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"

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.

Study Overview

• Status: Recruiting
• Conditions: Pelvic Floor Disorders

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Boris Gabriel, Prof. Dr. med.; Phone Number: +496111771500; Email: bgabriel@joho.de
• Study Contact Backup: Name: Bettina Blau-Schneider, Dr. med.; Phone Number: +496111770; Email: bblauschneider@joho.de

Study Locations

• Germany
  • Wiesbaden, Germany, 65189
    • Recruiting
    • St. Josefs-Hospital Wiesbaden GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with gynecological tumors and breast cancer under systemic tumor therapy

Description

Inclusion Criteria:

• Breastcancer under tumor therapy
• Gynecological carcinoma under tumor therapy

Exclusion Criteria:

• none

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Endpoint	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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Endpoint	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.	12 months

Collaborators and Investigators

• Sponsor: St. Josefs-Hospital Wiesbaden GmbH

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 19, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (Actual): December 4, 2020

Study Record Updates

• Last Update Posted (Estimated): September 23, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Pelvic Floor Disorders
• Other Study ID Numbers: PANTHERA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No