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NCT06122363 Clinical Trial

Impact of Incomplete Endometrial Ablation

Heavy Menstrual Bleeding Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT06122363
Other study ID # Incomplete Novasure ablation
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date March 1, 2023
Est. completion date December 30, 2023

Study information
Verified date December 2023
Source Maxima Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 121
Est. completion date December 30, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers
Gender Female
Age group 34 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• hysteroscopy
uterine hysteroscopy right after Novasure endometrial ablation

Locations
Country Name City State
Netherlands Máxima MC Veldhoven Noord-Brabant

Sponsors (1)
Lead Sponsor Collaborator
Maxima Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Other 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
Primary 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 Rate of reintervention Surgical and Medical reintervention 24 months
Secondary Dysmennorrhea Presence of dysmennorrhea. Categorized as absence, mild, moderate and severe. 24 months
Secondary Number of patients having controlled bleeding Pictorial Blood Assessment Chart (PBAC) score less than 75. 24 months
Secondary 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
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