Hologic Nova Sure 08 RF Mode D'emploi Et Manuel page 8

wire loop resection of the endometrium as a mechanical means of
endometrial pretreatment followed by rollerball ablation. Study subjects
were required to meet the following key patient selection criteria:
Inclusion criteria
• Refractory menorrhagia with no definable organic cause (dysfunctional
uterine bleeding)
• Ages 25 to 50 years of age
• Uterine sound measurement of 6.0–10.0 cm (external os to internal
fundus)
• Minimum PBLAC score of >150 for 3 months prior to study enrollment;
or PBLAC score >150 for one month for women who:
- had at least 3 prior months (documented) failed medical therapy;
- had a contraindication to medical therapy; or
- refused medical therapy.
Exclusion criteria
• Presence of bacteremia, sepsis or other active systemic infection
• Active or recurrent chronic pelvic inflammatory disease
• Patient with documented coagulopathies or on anticoagulants
• Symptomatic endometriosis
• Prior uterine surgery (except low segment cesarean section)
that interrupts the integrity of the uterine wall e.g., transmural
myomectomy or classical cesarean section
• Prior endometrial ablation
• Patient on medications that could thin the myometrial muscle, such as
long-term steroid use
• Patient desire to have children or to preserve fertility
• Patient currently on hormonal birth control therapy or unwilling to use
a non-hormonal birth control post-ablation
• Abnormal/obstructed cavity as confirmed by hysteroscopy, SIS or HSG.
Specifically:
- septate or bicornuate uterus or other congenital malformation of the
uterine cavity
- pedunculated, submucous leiomyomata or other leiomyomata which
distort the cavity; polyps (larger than 2 cm) which are likely to be the
cause of the patient's menorrhagia
- presence of an IUD
• Suspected or confirmed uterine malignancy within the last five years
as confirmed by histology
• Endometrial hyperplasia as confirmed by histology
• Unaddressed cervical dysplasia
• Elevated FSH levels consistent with ovarian failure >40 IU/ml
• Pregnancy
• Active sexually transmitted disease
Patient population: A total of 265 patients were enrolled in this study.
Patients were between the ages of 25 to 50 with 46% under the age
of 40 and 54% 40 years of age or older. There were no differences in
demographic or gynecological history parameters between the treatment
groups, between the age groupings or among the nine investigational sites.
Table 2. Patient Accountability
Number of Patients
Entered into Study
(Intent-to-Treat population)
Aborted procedures* 1
Treated
Additional treatment*
Hysterectomy*
2
Lost to follow-up*
Hodgkin's disease*
Pelvic Pain - administered
leuprolide*
12-Month
follow-up data available
Additional treatment*
Hysterectomy*
2
Lost to follow-up*
Missed visit
Declined to participate*
Pregnancy*
24-Month
follow-up data available
Additional treatment*
Hysterectomy*
2
Lost to follow-up*
36-Month follow-up
Subject lost to follow-up at
24 mos., returned at 36 mos.
36-Month follow-up data
available
* Discontinued patients
Four NovaSure did not meet protocol Inclusion Criteria; Two Rollerball had uterine perforation
1
2 For hysterectomy, see Table 7
Results
Primary effectiveness endpoint: bleeding score
Patient success at 12-months post-procedure is defined as a reduction
in diary score from >150 pre-operatively to <75 post-procedure.
Amenorrhea is defined as a score of 0. Success at 24 and 36 months,
based on telephone questionnaires, is defined as elimination of bleeding
or reduction to light or normal flow. Data presented in Table 3 (below)
represent the clinical results based on the total number of 265 patients
randomized (Intent-to-Treat group (ITT)) for the study. The worst-case
scenario is presented whereby each of the discontinued patients
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ENGLISH
NovaSure Wire Loop
Resection
Plus Rollerball
175 90
-4 -2
171 88
-4 -2
-3 -2
-5 -2
-1 0
-1 0
157 82
-2 -1
-3 -1
-2 -5
-1 -1
-1 0
-1 0
147 74
0 -4
-5 -1
-4 -2
138 67
+1 +1
139 68