Impact of Incomplete Endometrial Ablation

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Heavy Menstrual Bleeding
• Intervention / Treatment: Device: hysteroscopy

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 121

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Brabant
    • Veldhoven, Noord-Brabant, Netherlands, 5500MB
      • Máxima MC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This retrospective cohort study was carried out using the data of women who participated in the MIRA study and the MIRA2 study including RCT and prospective cohort database. These women have given informed consent for their data to be used for future research into treatments for heavy menstrual bleeding. To be eligible for study inclusion, women had to suffer from heavy menstrual bleeding, and have undergone Novasure endometrial ablation at Máxima MC between January 2012 and July 2023. Women were excluded from the database if the hysteroscopy images were not saved, or these images were of poor quality.

Description

Inclusion Criteria:

• Endometrial ablation between 2012 and 2023 in Máxima Medical Centre
• Women had to suffer from heavy menstrual bleeding

Exclusion Criteria:

- No saved hysteroscopy images or bad quality hysteroscopy images

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Complete Novasure endometrial ablation; After treatment with novasure, the hysteroscopy showed no remains of endometrium, , so a complete novasure endomentrial ablation	Device: hysteroscopy; uterine hysteroscopy right after Novasure endometrial ablation
Incomplete Novasure endometrial ablation; After treatment with novasure, the hysteroscopy showed remains of endometrium, so an incomplete novasure endomentrial ablation	Device: hysteroscopy; uterine hysteroscopy right after Novasure endometrial ablation

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of possible prognostic variables predicting the occurrence of incomplete endometrial ablation.	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	baseline

Collaborators and Investigators

• Sponsor: Maxima Medical Center
• Investigators: Principal Investigator: Marlies M.Y. Bongers, PhD, MD, Maxima Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: November 5, 2023
• First Submitted That Met QC Criteria: November 5, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Actual): June 12, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Hemorrhage; Uterine Hemorrhage; Menstruation Disturbances; Menorrhagia
• Other Study ID Numbers: Incomplete Novasure ablation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No