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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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04655066
Recruitment Status : Recruiting
First Posted : December 4, 2020
Last Update Posted : December 4, 2020
Information provided by (Responsible Party):
St. Josefs-Hospital Wiesbaden GmbH

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.

Condition or disease
Pelvic Floor Disorders

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: PANTHERA-Studie "Pelvic Floor Disorders in Patients Under ANtineoplastic THERApy"
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  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 Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with gynecological tumors and breast cancer under systemic tumor therapy

Inclusion Criteria:

  • Breastcancer under tumor therapy
  • Gynecological carcinoma under tumor therapy

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04655066

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Contact: Boris Gabriel, Prof. Dr. med. +496111771500
Contact: Bettina Blau-Schneider, Dr. med. +496111770

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St. Josefs-Hospital Wiesbaden GmbH Recruiting
Wiesbaden, Germany, 65189
Sponsors and Collaborators
St. Josefs-Hospital Wiesbaden GmbH
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Responsible Party: St. Josefs-Hospital Wiesbaden GmbH Identifier: NCT04655066    
Other Study ID Numbers: PANTHERA
First Posted: December 4, 2020    Key Record Dates
Last Update Posted: December 4, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pelvic Floor Disorders
Pregnancy Complications