Poly-L-lactic acid injections for vulvovaginal tissue regeneration
Intravaginal Injection of Poly-L-Lactic Acid for Treatment of Cystocele: A Randomized Trial
This trial will try injections of poly-L-lactic acid (PLLA) versus placebo to see if they strengthen vaginal tissue and reduce bulge symptoms and sexual problems in women with stage II anterior vaginal wall prolapse (cystocele).
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 21 Years and up |
| Sex | Female |
| Sponsor | Duke University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT07544667 on ClinicalTrials.gov |
What this trial studies
This interventional trial compares intravaginal injections of poly-L-lactic acid (PLLA, Sculptra) with placebo (sterile water) in women who have symptomatic stage II anterior vaginal wall prolapse. Participants are adult women (over 21) with a measured Ba point ≥ -1 and report bulge symptoms; they must be abstinent, using contraception, or postmenopausal at the time of injection. The study focuses on safety and preliminary signals of tissue regeneration, vaginal topography, and sexual function after treatment. Procedures and follow-up visits occur at Duke Urogynecology and will monitor adverse events and symptom changes over the study period.
Who should consider this trial
Good fit: Ideal candidates are women over 21 with symptomatic stage II anterior vaginal wall prolapse (Ba ≥ -1), able to be abstinent or using contraception or postmenopausal at injection, and able to read or understand English.
Not a fit: Patients with apical or posterior prolapse greater than stage I, prior pelvic radiation or prior vaginal reconstructive surgery (except total vaginal hysterectomy or sling), chronic vaginal infections, recent or planned vaginal laser/topical treatments, or allergy to Sculptra components are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, injections could strengthen anterior vaginal wall tissue and preserve or improve vaginal sensation and sexual function while avoiding more invasive surgery.
How similar studies have performed: PLLA has an established safety record as a dermatologic biostimulant, but using PLLA for vaginal tissue regeneration in POP is a novel application with limited clinical evidence to date.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Durham, North Carolina
- Duke Urogynecology, Patterson Place — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Cassandra Kisby, MD MS FACOG FACS — Duke University
- Study coordinator: Cassandra Kisby, MD MS FACOG FACS
- Email: cassandra.kisby@duke.edu
- Phone: 9194011000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.