Poly-L-Lactic Acid for Pelvic Organ Prolapse
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Cassandra Kisby, MD MS FACOG FACS
Principal Investigator
Duke University
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive three injections of PLLA or placebo, one per month, in the tissues of the front wall of the vagina
Follow-up
Participants are monitored for safety and effectiveness after treatment, including adverse events and pelvic organ prolapse quantification
What Are the Treatments Tested in This Trial?
Interventions
- Poly-L-Lactic Acid
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive three injections of PLLA, one per month, in the tissues of the front wall of the vagina
Participants will receive three injections of sterile water, one per month, in the tissues of the front wall of the vagina
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cassandra Kisby
Lead Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
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