Lower Urinary Tract Symptoms After Intravesical Therapy

NCT ID: NCT05844059

Last Updated: 2023-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-21

Study Completion Date

2026-04-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chemotherapy Effect Chemotherapeutic Toxicity Lower Urinary Tract Symptoms Overactive Bladder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients undergoing instillation therapy with BCG

All patients that undergo therapy with BCG after diagnosis of non-muscle-invasive bladder cancer

Validated questionnaires

Intervention Type OTHER

BPIC-SS, ICIQ-OABqol, IIEF-EF oder FSFI, ICIQ-MLUTS oder ICIQ-FLUTS

Patients undergoing instillation therapy with Mitomycin C

All patients that undergo therapy with Mitomycin C after diagnosis of non-muscle-invasive bladder cancer

Validated questionnaires

Intervention Type OTHER

BPIC-SS, ICIQ-OABqol, IIEF-EF oder FSFI, ICIQ-MLUTS oder ICIQ-FLUTS

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Validated questionnaires

BPIC-SS, ICIQ-OABqol, IIEF-EF oder FSFI, ICIQ-MLUTS oder ICIQ-FLUTS

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Benedikt Ebner

Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nikolaos Pyrgidis

Munich, Bavaria, Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nikolaos Pyrgidis, Urologist

Role: CONTACT

004989440073531

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Nikolaos Pyrgidis

Role: primary

004989440073531

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

23-0226

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

POST URS Chemotherapy Instillation
NCT06167057 RECRUITING NA