CavatermTM vs TCRE in Women With DUB

Pnn Medical

Status and phase

Unknown

Phase 4

Conditions

Dysfunctional Uterine Bleeding

Treatments

Device: Transcervical Resection of the Endometrium

Device: Thermal Balloon Endometrial Ablation

Study type

Interventional

Funder types

Industry

Identifiers

NCT00549159

2006-0026-06 dd20070920

Details and patient eligibility

About

The purpose of study is to compare the treatment success in the study groups.

Full description

Study success will be defined as reduction of uterine bleeding evaluated by number of patients obtaining amenorrhea, hypomenorrhea or eumenorrhea quantified by PBLAC<75.

Enrollment

158 estimated patients

Sex

Female

Ages

30 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Willingness and adequate mental capacity to sign written, informed consent
Willingness to adhere to study plan regarding control visits and recording of PBLAC
> 30 years old
Pre-menopausal as determined by FSH ≤30
Agree not to use hormonal contraception or any other intervention for bleeding during study
Suitable for local and/or general anesthesia
A minimum PBLAC score of ≥ 150 for three months prior to study enrollment; OR PBLAC score 150 for one month for women who 1) had at least 3 (documented) prior months of failed medical therapy; 2) had a contraindication to medical therapy; or 3) refused medical therapy
Uterine cavity sound measurement ≥ 4 cm and ≤ 10 cm.

Exclusion criteria

Presence of bacteriaemia, sepsis, or other active systemic infection
Active pelvic inflammatory disease
Clotting defects or bleeding disorders
Unwillingness to use a non-hormonal birth control post-ablation
Desire for future fertility
Abnormal cavity as confirmed by hysteroscopy, transvaginal ultrasound or HSG e.g. large fibroids, septum etc. Small submucosal fibroids defined as < 2 cm are in this context not considered abnormal.
Any condition leading to possible uterine wall weakness with total wall thickness < 15 mm e.g. at c.section, postmyomectomy scars etc. In case of uniform uterine wall the wall thickness at the fundus should be measured.
Premalignant or malignant uterine condition within the last five years as confirmed by histology
Pregnancy
Cervical length > 6 cm.
Uterine cavity >30 ml defined as balloon can be filled with 30ml glucose solution without reaching the target pressure of 240 mmHg. (These patients may still be treated as planned but will be withdrawn from the study and their data will be analysed separately. The patients will be recorded as screening failures).
Previous ablation or subtotal hysterectomy