Poly-L-Lactic Acid for Vulvovaginal Tissue Regeneration
United States20 participantsStarted 2026-07
Plain-language summary
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 can participate
Age range
21 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \> 21
* Stage II POP of anterior vaginal wall (Ba ≥ -1)
* Symptomatic bulge symptoms
* Positive response to PFDI-20 question 3: Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?
* AND any degree of bother. Providing any answer other than "not at all" to "how much does this bother you"
* Abstinent, on contraception, or postmenopausal at time of injection
* Must read or understand English
Exclusion Criteria:
* Concurrent apical or posterior prolapse \> stage 1
* Prior pelvic radiation
* Previous vaginal reconstructive surgery (Except total vaginal hysterectomy or sling)
* History of chronic vaginal infections (ex. Sexually transmitted infection or bacterial vaginosis)
* Prior vaginal laser treatment \< 6 months
* Planned vaginal laser/topical treatment
* History of hypertrophic reaction to vicryl (polyglactin-910)
* Allergy to Sculptra aesthetic or any components of Sculptra (PLLA, carboxymethylcellulose, non-pyrogenic mannitol)
* Allergy to silicone
* Premenopausal without contraception or abstinence during treatment phase
* Currently breastfeeding
* Connective tissue disorder
* Uncontrolled diabetes (defined as HbA1c \> 8)
* Does not read or understand English
* Inability to provide informed consent
* Physical limitations that would prevent subjects from performing the required pelvic wand massage sessions after each injection, such as significant arthritis or other mobility limitations.
* Pres…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of adverse events between groups
Timeframe: We will measure AEs 2 weeks after each of the three injections, and at in-person study visits (last being 9 months)