Timing of Repeat Voiding Trials After Outpatient Pelvic Floor Surgery

. This study would be powered to detect differences in UTIs and Foley catheter re-insertion
rates. Assuming a 10% drop-out rate, 100 total subjects should be enrolled in the study.

All patients that meet the appropriate inclusion criteria and are scheduled for outpatient
pelvic floor surgery will be considered for the study. Patients will be counseled about the
study either in the office during a surgical planning office visit, over a pre-operative
telephone call, or in the pre-operative area just prior to surgery. Consents will be signed
in the pre-operative area.

After surgery, the patient will be given a standardized voiding trial as per the usual
protocol. If the patient is un-successful in emptying her bladder she will be discharged home
with an indwelling Foley catheter with antibiotics. On post-operative day (POD) #1 the
patient will be re-assessed for meeting eligibility requirements and will be called and
randomized to either the early voiding trial group (EVT) or the late voiding trial group
(LVT). Subjects in EVT will be scheduled for a repeat VT on POD#2, POD#3, or POD#4, whereas
those in LVT will be scheduled for a repeat VT on or after POD#7. Subjects that are
unsuccessful in the repeat VT will have a Foley catheter re-inserted and will return for
another VT in 5-7 days. Subjects who fail the third VT from either group will have the Foley
catheter replaced and will return for another office VT after waiting an additional 5-7 days
or will be started on clean intermittent self-catheterization.

Subjects will be monitored for a 6 week period for voiding and urinary symptoms. Urine will
be tested via in-office urinalysis at each office visit, including pre-operatively, and will
be sent for a urine culture per usual practice based upon abnormal urinalysis results. Urine
cultures that grow out a single organism >10,000 CFU will be treated with appropriate
antibiotics. In addition, patients will complete quality of life questionnaires at the time
of catheter removal, the standard 2 week post-op visit and at 6weeks post-operatively.

Inclusion Criteria:

- Female patients

- Over 18 years old

- Speak English and are capable of giving informed consent and are able to complete the
English patient questionnaire

- Are willing to return to the office for all necessary visits associated with the study

- Had outpatient gynecology pelvic floor surgery for prolapse or stress urinary
incontinence

- Failed the voiding trial in the recovery room

- Discharged to home on POD#0

Exclusion Criteria:

- Pre-operative urinary retention as defined as PVR > 200ml

- Prior incontinence surgery

- Passed the voiding trial in the recovery room

- Require prolonged catheterization due to urethral/bladder abnormality (ie
vesicovaginal fistula, urethral diverticulum) or intra-op urethral or bladder injury
or for intensive post-operative monitoring

- Patients who take any post-operative antibiotics, other than prophylaxis during
catheterization, for reasons other than a UTI as diagnosed and prescribed as part of
the study

- Patients who take any supplements to prevent UTIs, including but not limited to
D-Mannose, Hiprex, or Ellura

- Receive any post-operative vaginal estrogen during the study period

- Have any neurological conditions that may affect bladder function (ie. Multiple
sclerosis, spinal cord injuries, etc.)

- Patients with pre-operative narcotic medication use due to chronic pain

- Patients who take any over-active bladder medication within one week of their surgery