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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04010656
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
American Urogynecologic Society
American Association of Gynecologic Laparoscopists
Information provided by (Responsible Party):
Anne Cooper, MD, Dartmouth-Hitchcock Medical Center

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
Urinary Retention Postoperative Voiding Disorders Procedure: PVR-based self-catheterization Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Optimization of Spontaneous Trial of Void: a Prospective Cohort Study
Actual Study Start Date : September 10, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Incidence of post-operative urinary retention [ Time Frame: 24-72 hours postoperative ]
    Based on defined criteria

  2. 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.

Secondary Outcome Measures :
  1. Rate of post-operative and post-discharge urinary retention [ Time Frame: 24-72 hours postoperative ]
    Based on post-void residual volume

  2. Rate of post-operative urinary tract infection [ Time Frame: 6 weeks postoperative ]
    UTI in first 6 weeks postoperative

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

  4. Time to first void postoperative [ Time Frame: 4 hours postoperative ]
    To assess time to spontaneous void after surgery

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04010656

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Contact: Anne C Cooper, MD, MA 401-453-7560
Contact: Sophie Craig 401-453-7560

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United States, Rhode Island
Women & Infants Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Julia Shinnick, MD    401-453-7560   
Contact: Sophie Craig    4011-453-7560   
Principal Investigator: Julia Shinnick, MD         
Sponsors and Collaborators
Women and Infants Hospital of Rhode Island
American Urogynecologic Society
American Association of Gynecologic Laparoscopists
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Principal Investigator: Anne C Cooper, MD, MA Dartmouth-Hitchcock Medical Center, Lebanon NH
Principal Investigator: Julia Shinnick, MD Women & Infants Hospital, Providence RI

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Responsible Party: Anne Cooper, MD, Assistant Professor of Urogynecology, Dartmouth-Hitchcock Medical Center Identifier: NCT04010656    
Other Study ID Numbers: WIH IRB 1145237
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anne Cooper, MD, Dartmouth-Hitchcock Medical Center:
Urogynecologic surgery
Urinary retention postoperative
Additional relevant MeSH terms:
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Urinary Retention
Urination Disorders
Urologic Diseases