Catheter Removal Methods for Urinary Retention

Recruiting at 1 trial location

Overseen By Ekaterina Grebenyuk, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Urinary tract abnormalities, Voiding dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 week

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which method of removing urinary catheters after gynecologic surgery is more convenient and satisfying for patients. It compares catheter removal at home with removal at the doctor's office. The trial focuses on patients in rural areas who have difficulty returning to the clinic soon after surgery. Individuals who recently underwent gynecologic surgery and anticipate difficulty urinating independently might be suitable candidates. The study seeks to identify which method patients prefer and which is most effective for them. As an unphased trial, it offers patients the opportunity to contribute to enhancing post-surgical care for others in similar situations.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that these catheter removal methods are safe?

Research has shown that removing a Foley catheter at home is safe and effective. In one study, patients who removed their catheters themselves found the process easy and safe, reporting few problems. Another study confirmed these findings, showing that patients preferred doing it themselves and were satisfied with the experience.

However, some risks exist. If the catheter is pulled out accidentally or without care, it might cause harm. With clear instructions, though, most people can safely perform the removal at home.

The standard method involves removal at a clinic, which is also safe but may be less convenient for those living far away. Both methods are generally well-tolerated, with the main difference being the location of the removal. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative methods for removing Foley catheters in patients with urinary retention. The trial compares at-home self-removal with a passive void trial to the traditional in-office backfill void trial. The at-home approach offers the convenience of managing catheter removal in the comfort of one's home, potentially reducing the need for clinic visits. Additionally, it empowers patients to actively participate in their postoperative care, which could lead to better patient satisfaction and outcomes. This trial aims to determine if these new methods are as safe and effective as the standard in-office procedure, possibly transforming how we manage urinary retention after surgery.

What evidence suggests that this trial's treatments could be effective for managing urinary retention after gynecologic surgery?

Research has shown that removing a Foley catheter at home, which participants in this trial may do, is safe and often successful. Studies found that about 84% of individuals who removed their catheters at home could urinate without problems. In this trial, another group of participants will have their catheters removed in a clinic setting, where about 73% were able to urinate without issues. Reports indicate that people are equally satisfied whether they remove the catheter themselves or have it done by a healthcare professional. This suggests that home removal can be just as effective and offers a convenient option for those living far from medical centers. ^{6 7 8 9 10}

Who Is on the Research Team?

Ekaterina Grebenyuk, MD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Are You a Good Fit for This Trial?

This trial is for patients who have difficulty urinating after gynecologic surgery and live in rural areas. They must be able to come back to the clinic or be willing to remove their catheter at home.

Inclusion Criteria

English-speaking

Willing and able to provide informed consent

Willing to comply with study procedures, including follow-up phone calls and surveys

Exclusion Criteria

Presence of significant cognitive or physical impairments that limit the ability to comply with study procedures

I need to use a catheter due to voiding issues before surgery.

I need a catheter for some time due to surgery complications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo either at-home passive void trial or in-office backfill void trial 48-72 hours postoperatively

1 week

1 visit (in-person) for in-office group

Follow-up

Participants are monitored for patient satisfaction, urinary tract infections, and healthcare resource utilization

4 weeks

1 visit (in-person) at 2 weeks, additional monitoring up to 30 days

What Are the Treatments Tested in This Trial?

Interventions

• At-home Foley Catheter Self-Removal with Passive Void Trial
• In-Office Foley Catheter Removal and Backfill Void Trial

Trial Overview The study compares two methods of managing urinary retention: self-removal of a Foley catheter at home versus traditional in-office removal by medical staff, focusing on patient satisfaction and convenience.

How Is the Trial Designed?

Group I: At-home passive void trial Experimental Treatment 1 Intervention

Participants will be instructed to remove their foley catheter at home 48-72 hours postoperatively. After removal, they will perform a passive void trial and will be monitored for successful voiding within a designated time frame. Instructions will be provided, and participants will be advised to contact the clinic if unable to void.

Group II: In-office backfill void trial Active Control 1 Intervention

Participants will return to the clinic 48-72 hours postoperatively for standard foley catheter removal and a backfill void trial. The bladder will be filled with 300 mL of sterile water, and voiding will be assessed in clinic per institutional protocol.

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07041151

Self-discontinuation of Urinary Catheters in a Rural ... Participants will be instructed to remove their foley catheter at home 48-72 hours postoperatively. After removal, they will perform a passive void trial and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02886143

Effect of Active vs. Passive Voiding Trials on Time to ... This study seeks to determine the effect of active vs passive voiding trials on time to hospital discharge, rate of urinary tract infections, and rate or ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37330128/

ASSESSMENT OF PATIENT SATISFACTION WITH HOME ... Voiding trial pass rate was similar between women who underwent home (83.8%) versus office (72.5%) catheter removal (p=0.23). No participants ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38373241/

A Retrospective Cohort Study of At-Home Catheter ... The purpose of this study was to compare 30-day postoperative outcomes between participants who performed an at-home autofill VT after catheter self- ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002937824002515

a cost analysis of second postoperative void trials While a second attempt does improve pass rates and decreases the need for outpatient management of urinary retention, it also extends time in the PACU and ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK482270/

Prevention of Inappropriate Self-Extraction of Foley Catheters Traumatic, unintended Foley catheter extractions, whether patient-initiated or accidental, can cause permanent urologic complications, affect hospital length of ...

7. cureus.com cureus.com/articles/420640-self-urinary-catheter-removal-for-urology-day-cases-a-safe-efficient-sustainable-and-patient-centred-approach

Self-Urinary Catheter Removal for Urology Day Cases This study demonstrates that self-TWOC, supported by a virtual ward, is safe, feasible, and well-accepted by patients undergoing day-case ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002937823004179

Assessment of patient satisfaction with home vs office ... This study aimed to assess patient satisfaction with location of indwelling catheter removal placed for urinary retention after urogynecologic surgery.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT03373773

Home vs. Office Foley Catheter Removal in Women With ... The purpose of this study is to evaluate the patient satisfaction with voiding assessment remotely after removal of Foley catheter at home by the patient or ...

10. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2821168

Urinary Retention Evaluation and Catheterization ... A UR evaluation and catheterization algorithm was developed to improve patient safety by increasing appropriate use of bladder scanners and catheterization.