Post-operative Voiding Dysfunction: the Preferred Method for Catheterization
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Part 1: Patient catheter preference
研究概览
简要总结
This study is divided into two parts. The first part is a prospective observational study of patients undergoing pelvic organ prolapse (POP) surgery. The goal is to determine patient preference between 3 different methods of bladder drainage in case of post-operative voiding dysfunction (POVD): transurethral indwelling catheterization (TIC), clean intermittent self-catheterization (CISC), and suprapubic tube (SPT). The second part of the study will be for those that choose CISC as their preferred method, whereby these patients will be randomized to receive CISC instruction either pre- or post-operatively to determine whether there is a difference in overall patient satisfaction based on timing of teaching.
The investigators hypothesize that patients that receive informed consent pre-operatively will favour the use of SPT over TIC and CISC to manage potential POVD.
Among those patients who opted for CISC in management of their post-operative voiding dysfunction, patients that are taught how to perform CISC pre-operatively in the clinic will have a higher level of satisfaction compared to those that are taught post-operatively in the hospital.
详细描述
Method PART 1 For the first part of the study, patient preference between TIC, CISC, SPT will be assessed during a face-to-face interview after the patient has had sufficient time to read the information sheet about the three options available and has had the opportunity to ask questions. This will ensure that every patient will receive the same information. The face-to-face interview will be performed by the patient's physician or by one of the two urogynecology nurses working at the St. Michael's Hospital Women's Health Care Centre. The patient's choice will be recorded in the pre-operative record and then in the study database by one of the study personnel.
Other data collected will include patient demographics (age, education level, level of home support, current or past occupation), clinical characteristics (BMI, parity, International Continence Society (ICS) stage of prolapse, and any pre-operative urinary diagnoses) (Appendix 4).
Peri-operatively, data collected will include the surgery performed, the length of hospital stay, and the occurrence of any peri-operative complications. At our institution we have defined normal voiding function as having a voided volume of > 200 mL with a post-voided residual (PVR) of < 100 mL or having a voided volume of > 400 mL with a PVR of < 33% (1/3) of the total voided volume. Patients have to meet these criteria on two separate voids while in hospital or they will be classified as having post-operative voiding dysfunction. Once they meet the criteria for voiding dysfunction, then the method of bladder drainage used (TIC, CISC and SPT) and the length of time it was used for will be recorded.
To reduce the rate of bacteriuria and other signs of bladder infection [25], antibiotic prophylaxis will be administered as usual to all patients that require bladder drainage for more than 24 hours. The antibiotic regimen consist of: Macrodantin 100 mg PO daily for the time of the bladder drainage, or Trimethoprim 100 mg PO daily if allergic. This is the regimen currently being used in our department.
For those patients that underwent catheterization in the post-operative period, satisfaction with regard to catheter management will be assessed using a visual analog scale based on a previously published questionnaire. This questionnaire will be administered on the day of discharge, on post-operative day seven, and six weeks after surgery. Post-operative bladder function in those that required catheterization will be assessed on post-operative day seven and six weeks after surgery using uroflowmetry testing, PVR measurement, and a specimen for urine culture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •All pre-operative patients seen at the St. Michael's Hospital Women's Health Care Centre and consented for a POP surgery will be eligible to participate in the first part of this study.
- •All patients undergoing POP surgery that choose CISC as their preferred method of bladder drainage will then be eligible for the second part of the study.
- •Additional inclusion criteria for both parts of the study include: female gender, greater than 18 years of age, and able to read and write in the English language
排除标准
- •Significant cognitive impairment, a history of neurogenic voiding dysfunction, a history of prior catheter use in the outpatient setting, as well as any patients undergoing outpatient surgery or surgery that only includes the posterior vaginal compartment.
研究组 & 干预措施
CISC instruction post-operatively
For those patients that are randomized to CISC instruction before surgery, instruction will begin on post-operative day one. One of the nurses from the hospital gynecology unit will teach and supervise the patients until they feel comfortable with the technique or until catheterization is no longer required (e.g. when the patient passes her voiding trial on two separate occasions). This is the protocol currently in use at our institution.
CISC instruction pre-operatively
Patients allocated to the pre-operative CISC teaching group will be taught how to perform CISC by one of urogynecology nurses working at the Women's Health Care Centre. Patients will be allowed to practice until they feel comfortable with the technique. This should take approximately 30 minutes. The session will take place on the day of their pre-operative medical appointment (PAF), which normally occurs less than a month before the surgery. If a patient is not seen in PAF or is seen more than a month before her surgery, a separate appointment for CISC teaching during the month preceding the surgery will be organized. Post-operatively, a nurse from the hospital gynecology unit will review the technique to make sure the patient is still comfortable with performing CISC.
干预措施: CISC instruction pre-operatively (Procedure)
结局指标
主要结局
Part 1: Patient catheter preference
时间窗: 24 months
For the first part of the study, the primary outcome is determining patient preference for method of bladder drainage for potential post-operative voiding dysfunction when asked pre-operatively. They will be given the options of either transurethral indwelling catheter (TIC), clean intermittent self catheterization (CISC), or suprapubic tube (SPT).
Part 2: patient satisfaction with regard to timing of CISC teaching.
时间窗: 24 months
For the second part of the study, the primary outcome measure is the difference in patient satisfaction levels between those that had pre-operative CISC teaching compared with those that had the standard post-operative CISC teaching.
次要结局
- Patient satisfaction with catheter choice(24 months)
- Incidence of post-operative voiding dysfunction after prolapse surgery(24 months)
- Incidence of bacteruria/urinary tract infection after catheter use(24 months)
- Bladder function after catheter use(24 months)