Caribbean Medical Journal (Jun 2022)
Transvaginal Low Intensity Shockwave Therapy in Endometriosis (T-LISTE): Protocol for a Randomised pilot trial
Abstract
Background Endometriosis is a common disorder in women of childbearing age. Standard medical and surgical treatments are not always satisfactory. Shockwave therapy has been suggested as a possible novel treatment. There are no clinical data however to support this approach. This article describes the research protocol for a pilot interventional trial aiming to evaluate transvaginal low intensity shockwave therapy in women with endometriosis. Methods Adult women (anticipated N = 64) suffering from endometriosis will be recruited in a general gynaecology clinic and randomly allocated in a 1:1 ratio to an intervention group and a control group (parallel group design). The intervention group will receive 4 weekly sessions of transvaginal low intensity radial shockwave therapy. The control group will receive 4 sham procedures. The group allocation will be blinded to the patients but not to caregivers or data analysts (single blinded). Assessment will be carried at 1, 3 and 6 months. The primary endpoint is the visual analogue score for pelvic pain (dysmenorrhea, chronic pelvic pain, dysuria, dyschezia) and the deep dyspareunia score. Conclusion This prospective monocentric single blinded randomised controlled pilot trial will assess transvaginal low intensity shockwave therapy as a novel treatment for endometriosis.
