Self-discontinuation of Urinary Catheters in a Rural Population

NCT ID: NCT07041151

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-12
• Study Completion Date: 2026-11-30

Brief Summary

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.

Conditions

Post-Operative Urinary Retention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

At-home passive void trial

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 Type: EXPERIMENTAL

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

Intervention Type: OTHER

Participants will remove their foley catheter at home and perform a passive void trial. They will be instructed to drink fluids and attempt to void within a designated time frame. Instructions and support will be provided to ensure safety and follow-up, including clinic contact if voiding is unsuccessful.

In-office backfill void trial

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.

Group Type: ACTIVE_COMPARATOR

In-Office Foley Catheter Removal and Backfill Void Trial

Intervention Type: OTHER

Participants will return to clinic for removal of their foley catheter and undergo a backfill void trial. Standard protocols for instillation and assessment of urinary retention will be followed.

Interventions

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

Participants will remove their foley catheter at home and perform a passive void trial. They will be instructed to drink fluids and attempt to void within a designated time frame. Instructions and support will be provided to ensure safety and follow-up, including clinic contact if voiding is unsuccessful.

Intervention Type: OTHER

In-Office Foley Catheter Removal and Backfill Void Trial

Participants will return to clinic for removal of their foley catheter and undergo a backfill void trial. Standard protocols for instillation and assessment of urinary retention will be followed.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ekaterina.A.Grebenyuk

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ekaterina Grebenyuk, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status: RECRUITING

Dartmouth Manchester Ambulatory Surgery Center

Manchester, New Hampshire, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ekaterina Grebenyuk, MD

Role: CONTACT

ekaterina.a.grebenyuk@hitchcock.org

603-653-9300

Anne Cooper, MD, MS

Role: CONTACT

603-653-9300

Facility Contacts

Ekaterina Grebenyuk, MD

Role: primary

ekaterina.a.grebenyuk@hitchcock.org

603-653-9300

Ekaterina Grebenyuk, MD

Role: primary

ekaterina.a.grebenyuk@hitchcock.org

603-653-9300

Other Identifiers

STUDY02002854

Identifier Type: -

Identifier Source: org_study_id