Poly-L-Lactic Acid for Vulvovaginal Tissue Regeneration

NCT07544667 | Recruiting DMC FDA Device

• 2 other identifiers: Pro00118936K12AR084231-25
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

regenerative medicine; biostimulant; tissue regeneration; pelvic floor disorder; pelvic organ prolapse; cystocele

Outcome Measures

Primary Outcomes (1)

• Number of adverse events between groups

  The investigators will assess the number of adverse events between groups using Clavien Dindo classification system (Grade I-V)

  We will measure AEs 2 weeks after each of the three injections, and at in-person study visits (last being 9 months)

Secondary Outcomes (8)

• Pelvic Organ Prolapse Quantification Point Ba Between Groups

  9 months

• Patient Reported Pelvic Symptoms (PFDI-20)

  9 months

• Patient Reported Pelvic Symptoms (Vaginal health)

  9 months

• Patient Reported Pelvic Symptoms (Sexual function)

  9 months

• Patient Reported Pelvic Symptoms (Body Image)

  9 months

Study Arms (2)

PLLA (Sculptra) Injection

EXPERIMENTAL

Participants will receive three injections of PLLA, one per month, in the tissues of the front wall of the vagina

Device: Poly-L-Lactic Acid (Sculptra) injection

Control Injection

PLACEBO COMPARATOR

Participants will receive three injections of sterile water, one per month, in the tissues of the front wall of the vagina

Other: Placebo injection (sterile water)

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

Also known as: PLLA

PLLA (Sculptra) Injection

Placebo injection (sterile water) OTHER

8mL of sterile water will be combine with 1mL of lidocaine for injection in the anterior/ventral vagina

Control Injection

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cassandra Kisby: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Duke Urogynecology, Patterson Place

Durham, North Carolina, 27710, United States

RECRUITING

Related Publications (4)

• Sculptra. Poly-L-Lactic Acid. Galderma. https://www.galderma.com/au/sites/default/files/Sculptra%20IFU_Aug21.pdf

  BACKGROUND

• Haykal D, Haddad A, Cartier H, and Avelar L. Poly-L-Lactic Acid in Aesthetic Dermatology: A Decade Beyond Volume Restoration Toward Regenerative Biostimulation. Aesthet Surg J. 2025;45(10):1065-1072.

  BACKGROUND

• 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

  BACKGROUND

• Jelovsek, EJ, Maher, C, Barber, MD. Pelvic Organ Prolapse. Lancet. 369(9566): 1027-1038

  BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse; Cystocele; Pelvic Floor Disorders

Interventions

Injections

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pregnancy Complications

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Cassandra Kisby, MD MS FACOG FACS

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cassandra Kisby, MD MS FACOG FACS

CONTACT

9194011000; cassandra.kisby@duke.edu

Duke Urogynecology Clinical Research Coordinators

CONTACT

urogyn_research@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 22, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)