Menorrhagia
Conditions
Keywords
menorrhagia, dysfunctional uterine bleeding, endometrial ablation, cavatermTM, probe
Brief summary
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.
Interventions
Thermal Balloon Endometrial Ablation for 10 minutes after curettage
Sponsors
Medical University of Vienna
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* CavatermTM operation because of menorrhagia * timeframe: January 2006 till August 2009 * older than 29 years and younger than 56 years
Exclusion criteria
* pregnancy * fragmentary filled questionnaire * more than 1 CavatermTM operation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postsurgical change in bleeding patterns dependent on cavum probe length. | Corpus probe length will be measured during surgery, a questionnaire will be sent in September 2010, at least after one postsurgical year. | Success is defined as a-, hypo- or eumenorrhoea, regular cycle, reduction of dysmenorrhoea. |
| Postsurgical change in patient satisfaction dependent on cavum probe length. | Corpus probe length will be measured during surgery, a questionnaire will be sent in September 2010, at least after one postsurgical year. | The questionnaire will ask for satisfaction and recommendation to the best friend. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postsurgical change in dyspareunia | A questionnaire will be sent in September 2010, at least after one postsurgical year. | The questionnaire will ask for pre- and postsurgical dyspareunia. |
| Postsurgical change in Premenstrual Syndrome | A questionnaire will be sent in September 2010, at least after one postsurgical year. | The questionnaire will ask for pre- and postsurgical Premestrual Syndrome. |
| Prevention of further gynaecological therapies | A questionnaire will be sent in September 2010, at least after one postsurgical year. | The questionnaire will ask for postsurgical hysterectomy and further medications. |
| Improvement of quality of life | A questionnaire will be sent in September 2010, at least after one postsurgical year. | The questionnaire will ask for postsurgical quality of life. |
Countries
Austria
Outcome results
None listed