Poly-L-Lactic Acid for Vulvovaginal Tissue Regeneration

Official title

Intravaginal Injection of Poly-L-Lactic Acid for Treatment of Cystocele: A Randomized Trial

Overview

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)]

Secondary outcome measures (8)

• Pelvic Organ Prolapse Quantification Point Ba Between Groups [Time frame: 9 months]
• Patient Reported Pelvic Symptoms (PFDI-20) [Time frame: 9 months]
• Patient Reported Pelvic Symptoms (Vaginal health) [Time frame: 9 months]
• Patient Reported Pelvic Symptoms (Sexual function) [Time frame: 9 months]
• Patient Reported Pelvic Symptoms (Body Image) [Time frame: 9 months]
• Quality of Life Questionnaires (SF-12) [Time frame: 9 months]
• Quality of Life Questionnaires (PFIQ-7) [Time frame: 9 months]
• Tissue Histology [Time frame: 6 months]

Eligibility criteria

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.
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Duke Urogynecology, Patterson Place — Durham

Publications

• Sculptra. Poly-L-Lactic Acid. Galderma. https://www.galderma.com/au/sites/default/files/Sculptra%20IFU_Aug21.pdf
• Haykal D, Haddad A, Cartier H, Avelar L. Poly-L-Lactic Acid in Aesthetic Dermatology: A Decade Beyond Volume Restoration Toward Regenerative Biostimulation. Aesthet Surg J. 2025 Sep 16;45(10):1065-1072. doi: 10.1093/asj/sjaf121. PMID 40580932
• U.S. Food and Drug Administration. Sculptra: P030050/S039. FDA website. Accessed September 28, 2025. https://www.fda.gov/medical-devices/recently-approved-devices/sculptra-p030050s039
• Jelovsek JE, Maher C, Barber MD. Pelvic organ prolapse. Lancet. 2007 Mar 24;369(9566):1027-38. doi: 10.1016/S0140-6736(07)60462-0. PMID 17382829

Identifiers

NCT: NCT07544667 · Pro00118936 · K12AR084231-25

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