Water Vapor Endometrial Ablation for Heavy Menstrual Bleeding: 36-Month Follow-Up of a Prospective, Multicenter Pivotal Clinical Trial

Figures & data

Table 1 Study Subject Disposition

	N
Pivotal Clinical Study ITT Analysis Cohort: Vapor Ablation Attempted	155
No treatment received
Subject did not pass Integrity Test	−2
Subject did not pass Patency Test	−4
Incomplete Treatment	−2
Lost to follow-up	−1
Suicide	−1
Hysterectomy for pain (Ovarian Cyst)	−1
IUD for AUB	−1
Major protocol deviations	−2
12-Month Follow-up Cohort	141
Hysterectomy for AUB^a	−4
Repeat ablation for AUB^a	−1
Laparoscopy, operative hysteroscopy and hysteroscopic ablation for endometriosis^a	−1
Lost to follow-up	−1
Voluntary withdrawal	−1
24-Month Follow-up Cohort	133
Hysterectomy for AUB	−2
Hysterectomy for pelvic pain	−3
Mirena IUD placement for AUB	−2
Lost to follow-up	−2
Subject lost-to-follow-up at 12 and 24 months, returned prior to 36-month follow-up	+1
36-Month Follow-up Cohort	125

Note: ^aAll subjects previously deemed treatment failures at 12-month follow-up.

Table 2 Menstrual Status at 12, 24, and 36 Months Post-Ablation

Menstrual Status	Month 12, N=141	Month 24, N=133	Month 36, N=125
Amenorrhea	20.6% (29)	24.8% (33)	23.2% (29)
Light	46.8% (66)	50.4% (67)	48.8% (61)
Moderate	25.5% (36)	19.5% (26)	22.4% (28)
Heavy	6.4% (9)	3.8% (5)	3.2% (4)
Very Heavy	0.7% (1)	1.5% (2)	2.4% (3)

Figure 1 Menstrual status at 12, 24, and 36 months post-ablation.

Table 3 Quality of Life Improvement (MIQ)

MIQ Score	Baseline (N=141)	Month 12 (N=141)	Month 24 (N=133)	Month 36 (N=125)
Mean ±SD (median)	14.7 ± 2.9 (15.0)	6.6 ±.1.8 (6.0)	6.1 ±.1.7 (6.0)	6.3 ±.1.9 (6.0)
Range (min, max)	(6, 21)	(4, 15)	(4, 16)	(4, 17)
95% CI CI of mean change from baseline		−8.7, −7.6	−9.1, −8.0	−9.0, −7.8

Table 4 Menstrual Status in Subgroups at 36 Months

Menstrual Status at 36-Month Follow-Up	Leiomyoma, N=21	Cavity Length 10–12 cm, N=27	Leiomyoma and Cavity Length 10–12 cm, N=3	Essure Only, N=5
Amenorrhea	28.6% (6/21)	25.9% (7/27)	0	20% (1/5)
Light	47.6% (10/21)	48.1% (13/27)	67% (2/3)	80% (4/5)
Moderate	23.8% (5/21)	11.1% (3/27)	33% (1/3)	0
Heavy	0	7.4% (2/27)	0	0
Very Heavy	0	7.4% (2/27)	0	0