Patient-Centered Outcomes of Sacrocolpopexy Versus Uterosacral Ligament Suspension for the Treatment of Uterovaginal Prolapse
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 14
- 主要终点
- Treatment failure
研究概览
简要总结
The purpose of this study is to compare two types of surgery for the treatment of uterovaginal prolapse to determine which surgery works best from a patient's perspective and has the lowest number of short-term and long-term complications.
详细描述
This is a multi-site, randomized controlled trial, where women with the confirmed diagnosis of uterovaginal prolapse will be randomized in a 1:1 ratio to either A) a minimally invasive supracervical hysterectomy with sacrocolpopexy (MI-SCH+SCP) or B) total vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS). After surgery, participants will be followed for 3 years including physical pelvic exams and validated symptom questionnaires to assess for the primary and secondary outcomes. A subset of participants will participate in semi-structured interviews, before surgery and through 2 years after surgery, that will assess patient recovery, satisfaction with care, and calibrate surveyed and clinically assessed outcomes to the daily life experiences of women.
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
- Single (Participant)
盲法说明
Participants will be masked to the surgical randomization prior to surgery and will be informed of their surgical assignment (unmasked) after waking up from surgery and prior to discharge.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ≥ 18 years of age and ≤ 80 years of age
- •Have diagnosis of symptomatic uterovaginal prolapse
- •Have elected to undergo surgical management of uterovaginal prolapse after consultation with their physician
- •Are eligible for both minimally invasive supracervical hysterectomy with sacrocolpopexy (MI-SCH+SCP) and total vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS)
排除标准
- •Patients who wish to undergo uterine sparing procedures
- •Body mass index BMI) > 50
- •Previous hysterectomy or prior uterovaginal surgery
- •Have a diagnosis of neurogenic bladder, Parkinson's disease, multiple sclerosis, spinal cord injury, or cerebrovascular accident
- •Chronic indwelling urinary catheter
- •Urinary diversion of any type
- •Any condition or disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results
- •Unable to speak, read, understand English
研究组 & 干预措施
Sacrocolpopexy
Minimally invasive supracervical hysterectomy with sacrocolpopexy (MI-SCH+SCP)
干预措施: Minimally invasive supracervical hysterectomy and sacrocolpopexy (MI-SCH+SCP) (Procedure)
Uterosacral Ligament Suspension
Total vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS)
干预措施: Vaginal hysterectomy with uterosacral ligament suspension (TVH+USLS) (Procedure)
结局指标
主要结局
Treatment failure
时间窗: 36 months post-surgery
The primary outcome is treatment failure defined as the presence of at least one of the following: 1) presence of a vaginal bulge defined as lead point of prolapse beyond the hymen, 2) report of bothersome vaginal bulge symptoms irrespective of stage of prolapse, or 3) retreatment of symptomatic prolapse with pessary, or surgery.
次要结局
- Change in nausea using VAS(Baseline, Days 1, 7 and 14 post-surgery)
- Change in fatigue using MAF(Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, and 8 post-surgery)
- Postoperative pain medication use(Post-surgery through Day 14)
- Postoperative anti-emetic use(Post-surgery through Day 14)
- Change in bladder function using IIQ-7(Baseline, 2, 6, 12, 24, and 36 months post-surgery)
- Change in surgical pain using VAS(Baseline, Days 1, 7 and 14 post-surgery)
- Change in bladder function using UDI-6(Baseline, 2, 6, 12, 24, and 36 months post-surgery)
- Change in sexual function using FSFI(Baseline, 6, 12, 24, and 36 months post-surgery)
- Change in quality of life using P-QOL(Baseline, 2, 6, 12, 24, and 36 months post-surgery)
- Change in satisfaction with care using PGI-I(Baseline, 6, 12, 24, and 36 months post-surgery)
- Rate of Grade I-V DINDO complications in each surgical arm(Surgery through 36 months post-surgery)
- Change in bowel function using CRAD-8(Baseline, 2, 6, 12, 24, and 36 months post-surgery)
- Change in sexual function using PISQ-12(Baseline, 6, 12, 24, and 36 months post-surgery)
- Change in body image using BIPOP(Baseline, 6, 12, 24, and 36 months post-surgery)
研究者
Adonis Hijaz, MD
Professor of Urology
University Hospitals Cleveland Medical Center