Recruiting

PLLA

Sponsor:

Cassandra Kisby

Code:

NCT07544667

Conditions

Pelvic Organ Prolapse (POP)

Cystocele

Pelvic Floor Disorder

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Poly-L-Lactic Acid (Sculptra) injection

Placebo injection (sterile water)

Study Details

Brief summary:

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.

Conditions

Pelvic Organ Prolapse (POP)

Cystocele

Pelvic Floor Disorder

Study ID

NCT07544667

Start date

Aug 20, 2026

Status verified date

Aug, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PLLA (Sculptra) Injection

Participants will receive three injections of PLLA, one per month, in the tissues of the front wall of the vagina

placebo comparator: Control Injection

Participants will receive three injections of sterile water, one per month, in the tissues of the front wall of the vagina

Interventions

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

Placebo injection (sterile water)

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

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Cassandra Kisby, MD MS FACOG FACS

9194011000cassandra.kisby@duke.edu

Duke Urogynecology Clinical Research Coordinators

urogyn_research@duke.edu

Locations

Duke Urogynecology, Patterson Place

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Duke Urogynecology Clinical Research Coordinators

9194011000urogyn_research@duke.edu

More Information

Sponsor

Cassandra Kisby

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

  • regenerative medicine
  • biostimulant
  • tissue regeneration
  • pelvic floor disorder
  • pelvic organ prolapse
  • cystocele

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cassandra Kisby on 2026-08-21.