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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing instillation therapy with BCG | All patients that undergo therapy with BCG after diagnosis of non-muscle-invasive bladder cancer |
| |
| Patients undergoing instillation therapy with Mitomycin C | All patients that undergo therapy with Mitomycin C after diagnosis of non-muscle-invasive bladder cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Validated questionnaires | Other | BPIC-SS, ICIQ-OABqol, IIEF-EF oder FSFI, ICIQ-MLUTS oder ICIQ-FLUTS |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with urinary bladder carcinoma requiring instillation therapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nikolaos Pyrgidis, Urologist | Contact | 004989440073531 | nikolaos.pyrgidis@med.uni-muenchen.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nikolaos Pyrgidis | Recruiting | Munich | Bavaria | 81377 | Germany |
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| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001745 | Urinary Bladder Diseases |
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| During the study period approximately 12 months |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |