Endometrial Tissue Ablation, a clinical trial. Hydrotherm vs. Novasure

Phase 4

Completed

• Conditions: heavy menstruation; hypermenorrhoea; 10029903

• Registration Number: NL-OMON30019
• Lead Sponsor: Máxima Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

Dysfunctional uterine bleeding
Uterine sound measurements of 6.0-12.0 cm
Failed, contraindicated or intolerance to conservative (medical) therapy

Exclusion Criteria

Desire to have children or preserve fertility
Abnormal/ obstructed uterine cavity

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Quality of life, measured by questionnaires filled in by the patient<br /><br>pre-operative, 4 weeks, 6 and 12 months after treatment. Questionnaires contain<br /><br>Short Form 36 and a structured clinical history questionnaire. Patients<br /><br>satisfaction is measured by using a visual analogue scale.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Amenorrhoea. Using a pictorial chart in every questionnaire.</p><br>