Poly-L-Lactic Acid for Vulvovaginal Tissue Regeneration
ClinicalTrials.gov Studies
Summary
A randomized controlled trial (NCT07544667) has been registered on ClinicalTrials.gov to evaluate poly-L-lactic acid (Sculptra), an FDA-approved biostimulant, for the treatment of anterior wall pelvic organ prolapse (stage 2 cystocele) in women. The study will compare intravaginal PLLA injection versus placebo and will investigate safety and preliminary efficacy, including impact on sexual function. The trial plans to enroll women with stage 2 cystocele and follow them to assess whether regenerative biologics can shift prolapse management from surgical reconstruction to tissue regeneration.
“Millions of women in the United States are affected, and the number is expected to rise significantly in the coming decades.”
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What changed
A new clinical trial registration (NCT07544667) has been entered into ClinicalTrials.gov by NIH-affiliated investigators, evaluating poly-L-lactic acid (Sculptra) for vulvovaginal tissue regeneration in women with pelvic organ prolapse. The randomized controlled trial will compare intravaginal PLLA injection against placebo in women with stage 2 cystocele, with a primary focus on safety and preliminary efficacy, including effects on sexual function. The study is notable for its exploration of regenerative biologics as a potential alternative to surgical reconstruction for prolapse management.
Affected parties include clinical investigators conducting urogynecologic research, pharmaceutical manufacturers of biostimulant products, and healthcare providers specializing in pelvic floor disorders. The trial registration represents an addition to the clinical research landscape rather than a compliance obligation; it signals emerging interest in tissue-regeneration approaches for prolapse and may inform future off-label use or supplemental indications for FDA-approved biostimulants.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Poly-L-Lactic Acid for Vulvovaginal Tissue Regeneration
N/A NCT07544667 Kind: NA Apr 22, 2026
Abstract
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.
Conditions: Pelvic Organ Prolapse (POP), Cystocele, Pelvic Floor Disorder
Interventions: Poly-L-Lactic Acid (Sculptra) injection, Placebo injection (sterile water)
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