Health TrialsbyHealthPanel

Poly-L-Lactic Acid for Vulvovaginal Tissue Regeneration

ConditionsPelvic Organ Prolapse (POP)CystocelePelvic Floor Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21+
SponsorCassandra Kisby

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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?

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Poly-L-Lactic Acid (Sculptra) injection

    Device

    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 intervention

    8mL of sterile water will be combine with 1mL of lidocaine for injection in the anterior/ventral vagina

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: PLLA (Sculptra) InjectionExperimental treatment 1 intervention
Group B: Control InjectionPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
We will measure AEs 2 weeks after each of the three injections, and at in-person study visits (last being 9 months)

Secondary outcomes

1

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.

Time frame
9 months
2

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)

Time frame
9 months
3

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.

Time frame
9 months
4

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.

Time frame
9 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cassandra Kisby

Lead sponsor

Duke University

Sponsor institution

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Source ClinicalTrials.gov
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