Self-discontinuation of Urinary Catheters in a Rural Population

NCT07041151 | Withdrawn DMC

• 1 other identifier: STUDY02002854
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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

Keywords

Post-operative urinary retention; Self-removal of foley catheter; Self-discontinuation of foley catheter; Post-operative void trial; Urogynecology; Pelvic surgery; Catheter management

Outcome Measures

Primary Outcomes (1)

• Patient Satisfaction with Void Trial Process

  Measured using a 0-100 mm visual analog scale (VAS) administered at the 2-week follow-up visit.

  2 weeks postoperatively

Secondary Outcomes (4)

• Postoperative Urinary Retention

  within 72 hours postoperatively

• Urinary tract infection

  Within 30 days postoperatively

• Adverse Events Related to Foley Catheter Removal or Void Trial

  up to 30 days postoperatively

• Healthcare Resource Utilization

  up to 30 days postoperatively

Study Arms (2)

At-home passive void trial

EXPERIMENTAL

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.

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

In-office backfill void trial

ACTIVE COMPARATOR

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.

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

Interventions

In-Office Foley Catheter Removal and Backfill Void Trial 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.

In-office backfill void trial

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

At-home passive void trial

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Known urinary tract abnormalities (e.g., urethral strictures, neurogenic bladder) that may affect voiding.
• Diagnosis of voiding dysfunction prior to surgery with need to self-catheterize.
• Perioperative complication that necessitates indwelling catheter for a specific duration of time.
• 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)
• Presence of significant cognitive or physical impairments that limit the ability to comply with study procedures.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (2)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

Dartmouth Manchester Ambulatory Surgery Center

Manchester, New Hampshire, 03104, United States

Location

Study Officials

• Ekaterina Grebenyuk, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized in a 1:1 ratio to either at-home foley catheter removal with a passive void trial or in-office catheter removal with a backfill void trial. Each participant will receive one intervention only and will be followed through postoperative recovery.

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 27, 2025
• Study Start: August 12, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 1, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)