Efficacy and safety of a novel pain management device, AT-04, for endometriosis-related pain: study protocol for a phase III randomized controlled trial

Table 1 Secondary outcomes in this study

Outcomes		Evaluation tools	Time points
Efficacy for pain	Pelvic pain	NRS score	Comparison baseline* with 4, 8, 12, and 20 weeks after treatment initiation
	Pain during menstruation#	NRS score by ePRO^$	From treatment initiation to end of treatment
	Pain other than menstruation	NRS score by ePRO^$	From treatment initiation to end of treatment
	Chronic pelvic pain not related to menstruation, dysmenorrhea, and dyspareunia	Biberoglu & Behrman (B&B) scale	Comparison baseline* with 4,8,12, and 20 weeks after treatment initiation
Quality of life		Endometriosis Health Profile-30 (EHP-30) score	Comparison baseline* with 4, 8, 12, and 20 weeks after treatment initiation
		Health-related quality of life (EQ-5D)	Comparison baseline* with 4, 8, 12, and 20 weeks after treatment initiation
Efficacy for endometriosis lesions	Size of ovarian endometriotic cysts	Transvaginal ultrasound	Comparison baseline* with 16 weeks after treatment initiation**
Safety of the device	The frequency and proportion of malfunctions and adverse events in the test device

ISSN: 1742-4755