Could a simple injection replace surgery for pelvic organ prolapse?

NCT ID NCT07544667

First seen Jun 27, 2026 · Last updated Aug 06, 2026 · Updated 2 times

Summary

This study tests whether injecting poly-L-lactic acid (PLLA), a substance already used in cosmetic treatments, into the vaginal wall can safely and effectively treat cystocele (a type of pelvic organ prolapse). Twenty women with stage 2 cystocele will receive either PLLA or a placebo injection. The goal is to see if this non-surgical approach can strengthen vaginal tissue, reduce bulge symptoms, and improve sexual function, potentially offering an alternative to surgery.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
Poly-L-Lactic acid (PLLA, Sculptra) injection
What this could lead to
If it works, this could offer a non-surgical option to strengthen vaginal tissue and relieve bulge symptoms from cystocele, potentially improving sexual function and quality of life.
What could go wrong
This is a very small, early-stage trial with only 20 participants, so results may not apply to everyone. The treatment is not yet proven for this use, and there is a risk of side effects or no benefit compared to placebo.

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Conditions

The condition(s) this trial relates to.

Cystocele lateral cystocele Pelvic Floor Disorders pelvic organ prolapse

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Duke Urogynecology, Patterson Place

    Durham, North Carolina, 27710, United States

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