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NCT05844059 Clinical Trial

Lower Urinary Tract Symptoms After Intravesical Therapy

Overactive Bladder Clinical Trial

— LUTSI  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05844059
Other study ID # 23-0226
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 21, 2023
Est. completion date April 24, 2026

Study information
Verified date May 2023
Source Ludwig-Maximilians - University of Munich
Contact Nikolaos Pyrgidis, Urologist
Phone 004989440073531
Email nikolaos.pyrgidis@med.uni-muenchen.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date April 24, 2026
Est. primary completion date April 24, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Validated questionnaires
BPIC-SS, ICIQ-OABqol, IIEF-EF oder FSFI, ICIQ-MLUTS oder ICIQ-FLUTS

Locations
Country Name City State
Germany Nikolaos Pyrgidis Munich Bavaria

Sponsors (1)
Lead Sponsor Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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
Secondary Discontinuation rate of instillation therapy During the study period approximately 12 months
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