NCT07544667 · Cassandra Kisby
Poly-L-Lactic Acid for Vulvovaginal Tissue Regeneration
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Poly-L-Lactic Acid (Sculptra) injection
Sculptra will be diluted in 8mL of sterile water and 1mL of lidocaine and injected across the anterior/ventral vagina
OTHER
Placebo injection (sterile water)
8mL of sterile water will be combine with 1mL of lidocaine for injection in the anterior/ventral vagina
Primary outcome measures
Number of adverse events between groups
Time frame: We will measure AEs 2 weeks after each of the three injections, and at in-person study visits (last being 9 months)
The investigators will assess the number of adverse events between groups using Clavien Dindo classification system (Grade I-V)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
- Prescription anticoagulation therapy that cannot be safely discontinued (Aspirin and anti-platelet therapies would be considered acceptable)
- Current use of other treatments for prolapse, such as pessary, in subjects who are unwilling to discontinue these treatments during the study period.
- Planning to start pelvic floor physical therapy during the study
- Undergoing physical therapy and not willing to stop internal therapy for 2 weeks after an injection or biopsy
Where
- Durham, North Carolina
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 21, 2026 · Source of record for eligibility and locations