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
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.
Study Overview
Status
Conditions
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New Hampshire
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Lebanon, New Hampshire, United States, 03766
- Dartmouth Hitchcock Medical Center
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Manchester, New Hampshire, United States, 03104
- Dartmouth Manchester Ambulatory Surgery Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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.
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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.
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Active Comparator: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Patient Satisfaction with Void Trial Process
Time Frame: 2 weeks postoperatively
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Measured using a 0-100 mm visual analog scale (VAS) administered at the 2-week follow-up visit.
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2 weeks postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Postoperative Urinary Retention
Time Frame: within 72 hours postoperatively
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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).
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within 72 hours postoperatively
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Urinary tract infection
Time Frame: Within 30 days postoperatively
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Defined by positive urine culture (≥100,000 CFU/mL of uropathogen) and/or clinical diagnosis documented in the chart.
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Within 30 days postoperatively
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Adverse Events Related to Foley Catheter Removal or Void Trial
Time Frame: up to 30 days postoperatively
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Includes catheter reinsertion, pain, bleeding, ED visits, unplanned clinic visits, or other provider-documented complications.
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up to 30 days postoperatively
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Healthcare Resource Utilization
Time Frame: up to 30 days postoperatively
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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.
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up to 30 days postoperatively
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Collaborators and Investigators
Investigators
- Principal Investigator: Ekaterina Grebenyuk, MD, Dartmouth-Hitchcock Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY02002854
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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