Catheter Management After Pelvic Reconstructive Surgery

NCT ID: NCT03071211

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-26
• Study Completion Date: 2019-01-31

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.

Conditions

Urinary Retention Postoperative; Pelvic Organ Prolapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Plug-unplug Group

Participants randomized to plug-unplug catheter management. Participants plug and unplug catheters when they feel urge to void or at least every 4 hours during the day. Participants are given the option to use a large drainage bag for convenience overnight.

Group Type: EXPERIMENTAL

Plug-unplug catheter management

Intervention Type: DEVICE

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.

Continuous Drainage Group

Participants randomized to continuous drainage catheter management. Catheters are attached to a leg bag during the day and large drainage bag for convenience overnight.

Group Type: ACTIVE_COMPARATOR

Continuous drainage catheter management

Intervention Type: DEVICE

Transurethral catheter is attached to a continuous drainage bag.

Reference Group

Participants that do not fail inpatient voiding trial and go home without a catheter.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Plug-unplug catheter management

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.

Intervention Type: DEVICE

Continuous drainage catheter management

Transurethral catheter is attached to a continuous drainage bag.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hartford Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sarah Boyd

Fellow physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sarah S Boyd, MD

Role: PRINCIPAL_INVESTIGATOR

Hartford Hospital

Elena Tunitsky-Bitton, MD

Role: PRINCIPAL_INVESTIGATOR

Hartford Hospital

Locations

Hartford Hospital

Hartford, Connecticut, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31599826 (View on PubMed)

Other Identifiers

HHC-2016-0228

Identifier Type: -

Identifier Source: org_study_id