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JOURNAL ONKOLOGIE – STUDIE

Evaluation of the Subjectively Perceived Pelvic Floor Function in Patients With Gynecological Tumors and Breast Cancer Under Systemic Tumor Therapy Using a Validated Questionnaire

Rekrutierend

NCT-Nummer:
NCT04655066

Studienbeginn:
April 2018

Letztes Update:
29.11.2022

Wirkstoff:
-

Indikation (Clinical Trials):
Pelvic Floor Disorders

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
St. Josefs-Hospital Wiesbaden GmbH

Collaborator:
-

Kontakt

Studienlocations
(1 von 1)

St. Josefs-Hospital Wiesbaden GmbH
65189 Wiesbaden
(Hessen)
GermanyRekrutierend» Google-Maps

Studien-Informationen

Brief Summary:

The multimodal therapy of gynecological malignancies and breast cancer often leads to an

impairment of the pelvic floor function. This has a major impact on the quality of life of

cancer patients. The aim of the study is to record and analyze the potential subjective

impairment of the bladder, bowel and sexual function under systemic tumor therapy as well as

possible influencing factors by means of validated disease-specific questionnaires. to find

possible starting points for the prevention and treatment of the symptoms.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Breastcancer under tumor therapy

- Gynecological carcinoma under tumor therapy

Exclusion Criteria:

- none

Studien-Rationale

Primary outcome:

1. Primary Endpoint (Time Frame - 12 months):
The primary endpoint and basis for the sample size calculation is the incidence of clinically relevant deteriorations in the total score of pelvic floor function. Bladder function, bowel function, sedimentation problems and sexual function, QoL are recorded using scores using the validated German pelvic floor questionnaire



Secondary outcome:

1. Secondary Endpoint (Time Frame - 12 months):
Type of tumor (breast cancer, ovarian cancer, cervical cancer, endometrial cancer, vulvar cancer), TNM stage, body weight, height, age, type of tumor therapy, number of previous therapies (chemoline), parity, mode of delivery, nicotine abuse, medication, previous surgery.

Quelle: ClinicalTrials.gov


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