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NCT Number: NCT07544667

Poly-L-Lactic Acid for Vulvovaginal Tissue Regeneration

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.

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Key information

Conditions

Pelvic Organ Prolapse (POP) Cystocele Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Floor Disorder Pelvic Floor Disorders Pelvic Organ Prolapse Pregnancy Complications Prolapse Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Duke Urogynecology, Patterson Place

Durham, North Carolina, 27710, United States

Location contact

Duke Urogynecology Clinical Research Coordinators

CONTACT

[email protected]

9194011000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: PLLA

Placebo injection (sterile water)

Other

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. Pelvic Organ Prolapse Quantification Point Ba Between Groups

    Time frame: 9 months

    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.

  2. Patient Reported Pelvic Symptoms (PFDI-20)

    Time frame: 9 months

    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)

  3. Patient Reported Pelvic Symptoms (Vaginal health)

    Time frame: 9 months

    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.

  4. Patient Reported Pelvic Symptoms (Sexual function)

    Time frame: 9 months

    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.

  5. Patient Reported Pelvic Symptoms (Body Image)

    Time frame: 9 months

    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.

  6. Quality of Life Questionnaires (SF-12)

    Time frame: 9 months

    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.

  7. Quality of Life Questionnaires (PFIQ-7)

    Time frame: 9 months

    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.

  8. Tissue Histology

    Time frame: 6 months

    The investigators will evaluate histology (tissue) level changes between groups via a vaginal biopsy at baseline and at 6 months.

Study contacts

Contact information is provided by the study sponsor or research team.

Cassandra Kisby, MD MS FACOG FACS

CONTACT

[email protected]

9194011000

Duke Urogynecology Clinical Research Coordinators

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Cassandra Kisby

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 22, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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