Poly-L-Lactic Acid for Vulvovaginal Tissue Regeneration (NCT07544667)
Intravaginal Injection of Poly-L-Lactic Acid for Treatment of Cystocele: A Randomized Trial
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (21 items).
Location: Duke Urogynecology, Patterson Place — Durham, North Carolina
Age range: 21 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Duke Urogynecology, Patterson Place — Durham, North Carolina
📞 Contact the Study Coordinator
Phone: (919) 401-1000
Email: cassandra.kisby@duke.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Pelvic Organ Prolapse (POP)
- Suzetrigine for Opioid-Sparing Postoperative Analgesia Following Transvaginal Pelvic Reconstructive Surgery — Los Angeles, California
- Vaginal Estrogen for Improvement of Outcomes Following Pelvic Organ Prolapse Surgery — St. John's, Newfoundland and Labrador
- Evaluation of a Personalizable Pessary for Pelvic Organ Prolapse — Edmonton, Alberta
Explore by condition: All Pelvic Organ Prolapse (POP) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.