Samstag, 27. April 2024
Navigation öffnen
Anzeige:
Wefra Programatic
 
JOURNAL ONKOLOGIE – STUDIE
LUTSI

Lower Urinary Tract Symptoms After Intravesical Therapy

Rekrutierend

NCT-Nummer:
NCT05844059

Studienbeginn:
April 2023

Letztes Update:
06.05.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Urinary Bladder, Overactive, Lower Urinary Tract Symptoms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Ludwig-Maximilians - University of Munich

Collaborator:
-

Kontakt

Nikolaos Pyrgidis, Urologist
Kontakt:
Phone: 004989440073531
E-Mail: nikolaos.pyrgidis@med.uni-muenchen.de
» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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)

Studien-Rationale

Primary outcome:

1. 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

2. 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)

3. 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)

Secondary outcome:

1. 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

2. Discontinuation rate of instillation therapy (Time Frame - During the study period approximately 12 months)

Studien-Arme

  • Patients undergoing instillation therapy with BCG
    All patients that undergo therapy with BCG after diagnosis of non-muscle-invasive bladder cancer
  • Patients undergoing instillation therapy with Mitomycin C
    All patients that undergo therapy with Mitomycin C after diagnosis of non-muscle-invasive bladder cancer

Geprüfte Regime

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

Quelle: ClinicalTrials.gov


Sie können folgenden Inhalt einem Kollegen empfehlen:

"Lower Urinary Tract Symptoms After Intravesical Therapy"

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!

Die Verwendung Ihrer Daten für den Newsletter können Sie jederzeit mit Wirkung für die Zukunft gegenüber der MedtriX GmbH - Geschäftsbereich rs media widersprechen ohne dass Kosten entstehen. Nutzen Sie hierfür etwaige Abmeldelinks im Newsletter oder schreiben Sie eine E-Mail an: rgb-info[at]medtrix.group.