Timing of Repeat Voiding Trials After Outpatient Pelvic Floor Surgery
Primary Purpose
Pelvic Organ Prolapse, Urinary Incontinence,Stress, Surgery
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Foley catheter - Early Voiding Trial
Foley catheter - Late Voiding Trial
Sponsored by
About this trial
This is an interventional supportive care trial for Pelvic Organ Prolapse
Eligibility Criteria
Inclusion Criteria:
- Female patients
- Over 18 years old
- Speak English and are capable of giving informed consent and are able to complete the English patient questionnaire
- Are willing to return to the office for all necessary visits associated with the study
- Had outpatient gynecology pelvic floor surgery for prolapse or stress urinary incontinence
- Failed the voiding trial in the recovery room
- Discharged to home on POD#0
Exclusion Criteria:
- Pre-operative urinary retention as defined as PVR > 200ml
- Prior incontinence surgery
- Passed the voiding trial in the recovery room
- Require prolonged catheterization due to urethral/bladder abnormality (ie vesicovaginal fistula, urethral diverticulum) or intra-op urethral or bladder injury or for intensive post-operative monitoring
- Patients who take any post-operative antibiotics, other than prophylaxis during catheterization, for reasons other than a UTI as diagnosed and prescribed as part of the study
- Patients who take any supplements to prevent UTIs, including but not limited to D-Mannose, Hiprex, or Ellura
- Receive any post-operative vaginal estrogen during the study period
- Have any neurological conditions that may affect bladder function (ie. Multiple sclerosis, spinal cord injuries, etc.)
- Patients with pre-operative narcotic medication use due to chronic pain
- Patients who take any over-active bladder medication within one week of their surgery
Sites / Locations
- Cleveland Clinic Florida
- Wake Forest Baptist HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Early Voiding Trial
Late Voiding Trial
Arm Description
All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial. Subjects in this group will have their repeat voiding trial on post-op day #2, 3, or 4
All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial. Subjects in this group will have their repeat voiding trial on post-op day #7 or after. This is our current practice.
Outcomes
Primary Outcome Measures
Failed Voiding Trials
Determine the rates of failed voiding trials in each of the two groups
Secondary Outcome Measures
Urinary Tract Infections
Determine the rates of urinary tract infections in each of the two groups
Patient Satisfaction
Determine the rates of patient satisfaction in each of the two groups
Full Information
NCT ID
NCT03048682
First Posted
January 26, 2017
Last Updated
October 30, 2019
Sponsor
The Cleveland Clinic
Collaborators
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03048682
Brief Title
Timing of Repeat Voiding Trials After Outpatient Pelvic Floor Surgery
Official Title
Timing of Repeat Voiding Trials After Outpatient Pelvic Floor Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 5, 2017 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
January 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
Collaborators
Wake Forest University Health Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is a randomized controlled trial designed to assess the rate of failure of voiding trials in the early and late post-operative period within patients who underwent outpatient pelvic floor surgery that failed initial same day voiding trials.
Detailed Description
This study would be powered to detect differences in UTIs and Foley catheter re-insertion rates. Assuming a 10% drop-out rate, 100 total subjects should be enrolled in the study.
All patients that meet the appropriate inclusion criteria and are scheduled for outpatient pelvic floor surgery will be considered for the study. Patients will be counseled about the study either in the office during a surgical planning office visit, over a pre-operative telephone call, or in the pre-operative area just prior to surgery. Consents will be signed in the pre-operative area.
After surgery, the patient will be given a standardized voiding trial as per the usual protocol. If the patient is un-successful in emptying her bladder she will be discharged home with an indwelling Foley catheter with antibiotics. On post-operative day (POD) #1 the patient will be re-assessed for meeting eligibility requirements and will be called and randomized to either the early voiding trial group (EVT) or the late voiding trial group (LVT). Subjects in EVT will be scheduled for a repeat VT on POD#2, POD#3, or POD#4, whereas those in LVT will be scheduled for a repeat VT on or after POD#7. Subjects that are unsuccessful in the repeat VT will have a Foley catheter re-inserted and will return for another VT in 5-7 days. Subjects who fail the third VT from either group will have the Foley catheter replaced and will return for another office VT after waiting an additional 5-7 days or will be started on clean intermittent self-catheterization.
