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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
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pelvic Organ Prolapse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
January 26, 2017
Last Updated
October 30, 2019
Sponsor
The Cleveland Clinic
Collaborators
Wake Forest University Health Sciences
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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
Citations:
PubMed Identifier
9441144
Citation
Alonzo-Sosa JE, Flores-Contreras JT, Paredes-Canul M. [Method for transurethral catheterization for 1-3 days for pelvic floor relaxation in the postoperative period]. Ginecol Obstet Mex. 1997 Nov;65:455-7. Spanish.
Results Reference
background
PubMed Identifier
27004205
Citation
Chong C, Kim HS, Suh DH, Jee BC. Risk factors for urinary retention after vaginal hysterectomy for pelvic organ prolapse. Obstet Gynecol Sci. 2016 Mar;59(2):137-43. doi: 10.5468/ogs.2016.59.2.137. Epub 2016 Mar 16.
Results Reference
background
PubMed Identifier
23983149
Citation
Ferrante KL, Kim HY, Brubaker L, Wai CY, Norton PA, Kraus SR, Shepherd J, Sirls LT, Nager CW; Urinary Incontinence Treatment Network. Repeat post-op voiding trials: an inconvenient correlate with success. Neurourol Urodyn. 2014 Nov;33(8):1225-8. doi: 10.1002/nau.22489. Epub 2013 Aug 27.
Results Reference
background
PubMed Identifier
17712655
Citation
Glavind K, Morup L, Madsen H, Glavind J. A prospective, randomised, controlled trial comparing 3 hour and 24 hour postoperative removal of bladder catheter and vaginal pack following vaginal prolapse surgery. Acta Obstet Gynecol Scand. 2007;86(9):1122-5. doi: 10.1080/00016340701505317.
Results Reference
background
PubMed Identifier
15270931
Citation
Hakvoort RA, Elberink R, Vollebregt A, Ploeg T, Emanuel MH. How long should urinary bladder catheterisation be continued after vaginal prolapse surgery? A randomised controlled trial comparing short term versus long term catheterisation after vaginal prolapse surgery. BJOG. 2004 Aug;111(8):828-30. doi: 10.1111/j.1471-0528.2004.00181.x.
Results Reference
background
PubMed Identifier
26829348
Citation
Kandadai P, Duenas-Garcia OF, Pilzeck AL, Saini J, Flynn MK, Leung K, Patterson D. A Randomized Controlled Trial of Patient-Controlled Valve Catheter and Indwelling Foley Catheter for Short-term Bladder Drainage. Female Pelvic Med Reconstr Surg. 2016 Mar-Apr;22(2):88-92. doi: 10.1097/SPV.0000000000000249.
Results Reference
background
PubMed Identifier
18060968
Citation
Kenton K, Pham T, Mueller E, Brubaker L. Patient preparedness: an important predictor of surgical outcome. Am J Obstet Gynecol. 2007 Dec;197(6):654.e1-6. doi: 10.1016/j.ajog.2007.08.059.
Results Reference
background
PubMed Identifier
25075308
Citation
Nicolle LE. Catheter associated urinary tract infections. Antimicrob Resist Infect Control. 2014 Jul 25;3:23. doi: 10.1186/2047-2994-3-23. eCollection 2014.
Results Reference
background
PubMed Identifier
27319367
Citation
Ripperda CM, Kowalski JT, Chaudhry ZQ, Mahal AS, Lanzer J, Noor N, Good MM, Hynan LS, Jeppson PC, Rahn DD. Predictors of early postoperative voiding dysfunction and other complications following a midurethral sling. Am J Obstet Gynecol. 2016 Nov;215(5):656.e1-656.e6. doi: 10.1016/j.ajog.2016.06.010. Epub 2016 Jun 16.
Results Reference
background
PubMed Identifier
8798095
Citation
Schiotz HA. Comparison of 1 and 3 days' transurethral Foley catheterization after retropubic incontinence surgery. Int Urogynecol J Pelvic Floor Dysfunct. 1996;7(2):98-101. doi: 10.1007/BF01902381.
Results Reference
background
PubMed Identifier
16612711
Citation
Schiotz HA, Tanbo TG. Postoperative voiding, bacteriuria and urinary tract infection with Foley catheterization after gynecological surgery. Acta Obstet Gynecol Scand. 2006;85(4):476-81. doi: 10.1080/00016340500409877.
Results Reference
background
PubMed Identifier
20497880
Citation
Tan GW, Chan SP, Ho CK. Is transurethral catheterisation the ideal method of bladder drainage? A survey of patient satisfaction with indwelling transurethral urinary catheters. Asian J Surg. 2010 Jan;33(1):31-6. doi: 10.1016/S1015-9584(10)60006-1.
Results Reference
background
PubMed Identifier
25434837
Citation
Tunitsky-Bitton E, Murphy A, Barber MD, Goldman HB, Vasavada S, Jelovsek JE. Assessment of voiding after sling: a randomized trial of 2 methods of postoperative catheter management after midurethral sling surgery for stress urinary incontinence in women. Am J Obstet Gynecol. 2015 May;212(5):597.e1-9. doi: 10.1016/j.ajog.2014.11.033. Epub 2014 Nov 27.
Results Reference
background
PubMed Identifier
18082219
Citation
Wheeler TL 2nd, Richter HE, Greer WJ, Bowling CB, Redden DT, Varner RE. Predictors of success with postoperative voiding trials after a mid urethral sling procedure. J Urol. 2008 Feb;179(2):600-4. doi: 10.1016/j.juro.2007.09.080. Epub 2007 Dec 21.
Results Reference
background

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Timing of Repeat Voiding Trials After Outpatient Pelvic Floor Surgery

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