Could a simple injection replace surgery for pelvic organ prolapse?
NCT ID NCT07544667
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 3 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.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Duke Urogynecology, Patterson Place
RECRUITINGDurham, North Carolina, 27710, United States
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Other studies related to the condition(s) this trial covers.
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- Can a cream improve recovery after prolapse surgery?
- Mind over matter: could breathing and focus during labor shield pelvic floor?