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Optimization of Spontaneous Postoperative Trial of Void Among Women

NCT04010656 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 183

Last updated 2021-07-20

No results posted yet for this study

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.

Conditions

  • Urinary Retention Postoperative
  • Voiding Disorders

Interventions

PROCEDURE

PVR-based self-catheterization

Home self-catheterization based on standard of care

Sponsors & Collaborators

  • American Urogynecologic Society

    collaborator OTHER

  • American Association of Gynecologic Laparoscopists

    collaborator OTHER

  • Women and Infants Hospital of Rhode Island

    lead OTHER

Principal Investigators

  • Anne C Cooper, MD, MA · Dartmouth-Hitchcock Medical Center, Lebanon NH

  • Julia Shinnick, MD · Women & Infants Hospital, Providence RI

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-10
Primary Completion
2021-05-10
Completion
2021-12-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04010656 on ClinicalTrials.gov