An interventional study of Poly-L-Lactic Acid (Sculptra) injection and Placebo injection (sterile water) in Pelvic Organ Prolapse (POP), Cystocele and Pelvic Floor Disorder, sponsored by Cassandra Kisby. Recruiting at 1 site in United States. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Cassandra Kisby · Not applicable, Interventional, and Treatment
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.
Symptomatic bulge symptoms
Exclusion Criteria:
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
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)
Sculptra will be diluted in 8mL of sterile water and 1mL of lidocaine and injected across the anterior/ventral vagina
Also known as: PLLA
8mL of sterile water will be combine with 1mL of lidocaine for injection in the anterior/ventral vagina
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)
Time frame: We will measure AEs 2 weeks after each of the three injections, and at in-person study visits (last being 9 months)
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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 9 months
Tissue Histology
The investigators will evaluate histology (tissue) level changes between groups via a vaginal biopsy at baseline and at 6 months.
Time frame: 6 months
Plan to share: No
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