Lower Urinary Tract Symptoms After Intravesical Therapy (LUTSI)

May 3, 2023 updated by: Benedikt Ebner, Ludwig-Maximilians - University of Munich

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with urinary bladder carcinoma requiring instillation therapy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients undergoing instillation therapy with BCG
All patients that undergo therapy with BCG after diagnosis of non-muscle-invasive bladder cancer
Other: Validated questionnaires
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
Other: Validated questionnaires
BPIC-SS, ICIQ-OABqol, IIEF-EF oder FSFI, ICIQ-MLUTS oder ICIQ-FLUTS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of instillation therapy on quality of life
Time Frame: During the study period approximately 12 months
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
Time Frame: During the study period approximately 12 months
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
Time Frame: 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)
During the study period approximately 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications during instillation therapy
Time Frame: 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
During the study period approximately 12 months
Discontinuation rate of instillation therapy
Time Frame: During the study period approximately 12 months
During the study period approximately 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig-Maximilians - University of Munich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2023

Primary Completion (Anticipated)

April 24, 2025

Study Completion (Anticipated)

April 24, 2026

Study Registration Dates

First Submitted

April 22, 2023

First Submitted That Met QC Criteria

May 3, 2023

First Posted (Estimate)

May 4, 2023

Study Record Updates

Last Update Posted (Estimate)

May 4, 2023

Last Update Submitted That Met QC Criteria

May 3, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-0226

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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