Lower Urinary Tract Symptoms After Intravesical Therapy

NCT05844059 | Recruiting

• 1 other identifier: 23-0226
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy Effect; Chemotherapeutic Toxicity; Lower Urinary Tract Symptoms; Overactive Bladder

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Complications during instillation therapy

  During the study period approximately 12 months

• Discontinuation rate of instillation therapy

  During the study period approximately 12 months

Study Arms (2)

Patients undergoing instillation therapy with BCG

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

Other: Validated questionnaires

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

Interventions

Validated questionnaires OTHER

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

Patients undergoing instillation therapy with BCG; Patients undergoing instillation therapy with Mitomycin C

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with urinary bladder carcinoma requiring instillation therapy

You may qualify if:

• Urinary bladder carcinoma requiring instillation therapy
• Complete resection of the tumor
• No intravesical chemotherapy in the last 3 months

You may not qualify if:

• Patients who are unable to complete the questionnaires
• Patients who are not willing to participate
• Patients with contraindications for instillation therapy (allergic reactions, immunosuppression)

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (1)

Nikolaos Pyrgidis

Munich, Bavaria, 81377, Germany

RECRUITING

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Nikolaos Pyrgidis, Urologist

CONTACT

004989440073531; nikolaos.pyrgidis@med.uni-muenchen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: April 22, 2023
• First Posted: May 6, 2023
• Study Start: April 21, 2023
• Primary Completion: April 24, 2025
• Study Completion: April 24, 2026
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)