Self-discontinuation of Urinary Catheters in Patients With Urinary Retention Following Gynecologic Surgery in a Rural Population
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Patient Satisfaction with Void Trial Process
研究概览
简要总结
The goal of this study is to understand patient satisfaction with two different ways of managing difficulty urinating after gynecologic surgery with a focus on those patients who receive care in a rural area.
One common practice is to have an "office catheter removal." This means, if a patient has trouble urinating after surgery and goes home with a foley catheter, they usually have to come back to the clinic within 2-3 days to have the catheter removed and to do a test to see if they can urinate on their own. For some patients, coming back to the clinic so soon after surgery can be difficult, especially for those patients who live far away or are dependent on others for getting to appointments.
A second, less common, practice is to have patients remove their own catheter at home, or "self-removal of urinary (Foley) catheter." With self-removal, patients remove their Foley catheter at home, and confirm that they are urinating normally. This approach has been shown to be safe, with similar patient satisfactions, and success, but those studies did not take into account situations where patients may live a rural area and/or travel a long distance to the medical center to receive care.
This study is comparing the in-office removal with self-removal. The goal is to find out which option patients prefer, how convenient each approach is, and how well they work. The main goal of this study is to understand patient satisfaction and improve care after surgery.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older
- •Undergoing gynecologic surgery with planned postoperative trial of void to confirm normal voiding prior to discharge home
- •Willing and able to provide informed consent
- •English-speaking
- •Willing to comply with study procedures, including follow-up phone calls and surveys
排除标准
- •Known urinary tract abnormalities (e.g., urethral strictures, neurogenic bladder) that may affect voiding.
- •Diagnosis of voiding dysfunction prior to surgery with need to self-catheterize.
- •Perioperative complication that necessitates indwelling catheter for a specific duration of time.
- •Joint surgeries that would affect ability to comply with study methods (e.g. that necessitates longer inpatient admission or reduces mobility beyond that normal for postop patients after gynecologic surgery)
- •Presence of significant cognitive or physical impairments that limit the ability to comply with study procedures.
研究组 & 干预措施
At-home passive void trial
Participants will be instructed to remove their foley catheter at home 48-72 hours postoperatively. After removal, they will perform a passive void trial and will be monitored for successful voiding within a designated time frame. Instructions will be provided, and participants will be advised to contact the clinic if unable to void.
干预措施: At-home Foley Catheter Self-Removal with Passive Void Trial (Other)
In-office backfill void trial
Participants will return to the clinic 48-72 hours postoperatively for standard foley catheter removal and a backfill void trial. The bladder will be filled with 300 mL of sterile water, and voiding will be assessed in clinic per institutional protocol.
干预措施: In-Office Foley Catheter Removal and Backfill Void Trial (Other)
结局指标
主要结局
Patient Satisfaction with Void Trial Process
时间窗: 2 weeks postoperatively
Measured using a 0-100 mm visual analog scale (VAS) administered at the 2-week follow-up visit.
次要结局
- Postoperative Urinary Retention(within 72 hours postoperatively)
- Urinary tract infection(Within 30 days postoperatively)
- Adverse Events Related to Foley Catheter Removal or Void Trial(up to 30 days postoperatively)
- Healthcare Resource Utilization(up to 30 days postoperatively)
研究者
Ekaterina.A.Grebenyuk
Principal Investigator
Dartmouth-Hitchcock Medical Center