Poly-L-Lactic Acid for Vulvovaginal Tissue Regeneration

Conditions

• Cystocele
• Pelvic Floor Disorder
• Pelvic Organ Prolapse (POP)

Eligibility Criteria

Sex

FEMALE

Age

21 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Poly-L-Lactic Acid (Sculptra) injection — DEVICE
  Sculptra will be diluted in 8mL of sterile water and 1mL of lidocaine and injected across the anterior/ventral vagina
• Placebo injection (sterile water) — OTHER
  8mL of sterile water will be combine with 1mL of lidocaine for injection in the anterior/ventral vagina

Study Details

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.

Key Dates

Start date

Jul 31, 2026

Status verified

Jun 2026

Primary completion

Jun 30, 2027

Completion

Jun 30, 2028

Study Design

Enrollment

20 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: PLLA (Sculptra) Injection
  Participants will receive three injections of PLLA, one per month, in the tissues of the front wall of the vagina
• Placebo Comparator: Control Injection
  Participants will receive three injections of sterile water, one per month, in the tissues of the front wall of the vagina

Primary Outcome Measure

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) ]

Central Contacts

• Cassandra Kisby, MD MS FACOG FACS
  9194011000
  [email protected]
• Duke Urogynecology Clinical Research Coordinators
  [email protected]

Locations (1)

Find similar trials in Durham, NC

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