Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 3
- 主要终点
- Surgical "Failure" Defined by (i) Anatomic Assessment of Prolapse, (ii) Presence of Bulge Symptoms, and/or (Iii) Retreatment of Prolapse
研究概览
简要总结
This study randomizes postmenopausal women with symptomatic pelvic organ prolapse planning native tissue transvaginal surgical repair to 6-8 weeks of preoperative and 1-year continued postoperative vaginal estrogen cream compared to placebo cream. This clinical trial and basic science investigation are designed to understand the mechanisms by which local estrogen treatment affects connective tissues of the pelvic floor and determine whether its use before and after prolapse repair will (i) improve success rates of the surgical intervention and minimize prolapse recurrence and (ii) impact favorably upon symptoms of other pelvic floor disorders.
详细描述
This is a double-blind randomized trial of intravaginal estrogen (conjugated estrogens, 0.625mg/1g cream) vs. placebo in postmenopausal women (up to n=222 enrolled and randomized in order for 188 to undergo surgery) with symptomatic prolapse beyond the hymen planning transvaginal native tissue repairs. Medication will be started >5 weeks before surgery and continued for 1 year postoperatively, i.e. until scar remodeling is complete. The investigators aim to determine if pre- and postoperative intravaginal estrogen therapy (i) results in anatomic and patient-reported subjective improvement in pelvic organ support, and (ii) impacts other pelvic floor disorders (overactive bladder and incontinence, sexual function and pain, postoperative cystitis), satisfaction, quality of life, and vaginal wound healing. Finally, (iii) the investigators will determine the potential mechanisms by which local estrogen treatment alters pelvic organ support by examining full-thickness vaginal wall biopsies taken at the time of surgery for histologic, connective tissue, and smooth muscle synthesis and degradative changes. The investigators expect this will highlight other novel targets for future therapies in prolapse repair and prevention.
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
- 48 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal: no menses for >1 year
- •Minimum age: 48 years
- •Symptomatic apical and/or anterior vaginal wall prolapse, stage 2 or greater
- •No estrogen replacement within the last month (may come off current treatment, i.e. wash out, to join the study)
- •Medically fit for elective surgery
- •Physically able to apply/insert the study drug
- •Available for clinic follow-up for minimum 1yr
排除标准
- •Concurrent use of steroid creams for other indications (e.g. lichen sclerosis)
- •BMI >35 kg/m2
- •Recent history (within last month) of vaginal infection or vaginitis
- •Contraindications to estrogen therapy (e.g. spontaneous DVT, stroke, breast or endometrial/ hormone-responsive cancer, genital bleeding of unknown cause)
- •History of connective tissue disease
- •Any oral or transdermal estrogen, SERM, or other medication impacting vaginal milieu
- •History of vaginal irradiation
- •Allergy to Premarin or its constituents
- •Prior apical repair or use of mesh for prolapse repair
- •Current tobacco use
研究组 & 干预措施
Estrogen Cream
Conjugated Estrogens cream
干预措施: Conjugated Estrogens Cream (Drug)
Placebo Cream
Placebo cream
干预措施: Placebo Cream (Drug)
结局指标
主要结局
Surgical "Failure" Defined by (i) Anatomic Assessment of Prolapse, (ii) Presence of Bulge Symptoms, and/or (Iii) Retreatment of Prolapse
时间窗: 12 months
Cumulative failures, as measured by (i) anatomic assessment of prolapse, (ii) presence of bulge symptoms, and/or (iii) retreatment of pelvic organ prolapse
次要结局
- Condition Specific (i.e. Pelvic Organ Prolapse) Symptom Bother as Measured by Pelvic Floor Distress Inventory-20 (PFDI-20) Questionnaire(12 months)
- Urinary Symptoms as Measured by Urinary Subscale Questions of the Pelvic Floor Distress Inventory-20 (PFDI-20) Questionnaire, i.e. the Urinary Distress Inventory, UDI-6(12 months)
- Urinary Symptoms as Measured by Urinary Subscale Questions of the Pelvic Floor Impact Questionnaire (PFIQ-7), i.e. the Urinary Impact Questionnaire(12 months)
- Generic Quality of Life as Measured by SF-12 Questionnaire(12 months)
- Sexual Function as Measured by the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)(12 months)
- Number of Participants With Adverse Events(12 months)
- Condition Specific (i.e. Pelvic Organ Prolapse) Quality of Life as Measured by Pelvic Floor Impact Questionnaire-7 (PFIQ-7)(12 months)
研究者
David Rahn, MD
Associate Professor, Dept. of Obstetrics & Gynecology
University of Texas Southwestern Medical Center