Poly-L-Lactic Acid for Vulvovaginal Tissue Regeneration

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cystocele; Pelvic Floor Disorder; Pelvic Organ Prolapse (POP)
• Intervention / Treatment: Device: Poly-L-Lactic Acid (Sculptra) injection; Other: Placebo injection (sterile water)

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cassandra Kisby, MD MS FACOG FACS; Phone Number: 9194011000; Email: cassandra.kisby@duke.edu
• Study Contact Backup: Name: Duke Urogynecology Clinical Research Coordinators; Email: urogyn_research@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke Urogynecology, Patterson Place
      • Contact: Duke Urogynecology Clinical Research Coordinators; Phone Number: 9194011000; Email: urogyn_research@duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PLLA (Sculptra) Injection; 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; Sculptra will be diluted in 8mL of sterile water and 1mL of lidocaine and injected across the anterior/ventral vagina; Other Names: PLLA
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	Other: Placebo injection (sterile water); 8mL of sterile water will be combine with 1mL of lidocaine for injection in the anterior/ventral vagina

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic Organ Prolapse Quantification Point Ba Between Groups	The investigators will assess Ba (maximum descent of the anterior vaginal wall) values between intravaginal PLLA vs. placebo injection groups at initial visit, 1 month, 2 months, 6 months, and 9 months after injection. They will use linear regression models controlling for baseline Ba.	9 months
Patient Reported Pelvic Symptoms (PFDI-20)	Pelvic Floor Disability Index (PFDI-20) is a short form of the Pelvic Floor Distress Inventory. It is a patient reported outcome measure assessing bowel, bladder, or pelvic symptoms and severity of symptoms. It has a total score ranging from 0 to 300 (higher scores indicate greater distress)	9 months
Patient Reported Pelvic Symptoms (Vaginal health)	Vaginal health: Vulvovaginal Symptoms Questionnaire (VSQ) measures vulvovaginal health via a series of yes and no questions. The total score ranges from 0 to 16 for sexually inactive women and 0 to 20 for sexually active women, with higher scores indicating greater symptom severity.	9 months
Patient Reported Pelvic Symptoms (Sexual function)	Sexual function: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-IR) is used to assess patient reported sexual function in individuals with pelvic floor disorders. Items are generally answered on a 0-4 Likert scale, with higher scores indicating better sexual function for sexually active women and lower impact on sexual inactivity for non-sexually active women.	9 months
Patient Reported Pelvic Symptoms (Body Image)	Body Image in Women with Pelvic Organ Prolapse (BIPOP) is a self-reported outcomes questionnaire used to assess how prolapse affects a woman's body image. It is scored on a 1-5 scale based on 10 items, where higher mean scores (1-5) indicate a worse prolapse-related body image.	9 months
Quality of Life Questionnaires (SF-12)	Global: Short-Form 12 Health Survey (SF-12) uses a scale 0-47. It is scored using complex, weighted algorithms that aggregate 12 items into two main composite scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS). Using norm-based scoring, scores are transformed to have a mean of 50 and a standard deviation of 10, where a score > 50 indicates better-than-average health.	9 months
Quality of Life Questionnaires (PFIQ-7)	Disease specific: urinary, bowel, and prolapse scales of Pelvic Floor Impact Questionnaire (PFIQ-7) evaluates patient reported impact of pelvic organ prolapse on quality of life. s scored by assigning a value from 0 to 3 for each of the seven questions across three subscales (0="Not at all", 3="Quite a bit"). Subscale scores are calculated by obtaining the mean of answered items, then multiplying by to achieve a 0-100 range. The total PFIQ-7 score is the sum of the three subscales (0-300), where lower scores indicate better quality of life.	9 months
Tissue Histology	The investigators will evaluate histology (tissue) level changes between groups via a vaginal biopsy at baseline and at 6 months.	6 months

Collaborators and Investigators

• Sponsor: Cassandra Kisby
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Investigators: Principal Investigator: Cassandra Kisby, MD MS FACOG FACS, Duke University

Publications and helpful links

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

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: April 3, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: pelvic organ prolapse; regenerative medicine; cystocele; tissue regeneration; pelvic floor disorder; biostimulant
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Pathological Conditions, Anatomical; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Urinary Bladder Diseases; Prolapse; Pathological Conditions, Signs and Symptoms; Pelvic Organ Prolapse; Pelvic Floor Disorders; Cystocele; Therapeutics; Drug Administration Routes; Drug Therapy; Injections
• Other Study ID Numbers: Pro00118936; K12AR084231-25 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes