Impact of Incomplete Endometrial Ablation

Study Overview
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Brief Summary
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The aim of the proposed protocol is to study the impact of incomplete endometrial ablation on the PBAC score, reintervention, satisfaction, controlled bleeding and dysmenorrhea at 24 months after Novasure endometrial ablation, in women with heavy menstrual bleeding treated at Máxima Medical Centre Veldhoven, in The Netherlands.

Detailed Description
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The primary outcome is blood loss at 24 months after treatment, measured with the PBAC-score according to Higham. To calculate this score women were asked, in the MIRA and MIRA2 study, to record their menstrual blood loss for one month counting the number of super tampons or pads used each day. The total score was calculated using a score of 1 for each lightly saturated tampons. For pads the scores were respectively 1, 5 and 20. Secondary outcome measures were controlled bleeding, defined as a PBAC-score not exceeding 75 points, PBAC score of zero, re-intervention rate 24 months after treatment, satisfaction with treatment (measured with a 5-point Likert scale) and dysmenorrhea. In addition, multiple variables were analyzed in predicting the occurrence of incomplete endometrial ablation, including age, BMI, cavum length, cavum width, ablation time, ablation power, nulliparity, sterilization in history, section caesarea in history, position of the uterus (AVF/RVF), presence of myomas, the presence of adenomyosis and surgery under local anesthesia, generally without sterilization or generally in combination with sterilization. Information was collected from EPD and the MIRA and MIRA2 databases.

Official Title
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The Impact of Incomplete Endometrial Ablation on the Success Rate of Novasure Endometrial Ablation

Conditions
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Heavy Menstrual Bleeding

Intervention / Treatment
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* Device: hysteroscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Endometrial ablation between 2012 and 2021 in Máxima Medical Centre Women had to suffer from heavy menstrual bleeding Exclusion Criteria: - No saved hysteroscopy images or bad quality hysteroscopy images

Ages Eligible for Study
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Minimum Age: 34 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Complete Novasure endometrial ablation<br>After treatment with novasure, the hysteroscopy showed no remains of endometrium, , so a complete novasure endomentrial ablation | Device: hysteroscopy<br>* uterine hysteroscopy right after Novasure endometrial ablation<br>|
| Incomplete Novasure endometrial ablation<br>After treatment with novasure, the hysteroscopy showed remains of endometrium, so an incomplete novasure endomentrial ablation | Device: hysteroscopy<br>* uterine hysteroscopy right after Novasure endometrial ablation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pictorial Blood Assessment Chart (PBAC) score | Blood loss of 1 month, measured by the number of needed tampons/pads and how heavily they are filled with blood. The higher the score, the more severe blood loss. From 150 points the amount is defined as heavy menstrual bleeding. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of reintervention | Surgical and Medical reintervention | 24 months | 
| Dysmennorrhea | Presence of dysmennorrhea. Categorized as absence, mild, moderate and severe. | 24 months | 
| Number of patients having controlled bleeding | Pictorial Blood Assessment Chart (PBAC) score less than 75. | 24 months | 
| Satisfaction of the patient with the treatment | Satisfaction measured with a 5-point Likert scale. 1=very unsatisfied, 2= unsatisfied, 3= neutraal, 4= satisfied, 5= very satisfied. | 24 months |