Subjects will be monitored for a 6 week period for voiding and urinary symptoms. Urine will be tested via in-office urinalysis at each office visit, including pre-operatively, and will be sent for a urine culture per usual practice based upon abnormal urinalysis results. Urine cultures that grow out a single organism >10,000 CFU will be treated with appropriate antibiotics. In addition, patients will complete quality of life questionnaires at the time of catheter removal, the standard 2 week post-op visit and at 6weeks post-operatively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse, Urinary Incontinence,Stress, Surgery
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early Voiding Trial
Arm Type
Experimental
Arm Description
All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial.
Subjects in this group will have their repeat voiding trial on post-op day #2, 3, or 4
Arm Title
Late Voiding Trial
Arm Type
Active Comparator
Arm Description
All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial.
Subjects in this group will have their repeat voiding trial on post-op day #7 or after. This is our current practice.
Intervention Type
Device
Intervention Name(s)
Foley catheter - Early Voiding Trial
Intervention Description
All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial.
Subjects in the Early Voiding group will have their repeat voiding trial on post-op day #2, 3, or 4 will undergo an in-office voiding trial. The experimental group will return for an in-office voiding trial sooner than the active comparator.
Intervention Type
Device
Intervention Name(s)
Foley catheter - Late Voiding Trial
Intervention Description
All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial.
Subjects in the Late Voiding group will have their repeat voiding trial on post-op day #7 or after. This is our current practice
Primary Outcome Measure Information:
Title
Failed Voiding Trials
Description
Determine the rates of failed voiding trials in each of the two groups
Time Frame
two years
Secondary Outcome Measure Information:
Title
Urinary Tract Infections
Description
Determine the rates of urinary tract infections in each of the two groups
Time Frame
two years
Title
Patient Satisfaction
Description
Determine the rates of patient satisfaction in each of the two groups
Time Frame
two years
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female patients
Over 18 years old
Speak English and are capable of giving informed consent and are able to complete the English patient questionnaire
Are willing to return to the office for all necessary visits associated with the study
Had outpatient gynecology pelvic floor surgery for prolapse or stress urinary incontinence
Failed the voiding trial in the recovery room
Discharged to home on POD#0
Exclusion Criteria:
Pre-operative urinary retention as defined as PVR > 200ml
Prior incontinence surgery
Passed the voiding trial in the recovery room
Require prolonged catheterization due to urethral/bladder abnormality (ie vesicovaginal fistula, urethral diverticulum) or intra-op urethral or bladder injury or for intensive post-operative monitoring
Patients who take any post-operative antibiotics, other than prophylaxis during catheterization, for reasons other than a UTI as diagnosed and prescribed as part of the study
Patients who take any supplements to prevent UTIs, including but not limited to D-Mannose, Hiprex, or Ellura
Receive any post-operative vaginal estrogen during the study period
Have any neurological conditions that may affect bladder function (ie. Multiple sclerosis, spinal cord injuries, etc.)
Patients with pre-operative narcotic medication use due to chronic pain
Patients who take any over-active bladder medication within one week of their surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey Schachar, MD
Phone
954-569-5559
Email
SchachJ@ccf.org
First Name & Middle Initial & Last Name or Official Title & Degree
Guillermo Davila, MD
Phone
954-659-5559
Email
DavilaG@ccf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Schachar, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Matthews, MD
Email
CAMatthe@wakehealth.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There no plan to make individual participant data available to other researchers
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Citation
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Timing of Repeat Voiding Trials After Outpatient Pelvic Floor Surgery
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