Pelvic Organ Prolapse (POP)NCT07544667
Poly-L-Lactic Acid for Vulvovaginal Tissue Regeneration
A study testing Poly-L-Lactic Acid (Sculptra) injection in people with Pelvic Organ Prolapse (POP) and Cystocele, run by Cassandra Kisby at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse (POP), Cystocele, Pelvic Floor Disorder
- What is being tested?
- Poly-L-Lactic Acid (Sculptra) injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Duke Urogynecology Clinical Research Coordinators contact
United States1 site, 1 recruiting
- Recruiting
Duke Urogynecology, Patterson Place
Durham, North Carolina, 27710
Duke Urogynecology Clinical Research Coordinators, 9194011000, urogyn_research@duke.edu
About this study
Official title: 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.
- Being tested
- Poly-L-Lactic Acid (Sculptra) injection, Placebo injection (sterile water)
- Keywords
- regenerative medicine, biostimulant, tissue regeneration, pelvic floor disorder, pelvic organ prolapse, cystocele
- Medical subject headings
- Pelvic Organ Prolapse, Cystocele, Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poly-L-Lactic Acid (Sculptra) injectionDevice
Also called PLLA
Sculptra will be diluted in 8mL of sterile water and 1mL of lidocaine and injected across the anterior/ventral vagina
Placebo injection (sterile water)Other
8mL of sterile water will be combine with 1mL of lidocaine for injection in the anterior/ventral vagina
| Study group | Role | What they receive |
|---|---|---|
| PLLA (Sculptra) Injection | Experimental | Participants will receive three injections of PLLA, one per month, in the tissues of the front wall of the vagina Receives: Device: Poly-L-Lactic Acid (Sculptra) injection |
| Control Injection | Placebo comparator | Participants will receive three injections of sterile water, one per month, in the tissues of the front wall of the vagina Receives: Other: Placebo injection (sterile water) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events between groups
The investigators will assess the number of adverse events between groups using Clavien Dindo classification system (Grade I-V)
Measured: We will measure AEs 2 weeks after each of the three injections, and at in-person study visits (last being 9 months)
Secondary outcomes (8)
Pelvic Organ Prolapse Quantification Point Ba Between Groups
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.
Measured: 9 months
Patient Reported Pelvic Symptoms (PFDI-20)
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)
Measured: 9 months
Patient Reported Pelvic Symptoms (Vaginal health)
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.
Measured: 9 months
Patient Reported Pelvic Symptoms (Sexual function)
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.
Measured: 9 months
Patient Reported Pelvic Symptoms (Body Image)
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.
Measured: 9 months
Quality of Life Questionnaires (SF-12)
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.
Measured: 9 months
Quality of Life Questionnaires (PFIQ-7)
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.
Measured: 9 months
Tissue Histology
The investigators will evaluate histology (tissue) level changes between groups via a vaginal biopsy at baseline and at 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start20 Aug 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ Prolapse (POP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cassandra Kisby
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor-investigator, Cassandra Kisby, Duke University
- Investigators
- Cassandra Kisby, MD MS FACOG FACS, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544667
- Sponsor's protocol ID
- Pro00118936
- Other IDs
- K12AR084231-25
- Status last verified
- Aug 2026
- First submitted
- 3 Apr 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Sculptra. Poly-L-Lactic Acid. Galderma. https://www.galderma.com/au/sites/default/files/Sculptra%20IFU_Aug21.pdf
Haykal D, Haddad A, Cartier H, Avelar L. Poly-L-Lactic Acid in Aesthetic Dermatology: A Decade Beyond Volume Restoration Toward Regenerative Biostimulation. Aesthet Surg J. 2025 Sep 16;45(10):1065-1072. doi: 10.1093/asj/sjaf121.
PubMed 40580932U.S. Food and Drug Administration. Sculptra: P030050/S039. FDA website. Accessed September 28, 2025. https://www.fda.gov/medical-devices/recently-approved-devices/sculptra-p030050s039
Jelovsek JE, Maher C, Barber MD. Pelvic organ prolapse. Lancet. 2007 Mar 24;369(9566):1027-38. doi: 10.1016/S0140-6736(07)60462-0.
PubMed 17382829
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravaginal Injection of Poly-L-Lactic Acid for Treatment of Cystocele: A Randomized Trial
- ClinicalTrials.gov ID
- NCT07544667
- Acronym / sponsor ID
- Pro00118936
- Keywords
- regenerative medicine, biostimulant, tissue regeneration, pelvic floor disorder, pelvic organ prolapse, cystocele
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cassandra KisbyUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 20 Aug 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PLLA (Sculptra) Injection | Experimental | Device: Poly-L-Lactic Acid (Sculptra) injectionParticipants will receive three injections of PLLA, one per month, in the tissues of the front wall of the vagina |
| Control Injection | Placebo comparator | Other: Placebo injection (sterile water)Participants will receive three injections of sterile water, one per month, in the tissues of the front wall of the vagina |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 21
- Stage II POP of anterior vaginal wall (Ba ≥ -1)
- Symptomatic bulge symptoms
- Abstinent, on contraception, or postmenopausal at time of injection
- Must read or understand English
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Poly-L-Lactic Acid (Sculptra) injectionAlso: PLLASculptra will be diluted in 8mL of sterile water and 1mL of lidocaine and injected across the anterior/ventral vagina | Device | PLLA (Sculptra) Injection |
| Placebo injection (sterile water)8mL of sterile water will be combine with 1mL of lidocaine for injection in the anterior/ventral vagina | Other | Control Injection |
Primary outcome
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)
8 secondary outcomes
Pelvic Organ Prolapse Quantification Point Ba Between Groups
Time frame: 9 months
Patient Reported Pelvic Symptoms (PFDI-20)
Time frame: 9 months
Patient Reported Pelvic Symptoms (Vaginal health)
Time frame: 9 months
Patient Reported Pelvic Symptoms (Sexual function)
Time frame: 9 months
Patient Reported Pelvic Symptoms (Body Image)
Time frame: 9 months
Quality of Life Questionnaires (SF-12)
Time frame: 9 months
Quality of Life Questionnaires (PFIQ-7)
Time frame: 9 months
Tissue Histology
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- BackgroundSculptra. Poly-L-Lactic Acid. Galderma. https://www.galderma.com/au/sites/default/files/Sculptra%20IFU_Aug21.pdf
- Background: PubMed 40580932Haykal D, Haddad A, Cartier H, Avelar L. Poly-L-Lactic Acid in Aesthetic Dermatology: A Decade Beyond Volume Restoration Toward Regenerative Biostimulation. Aesthet Surg J. 2025 Sep 16;45(10):1065-1072. doi: 10.1093/asj/sjaf121.
- BackgroundU.S. Food and Drug Administration. Sculptra: P030050/S039. FDA website. Accessed September 28, 2025. https://www.fda.gov/medical-devices/recently-approved-devices/sculptra-p030050s039
- Background: PubMed 17382829Jelovsek JE, Maher C, Barber MD. Pelvic organ prolapse. Lancet. 2007 Mar 24;369(9566):1027-38. doi: 10.1016/S0140-6736(07)60462-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Duke Urogynecology Clinical Research Coordinators contact
Cassandra Kisby, MD MS FACOG FACS principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Poly-L-Lactic Acid (Sculptra) injection in people with Pelvic Organ Prolapse (POP) and Cystocele, run by Cassandra Kisby at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cassandra Kisby, MD MS FACOG FACS (9194011000, cassandra.kisby@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07544667, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.