What this study is
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.
What's being tested
- Poly-L-Lactic Acid (Sculptra) injection
Intervention · DEVICE
Sculptra will be diluted in 8mL of sterile water and 1mL of lidocaine and injected across the anterior/ventral vagina
- Placebo injection (sterile water)
Intervention · OTHER
8mL of sterile water will be combine with 1mL of lidocaine for injection in the anterior/ventral vagina
Study details
- Official title
- Intravaginal Injection of Poly-L-Lactic Acid for Treatment of Cystocele: A Randomized Trial
- Sponsor
- Cassandra Kisby
- Conditions
- Pelvic Organ Prolapse (POP) · Cystocele · Pelvic Floor Disorder
- Enrolling
- 20 people
- Starts
- 2026-08-20
- Est. completion
- 2028-07
- Design
- Triple-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 21 Years and overSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openDuke Urogynecology, Patterson Place
Durham, North Carolina, United States
- Duke Urogynecology Clinical Research Coordinators · Contact9194011000urogyn_research@duke.edu
Recruiting
Study team
Sponsor
Cassandra Kisby
Study ID Pro00118936
Principal investigator
Cassandra Kisby, MD MS FACOG FACS
Duke University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.