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The aim of the study is to answer the question, whether in patients with symptomatic and medically not sufficiently treatable uterine fibroids (population) the "Magnetic-Resonance-Guided Focused Ultrasound Surgery" short, MRgFUS-TUF (intervention) offers less burdensome therapy and patient-relevant advantages (symptom relief) compared to the operative myomectomy (comparison). The study will hence investigate the therapeutic benefit of this method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A Myomectomy | Active Comparator | Removement of uterine fibroids by myomectomy |
|
| B MRgFUS-TUF | Experimental | Removement of uterine fibroids by Magnetic Resonance Imaging-controlled high-focussed ultrasound therapy (MRgFUS-TUF) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Imaging-controlled high-focussed ultrasound therapy | Procedure | Magnetic Resonance Imaging-controlled high-focussed ultrasound |
|
| Measure | Description | Time Frame |
|---|---|---|
| WAI question 4 | 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). | Until at least three consecutive days questionnaire was answered as indicated, up to 12 months |
| Symptom Severity Score of the UFS-QoL | 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). | 12 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital stay in days | 12 months after treatment | |
| Pain according to visual analog scale | Visual analog scale ranges from 0-100, 0 indicating no pain, 100 severe pain | 12 months after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thorsten O Götze, PD Dr. med. | Krankenhaus Nordwest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krankenhaus Nordwest | Frankfurt am Main | Hesse | 60488 | Germany | ||
| FOKUS Radiologische Gemeinschaftspraxis |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Myomectomy (laparoscopic or open surgical) | Procedure | Myomectomy (laparoscopic or open surgical) |
|
| Number of Adverse Events (AEs) | 12 months after treatment |
| Number of postinterventional/postsurgery treatment complications | 12 months after treatment |
| Number of re-interventions | 12 months after treatment |
| Alleviation of symptoms (irregular period, unfulfilled wish for child, pain, quality of life according to UFS-QoL | QoL: Quality of Life score regarding symptoms, ranges from 0-100, 0 indicating very low QoL, 100 indicating very high QoL | 12 months after treatment |
| Health related quality of life according to UFS-QoL | QoL: Quality of Life score regarding health, ranges from 0-100, 0 indicating very low QoL, 100 indicating very high QoL | 12 months after treatment |
| Sexuality related parameters according to UFS-QoL | QoL: Quality of Life score regarding sexuality, ranges from 0-100, 0 indicating very low QoL, 100 indicating very high QoL | 12 months after treatment |
| Number of pregnancies and live births | 12 months after treatment |
| Number of late complications like venous thromboembolisms within Follow up time frame | 12 months after treatment |
| Number of fibroid recurrences (de novo fibroids) within Follow up time frame | 12 months after treatment |
| 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 | at timepoints: months 1, 3 and 6 compared to baseline. | 12 months after treatment |
| Göttingen |
| Germany |
| Leipzig University | Leipzig | Germany |
| Marienhospital | Stuttgart | Germany |
| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D063186 | Uterine Myomectomy |
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
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