Lower Urinary Tract Symptoms After Intravesical Therapy

Study Overview
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Brief Summary
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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.

Official Title
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Lower Urinary Tract Symptoms After Intravesical Therapy With Mitomycin C or BCG in Patients With Carcinoma of the Bladder

Conditions
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Chemotherapy Effect, Chemotherapeutic Toxicity, Lower Urinary Tract Symptoms, Overactive Bladder

Intervention / Treatment
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* Other: Validated questionnaires


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing instillation therapy with BCG<br>All patients that undergo therapy with BCG after diagnosis of non-muscle-invasive bladder cancer | Other: Validated questionnaires<br>* BPIC-SS, ICIQ-OABqol, IIEF-EF oder FSFI, ICIQ-MLUTS oder ICIQ-FLUTS<br>|
| Patients undergoing instillation therapy with Mitomycin C<br>All patients that undergo therapy with Mitomycin C after diagnosis of non-muscle-invasive bladder cancer | Other: Validated questionnaires<br>* BPIC-SS, ICIQ-OABqol, IIEF-EF oder FSFI, ICIQ-MLUTS oder ICIQ-FLUTS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of instillation therapy on quality of life | Quality of life will be measured with validated questionnaires such as the ICIQ-OABqol | During the study period approximately 12 months | 
| Effect of instillation therapy on sexuality | Sexuality will be measured with validated questionnaires such as the IIEF-EF (men) and the FSFI (women) | During the study period approximately 12 months | 
| Effect of instillation therapy on lower urinary tract symptoms | Lower urinary tract symptoms will be measured with validated questionnaires such as the BPIC-SS, the ICIQ-MLUTS (men) and the ICIQ-FLUTS (women) | During the study period approximately 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications during instillation therapy | The frequency of all complications will be measured and will be subsequently classified based on the Clavien-Dindo classification | During the study period approximately 12 months | 
| Discontinuation rate of instillation therapy |  | During the study period approximately 12 months |