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

July 13, 2021 updated by: Anne Cooper, MD, Women and Infants Hospital of Rhode Island

Optimization of Spontaneous Trial of Void: a Prospective Cohort Study

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

183

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Women & Infants Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PVR-based home self-catheterization
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.
Procedure: PVR-based self-catheterization
Home self-catheterization based on standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of post-operative urinary retention
Time Frame: 24-72 hours postoperative
Based on defined criteria
24-72 hours postoperative
Diagnostic accuracy of trial of void parameters
Time Frame: 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.
First void postoperative (within 4 hours postop)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of post-operative and post-discharge urinary retention
Time Frame: 24-72 hours postoperative
Based on post-void residual volume
24-72 hours postoperative
Rate of post-operative urinary tract infection
Time Frame: 6 weeks postoperative
UTI in first 6 weeks postoperative
6 weeks postoperative
Patient satisfaction with self-catheterization method via questionnaire
Time Frame: 2 weeks postoperative
Novel questionnaire, 5 point Likert scale from "Very dissatisfied to Very satisfied"
2 weeks postoperative
Time to first void postoperative
Time Frame: 4 hours postoperative
To assess time to spontaneous void after surgery
4 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Women and Infants Hospital of Rhode Island

Collaborators

American Urogynecologic Society
American Association of Gynecologic Laparoscopists

Investigators

  • Principal Investigator: Anne C Cooper, MD, MA, Dartmouth-Hitchcock Medical Center, Lebanon NH
  • Principal Investigator: Julia Shinnick, MD, Women & Infants Hospital, Providence RI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 10, 2018

Primary Completion (ACTUAL)

May 10, 2021

Study Completion (ANTICIPATED)

December 30, 2021

Study Registration Dates

First Submitted

February 19, 2019

First Submitted That Met QC Criteria

July 3, 2019

First Posted (ACTUAL)

July 8, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 20, 2021

Last Update Submitted That Met QC Criteria

July 13, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WIH IRB 1145237

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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