Lower Urinary Tract Symptoms After Intravesical Therapy

Recruiting

• Conditions: Chemotherapy Effect; Lower Urinary Tract Symptoms; Overactive Bladder; Chemotherapeutic Toxicity
• Interventions: Other: Validated questionnaires

• Registration Number: NCT05844059
• Lead Sponsor: Ludwig-Maximilians - University of Munich

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-21
• Study First Submitted: 2023-04-22
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-03
• Last Update Submitted: 2023-05-03
• Study First Posted: 2023-05-06
• Last Update Posted: 2023-05-06
• Primary Completion: 2025-04-24
• Study Completion: 2026-04-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing instillation therapy with Mitomycin C	Validated questionnaires	All patients that undergo therapy with Mitomycin C after diagnosis of non-muscle-invasive bladder cancer
Patients undergoing instillation therapy with BCG	Validated questionnaires	All patients that undergo therapy with BCG after diagnosis of non-muscle-invasive bladder cancer

Primary Outcome Measures

Name	Time	Method
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)
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 quality of life	During the study period approximately 12 months	Quality of life will be measured with validated questionnaires such as the ICIQ-OABqol

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Nikolaos Pyrgidis; 🇩🇪 Munich, Bavaria, Germany