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Self-discontinuation of Urinary Catheters in a Rural Population

Self-discontinuation of Urinary Catheters in Patients With Urinary Retention Following Gynecologic Surgery in a Rural Population

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07041151
Enrollment
0
Registered
2025-06-27
Start date
2025-08-12
Completion date
2025-10-01
Last updated
2026-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

OTHERAt-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.

OTHERIn-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.

Sponsors

Dartmouth-Hitchcock Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Patient Satisfaction with Void Trial Process2 weeks postoperativelyMeasured using a 0-100 mm visual analog scale (VAS) administered at the 2-week follow-up visit.

Secondary

MeasureTime frameDescription
Postoperative Urinary Retentionwithin 72 hours postoperativelyDefined 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 infectionWithin 30 days postoperativelyDefined 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 Trialup to 30 days postoperativelyIncludes catheter reinsertion, pain, bleeding, ED visits, unplanned clinic visits, or other provider-documented complications.
Healthcare Resource Utilizationup to 30 days postoperativelyIncludes 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATOREkaterina Grebenyuk, MD

Dartmouth-Hitchcock Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026