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

PANTHERA-Studie Pelvic Floor Disorders in Patients Under ANtineoplastic THERApy

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04655066

Enrollment

200

Registered

2020-12-04

Start date

2018-04-01

Completion date

2026-12-31

Last updated

2025-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Floor Disorders

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

* Breastcancer under tumor therapy * Gynecological carcinoma under tumor therapy

Exclusion criteria

* none

Design outcomes

Primary

Measure	Time frame	Description
Primary Endpoint	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

Measure	Time frame	Description
Secondary Endpoint	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.

Countries

Germany

Contacts

Primary ContactBoris Gabriel, Prof. Dr. med.

bgabriel@joho.de+496111771500

Backup ContactBettina Blau-Schneider, Dr. med.

bblauschneider@joho.de+496111770

Outcome results