Not provided
Not provided
Not provided
Not provided
Not provided
Inadequate recruitment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Urinary Retention | 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). | within 72 hours postoperatively |
| Urinary tract infection |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ekaterina Grebenyuk, MD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03766 | United States | ||
| Dartmouth Manchester Ambulatory Surgery Center |
This is a single-center, investigator-initiated study. There are no plans to share individual participant data at this time.
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
Defined by positive urine culture (≥100,000 CFU/mL of uropathogen) and/or clinical diagnosis documented in the chart. |
| Within 30 days postoperatively |
| Adverse Events Related to Foley Catheter Removal or Void Trial | Includes catheter reinsertion, pain, bleeding, ED visits, unplanned clinic visits, or other provider-documented complications. | up to 30 days postoperatively |
| Healthcare Resource Utilization | 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. | up to 30 days postoperatively |
| Manchester |
| New Hampshire |
| 03104 |
| United States |