validated questionnaires

Patients undergoing instillation therapy with Mitomycin C

Description:

All patients that undergo therapy with Mitomycin C after diagnosis of non-muscle-invasive bladder cancer

Treatment:

Other: Validated questionnaires