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NCT Number: NCT04655066

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

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.

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Key information

Conditions

Pelvic Floor Disorders Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Josefs-Hospital Wiesbaden GmbH

Wiesbaden, 65189, Germany

Location status: Recruiting

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Breastcancer under tumor therapy
  • Gynecological carcinoma under tumor therapy

Exclusion criteria

  • none

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bettina Blau-Schneider, Dr. med.

CONTACT

[email protected]

+496111770

Boris Gabriel, Prof. Dr. med.

CONTACT

[email protected]

+496111771500

Sponsors and collaborators

Lead sponsor

St. Josefs-Hospital Wiesbaden GmbH

Other

Registry information

Official study title

PANTHERA-Studie "Pelvic Floor Disorders in Patients Under ANtineoplastic THERApy"

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Dec 4, 2020
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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