Trials Today

Poly-L-Lactic Acid for Vulvovaginal Tissue Regeneration

Purpose

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

Eligibility

Eligible Ages: Over 21 Years
Eligible Sex: Female
Accepts Healthy Volunteers: No

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

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental PLLA (Sculptra) Injection	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 Sculptra will be diluted in 8mL of sterile water and 1mL of lidocaine and injected across the anterior/ventral vagina Other names: PLLA
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	Other: Placebo injection (sterile water) 8mL of sterile water will be combine with 1mL of lidocaine for injection in the anterior/ventral vagina

Recruiting Locations

More Details

NCT ID: NCT07544667
Status: Not yet recruiting
Sponsor: Cassandra Kisby

Study Contact

Cassandra Kisby, MD MS FACOG FACS
9194011000
cassandra.kisby@duke.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.