Home vs. Office Foley Catheter Removal in Women With Voiding Difficulty Following Pelvic Reconstructive Surgery
Condition: Voiding Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the patient satisfaction with voiding assessment
      remotely after removal of Foley catheter at home by the patient or her caregiver compared to
      removal at the office by a healthcare provider in patients who have been diagnosed to have
      voiding difficulty after pelvic reconstructive surgery.
    

Detailed description: 
      While in the hospital, all women who undergo surgery for pelvic organ prolapse and/or urinary
      incontinence will have a voiding trial to evaluate whether their bladder is working as it
      should. A voiding trial is when you are asked to urinate when you feel the desire to do so,
      sometimes, a physician may fill your bladder with water prior to removing the Foley catheter.
      This allows the physician to know exactly how much is left in your bladder. This evaluation
      will occur in the recovery room for subjects who have a same-day procedure. Those who are
      admitted to the hospital will have the voiding trial before their discharge typically on
      postoperative day 1. Those who fail the voiding trial will be diagnosed with urinary
      retention (bladder not working as well as we expect) and will be discharged home with a Foley
      catheter. If you agree to participate you will be randomly assigned to one of two groups:
      Subjects in the one group will remove their indwelling Foley catheter at home and will have a
      voiding assessment done over the telephone based on their self-reported force of urinary
      stream. The other group will follow up in the Uro/Gynecology office for Foley catheter
      removal and voiding trial. Which group you are assigned to will be random. You have an equal
      chance to be assigned to either group. It is important to note that outside of the study,
      physicians choose to manage patients one of these two ways. Removal of the Foley catheter at
      home is not experimental, and often done in these situations.

      Both groups of women will be given instructions on urinary catheter and bag (where the urine
      drains into) management. Prior to discharge, every subject from the home removal group as
      well as their significant other/caregiver/family member if applicable will receive a
      standardized education session and written and illustrated instructions on Foley catheter
      removal. This teaching will be done by an experienced and qualified nurse. You will be
      provided with the syringe for catheter removal, urine collection pan, and a diary to record
      their voiding quality and quantity. Both groups of women will have the catheter removal in 2
      days. This will have to be delayed up to 4 days due to weekends if the procedure is performed
      on a Thursday or Friday.

      In the home removal group, you and your significant other/caregiver/family member will be
      instructed to remove the Foley catheter at the pre-set date prior to 8 am. The research nurse
      or Uro/Gynecology (uro/Gyn) office nurse will contact contact 4 hours after removal. Voiding
      function will be evaluated by your self reported Force of Stream (FOS). This means the force
      that urine is expelled from your body compared to normal. A report of FOS of at least 5 on a
      0-10 has been shown to be a safe and effective method of assessing voiding function.
      Additionally, volume of each void will be measured by you and reported to the research nurse
      and/or the UroGyn office nurse. If there is evidence of voiding difficulty as indicated by a
      FOS below 5/10, the research and/or UroGyn nurse will instruct you to follow up in the office
      immediately for clean intermittent self-catheterization (CISC) teaching. This means inserting
      a small, thin plastic tube in your urethra (opening of the body where urine is expelled). If
      your voiding pattern qualifies as adequate, you will not require an office visit for voiding
      assessment. However, you will be instructed to contact the office if you feel full after
      voiding, are voiding less than 2 ounces or 50 mL each time and more often than every 30
      minutes, or feel pressure and discomfort in their lower abdomen.

      Women in the other group will return to the office in 2-4 days and will undergo a voiding
      trial via retrograde fill with 10 ounces (300 mL) of normal saline or until your bladder
      capacity is reached. This means that a catheter will be inserted in your urethra and normal
      saline will be put in your bladder via a large syringe that acts as a funnel. You would be
      considered to have failed the voiding trial and be taught clean intermittent
      self-catheterization if you do not void 5 ounces (150 mL) within an hour or you become too
      uncomfortable with the bladder fullness, and your postvoid residual volume is greater than
      150 mL. The residual volume is determined by a portable ultrasound like machine via an
      external probe which is scanned over your lower pelvic area.

      At the routine 2 - 4 week post-operative visit, both groups will receive a 5 question survey
      asking about your experience with removal of the Foley catheter.
    

Intervention name(s): Foley catheter removal
Intervention type(s): Procedure
Intervention description(s): After reinsertion of the Foley catheter, both groups of women will be given instructions on urinary catheter and bag management, this will be done by an RN as per standard protocol. Prior to discharge, every subject from the home removal group as well as their significant other/caregiver/family member will receive a standardized education session and written and illustrated instructions on Foley catheter removal from RN, per standard protocol. They will be provided with the syringe for catheter removal, urine collection pan, and a diary to record their voiding quality and quantity. Both groups of women will have the catheter removal in 2 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: pelvic reconstructive surgery; foley catheter; Foley removal; Urogynecology; Urinary Retention; Gynecologic surgery