Hologic NovaSure Advanced - Page 9

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Table 3. Effectiveness: Success Rates–Intent-To-Treat Patients
NovaSure
(n=175)
Wire Loop Resection
Plus Rollerball
(n=90)
Months post ablation 12* 24** 36** 12* 24** 36**
Number of
successful patients 136 143 134 67 68 63
Study success rate 77.7% 81.7% 76.6% 74.4% 75.6% 70.0%
# of patients with
Amenorrhea 63 64 58 29 26 23
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
Wire Loop Resection
Plus Rollerball
Number of Patients Responding to Quality of Life Questionaire
#
Pre-operatively 175 90
12 Months 154 82
24 Months 143 73
36 Months 139 67
Percent of Patients Satisified Or Very Satisified
12 Months 92.8% 93.9%
24 Months 93.9% 89.1%
36 Months 96.3% 89.7%
Percent of Patients Who Probably Or Definitely Would Recommend
This Procedure
12 Months 96.7% 95.9%
24 Months 96.6% 94.5%
36 Months 97.8% 92.6%
Percent of Patients with Dysemenorrhea
Pre-operatively 57.1% 55.6%
12 Months 20.8%
&
34.2%
*,&
24 Months 20.3%* 30.1%*
36 Months 17.3%* 28.4%*
Percent of Patients with PMS
Pre-operatively 65.1% 66.7%
12 Months 36.4%* 35.4%*
24 Months 44.0%* 46.6%*
36 Months 34.5%* 41.2%*
Percent of Patients Reporting Sometimes, Frequently Or Always
Have Difficulty Performing Work Or Other Activities Due to Menses
Pre-operatively 66.3% 65.5%
Table 4. Effectiveness: Quality of Life (QOL)
NovaSure
Wire Loop Resection
Plus Rollerball
12 Months 9.9%* 8.6%*
24 Months 14.5%* 15.0%*
36 Months 16.3%* 13.3%*
Percent of Patients Reporting Sometimes, Frequently Or Always
Feel Anxious Due to Menses
Pre-operatively 74.7% 68.9%
12 Months 23.6%* 18.5%*
24 Months 24.2%* 19.2%*
36 Months 18.7%* 19.1%*
Percent of Patients Reporting Sometimes, Frequently Or Always
Miss Social Activities Due to Menses
Pre-operatively 63.3% 62.2%
12 Months 8.5%* 8.6%*
24 Months 9.0%* 11.1%*
36 Months 8.1%* 10.8%*
# 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
NovaSure
n=175
Wire Loop Resection
Plus Rollerball
n=90
Number of treated patients* 171 88
Procedure time minutes (± SD)
(Device insertion to device
removal)
4.2 ± 3.5** 24.2 ± 11.4**
Procedure time in seconds (±SD)
(Time of energy delivery)
84.0 ± 25.0 ND
#
* See Table 2 for patient accountability
** Statistically significant difference between treatment groups (Student’s t-test; p < 0.05)
#
Not determined