Reducing Postoperative Catheterization
Condition: Urinary Retention; Urinary Incontinence; Pelvic Organ Prolapse; Urinary Tract Infections
MeSH terms: Urinary Tract Infections; Urinary Incontinence; Urinary Retention; Prolapse; Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      After reconstructive pelvic surgery urinary retention occurs in up to 60% of patients
      requiring an indwelling catheter or self-catheterization (1-5). Up to 35% of women with acute
      retention experience urinary tract infections in the postoperative period (6, 7). Many women
      consider being discharged with a Foley catheter to be a surgical complication and describe
      catheter use as the worst aspect of their surgery(8). At this time there is no consensus
      within the field of Female Pelvic Medicine and Reconstructive Surgery (FPMRS) on how to best
      assess voiding function postoperatively. FPMRS providers both within the United States and
      around the world utilize a variety of void trial methods and varying criteria to determine
      adequacy of post-operative voiding efficiency (5).

      The traditional backfill assisted void trial method involves the assessment of a postvoid
      residual (PVR) volume obtained either via catheterization or bladder scan (3). Recently,
      there have been efforts to determine ways to avoid the assessment of a PVR as it is
      time-consuming and potentially exposes the patient to additional catheterizations (9, 10).
      Many FPMRS providers utilize the backfill assisted method without assessing a PVR and instead
      utilize a certain voided volume threshold to determine adequate voiding. However, to date, no
      one has directly studied this approach or compared the traditional backfill assisted void
      trial to a PVR-free backfill assisted void trial. By decreasing catheterization and creating
      a more efficient void trial method, the investigators hope improve patients' postoperative
      experience and reduce catheterization and risk of urinary tract infection (UTI).

      This study aims to compare two void trial methodologies in order to help standardize
      post-operative care in the urogynecology population. This study also has potential to lead to
      an overall change in our field and improve the postoperative course for women across the
      country and abroad.
    

Detailed description: 
      Data Collection Demographic characteristics (i.e. age, race, body mass index, medical
      history) will be collected at the time of preoperative visit. On the day of surgery,
      operative data will be recorded on a standard form to document procedures performed,
      intra-operative complications (if any), EBL and operative time. Prior to discharge the
      randomized void trial will be preformed. Data regarding the void trial will be documented on
      a standard form and will include which void trial was performed, amount backfilled, amount
      voided, post void residual when assessed, and if the patient was discharged voiding
      spontaneously, with a Foley catheter or performing CISC. All subjects will be instructed to
      call our clinical office to report any urinary complaints and treatment for UTI. Information
      will be collected from electronic medical records regarding any office visits, urine cultures
      performed or treatment for UTI during this 6-week period. Participants will be called 1 week
      from the time of surgery to complete the Short-term Catheter Burden Questionnaire.

      Pre-operative Visit The preoperative visit may occur up to 3 months prior to surgery.
      Patients electing to participate in the study will be consented in a private exam to protect
      confidentiality. Once consented the subjects will be assigned a subject identification number
      for study identification purposes, which will consist of "A" if the patient's surgery is
      performed at Rex Hospital or "B" if the patient's surgery is performed at Hillsborough. A
      number will then follow the letter.

      Void Trial Protocols

        1. Traditional backfill assisted voiding trial (control): Backfill the bladder with up to
           300 ml as tolerated of normal saline or sterile water through an indwelling Foley
           catheter. The catheter is removed and the patient is given 15 minutes to void and the
           voided volume is measured. A post void residual (PVR) is measured after voiding (or
           attempt to void) using either an in and out catheter or a bladder scanner. The
           participant is considered to have passed the void trial if they have a PVR of less than
           100 mL or less than half the voided volume if voided volume is greater than 200 mL.

        2. The post-void residual free voiding trial (intervention): Backfill the bladder with up
           to 300 ml as tolerated of normal saline or sterile water through an indwelling Foley
           catheter. The catheter is removed and the patient is given 15 minutes to void and the
           voided volume is measured. The participant is considered to have passed the void trial
           if they void more than 1/2 the instilled volume. A PVR will not be performed.

      If the participant fails the voiding trial through either method they will be discharged to
      home with an indwelling catheter or with clean intermittent self-catheterization (CISC) per
      the participants preference. Subjects with an indwelling catheter will return to clinic
      within 1-3 days for a repeat voiding trial using the same voiding trial guidelines. If the
      subject is discharged on clean intermittent self-catheterization (CISC) she will document her
      voided volumes and PVRs at home. Our nurse will then call the participant every 1-2 business
      days to determine when they can stop CISC (2 consecutive PVRs less than 100 mL). Nurses will
      document all information into a standardized template in EPIC per routine clinic protocol.

      Follow-Up Participants will be scheduled for their post-operative appointment at the time of
      scheduling their surgery per usual protocol. They will be called 1 week after surgery to
      complete a questionnaire. The postoperative visit usually takes place approximately 6 weeks
      after surgery. Any additional visits or calls to Urogynecology clinic prior to their
      post-operative appointment will be documented in the electronic medical record per routine
      clinical practice.

      All efforts will be made to ensure minimal loss to follow-up of participants. This plan may
      include efforts such as telephone follow-up or electronic medical record communication with
      the patient.

      Week 1 Phone Call The patient will be called one week after their surgery to answer the
      questions from the Short-Term Catheter Burden Questionnaire.

      Week 6 Visit (-2 weeks/+2 weeks) The primary outcome will be assessed at the time of the
      post-operative visit with confirmation of need for catheterization. At this visit the subject
      will also have the patient complete a questionnaire regarding catheter use.
    

Intervention name(s): Post-void residual free voiding trial
Intervention type(s): Other
Intervention description(s): Will proceed with voiding trial and assess bladder emptying based on voided amount without checking a post-void residual.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention