NCT04655066

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Apr 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress93%
Apr 2018Dec 2026

Study Start

First participant enrolled

April 1, 2018

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

8.8 years

First QC Date

November 19, 2020

Last Update Submit

September 22, 2025

Conditions

Pelvic Floor Disorders

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Secondary Endpoint

    12 months

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with gynecological tumors and breast cancer under systemic tumor therapy

You may qualify if:

  • Breastcancer under tumor therapy
  • Gynecological carcinoma under tumor therapy

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Josefs-Hospital Wiesbaden GmbH

Wiesbaden, 65189, Germany

RECRUITING

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPregnancy ComplicationsMale Urogenital Diseases

Central Study Contacts

Boris Gabriel, Prof. Dr. med.

CONTACT

+496111771500bgabriel@joho.de

Bettina Blau-Schneider, Dr. med.

CONTACT

+496111770bblauschneider@joho.de

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2020

First Posted

December 4, 2020

Study Start

April 1, 2018

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

September 23, 2025

Record last verified: 2025-09

Locations

DE(1)