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Could a simple injection replace surgery for pelvic organ prolapse?

NCT ID NCT07544667

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

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

21 years and older

Sex

Female participants only

Healthy volunteers

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

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.

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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Duke Urogynecology, Patterson Place

    RECRUITING

    Durham, North Carolina, 27710, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.