Clinical trial NCT03071211: Catheter Management After Pelvic Reconstructive Surgery
Official title: Catheter Management After Pelvic Reconstructive Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Retention Postoperative
Pelvic Organ Prolapse
Keywords: pelvic organ prolapse
urinary catheters
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
First posted: 2017-03-06
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Activity Assessment Scale
timeFrame: Postoperative day 3-5
Secondary outcomes:
measure: Preoperative expectations
timeFrame: At the time of consent
measure: Days until passing voiding trial
timeFrame: up to 6 weeks postoperatively
measure: Urinary Tract infection
timeFrame: up to 6 weeks postoperatively
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
Study officials:
affiliation: Hartford Hospital
name: Sarah S Boyd, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hartford Hospital
name: Elena Tunitsky-Bitton, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boyd SS, O'Sullivan DM, Tunitsky-Bitton E. A Comparison of Two Methods of Catheter Management After Pelvic Reconstructive Surgery: A Randomized Controlled Trial. Obstet Gynecol. 2019 Nov;134(5):1037-1045. doi: 10.1097/AOG.0000000000003525.