Self-discontinuation of Urinary Catheters in a Rural Population

Dartmouth Health

Status: Enrolling

Conditions: Post-Operative Urinary Retention

Treatments: Other: At-home Foley Catheter Self-Removal with Passive Void Trial; Other: In-Office Foley Catheter Removal and Backfill Void Trial

Study type: Interventional

Funder types: Other

Identifiers

NCT07041151

STUDY02002854

Details and patient eligibility

About

The goal of this study is to understand patient satisfaction with two different ways of managing difficulty urinating after gynecologic surgery with a focus on those patients who receive care in a rural area.

One common practice is to have an "office catheter removal." This means, if a patient has trouble urinating after surgery and goes home with a foley catheter, they usually have to come back to the clinic within 2-3 days to have the catheter removed and to do a test to see if they can urinate on their own. For some patients, coming back to the clinic so soon after surgery can be difficult, especially for those patients who live far away or are dependent on others for getting to appointments.

A second, less common, practice is to have patients remove their own catheter at home, or "self-removal of urinary (Foley) catheter." With self-removal, patients remove their Foley catheter at home, and confirm that they are urinating normally. This approach has been shown to be safe, with similar patient satisfactions, and success, but those studies did not take into account situations where patients may live a rural area and/or travel a long distance to the medical center to receive care.

This study is comparing the in-office removal with self-removal. The goal is to find out which option patients prefer, how convenient each approach is, and how well they work. The main goal of this study is to understand patient satisfaction and improve care after surgery.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults aged 18 years or older
2. Undergoing gynecologic surgery with planned postoperative trial of void to confirm normal voiding prior to discharge home
3. Willing and able to provide informed consent
4. English-speaking
5. Willing to comply with study procedures, including follow-up phone calls and surveys

Exclusion criteria

1. Known urinary tract abnormalities (e.g., urethral strictures, neurogenic bladder) that may affect voiding.
2. Diagnosis of voiding dysfunction prior to surgery with need to self-catheterize.
3. Perioperative complication that necessitates indwelling catheter for a specific duration of time.
4. Joint surgeries that would affect ability to comply with study methods (e.g. that necessitates longer inpatient admission or reduces mobility beyond that normal for postop patients after gynecologic surgery)
5. Presence of significant cognitive or physical impairments that limit the ability to comply with study procedures.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

At-home passive void trial

Experimental group

Description:

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.

Treatment:

Other: At-home Foley Catheter Self-Removal with Passive Void Trial

In-office backfill void trial

Active Comparator group

Description:

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.

Treatment:

Other: In-Office Foley Catheter Removal and Backfill Void Trial