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Timing of Repeat Voiding Trials After Outpatient Pelvic Floor Surgery

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ClinicalTrials.gov Identifier: NCT03048682
Recruitment Status : Recruiting
First Posted : February 9, 2017
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Jeffrey Schachar, The Cleveland Clinic

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.

Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Urinary Incontinence,Stress Surgery Device: Foley catheter - Early Voiding Trial Device: Foley catheter - Late Voiding Trial Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Timing of Repeat Voiding Trials After Outpatient Pelvic Floor Surgery
Actual Study Start Date : January 5, 2017
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Early Voiding Trial

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

Device: Foley catheter - Early Voiding Trial

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.


Active Comparator: Late Voiding Trial

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.

Device: Foley catheter - Late Voiding Trial

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 Measures :
  1. Failed Voiding Trials [ Time Frame: two years ]
    Determine the rates of failed voiding trials in each of the two groups


Secondary Outcome Measures :
  1. Urinary Tract Infections [ Time Frame: two years ]
    Determine the rates of urinary tract infections in each of the two groups

  2. Patient Satisfaction [ Time Frame: two years ]
    Determine the rates of patient satisfaction in each of the two groups



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03048682


Contacts
Contact: Jeffrey Schachar, MD 954-569-5559 SchachJ@ccf.org
Contact: Guillermo Davila, MD 954-659-5559 DavilaG@ccf.org

Locations
United States, Florida
Cleveland Clinic Florida Recruiting
Weston, Florida, United States, 33331
Contact: Jeffrey Schachar, MD    954-659-5559    SchachJ@CCF.org   
Contact: Guillermo Davila, MD    954-659-5559    DavilaG@CCF.org   
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Jeffrey Schachar, MD The Cleveland Clinic

Publications:

Responsible Party: Jeffrey Schachar, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03048682     History of Changes
Other Study ID Numbers: FLA 16-123
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There no plan to make individual participant data available to other researchers

Additional relevant MeSH terms:
Urination Disorders
Urinary Incontinence
Enuresis
Prolapse
Pelvic Organ Prolapse
Urinary Incontinence, Stress
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Pathological Conditions, Anatomical