Back to resultsUrinary Catheter Self-Discontinuation After Urogynecology Surgery (CATH)
Primary Purpose
Urinary Retention, Pelvic Organ Prolapse, Stress Urinary Incontinence
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Catheter self-discontinuation
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Retention focused on measuring Post-operative urinary retention, Pelvic organ prolapse, Stress urinary incontinence, Cather self-discontinuation
Eligibility Criteria
Inclusion Criteria: Are at least 18 years of age Are fluent and able to read in English or Spanish Undergo POP and/or SUI surgery (uterosacral ligament suspension, sacrospinous ligament fixation, sacral colpopexy, anterior colporrhaphy, posterior colporrhaphy, and/or mid-urethral sling) that occurs on Monday - Thursday Have transurethral catheter in place at the conclusion of surgery as part of standard care Are diagnosed with POUR on POD0 based on ultrasound bladder scan PVR of 100 mL or more Are discharged home on the same day of surgery (POD 0) Exclusion Criteria: Have preoperative voiding dysfunction requiring self-catheterization or indwelling transurethral catheter Have physical or mental impairment that would impact their ability to remove their catheter themselves. Undergo urethral bulking injections as part of surgery Have undergone a planned or unplanned urinary tract procedure requiring prolonged catheterization as standard of care (e.g. cystotomy repair, ureteral reimplantation, vesicovaginal fistula repair, urethral diverticulum repair)
Sites / Locations
- University of Texas of Austin - Dell Seton Medical Center
- Seton Medical Center Austin
- Ascension Seton Hays Hospital
- Seton Medical Center Williamson
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Catheter office-discontinuation group
Catheter self-discontinuation group
Arm Description
The patients randomized to the office-discontinuation group will visit the office for a repeat voiding trial on postoperative day 1. At this visit, the patients will undergo a backfill voiding trial.
The patients randomized to the catheter self-discontinuation group will be provided with a diagrammatic handout and will be instructed to remove their indwelling urinary catheter at home on the morning of Postoperative day 1.
Outcomes
Primary Outcome Measures
Number of Participants With Postoperative Urinary Retention
Non-inferiority comparison of the rates of persistent POUR on POD1 between catheter self-discontinuation and standard office catheter. Persistent POUR is defined as PVR greater than 100 mL by bladder scan on POD1.
Secondary Outcome Measures
Rates of postoperative urinary tract infection (UTI)
Rates of postoperative UTI within 6 weeks of surgery - UTI will be defined as treatment with antibiotics for symptoms of UTI.
Incidence of recurrent POUR
Recurrent POUR will be defined as any participant with successful POD1 voiding trial who later requires replacement of catheter due to recurrent POUR within 6 weeks of surgery. Recurrent POUR is defined as PVR greater than 100 mL by bladder scan after passing initial POD1 voiding trial.
Number of postoperative patient encounters
Number of postoperative patient encounters, including any patient call to the office, electronic medical record message to office from patient, office visit, or emergency department visit.
Patient satisfaction assessment via the Acceptability of Intervention Measure (AIM) Questionnaire
Patient satisfaction with catheter removal method as assessed via the Acceptability of Intervention Measure (AIM) Questionnaire.
The AIM Questionnaire is a 4-item questionnaire on a 5-point Likert scale. Response Scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree Scoring Instructions: Scale is created by averaging responses. Scale values range from 1 to 5.
The higher the score is, the higher the degree the patient finds the intervention acceptable.
Patient satisfaction assessment via the the Surgical Satisfaction Questionnaire - 8 (SSQ-8).
Patient satisfaction with catheter removal method as assessed via the Surgical Satisfaction Questionnaire - 8 (SSQ-8).
The SSQ-8 is an 8-item questionnaire, with responses recorded on a 5-point Likert scale with responses from 0 "Very Unsatisfied" to 4 "Very Satisfied." Scoring uses the mean average of the 8 scores being multiplied by 25 (the questionnaire is considered incomplete if more than 2 items are not answered), yielding a potential range of scores from 0 to 100. The higher the score is, the greater the degree of surgical satisfaction.
Full Information
NCT ID
NCT05860634
First Posted
April 27, 2023
Last Updated
May 5, 2023
Sponsor
University of Texas at Austin
1. Study Identification
Unique Protocol Identification Number
NCT05860634
Brief Title
Urinary Catheter Self-Discontinuation After Urogynecology Surgery
Acronym
CATH
Official Title
Urinary Catheter Self-Discontinuation After Urogynecology Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas at Austin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of this randomized clinical trial is to determine if removal of transurethral urinary catheters by patients at home is as safe as catheter removal in the office following urogynecologic surgery.
Participants will be randomized to either standard catheter removal in the office or catheter self-removal at home.
Detailed Description
This is a prospective, randomized, two-parallel arm, non-inferiority trial to evaluate two methods of catheter discontinuation in women with post-operative urinary retention (POUR) after surgery for pelvic organ prolapse (POP) or stress urinary incontinence (SUI). This study will evaluate whether self-discontinuation of transurethral catheter by patients is non-inferior to standard office discontinuation based on rates of persistent POUR on post-operative day (POD) 1.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention, Pelvic Organ Prolapse, Stress Urinary Incontinence, Catheter Related Complication
Keywords
Post-operative urinary retention, Pelvic organ prolapse, Stress urinary incontinence, Cather self-discontinuation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
118 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Catheter office-discontinuation group
Arm Type
No Intervention
Arm Description
The patients randomized to the office-discontinuation group will visit the office for a repeat voiding trial on postoperative day 1. At this visit, the patients will undergo a backfill voiding trial.
