Evaluating the Effect of Tamsulosin on Postoperative Urinary Retention in Women Undergoing Same Day Hospital Discharge Following Pelvic Reconstructive Surgery: A Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Number of Participants With Postoperative (Day 0) Urinary Retention
研究概览
简要总结
This is a double-blinded randomized controlled trial of perioperative use of tamsulosin to prevent postoperative urinary retention in female pelvic reconstructive surgery undergoing same-day discharge with an enhanced recovery after surgery protocol.
详细描述
The primary objective is to determine the effect of Tamsulosin on same-day active voiding trial in women undergoing female pelvic reconstructive surgery with vaginal native tissue repair with same-day discharge planned.
Duration of catheterization, postoperative urinary tract infection rates, patient level of satisfaction, Emergency Department (ED) visits and adverse events postoperatively will also be compared between women receiving Tamsulosin versus placebo.
Patients will be offered participation in the study at their postoperative visit if they meet study criteria. Once consent is obtained, patients will be randomized to receive Tamsulosin 0.4 mg orally once daily or matching placebo capsules for a total of 10 days starting 5 days pre-operatively.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Stage II or greater pelvic organ prolapse in > 1 vaginal compartment
- •Plan for multicompartment native tissue vaginal repair (which would include any combination of uterosacral ligament suspension, sacrospinous ligament suspension, cystocele and/or rectocele repair, with or without hysterectomy and with or without concomitant mid-urethral sling) or vaginal closure with female pelvic medicine and reconstructive surgery (FPMRS) - trained surgeons at Wake Forest Baptist Health
- •Participation in Enhanced-Recovery-After-Surgery protocol with plan for same-day hospital discharge
- •Willing to remain compliant with Investigation Product (IP)
排除标准
- •Intraoperative complication necessitating prolonged bladder drainage or placement of a vaginal pack x 24 hours (patients would exit study after randomization and will be excluded from the per-protocol analysis)
- •Patients whose surgical plan would necessitate a voiding trial on postop day >0
- •Less than 21 years of age
- •Unable to understand English
- •Patients who are scheduled to undergo combined colorectal procedures such as rectopexy, sphincteroplasty
- •Patient with known allergy to Tamsulosin or sulfa drugs
- •Patients with upcoming cataract surgery
- •Patient with orthostatic hypotension
- •History of postvoid residual (PVR>150) prior to surgery with prolapse reduction
- •Patients with hypertension on alpha-blockers
- •Single compartment prolapse repair (anterior or posterior repair only)
- •Use of mesh for prolapse repair
- •High tone pelvic floor dysfunction
研究组 & 干预措施
Placebo
Patients in this arm will receive 10 days of identical-appearing placebo once daily starting 5 days pre-operatively and continuing until all pills are completed.
干预措施: Placebo (Drug)
Tamsulosin
Patients in this arm will receive 10 days of 0.4 mg of oral tamsulosin once daily starting 5 days pre-operatively and continuing until all pills are completed.
干预措施: Tamsulosin (Drug)
结局指标
主要结局
Number of Participants With Postoperative (Day 0) Urinary Retention
时间窗: Up to 6 weeks postoperatively
Urinary retention can be defined as \>150cc residual volume during an active voiding trial
次要结局
- Urinary Tract Infection Rate(Week 6)
- Incidence of Delayed Urinary Retention(Week 6)
- Number Emergency Department (ED) Visits(Up to 30 days postoperatively)
- Total Number of Days of Bladder Catheterization(Week 6)
- Patient Level of Satisfaction With Voiding Function(Day 0 and 1 week postoperatively)