Poly-L-Lactic Acid for Vulvovaginal Tissue Regeneration

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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
• Другое Placebo injection (sterile water)
  8mL of sterile water will be combine with 1mL of lidocaine for injection in the anterior/ventral vagina

Первичные конечные точки

• Number of adverse events between groups [Срок оценки: We will measure AEs 2 weeks after each of the three injections, and at in-person study visits (last being 9 months)]

Вторичные конечные точки (8)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Duke Urogynecology, Patterson Place — Durham

Публикации

• 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

Идентификаторы

NCT: NCT07544667 · Pro00118936 · K12AR084231-25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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