Self-discontinuation of Urinary Catheters in a Rural Population

Not Applicable

Not yet recruiting

• Conditions: Post-Operative Urinary Retention

• Registration Number: NCT07041151
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-06-18
• Study First Submitted QC: 2025-06-18
• Last Update Submitted: 2025-06-18
• Study First Posted: 2025-06-27
• Last Update Posted: 2025-06-27
• Study Start: 2025-08-04
• Primary Completion: 2026-09
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction with Void Trial Process	2 weeks postoperatively	Measured using a 0-100 mm visual analog scale (VAS) administered at the 2-week follow-up visit.

Secondary Outcome Measures

Name	Time	Method
Postoperative Urinary Retention	within 72 hours postoperatively	Defined as inability to void ≥200 mL within 30 minutes after backfill (in-office) or failure to void minimum volume within 6 hours post-catheter removal (at-home).
Urinary tract infection	Within 30 days postoperatively	Defined by positive urine culture (≥100,000 CFU/mL of uropathogen) and/or clinical diagnosis documented in the chart.
Adverse Events Related to Foley Catheter Removal or Void Trial	up to 30 days postoperatively	Includes catheter reinsertion, pain, bleeding, ED visits, unplanned clinic visits, or other provider-documented complications.
Healthcare Resource Utilization	up to 30 days postoperatively	Includes the number of MyDH messages, telephone encounters, and unplanned clinic or emergency department visits related to the void trial process, as documented in the electronic medical record.

Trial Locations

Locations (2)

Dartmouth Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

Dartmouth Manchester Ambulatory Surgery Center; 🇺🇸 Manchester, New Hampshire, United States