Optimization of Spontaneous Postoperative Trial of Void Among Women

NCT04010656 | Unknown

• 1 other identifier: WIH IRB 1145237
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Retention Postoperative; Voiding Disorders

Keywords

Urogynecologic surgery; Urinary retention postoperative

Outcome Measures

Primary Outcomes (2)

• Incidence of post-operative urinary retention

  Based on defined criteria

  24-72 hours postoperative

• 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.

  First void postoperative (within 4 hours postop)

Secondary Outcomes (4)

• Rate of post-operative and post-discharge urinary retention

  24-72 hours postoperative

• Rate of post-operative urinary tract infection

  6 weeks postoperative

• Patient satisfaction with self-catheterization method via questionnaire

  2 weeks postoperative

• Time to first void postoperative

  4 hours postoperative

Study Arms (1)

PVR-based home self-catheterization

EXPERIMENTAL

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

Interventions

PVR-based self-catheterization PROCEDURE

Home self-catheterization based on standard of care

PVR-based home self-catheterization

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead
• American Urogynecologic Society: collaborator
• American Association of Gynecologic Laparoscopists: collaborator

Study Sites (1)

Women & Infants Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (30)

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Study Officials

• Anne C Cooper, MD, MA

  Dartmouth-Hitchcock Medical Center, Lebanon NH

  PRINCIPAL INVESTIGATOR

• Julia Shinnick, MD

  Women & Infants Hospital, Providence RI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Urogynecology

Model Details: 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.

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: July 8, 2019
• Study Start: September 10, 2018
• Primary Completion: May 10, 2021
• Study Completion: December 30, 2021
• Last Updated: July 20, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)