Catheter Management After Pelvic Reconstructive Surgery
Condition: Urinary Retention Postoperative; Pelvic Organ Prolapse
MeSH terms: Urinary Retention; Prolapse; Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      This is a randomized controlled trial comparing plug-unplug catheter management, continuous
      drainage catheter systems and patients that do not get discharged with catheters after
      inpatient pelvic reconstructive surgery.
    

Detailed description: 
      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.
    

Intervention name(s): Plug-unplug catheter management; Continuous drainage catheter management
Intervention type(s): Device; Device
Intervention description(s): Transurethral catheter is plugged with a plastic cap and participants are taught to unplug during the day when they feel the urge to void or at least every 4 hours.; Transurethral catheter is attached to a continuous drainage bag.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pelvic organ prolapse; urinary catheters