Ignite Creation Date:
2024-05-06 @ 9:32 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03009968
Status:
COMPLETED
Last Update Posted:
2018-03-19
First Post:
2017-01-02
Brief Title:
Reducing Postoperative Catheterization
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Reducing Postoperative Catheterization After Urogynecology Surgery A Randomized Trial
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
After reconstructive pelvic surgery urinary retention occurs in up to 60 of patients requiring an indwelling catheter or self-catheterization 1-5 Up to 35 of women with acute retention experience urinary tract infections in the postoperative period 6 7 Many women consider being discharged with a Foley catheter to be a surgical complication and describe catheter use as the worst aspect of their surgery8 At this time there is no consensus within the field of Female Pelvic Medicine and Reconstructive Surgery FPMRS on how to best assess voiding function postoperatively FPMRS providers both within the United States and around the world utilize a variety of void trial methods and varying criteria to determine adequacy of post-operative voiding efficiency 5
The traditional backfill assisted void trial method involves the assessment of a postvoid residual PVR volume obtained either via catheterization or bladder scan 3 Recently there have been efforts to determine ways to avoid the assessment of a PVR as it is time-consuming and potentially exposes the patient to additional catheterizations 9 10 Many FPMRS providers utilize the backfill assisted method without assessing a PVR and instead utilize a certain voided volume threshold to determine adequate voiding However to date no one has directly studied this approach or compared the traditional backfill assisted void trial to a PVR-free backfill assisted void trial By decreasing catheterization and creating a more efficient void trial method the investigators hope improve patients postoperative experience and reduce catheterization and risk of urinary tract infection UTI
This study aims to compare two void trial methodologies in order to help standardize post-operative care in the urogynecology population This study also has potential to lead to an overall change in our field and improve the postoperative course for women across the country and abroad
The traditional backfill assisted void trial method involves the assessment of a postvoid residual PVR volume obtained either via catheterization or bladder scan 3 Recently there have been efforts to determine ways to avoid the assessment of a PVR as it is time-consuming and potentially exposes the patient to additional catheterizations 9 10 Many FPMRS providers utilize the backfill assisted method without assessing a PVR and instead utilize a certain voided volume threshold to determine adequate voiding However to date no one has directly studied this approach or compared the traditional backfill assisted void trial to a PVR-free backfill assisted void trial By decreasing catheterization and creating a more efficient void trial method the investigators hope improve patients postoperative experience and reduce catheterization and risk of urinary tract infection UTI
This study aims to compare two void trial methodologies in order to help standardize post-operative care in the urogynecology population This study also has potential to lead to an overall change in our field and improve the postoperative course for women across the country and abroad
Detailed Description:
Data Collection Demographic characteristics ie age race body mass index medical history will be collected at the time of preoperative visit On the day of surgery operative data will be recorded on a standard form to document procedures performed intra-operative complications if any EBL and operative time Prior to discharge the randomized void trial will be preformed Data regarding the void trial will be documented on a standard form and will include which void trial was performed amount backfilled amount voided post void residual when assessed and if the patient was discharged voiding spontaneously with a Foley catheter or performing CISC All subjects will be instructed to call our clinical office to report any urinary complaints and treatment for UTI Information will be collected from electronic medical records regarding any office visits urine cultures performed or treatment for UTI during this 6-week period Participants will be called 1 week from the time of surgery to complete the Short-term Catheter Burden Questionnaire
Pre-operative Visit The preoperative visit may occur up to 3 months prior to surgery Patients electing to participate in the study will be consented in a private exam to protect confidentiality Once consented the subjects will be assigned a subject identification number for study identification purposes which will consist of A if the patients surgery is performed at Rex Hospital or B if the patients surgery is performed at Hillsborough A number will then follow the letter
Void Trial Protocols
1 Traditional backfill assisted voiding trial control Backfill the bladder with up to 300 ml as tolerated of normal saline or sterile water through an indwelling Foley catheter The catheter is removed and the patient is given 15 minutes to void and the voided volume is measured A post void residual PVR is measured after voiding or attempt to void using either an in and out catheter or a bladder scanner The participant is considered to have passed the void trial if they have a PVR of less than 100 mL or less than half the voided volume if voided volume is greater than 200 mL
