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CavatermTM is a second-generation thermal balloon ablation device in the management of menorrhagia. The purpose of this study is to investigate the success (questionnaire) of CavatermTM dependent on uterus probe length, especially corpus probe length, which is measured during surgery.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermal Balloon Endometrial Ablation | Device | Thermal Balloon Endometrial Ablation for 10 minutes after curettage |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postsurgical change in bleeding patterns dependent on cavum probe length. | Success is defined as a-, hypo- or eumenorrhoea, regular cycle, reduction of dysmenorrhoea. | Corpus probe length will be measured during surgery, a questionnaire will be sent in September 2010, at least after one postsurgical year. |
| Postsurgical change in patient satisfaction dependent on cavum probe length. | The questionnaire will ask for satisfaction and recommendation to the best friend. | Corpus probe length will be measured during surgery, a questionnaire will be sent in September 2010, at least after one postsurgical year. |
| Measure | Description | Time Frame |
|---|---|---|
| Postsurgical change in dyspareunia | The questionnaire will ask for pre- and postsurgical dyspareunia. | A questionnaire will be sent in September 2010, at least after one postsurgical year. |
| Postsurgical change in Premenstrual Syndrome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beda W. Hartmann, Univ.-Doz. | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Landesklinikum Thermenregion Neunkirchen | Neunkirchen | Lower Austria | 2620 | Austria |
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| ID | Term |
|---|---|
| D008595 | Menorrhagia |
| D008796 | Metrorrhagia |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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The questionnaire will ask for pre- and postsurgical Premestrual Syndrome.
| A questionnaire will be sent in September 2010, at least after one postsurgical year. |
| Prevention of further gynaecological therapies | The questionnaire will ask for postsurgical hysterectomy and further medications. | A questionnaire will be sent in September 2010, at least after one postsurgical year. |
| Improvement of quality of life | The questionnaire will ask for postsurgical quality of life. | A questionnaire will be sent in September 2010, at least after one postsurgical year. |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |