Poly-L-Lactic Acid for Vulvovaginal Tissue Regeneration

Pelvic organ prolapse (POP) is a condition characterized by descent of vaginal walls, uterus and cervix, or the perineum and causes a sensation of vaginal bulge and pelvic pressure. Millions of women in the United States are affected, and the number is expected to rise significantly in the coming decades. Current treatments either involve conservative measures or surgery. Surgery may lead to changes in vaginal topography and scar tissue, both of which impact sexual function. There are no treatment options that restore vaginal tissue strength and preserve, even optimize, sensation and blood flow to the vagina. This project will evaluate the use of poly-L-lactic acid (PLLA), an FDA-approved biostimulant for dermatologic use with an expansive safety profile over the past decade, in the treatment of anterior wall POP and its impact on sexual function. Our study will compare intravaginal injection of PLLA vs. placebo in women with stage 2 cystocele and investigate safety and preliminary efficacy of PLLA. Prior study of regenerative biologics for the vulva and vagina have shown great promise, but use of these has not been explored for POP. This randomized controlled trial has the potential to shift the paradigm of prolapse management from surgical reconstruction to regeneration. This shift will prevent the risks of surgery and has the potential to improve sexual function and quality of life by resolving POP.

NCT Number	NCT07544667
Lead Sponsor	Cassandra Kisby Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions	Pelvic Organ Prolapse (POP), Cystocele, Pelvic Floor Disorder
Enrollment	20 participants
Start Date	2026-08
Primary Completion	2027-06 (estimated)
Study Completion	2028-06 (estimated)
Updated on ClinicalTrials.gov	2026-08-05