Poly-L-lactic acid injections for vulvovaginal tissue regeneration

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.