Poly-L-Lactic Acid for Vulvovaginal Tissue Regeneration

June 2, 2026 updated by: Cassandra Kisby

Intravaginal Injection of Poly-L-Lactic Acid for Treatment of Cystocele: A Randomized Trial

Pelvic organ prolapse (POP) is a condition characterized by descent of vaginal walls, uterus and cervix, or the perineum and causes a sensation of vaginal bulge and pelvic pressure. Millions of women in the United States are affected, and the number is expected to rise significantly in the coming decades. Current treatments either involve conservative measures or surgery. Surgery may lead to changes in vaginal topography and scar tissue, both of which impact sexual function. There are no treatment options that restore vaginal tissue strength and preserve, even optimize, sensation and blood flow to the vagina. This project will evaluate the use of poly-L-lactic acid (PLLA), an FDA-approved biostimulant for dermatologic use with an expansive safety profile over the past decade, in the treatment of anterior wall POP and its impact on sexual function. Our study will compare intravaginal injection of PLLA vs. placebo in women with stage 2 cystocele and investigate safety and preliminary efficacy of PLLA. Prior study of regenerative biologics for the vulva and vagina have shown great promise, but use of these has not been explored for POP. This randomized controlled trial has the potential to shift the paradigm of prolapse management from surgical reconstruction to regeneration. This shift will prevent the risks of surgery and has the potential to improve sexual function and quality of life by resolving POP.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Urogynecology, Patterson Place
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PLLA (Sculptra) Injection
Participants will receive three injections of PLLA, one per month, in the tissues of the front wall of the vagina
Device: Poly-L-Lactic Acid (Sculptra) injection
Sculptra will be diluted in 8mL of sterile water and 1mL of lidocaine and injected across the anterior/ventral vagina
Other Names:
  • PLLA
Placebo Comparator: Control Injection
Participants will receive three injections of sterile water, one per month, in the tissues of the front wall of the vagina
Other: Placebo injection (sterile water)
8mL of sterile water will be combine with 1mL of lidocaine for injection in the anterior/ventral vagina

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of adverse events between groups
Time Frame: We will measure AEs 2 weeks after each of the three injections, and at in-person study visits (last being 9 months)
The investigators will assess the number of adverse events between groups using Clavien Dindo classification system (Grade I-V)
We will measure AEs 2 weeks after each of the three injections, and at in-person study visits (last being 9 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pelvic Organ Prolapse Quantification Point Ba Between Groups
Time Frame: 9 months
The investigators will assess Ba (maximum descent of the anterior vaginal wall) values between intravaginal PLLA vs. placebo injection groups at initial visit, 1 month, 2 months, 6 months, and 9 months after injection. They will use linear regression models controlling for baseline Ba.
9 months
Patient Reported Pelvic Symptoms (PFDI-20)
Time Frame: 9 months
Pelvic Floor Disability Index (PFDI-20) is a short form of the Pelvic Floor Distress Inventory. It is a patient reported outcome measure assessing bowel, bladder, or pelvic symptoms and severity of symptoms. It has a total score ranging from 0 to 300 (higher scores indicate greater distress)
9 months
Patient Reported Pelvic Symptoms (Vaginal health)
Time Frame: 9 months
Vaginal health: Vulvovaginal Symptoms Questionnaire (VSQ) measures vulvovaginal health via a series of yes and no questions. The total score ranges from 0 to 16 for sexually inactive women and 0 to 20 for sexually active women, with higher scores indicating greater symptom severity.
9 months
Patient Reported Pelvic Symptoms (Sexual function)
Time Frame: 9 months
Sexual function: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-IR) is used to assess patient reported sexual function in individuals with pelvic floor disorders. Items are generally answered on a 0-4 Likert scale, with higher scores indicating better sexual function for sexually active women and lower impact on sexual inactivity for non-sexually active women.
9 months
Patient Reported Pelvic Symptoms (Body Image)
Time Frame: 9 months
Body Image in Women with Pelvic Organ Prolapse (BIPOP) is a self-reported outcomes questionnaire used to assess how prolapse affects a woman's body image. It is scored on a 1-5 scale based on 10 items, where higher mean scores (1-5) indicate a worse prolapse-related body image.
9 months
Quality of Life Questionnaires (SF-12)
Time Frame: 9 months
Global: Short-Form 12 Health Survey (SF-12) uses a scale 0-47. It is scored using complex, weighted algorithms that aggregate 12 items into two main composite scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS). Using norm-based scoring, scores are transformed to have a mean of 50 and a standard deviation of 10, where a score > 50 indicates better-than-average health.
9 months
Quality of Life Questionnaires (PFIQ-7)
Time Frame: 9 months
Disease specific: urinary, bowel, and prolapse scales of Pelvic Floor Impact Questionnaire (PFIQ-7) evaluates patient reported impact of pelvic organ prolapse on quality of life. s scored by assigning a value from 0 to 3 for each of the seven questions across three subscales (0="Not at all", 3="Quite a bit"). Subscale scores are calculated by obtaining the mean of answered items, then multiplying by to achieve a 0-100 range. The total PFIQ-7 score is the sum of the three subscales (0-300), where lower scores indicate better quality of life.
9 months
Tissue Histology
Time Frame: 6 months
The investigators will evaluate histology (tissue) level changes between groups via a vaginal biopsy at baseline and at 6 months.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cassandra Kisby

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cassandra Kisby, MD MS FACOG FACS, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00118936
  • K12AR084231-25 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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