Hologic Nova Sure 08 RF Mode D'emploi Et Manuel page 9

ENGLISH
(described in Table 2 for patient accountability) is counted as a "failure"
for calculating the values listed in the table.
Table 3. Effectiveness: Success Rates–Intent-To-Treat Patients
NovaSure
(n=175)
Months post ablation 12*
Number of
successful patients 136
Study success rate 77.7% 81.7% 76.6% 74.4% 75.6% 70.0%
# of patients with
Amenorrhea 63
Amenorrhea rate 36.0% 36.6% 33.1% 32.2% 28.9% 25.6%
* Based on diary scores
** Based on telephone questionnaires
Secondary effectiveness endpoint: quality of life
Patient quality of life (QOL) was assessed by administering the quality of
life questionnaire (SF-12) and the menstrual impact questionnaire prior
to treatment and at 3, 6, 12, 24 and 36 months post-procedure. Table 4
shows the patient responses for both groups pre-operatively, where
appropriate, and at 12, 24 and 36 months post-procedure.
Table 4. Effectiveness: Quality of Life (QOL)
NovaSure
Number of Patients Responding to Quality of Life Questionaire
Pre-operatively 175
12 Months 154
24 Months 143
36 Months 139
Percent of Patients Satisified Or Very Satisified
12 Months 92.8%
24 Months 93.9%
36 Months 96.3%
Percent of Patients Who Probably Or Definitely Would Recommend
This Procedure
12 Months 96.7%
24 Months 96.6%
36 Months 97.8%
Percent of Patients with Dysemenorrhea
Pre-operatively 57.1%
12 Months 20.8%
24 Months 20.3%*
36 Months 17.3%*
Percent of Patients with PMS
Pre-operatively 65.1%
12 Months 36.4%*
24 Months 44.0%*
36 Months 34.5%*
Wire Loop Resection
Plus Rollerball
(n=90)
24** 36** 12* 24**
143 134 67 68
64 58 29 26
Wire Loop Resection
Plus Rollerball
#
90
82
73
67
93.9%
89.1%
89.7%
95.9%
94.5%
92.6%
55.6%
34.2%
& *,&
30.1%*
28.4%*
66.7%
35.4%*
46.6%*
41.2%*
Table 4. Effectiveness: Quality of Life (QOL)
Percent of Patients Reporting Sometimes, Frequently Or Always
Have Difficulty Performing Work Or Other Activities Due to Menses
Pre-operatively
12 Months
36**
24 Months
36 Months
63
Percent of Patients Reporting Sometimes, Frequently Or Always
Feel Anxious Due to Menses
Pre-operatively
23
12 Months
24 Months
36 Months
Percent of Patients Reporting Sometimes, Frequently Or Always
Miss Social Activities Due to Menses
Pre-operatively
12 Months
24 Months
36 Months
# Not all patients completed questionnaire
* Statistically significant difference from pre-operative response (Chi-Square; p < 0.05)
& Statistically significant difference between NovaSure and Rollerball Groups
(Chi-Square; p = 0.02)
Safety endpoint
Adverse event information is described in the "Adverse Events" section of this manual.
Secondary endpoint: procedure time
Procedure time, a secondary endpoint, was determined for each patient
by recording the time of device insertion and the time of device removal.
The mean procedure time for the NovaSure patients was significantly
less than the procedure time for the rollerball group, (4.2 ± 3.5 minutes
and 24.2 ± 11.4 minutes, respectively). Mean time for application of RF
energy was 84.0 ± 25.0 seconds in a subset of monitored NovaSure
patients (Table 5).
Table 5. Operative Procedure Time
Operative Parameters
Number of treated patients*
Procedure time minutes (± SD)
(Device insertion to device
removal)
Procedure time in seconds (±SD)
(Time of energy delivery)
* See Table 2 for patient accountability
** Statistically significant difference between treatment groups (Student's t-test; p < 0.05)
# Not determined
8
Wire Loop Resection
NovaSure Plus Rollerball
66.3% 65.5%
9.9%* 8.6%*
14.5%* 15.0%*
16.3%* 13.3%*
74.7% 68.9%
23.6%* 18.5%*
24.2%* 19.2%*
18.7%* 19.1%*
63.3% 62.2%
8.5%* 8.6%*
9.0%* 11.1%*
8.1%* 10.8%*
Wire Loop Resection
NovaSure Plus Rollerball
n=175
171
4.2 ± 3.5** 24.2 ± 11.4**
84.0 ± 25.0
n=90
88
ND
#