A RANDOMISED CONTROLLED TRIAL COMPARING BALLOON ENDOMETRIAL ABLATION (THERMABLATE) VERSUS BIPOLAR ENDOMETRIAL ABLATION (NOVASURE) IN THE OUTPATIENT CLINIC WITH LOCAL ANESTHESIA

Completed

Conditions: heavy menstrual bleeding
menorrhagia
10013326

Registration Number: NL-OMON34001

Lead Sponsor: Máxima Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 160

Inclusion Criteria

Refractory menorraghia ;Uterine sound measurement of 6.0 - 12 cm ;Failed, contraindicated or intolerance to conservative therapy. ;Menstrual Diary A minimum score of >150 for 1 months ;Willing to undergo the treatment under local anesthesia in the outpatient clinic

Exclusion Criteria

3.2.2.1 Presence of bacteremia, sepsis, or other active systemic infection;3.2.2.2 Active or recurrent chronic pelvic inflammatory disease ;3.2.2.3 Prior uterine surgery (except low segment cesarean section) which interrupts the integrity of the uterine wall e.g., transmural myomectomy or classical cesarean section. Prior endometrial ablations.;3.2.2.4 Desire to preserve fertility ;3.2.2.5 Abnormal/Obstructed Cavity as confirmed by hysterscopy, Saline Infused Sonography (SIS) ;3.2.2.6 Suspected or confirmed uterine malignancy or confirmed uterine malignancy within the last five years as confirmed by histology );3.2.2.7 Endometrial hyperplasia as confirmed by histology ;3.2.2.8 Unaddressed cervical dysplasia;3.2.2.9 Elevated FSH levels consistent with ovarian failure ( > 40 IU/ml) ;3.2.2.10 Active sexually transmitted disease

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Objective Evaluate the effectiveness of Device procedure compared to<br /><br>in achieving amenorrhea at twelve months post-treatment for menorrhagia<br /><br>secondary to DUB </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Evaluate and compare pain and acceptability scores of the hot fluid balloon<br /><br>ablation (Thermablate) procedure and the Novasure Endometrial Ablation<br /><br>procedure as an outpatient treatment. </p><br>