Clinical trial NCT04010656: Optimization of Spontaneous Postoperative Trial of Void Among Women
Official title: Optimization of Spontaneous Trial of Void: a Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Retention Postoperative
Voiding Disorders
Keywords: Urogynecologic surgery
Urinary retention postoperative
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
Collaborators: name: American Urogynecologic Society
name: American Association of Gynecologic Laparoscopists
First posted: 2019-07-08
Enrollment: 183
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of post-operative urinary retention
timeFrame: 24-72 hours postoperative
measure: Diagnostic accuracy of trial of void parameters
timeFrame: First void postoperative (within 4 hours postop)
Secondary outcomes:
measure: Rate of post-operative and post-discharge urinary retention
timeFrame: 24-72 hours postoperative
measure: Rate of post-operative urinary tract infection
timeFrame: 6 weeks postoperative
measure: Patient satisfaction with self-catheterization method via questionnaire
timeFrame: 2 weeks postoperative
measure: Time to first void postoperative
timeFrame: 4 hours postoperative
Other outcomes:
Locations:
city: Providence
country: United States
facility: Women & Infants Hospital
state: Rhode Island
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center, Lebanon NH
name: Anne C Cooper, MD, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: Women & Infants Hospital, Providence RI
name: Julia Shinnick, MD
role: PRINCIPAL_INVESTIGATOR
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