Chemotherapy Effect, Chemotherapeutic Toxicity, Lower Urinary Tract Symptoms, Overactive Bladder
Conditions
Brief summary
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.
Interventions
BPIC-SS, ICIQ-OABqol, IIEF-EF oder FSFI, ICIQ-MLUTS oder ICIQ-FLUTS
Sponsors
Ludwig-Maximilians - University of Munich
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of instillation therapy on quality of life | During the study period approximately 12 months | Quality of life will be measured with validated questionnaires such as the ICIQ-OABqol |
| Effect of instillation therapy on sexuality | During the study period approximately 12 months | Sexuality will be measured with validated questionnaires such as the IIEF-EF (men) and the FSFI (women) |
| Effect of instillation therapy on lower urinary tract symptoms | During the study period approximately 12 months | Lower urinary tract symptoms will be measured with validated questionnaires such as the BPIC-SS, the ICIQ-MLUTS (men) and the ICIQ-FLUTS (women) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications during instillation therapy | During the study period approximately 12 months | The frequency of all complications will be measured and will be subsequently classified based on the Clavien-Dindo classification |
| Discontinuation rate of instillation therapy | During the study period approximately 12 months | — |
Countries
Germany
Contacts
Primary ContactNikolaos Pyrgidis, Urologist
Outcome results
None listed