Comparing Force of Stream to Retrograde Fill Voiding Trial After Vaginal Apex Suspension
Condition: Vaginal Apical Prolapse
MeSH terms: Prolapse
Study type: Interventional

Summary: 
      Voiding difficulties are common after prolapse and incontinence surgeries. All patients after
      vaginal prolapse surgery must complete a voiding trial if they are to be discharged home
      without a catheter. Accepted protocols for voiding trials after prolapse and incontinence
      surgeries do not exist. The purpose of this study is to compare two different types of
      postoperative voiding trials to determine which leads to less postoperative issues, such as
      urinary retention requiring catheterization. You are being asked to participate because you
      are having a vaginal apex suspension surgery.
    

Detailed description: 
      It is common to have voiding difficulties after prolapse and incontinence surgeries.
      Difficulties in voiding are seen in up to 47% of patients after transvaginal prolapse surgery
      in the immediate hours postoperatively (6). Accepted protocols for voiding trials after
      prolapse and incontinence surgeries do not exist. Traditionally, many surgeons measure
      postvoid residual (PVR) urine volume to assess incomplete bladder emptying by retrograde
      filling the bladder with a predetermined amount of normal saline or water. The catheter is
      then removed and the patient is permitted to void into a collection basin. The need for
      postoperative catheterization is generally based on arbitrarily determined ratios of voided
      urine to PVR. The force of stream trial (FAST) does not prioritize amount voided, but rather
      the patient's subjective force of stream. Using FAST, a patient uses a visual analog scale
      (VAS) scale to quantify her force of stream. If she states that her Force of Stream (FOS) is
      >50% of her baseline prior to surgery, independent of the amount voided, she is discharged
      without a catheter. If the FOS is <50%, a PVR is measured via bladder scan. If her PVR is
      <500cc the patient is discharged home.

      No randomized control trials (RCT) have been performed comparing the FAST method to the
      traditional retrograde voiding trial in subjects undergoing vaginal apex prolapse surgery
      despite the promising findings that FAST voiding trials are as reliable and safe as
      retrograde voiding trials in patients undergoing anti-incontinence surgeries. Standard in our
      practice is to perform a voiding trial on postoperative day 1 on all patients after vaginal
      apical prolapse surgery if they are to be discharged without a catheter. Investigators would
      like to compare the FAST voiding trial to a traditional retrograde fill voiding trial with
      respect to the rate of catheterization among those discharged without a catheter within the
      six-week postoperative period in patients undergoing a vaginal apex prolapse surgery.
      Investigators hypothesize the FAST voiding trial method is not inferior to traditional
      retrograde voiding trial. Subjects will complete questionnaires to examine postoperative
      bladder function, symptom distress and quality of life before and after surgery during their
      routine postoperative visits.
    

Intervention name(s): voiding trial; Foley catheter
Intervention type(s): Other; Device
Intervention description(s): 1 of 2 tests to assess bladder function after vaginal apex suspension surgery with or without mid-urethral sling; If subject is unable to void adequately, a Foley catheter will be placed as per protocol and the subject discharged home with catheter. The subject will follow up in the office for removal of catheter.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: voiding trial; prolapse