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Self-Removal of Catheters After Urogynecologic Surgery (CATH Trial)
N/A
Recruiting
Led By Mary M Rieger, MD
Research Sponsored by University of Texas at Austin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Are diagnosed with POUR on POD0 based on ultrasound bladder scan PVR of 100 mL or more
Have transurethral catheter in place at the conclusion of surgery as part of standard care
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 6 weeks of surgery
Awards & highlights
CATH Trial Summary
This trial will test if patients can safely remove their own catheters at home after surgery instead of in the doctor's office.
Who is the study for?
This trial is for adults fluent in English or Spanish who have had urogynecologic surgery, need a catheter afterwards, and are sent home the same day. It's not for those with preoperative voiding issues requiring self-catheterization, mental or physical impairments affecting catheter removal ability, or additional urinary tract procedures needing longer catheter use.Check my eligibility
What is being tested?
The study tests if patients can safely remove their urinary catheters at home after urogynecology surgery compared to standard removal in the office. Participants will be randomly assigned to either self-removal at home or office removal.See study design
What are the potential side effects?
Potential side effects may include discomfort during self-removal of the catheter, infection risk due to improper handling, and possible complications from incorrect removal technique.
CATH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was diagnosed with urinary retention right after surgery.
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I will have a catheter placed through the urethra after surgery as usual care.
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I am 18 years old or older.
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I went home the same day I had surgery.
CATH Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 6 weeks of surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 6 weeks of surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Postoperative Urinary Retention
Secondary outcome measures
Incidence of recurrent POUR
Number of postoperative patient encounters
Patient satisfaction assessment via the Acceptability of Intervention Measure (AIM) Questionnaire
+2 moreCATH Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Catheter self-discontinuation groupExperimental Treatment1 Intervention
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.
Group II: Catheter office-discontinuation groupActive Control1 Intervention
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.
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Who is running the clinical trial?
University of Texas at AustinLead Sponsor
353 Previous Clinical Trials
81,126 Total Patients Enrolled
Mary M Rieger, MDPrincipal InvestigatorUniversity of Texas at Austin
Collin M McKenzie, MDPrincipal InvestigatorUniversity of Texas at Austin
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was diagnosed with urinary retention right after surgery.I will have a catheter placed through the urethra after surgery as usual care.I am 18 years old or older.I cannot remove my catheter by myself due to a physical or mental condition.I went home the same day I had surgery.I've had a urinary tract surgery that required a long-term catheter.I use a catheter for urination due to bladder issues.I will receive injections to bulk up my urethra during surgery.I am having surgery for pelvic organ prolapse or urinary incontinence.I can read and speak English or Spanish fluently.
Research Study Groups:
This trial has the following groups:- Group 1: Catheter office-discontinuation group
- Group 2: Catheter self-discontinuation group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants welcomed to join this experiment?
"As per clinicaltrials.gov, this medical research is no longer recruiting patients as the trial was last updated on May 5th 2023. Nevertheless, 260 other studies are in search of volunteers currently."
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