Urinary Retention Postoperative, Voiding Disorders
Conditions
Keywords
Urogynecologic surgery, Urinary retention postoperative
Brief summary
Trial of void (TOV) is a diagnostic test performed on all women who undergo prolapse repair or incontinence surgery, due to the importance of diagnosing postoperative urinary retention (POUR). Incidence of POUR may be as high as 62% in some studies. Timely and accurate diagnosis is important to avoid complications such as urinary tract infection, bladder overdistension, and permanent bladder injury. Despite the frequent use of TOV, there is no gold standard for the test, and it likely has poor specificity, leading to discharge of more patients with catheter than required. This prospective cohort study will seek to establish evidence-based optimal parameters for spontaneous trial of void, a TOV modality that has merit for further evaluation given lower theoretical risk of urinary tract infection.
Detailed description
Patients will learn to perform self-catheterization ('clean intermittent catheterization', or CIC) preoperatively; after surgery, the investigators will collect a range of voiding parameters used during different TOV protocols (including minimum voided volume \[MVV\], post-void residual via bladder scanner \[PVR\], subjective force of urinary stream \[sFOS\]). Patients will discharge home to perform CIC until two sequential post-void residuals of less than half the volume voided have been achieved. The rate of voiding dysfunction and resulting PVRs will be used to compare the diagnostic accuracy of the perioperative voiding parameters to predict need to perform CIC and post-operative urinary retention.
Interventions
PROCEDUREPVR-based self-catheterization
Home self-catheterization based on standard of care
Sponsors
American Urogynecologic Society
American Association of Gynecologic Laparoscopists
Women and Infants Hospital of Rhode Island
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Subjects will be taught to perform self-catheterization prior to prolapse repair or incontinence surgery; voiding data will be collected on the participant's first void after surgery. Participants will be discharged home to perform self-catheterization until post-void residual is less than half the volume voided on 2 sequential voids to assess actual voiding function, and this data will be used to calculate the diagnostic accuracy of pre-determined combinations of the TOV parameters.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* English-speaking women, age \>18yo * Scheduled for urogynecology procedure which will need post-operative trial of void (including pelvic organ prolapse and/or stress urinary incontinence repair), with plan for same-day discharge.
Exclusion criteria
* Unable or unwilling to perform self-catheterizatoin either by patient or willing family member * Pre-existing voiding dysfunction defined as documented PVR \> 200 mL * Intraoperative urinary tract injury needing indwelling catheter on discharge * Need for overnight admission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of post-operative urinary retention | 24-72 hours postoperative | Based on defined criteria |
| Diagnostic accuracy of trial of void parameters | First void postoperative (within 4 hours postop) | Comparison of sensitivity, specificity, positive/negative predictive value of different trial of void parameters from first postoperative void, based on those used in the literature. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of post-operative and post-discharge urinary retention | 24-72 hours postoperative | Based on post-void residual volume |
| Rate of post-operative urinary tract infection | 6 weeks postoperative | UTI in first 6 weeks postoperative |
| Patient satisfaction with self-catheterization method via questionnaire | 2 weeks postoperative | Novel questionnaire, 5 point Likert scale from Very dissatisfied to Very satisfied |
| Time to first void postoperative | 4 hours postoperative | To assess time to spontaneous void after surgery |
Countries
United States
Outcome results
None listed