Catheter Management After Pelvic Reconstructive Surgery

This study will be a randomized controlled trial comparing plug-unplug (PUP) catheter
management, continuous drainage (CD) catheter systems and patients that do not get discharged
with catheters (reference) after pelvic reconstructive surgery. The primary objective of this
study is to assess impact on activity. The secondary objectives are to compare the rate of
urinary tract infection between the groups, duration of time (days) it takes for patients to
resume normal voiding, impact on post-operative pain and satisfaction with surgery experience
and post-operative recovery. The investigators hypothesize that patient activity/mobility one
week after surgery between the two methods of managing the transurethral catheter will be
different between arms. Subjects will be recruited at the Hartford Hospital Division of
Female Pelvic Medicine and Reconstructive Surgery during preoperative consultation for pelvic
reconstructive surgery with 1:1:1 assignment and randomization for PUP and CD groups only.
Prior to surgery, baseline activity will be assessed using the Activity Assessment Scale, as
well as postoperative expectations. Prior to hospital discharge, patients will undergo a
postoperative voiding trial (PVT) per regular clinical practice. Upon failure of PVT,
participants will be randomized 1:1 to one of two arms in which participants receive a
catheter: PUP or CD. The investigator responsible for data collection will remain blinded to
the treatment assignment throughout the study. Subjects who pass the PVT test and therefore
do not require a catheter will be assigned to the reference arm (Arm C). Subjects will be
followed after hospital discharge and assessed using the same pre- and post-operative
questionnaires as participants randomized to the CD and PUP arms and will comprise the first
32 consenting patients who do not require a catheter.

Subjects randomized to CD will have a 16F transurethral catheter attached to a leg bag and
receive teaching regarding home maintenance. Subjects randomized to PUP will have the same
16F transurethral catheter placed with a plastic plug and instructed to unplug and drain the
catheter when they feel the urge to void, or at least every four hours throughout the day.
Subjects in both groups will be provided a large bag for gravity-based drainage during the
night. Subjects also will be encouraged to call the research team with any catheter-related
questions or concerns including symptoms of urinary tract infection (UTI). Subjects with
symptoms of UTI (e.g., dysuria, urgency, frequency, and/or hematuria) will be evaluated and
treated per standard of care. All participants will then return for an office voiding trial
(OVT) five to seven days after hospital discharge, following the same protocol as the PVT. At
this time urinalysis will be obtained. Only those participants who endorse symptoms of UTI
will have a urine specimen collected and sent for culture. This is in line with the current
clinical practice by the investigators. Participants will be treated for UTI based on culture
results or if there is high clinical suspicion at the time of office follow-up. Participants
who fail the OVT will be discharged home with bladder drainage per standard of care and
undergo routine follow-up until they pass a repeat voiding trial.

The subjects will complete a post-operative questionnaire assessing pain, impact on activity
and satisfaction. Outcomes will be followed for up to six weeks after initial OVT if it is
failed; however, no additional research-associated visits will be necessary from study
participants beyond the initial office visit.

Inclusion Criteria:

- Female

- Age 18-89

- Inpatient surgery

- surgery for pelvic organ prolapse with or without mid-urethral slings who fail initial
voiding trial at the time of hospital discharge

- willing/able to provide written informed consent

Exclusion Criteria:

- male

- age < 18 or >89

- unwilling or unable to provide written informed consent

- undergoing outpatient surgery.

- planned postoperative catheter use

- discharged to a nursing facility or who are not candidates for the plug-unplug method
for another reason (e.g., poor hand dexterity, paraplegia)

- suprapubic catheter placement

- procedures involving urethral bulking or Onabotulinum toxin A (Botox) injection

- procedures involving planned urethral or bladder surgery (e.g., fistula excision, mesh
excision, excision of urethral diverticulum)

- procedures with only posterior vaginal repair

- presence of a neurologic condition affecting urinary function