Clinical Trials Logo
  1. Home
  2. Pelvic Floor Disorders
  3. NCT04655066
  4. Details
NCT04655066 Clinical Trial

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

Pelvic Floor Disorders Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04655066
Other study ID # PANTHERA
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2018
Est. completion date December 31, 2025

Study information
Verified date April 2024
Source St. Josefs-Hospital Wiesbaden GmbH
Contact Boris Gabriel, Prof. Dr. med.
Phone +496111771500
Email bgabriel@joho.de
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 31, 2025
Est. primary completion date June 30, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Breastcancer under tumor therapy - Gynecological carcinoma under tumor therapy Exclusion Criteria: - none

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany St. Josefs-Hospital Wiesbaden GmbH Wiesbaden

Sponsors (1)
Lead Sponsor Collaborator
St. Josefs-Hospital Wiesbaden GmbH

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
See also
  Status Clinical Trial Phase
Completed NCT03623880 - Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders N/A
Completed NCT05690555 - Pelvic Floor Physical Therapy vs Standard Care in Transgender Women Undergoing Vaginoplasty for Gender Affirmation N/A
Not yet recruiting NCT06455150 - Prevalence of Pelvic Floor Dysfunctions in Female Badminton Athletes and Sedentary
Not yet recruiting NCT03456310 - Transperineal US on Basis of MRI in Female Pelvic Floor Dysfunction N/A
Completed NCT01938092 - Vaginal Diazepam for the Treatment of Female Pelvic Pain Phase 2
Completed NCT00884871 - Study of Surgically-Induced Weight Loss on Pelvic Floor Disorders N/A
Completed NCT06014021 - Tele-rehabilitation for Female Athletes With Pelvic Floor Dysfunctions N/A
Recruiting NCT05950633 - Postoperative Active Recovery N/A
Not yet recruiting NCT05530681 - Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth N/A
Completed NCT06206993 - Effects of Kieser Resistance Training Plus Kieser Pelvic Floor Training vs. Kieser Resistance Training Plus Traditional Pelvic Floor Exercise on Urinary Incontinence in Prostate Cancer Patients After Radical Prostatectomy N/A
Recruiting NCT03683264 - Forceps vs Vacuum. Rate of Levator Ani Muscle Avulsion: Clinical Trial. N/A
Active, not recruiting NCT04172519 - Pelvic Floor Muscles Training After Radical Prostatectomy. N/A
Suspended NCT04544735 - Improving Women's Function After Pelvic Radiation N/A
Completed NCT03715777 - Electromyographic Study for the Help and Guidance of BoNTA Administration in the Treatment of Chronic Pelvic Floor Pain Phase 3
Completed NCT05127512 - Pelvic Floor Disorder Education in Prenatal Care N/A
Completed NCT02259712 - Effectiveness of Hypopressive Exercises Versus Pelvic-perineal Physiotherapy N/A
Completed NCT03714984 - The Efficacy of Pre-operative Educational Pelvic Floor Intervention on Urinary Continence N/A
Not yet recruiting NCT05399901 - M-mode Ultrasonography in the Assessment and Treatment of Pelviperineal Dysfunctions (PerineUM) N/A
Completed NCT05318768 - Association Between Physical Activity Level ，Overall Muscle Strength and Pelvic Floor Muscle Function in Women.
Completed NCT06193395 - Translation and Validation of the ICIQ-B in Danish N/A