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OPTION: Optimization of Spontaneous Postoperative Trial of Void Among Women

Sponsor
Women and Infants Hospital of Rhode Island (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04010656
Collaborator
American Urogynecologic Society (Other), American Association of Gynecologic Laparoscopists (Other)
183
Enrollment
1
Location
1
Arm
39.7
Anticipated Duration (Months)
4.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: PVR-based self-catheterization
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
183 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
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.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)
Primary Purpose:
Diagnostic
Official Title:
Optimization of Spontaneous Trial of Void: a Prospective Cohort Study
Actual Study Start Date :
Sep 10, 2018
Actual Primary Completion Date :
May 10, 2021
Anticipated Study Completion Date :
Dec 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Incidence of post-operative urinary retention [24-72 hours postoperative]

    Based on defined criteria

  2. Diagnostic accuracy of trial of void parameters [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.

Secondary Outcome Measures

  1. Rate of post-operative and post-discharge urinary retention [24-72 hours postoperative]

    Based on post-void residual volume

  2. Rate of post-operative urinary tract infection [6 weeks postoperative]

    UTI in first 6 weeks postoperative

  3. Patient satisfaction with self-catheterization method via questionnaire [2 weeks postoperative]

    Novel questionnaire, 5 point Likert scale from "Very dissatisfied to Very satisfied"

  4. Time to first void postoperative [4 hours postoperative]

    To assess time to spontaneous void after surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Women & Infants Hospital Providence Rhode Island United States 02903

Sponsors and Collaborators

  • Women and Infants Hospital of Rhode Island
  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Anne Cooper, MD, Assistant Professor of Urogynecology, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT04010656
Other Study ID Numbers:
  • WIH IRB 1145237
First Posted:
Jul 8, 2019
Last Update Posted:
Jul 20, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Anne Cooper, MD, Assistant Professor of Urogynecology, Dartmouth-Hitchcock Medical Center
Urogynecologic surgery
Urinary retention postoperative
Additional relevant MeSH terms:
Urinary Retention

Study Results

No Results Posted as of Jul 20, 2021