2 The post-void residual free voiding trial intervention Backfill the bladder with up to 300 ml as tolerated of normal saline or sterile water through an indwelling Foley catheter The catheter is removed and the patient is given 15 minutes to void and the voided volume is measured The participant is considered to have passed the void trial if they void more than 12 the instilled volume A PVR will not be performed
If the participant fails the voiding trial through either method they will be discharged to home with an indwelling catheter or with clean intermittent self-catheterization CISC per the participants preference Subjects with an indwelling catheter will return to clinic within 1-3 days for a repeat voiding trial using the same voiding trial guidelines If the subject is discharged on clean intermittent self-catheterization CISC she will document her voided volumes and PVRs at home Our nurse will then call the participant every 1-2 business days to determine when they can stop CISC 2 consecutive PVRs less than 100 mL Nurses will document all information into a standardized template in EPIC per routine clinic protocol
Follow-Up Participants will be scheduled for their post-operative appointment at the time of scheduling their surgery per usual protocol They will be called 1 week after surgery to complete a questionnaire The postoperative visit usually takes place approximately 6 weeks after surgery Any additional visits or calls to Urogynecology clinic prior to their post-operative appointment will be documented in the electronic medical record per routine clinical practice
All efforts will be made to ensure minimal loss to follow-up of participants This plan may include efforts such as telephone follow-up or electronic medical record communication with the patient
Week 1 Phone Call The patient will be called one week after their surgery to answer the questions from the Short-Term Catheter Burden Questionnaire
Week 6 Visit -2 weeks2 weeks The primary outcome will be assessed at the time of the post-operative visit with confirmation of need for catheterization At this visit the subject will also have the patient complete a questionnaire regarding catheter use
Pre-operative Visit The preoperative visit may occur up to 3 months prior to surgery Patients electing to participate in the study will be consented in a private exam to protect confidentiality Once consented the subjects will be assigned a subject identification number for study identification purposes which will consist of A if the patients surgery is performed at Rex Hospital or B if the patients surgery is performed at Hillsborough A number will then follow the letter
Void Trial Protocols
1 Traditional backfill assisted voiding trial control Backfill the bladder with up to 300 ml as tolerated of normal saline or sterile water through an indwelling Foley catheter The catheter is removed and the patient is given 15 minutes to void and the voided volume is measured A post void residual PVR is measured after voiding or attempt to void using either an in and out catheter or a bladder scanner The participant is considered to have passed the void trial if they have a PVR of less than 100 mL or less than half the voided volume if voided volume is greater than 200 mL
2 The post-void residual free voiding trial intervention Backfill the bladder with up to 300 ml as tolerated of normal saline or sterile water through an indwelling Foley catheter The catheter is removed and the patient is given 15 minutes to void and the voided volume is measured The participant is considered to have passed the void trial if they void more than 12 the instilled volume A PVR will not be performed
If the participant fails the voiding trial through either method they will be discharged to home with an indwelling catheter or with clean intermittent self-catheterization CISC per the participants preference Subjects with an indwelling catheter will return to clinic within 1-3 days for a repeat voiding trial using the same voiding trial guidelines If the subject is discharged on clean intermittent self-catheterization CISC she will document her voided volumes and PVRs at home Our nurse will then call the participant every 1-2 business days to determine when they can stop CISC 2 consecutive PVRs less than 100 mL Nurses will document all information into a standardized template in EPIC per routine clinic protocol
Follow-Up Participants will be scheduled for their post-operative appointment at the time of scheduling their surgery per usual protocol They will be called 1 week after surgery to complete a questionnaire The postoperative visit usually takes place approximately 6 weeks after surgery Any additional visits or calls to Urogynecology clinic prior to their post-operative appointment will be documented in the electronic medical record per routine clinical practice
All efforts will be made to ensure minimal loss to follow-up of participants This plan may include efforts such as telephone follow-up or electronic medical record communication with the patient
Week 1 Phone Call The patient will be called one week after their surgery to answer the questions from the Short-Term Catheter Burden Questionnaire
Week 6 Visit -2 weeks2 weeks The primary outcome will be assessed at the time of the post-operative visit with confirmation of need for catheterization At this visit the subject will also have the patient complete a questionnaire regarding catheter use
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None