Intravaginal Injection of Poly-L-Lactic Acid for Treatment of Cystocele: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of adverse events between groups
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control Injection
Participants will receive three injections of sterile water, one per month, in the tissues of the front wall of the vagina
干预措施: Placebo injection (sterile water) (Other)
PLLA (Sculptra) Injection
Participants will receive three injections of PLLA, one per month, in the tissues of the front wall of the vagina
干预措施: Poly-L-Lactic Acid (Sculptra) injection (Device)
结局指标
主要结局
Number of adverse events between groups
时间窗: 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)
次要结局
- Pelvic Organ Prolapse Quantification Point Ba Between Groups(9 months)
- Patient Reported Pelvic Symptoms (PFDI-20)(9 months)
- Patient Reported Pelvic Symptoms (Vaginal health)(9 months)
- Patient Reported Pelvic Symptoms (Sexual function)(9 months)
- Patient Reported Pelvic Symptoms (Body Image)(9 months)
- Quality of Life Questionnaires (SF-12)(9 months)
- Quality of Life Questionnaires (PFIQ-7)(9 months)
- Tissue Histology(6 months)
研究者
Cassandra Kisby
Assistant Professor
Duke University