Thorsten O Götze, PD Dr. med. Principal Investigator Krankenhaus Nordwest
Kontakt
Thorsten O Götze, PD Dr. med. Kontakt: Phone: 06976014187 E-Mail: goetze.thorsten@khnw.de» Kontaktdaten anzeigen
Studienlocations (3 von 4)
Onkologisches Zentrum Krankenhaus Nordwest Steinbacher Hohl 2-26 60488 Frankfurt am Main DeutschlandRekrutierend» Google-Maps Ansprechpartner: Markus Düx, Prof. Dr.» Ansprechpartner anzeigenFOKUS Radiologische Gemeinschaftspraxis Göttingen (Niedersachsen) GermanyRekrutierend» Google-Maps Ansprechpartner: Peter Hunold, PD Dr.» Ansprechpartner anzeigenLeipzig University Leipzig (Sachsen) GermanyRekrutierend» Google-Maps Ansprechpartner: Bahriye Aktas, Prof. Dr.
Brustzentrum Stuttgart am Marienhospital Böheimstraße 37 70199 Stuttgart DeutschlandRekrutierend» Google-Maps Ansprechpartner: Markus Zähringer, Prof. Dr.
1. WAI question 4 (Time Frame - Until at least three consecutive days questionnaire was answered as indicated, up to 12 months): Time to sustainably return to normal activities, based on the daily Work Activity Index (WAI) dimension, "Estimated Impairment of Disease Performance". The return to normal activities is considered to be given if the question "Hindrance of medical condition or injury at work?" (min max: 1: 'in my opinion, I am completely unable to work', 6: 'No Disability') is answered for at least three consecutive days with "No Disability" (6) or "I can do my job, but have complaints" (5).
2. Symptom Severity Score of the UFS-QoL (Time Frame - 12 months after treatment): The symptom severity is determined to be the co- primary endpoint for assessing therapeutic efficacy, based on the SSS (Symptom Severity Score) of the UFS-QoL (Uterine fibroid symptom and quality of life questionnaire). The co-primary assessment is performed 12 months after the primary treatment and for the evaluation the proportion of patients with at least 25 points improvement in the SSS is determined (0-100 scale, 100 indicating very strong symptoms, 0 no or low symptoms).
Secondary outcome:
1. Hospital stay in days (Time Frame - 12 months after treatment)
2. Pain according to visual analog scale (Time Frame - 12 months after treatment): Visual analog scale ranges from 0-100, 0 indicating no pain, 100 severe pain
3. Number of Adverse Events (AEs) (Time Frame - 12 months after treatment)
4. Number of postinterventional/postsurgery treatment complications (Time Frame - 12 months after treatment)
5. Number of re-interventions (Time Frame - 12 months after treatment)
6. Alleviation of symptoms (irregular period, unfulfilled wish for child, pain, quality of life according to UFS-QoL (Time Frame - 12 months after treatment): QoL: Quality of Life score regarding symptoms, ranges from 0-100, 0 indicating very low QoL, 100 indicating very high QoL
7. Health related quality of life according to UFS-QoL (Time Frame - 12 months after treatment): QoL: Quality of Life score regarding health, ranges from 0-100, 0 indicating very low QoL, 100 indicating very high QoL
8. Sexuality related parameters according to UFS-QoL (Time Frame - 12 months after treatment): QoL: Quality of Life score regarding sexuality, ranges from 0-100, 0 indicating very low QoL, 100 indicating very high QoL
9. Number of pregnancies and live births (Time Frame - 12 months after treatment)
10. Number of late complications like venous thromboembolisms within Follow up time frame (Time Frame - 12 months after treatment)
11. Number of fibroid recurrences (de novo fibroids) within Follow up time frame (Time Frame - 12 months after treatment)
12. Time period until return to normal physical activities, measured by the rate of patients, who achieved an a priori clinically relevant reduction of SSS of UFS-QoL (Time Frame - 12 months after treatment): at timepoints: months 1, 3 and 6 compared to baseline.
