A Cohort Observational Study Comparing the Outcomes of Single-incision Sling vs Urethral Bulking During Prolapse Surgery for Occult Stress Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Urinary Distress Inventory, Short Form (UDI-6)
研究概览
简要总结
The aim is to compare outcomes of two different procedures to prevent occult stress urinary incontinence (SUI) in patients who are having pelvic organ prolapse surgeries
详细描述
The aim is to compare outcomes of two different procedures to prevent occult stress urinary incontinence (SUI) in patients who are having pelvic organ prolapse surgeries. Charts will be reviewed for patients who had single- incision sling or urethral bulking injection with other prolapse surgeries to address occult stress incontinence at The Christ Hospital from the period of January 2019 to June 2021. Patients who didn't have any occult stress incontinence pre-operatively and didn't receive any anti-incontinence procedure during their prolapse surgery will be included as a control group. Surgical details, adverse events and postoperative voiding times will be collected from the chart. Patients will be contacted by a telephone to administer a validated questionnaire; a 3-day bladder diary to quantify urinary incontinence will be send to the patient to complete and return by mail.
The purpose of the study is to investigate whether urethral bulking is as effective as single- incision sling in treating occult stress incontinence.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- 是
入选标准
- •-Females who are 18 years or old who were scheduled to either urethral bulking (Bulkamid) or single-incision sling (Altis sling) to address occult SUI with prolapse surgery. All patients reported no history of SUI preoperatively and during office physical exam, positive SUI was demonstrated during prolapse reduction.
- •Females who are 18 years or old who didn't have occult stress incontinence before their prolapse surgery and didn't receive any stress incontinence surgery during their prolapse surgery during the same period will be included as a control group.
- •English speaking patients.
排除标准
- •Patients who had either single-incision sling or urethral bulking with documented preoperative history of stress incontinence. Patients with a history of previous surgery for SUI.
研究组 & 干预措施
Urethral bulking group
The patient will receive Bulkamid urethral bulking agent for treatment of SUI
干预措施: Bulkamid bulking agent (Drug)
Single incision sling group
The patient will receive Altis mini-incision sling for treatment of occult SUI
干预措施: Single incision sling (Device)
结局指标
主要结局
Urinary Distress Inventory, Short Form (UDI-6)
时间窗: one year after surgery
Voiding diary
时间窗: one year after surgery
Incontinence Impact Questionnaire, Short Form (IIQ-7)
时间窗: one year after surgery
次要结局
- The rate of complications in both groups which includes adverse events, rate of urine retention with prolonged catheterization, and UTI.(one year after surgery)