Arm Title
Catheter self-discontinuation group
Arm Type
Experimental
Arm Description
The patients randomized to the catheter self-discontinuation group will be provided with a diagrammatic handout and will be instructed to remove their indwelling urinary catheter at home on the morning of Postoperative day 1.
Intervention Type
Procedure
Intervention Name(s)
Catheter self-discontinuation
Intervention Description
Self-discontinuation of a transurethral catheter
Primary Outcome Measure Information:
Title
Number of Participants With Postoperative Urinary Retention
Description
Non-inferiority comparison of the rates of persistent POUR on POD1 between catheter self-discontinuation and standard office catheter. Persistent POUR is defined as PVR greater than 100 mL by bladder scan on POD1.
Time Frame
Post-operative day 1
Secondary Outcome Measure Information:
Title
Rates of postoperative urinary tract infection (UTI)
Description
Rates of postoperative UTI within 6 weeks of surgery - UTI will be defined as treatment with antibiotics for symptoms of UTI.
Time Frame
within 6 weeks of surgery
Title
Incidence of recurrent POUR
Description
Recurrent POUR will be defined as any participant with successful POD1 voiding trial who later requires replacement of catheter due to recurrent POUR within 6 weeks of surgery. Recurrent POUR is defined as PVR greater than 100 mL by bladder scan after passing initial POD1 voiding trial.
Time Frame
within 6 weeks of surgery
Title
Number of postoperative patient encounters
Description
Number of postoperative patient encounters, including any patient call to the office, electronic medical record message to office from patient, office visit, or emergency department visit.
Time Frame
within 6 weeks of surgery
Title
Patient satisfaction assessment via the Acceptability of Intervention Measure (AIM) Questionnaire
Description
Patient satisfaction with catheter removal method as assessed via the Acceptability of Intervention Measure (AIM) Questionnaire.
The AIM Questionnaire is a 4-item questionnaire on a 5-point Likert scale. Response Scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree Scoring Instructions: Scale is created by averaging responses. Scale values range from 1 to 5.
The higher the score is, the higher the degree the patient finds the intervention acceptable.
Time Frame
Post-operative day 1
Title
Patient satisfaction assessment via the the Surgical Satisfaction Questionnaire - 8 (SSQ-8).
Description
Patient satisfaction with catheter removal method as assessed via the Surgical Satisfaction Questionnaire - 8 (SSQ-8).
The SSQ-8 is an 8-item questionnaire, with responses recorded on a 5-point Likert scale with responses from 0 "Very Unsatisfied" to 4 "Very Satisfied." Scoring uses the mean average of the 8 scores being multiplied by 25 (the questionnaire is considered incomplete if more than 2 items are not answered), yielding a potential range of scores from 0 to 100. The higher the score is, the greater the degree of surgical satisfaction.
Time Frame
Post-operative day 1
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Are at least 18 years of age
Are fluent and able to read in English or Spanish
Undergo POP and/or SUI surgery (uterosacral ligament suspension, sacrospinous ligament fixation, sacral colpopexy, anterior colporrhaphy, posterior colporrhaphy, and/or mid-urethral sling) that occurs on Monday - Thursday
Have transurethral catheter in place at the conclusion of surgery as part of standard care
Are diagnosed with POUR on POD0 based on ultrasound bladder scan PVR of 100 mL or more
Are discharged home on the same day of surgery (POD 0)
Exclusion Criteria:
Have preoperative voiding dysfunction requiring self-catheterization or indwelling transurethral catheter
Have physical or mental impairment that would impact their ability to remove their catheter themselves.
Undergo urethral bulking injections as part of surgery
Have undergone a planned or unplanned urinary tract procedure requiring prolonged catheterization as standard of care (e.g. cystotomy repair, ureteral reimplantation, vesicovaginal fistula repair, urethral diverticulum repair)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary M Rieger, MD
Phone
512-324-8670
Email
mary.rieger@austin.utexas.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary M Rieger, MD
Organizational Affiliation
University of Texas at Austin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Collin M McKenzie, MD
Organizational Affiliation
University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas of Austin - Dell Seton Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78701
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Collin M McKenzie, MD
Phone
512-324-8670
Email
collin.mckenzie@austin.utexas.edu
Facility Name
Seton Medical Center Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Collin M McKenzie, MD
Phone
512-324-8670
Email
collin.mckenzie@austin.utexas.edu
Facility Name
Ascension Seton Hays Hospital
City
Kyle
State/Province
Texas
ZIP/Postal Code
78640
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Collin M McKenzie, MD
Phone
512-324-8670
Email
collin.mckenzie@austin.utexas.edu
Facility Name
Seton Medical Center Williamson
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78665
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Collin M McKenzie, MD
Phone
512-324-8670
Email
collin.mckenzie@austin.utexas.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Urinary Catheter Self-Discontinuation After Urogynecology Surgery
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