NCT06122363

Impact of Incomplete Endometrial Ablation

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 121 (estimated)
• Sponsor: Maxima Medical Center · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Heavy Menstrual Bleeding

Interventions

Type	Name	Description
DEVICE	hysteroscopy	uterine hysteroscopy right after Novasure endometrial ablation

Timeline

• Start date: 2023-03-01
• Primary completion: 2025-08-01
• Completion: 2025-12-30
• First posted: 2023-11-08
• Last updated: 2025-06-12

Locations

1 site across 1 country: Netherlands