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Optimization of Spontaneous Postoperative Trial of Void Among Women (OPTION)

Primary Purpose

Urinary Retention Postoperative, Voiding Disorders

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PVR-based self-catheterization
Sponsored by
Women and Infants Hospital of Rhode Island
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Urinary Retention Postoperative focused on measuring Urogynecologic surgery, Urinary retention postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Women & Infants Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PVR-based home self-catheterization

Arm Description

Patients will learn to self-catheterize preoperatively prior to urogynecology surgery requiring trial of void. First post-operative void will be used to collect basic information about voiding function. All participants will leave the hospital and self-catheterize until they achieve two sequential voids with post-void residual (PVR) less than half the volume voided. The cases of urinary retention captured with abnormal PVR will be used to compare the diagnostic accuracy of several commonly-used, pre-defined parameters for trial of void.

Outcomes

Primary Outcome Measures

Incidence of post-operative urinary retention
Based on defined criteria
Diagnostic accuracy of trial of void parameters
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 Outcome Measures

Rate of post-operative and post-discharge urinary retention
Based on post-void residual volume
Rate of post-operative urinary tract infection
UTI in first 6 weeks postoperative
Patient satisfaction with self-catheterization method via questionnaire
Novel questionnaire, 5 point Likert scale from "Very dissatisfied to Very satisfied"
Time to first void postoperative
To assess time to spontaneous void after surgery

Full Information

First Posted
February 19, 2019
Last Updated
July 13, 2021
Sponsor
Women and Infants Hospital of Rhode Island
Collaborators
American Urogynecologic Society, American Association of Gynecologic Laparoscopists
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1. Study Identification

Unique Protocol Identification Number
NCT04010656
Brief Title
Optimization of Spontaneous Postoperative Trial of Void Among Women
Acronym
OPTION
Official Title
Optimization of Spontaneous Trial of Void: a Prospective Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 10, 2018 (Actual)
Primary Completion Date
May 10, 2021 (Actual)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Women and Infants Hospital of Rhode Island
Collaborators
American Urogynecologic Society, American Association of Gynecologic Laparoscopists

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention Postoperative, Voiding Disorders
Keywords
Urogynecologic surgery, Urinary retention postoperative

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
183 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PVR-based home self-catheterization
Arm Type
Experimental
Arm Description
Patients will learn to self-catheterize preoperatively prior to urogynecology surgery requiring trial of void. First post-operative void will be used to collect basic information about voiding function. All participants will leave the hospital and self-catheterize until they achieve two sequential voids with post-void residual (PVR) less than half the volume voided. The cases of urinary retention captured with abnormal PVR will be used to compare the diagnostic accuracy of several commonly-used, pre-defined parameters for trial of void.
Intervention Type
Procedure
Intervention Name(s)
PVR-based self-catheterization
Intervention Description
Home self-catheterization based on standard of care
Primary Outcome Measure Information:
Title
Incidence of post-operative urinary retention
Description
Based on defined criteria
Time Frame
24-72 hours postoperative
Title
Diagnostic accuracy of trial of void parameters
Description
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.
Time Frame
First void postoperative (within 4 hours postop)
Secondary Outcome Measure Information:
Title
Rate of post-operative and post-discharge urinary retention
Description
Based on post-void residual volume
Time Frame
24-72 hours postoperative
Title
Rate of post-operative urinary tract infection
Description
UTI in first 6 weeks postoperative
Time Frame
6 weeks postoperative
Title
Patient satisfaction with self-catheterization method via questionnaire
Description
Novel questionnaire, 5 point Likert scale from "Very dissatisfied to Very satisfied"
Time Frame
2 weeks postoperative
Title
Time to first void postoperative
Description
To assess time to spontaneous void after surgery
Time Frame
4 hours postoperative

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne C Cooper, MD, MA
Organizational Affiliation
Dartmouth-Hitchcock Medical Center, Lebanon NH
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Julia Shinnick, MD
Organizational Affiliation
Women & Infants Hospital, Providence RI
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women & Infants Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Optimization of Spontaneous Postoperative Trial of Void Among Women

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