Heparin Intraoperative Instillation for Lower Urinary Tract Symptoms After Benign Hysterectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Lower urinary tract symptoms
研究概览
简要总结
This study will explore the application of placing heparin into the bladder via a catheter to decrease postoperative lower urinary tract symptoms (LUTS) and urinary tract infection (UTI) symptoms such as urinary frequency, urinary urgency, pain with urination, or difficulty voiding following hysterectomy (surgically removing the uterus). The investigators hypothesize that heparin bladder instillations will reduce LUTS, UTI symptoms, and improve patient satisfaction following hysterectomy.
详细描述
Data Collection
Subject demographics and history information will be obtained from The Christ Hospital Medical Center's electronic medical record. In addition, preoperative diagnosis, postoperative diagnosis, procedure performed, total operative time, estimated blood loss, intraoperative complications, anterior prolapse repair, use of cystoscopy, preoperative urinalysis, postoperative complications, uterine size, and any urine cultures collected within the 2 week postoperative period will also obtained from the electronic medical record.
The post-operative lower urinary tract symptoms assessments will be collected, the paper records will be secured in a locker labeled with the study identification number, which will then be entered into EXCEL on a password secured database and the paper copy will be disposed of in the secure destruction station.
Descriptive Analysis
Simple statistics and demographics will be done across the two cohorts. Categorical variables will be analyzed using Chi-square while continuous variables (e.g. UTISA scores) will be analyzed using t-test so long as the distribution of the data are normal. Additional analyzes as appropriate will be done to identify group differences based on patient demographics (e.g. age, concomitant procedures, surgeon, estrogen use, foley catheter placement, etc).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 to 85-years old
- •scheduled to undergo a benign hysterectomy
排除标准
- •non-English speakers
- •current use of anticoagulants or thrombolytic agents
- •known adverse reaction or hypersensitivity to heparin
- •history of or active genitourinary tract cancer (bladder, uterine, cervical, ovarian or vaginal)
- •history of neurogenic bladder
- •pelvic irradiation
- •chemical cystitis
- •pregnancy
- •antibiotic use within the past 30 days
- •Surgical procedures involving: anterior or posterior colporrhaphy, vaginal mesh excision, fistula repair, diverticulum repair, urethral reconstruction, planned or incidental cystotomy
研究组 & 干预措施
Heparin Bladder Instillation
At the completion of the scheduled benign hysterectomy, intravesicular bladder instillation containing 40,000U of heparin (40mL of 10,000U heparin/10mL) will be administered be introduced in a retrograde fashion by gravity via Foley catheter. The Foley catheter will be clamped for 30 minutes approximately 1cm from the vaginal opening.
干预措施: Heparin (Drug)
Normal Saline Bladder Instillation
Patients randomized to the control group will undergo intravesical instillation with 40mL of normal saline. The Foley catheter will be clamped for 30 minutes approximately 1cm from the vaginal opening.
干预措施: Normal saline (Drug)
结局指标
主要结局
Lower urinary tract symptoms
时间窗: Postoperative day 14
lower urinary tract symptoms such as urgency, frequency, dysuria, and hematuria measured by the Urinary Tract Infection Symptoms Assessment Questionnaire (UTISA)
次要结局
- Postoperative antibiotic use(Postoperative day 1 to 14)
- Postoperative patient satisfaction(Postoperative day 14)
研究者
Hyde Yuen
Female Pelvic Medicine and Reconstructive Surgery Fellow
The Christ Hospital