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Self-Removal of Catheters After Urogynecologic Surgery (CATH Trial)

N/A

Recruiting

Led By Collin M McKenzie, 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

Must not have

Have physical or mental impairment that would impact their ability to remove their catheter themselves.

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 6 weeks of surgery

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot remove my catheter by myself due to a physical or mental condition.

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I've had a urinary tract surgery that required a long-term catheter.

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I use a catheter for urination due to bladder issues.

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I will receive injections to bulk up my urethra during surgery.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 6 weeks of surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Postoperative Urinary Retention

Secondary study objectives

Incidence of recurrent POUR

Number of postoperative patient encounters

Patient satisfaction assessment via the Acceptability of Intervention Measure (AIM) Questionnaire

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 8Eligibility criteria met