Post-Operative Urinary RetentionNCT07041151
Self-discontinuation of Urinary Catheters in a Rural Population
A study testing At-home Foley Catheter Self-Removal with Passive Void Trial and In-Office Foley Catheter Removal and Backfill Void Trial in people with Post-Operative Urinary Retention, run by Dartmouth-Hitchcock Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post-Operative Urinary Retention
- What is being tested?
- At-home Foley Catheter Self-Removal with Passive Void Trial and In-Office Foley Catheter Removal and Backfill Void Trial
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Aug 2025to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03766
Dartmouth Manchester Ambulatory Surgery Center
Manchester, New Hampshire, 03104
About this study
Official title: 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.
Read more
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
- Being tested
- At-home Foley Catheter Self-Removal with Passive Void Trial, In-Office Foley Catheter Removal and Backfill Void Trial
- Keywords
- Post-operative urinary retention, Self-removal of foley catheter, Self-discontinuation of foley catheter, Post-operative void trial, Urogynecology, Pelvic surgery, Catheter management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
At-home Foley Catheter Self-Removal with Passive Void TrialOther
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.
In-Office Foley Catheter Removal and Backfill Void TrialOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: In-Office Foley Catheter Removal and Backfill Void Trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction with Void Trial Process
Measured using a 0-100 mm visual analog scale (VAS) administered at the 2-week follow-up visit.
Measured: 2 weeks postoperatively
Secondary outcomes (4)
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).
Measured: within 72 hours postoperatively
Urinary tract infection
Defined by positive urine culture (≥100,000 CFU/mL of uropathogen) and/or clinical diagnosis documented in the chart.
Measured: 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.
Measured: 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.
Measured: up to 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start12 Aug 2025
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
Why it stopped: Inadequate recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Operative Urinary RetentionStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ekaterina.A.Grebenyuk, Dartmouth-Hitchcock Medical Center
- Investigators
- Ekaterina Grebenyuk, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041151
- Sponsor's protocol ID
- STUDY02002854
- Status last verified
- Aug 2025
- First submitted
- 18 Jun 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a single-center, investigator-initiated study. There are no plans to share individual participant data at this time.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-discontinuation of Urinary Catheters in Patients With Urinary Retention Following Gynecologic Surgery in a Rural Population
- ClinicalTrials.gov ID
- NCT07041151
- Acronym / sponsor ID
- STUDY02002854
- 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
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Inadequate recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| At-home passive void trial | Experimental | Other: At-home Foley Catheter Self-Removal with Passive Void TrialParticipants 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 | Other: In-Office Foley Catheter Removal and Backfill Void TrialParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| At-home Foley Catheter Self-Removal with Passive Void TrialParticipants 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. | Other | At-home passive void trial |
| In-Office Foley Catheter Removal and Backfill Void TrialParticipants 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. | Other | In-office backfill void trial |
Primary outcome
Patient Satisfaction with Void Trial Process
Time frame: 2 weeks postoperatively
Measured using a 0-100 mm visual analog scale (VAS) administered at the 2-week follow-up visit.
4 secondary outcomes
Postoperative Urinary Retention
Time frame: within 72 hours postoperatively
Urinary tract infection
Time frame: Within 30 days postoperatively
Adverse Events Related to Foley Catheter Removal or Void Trial
Time frame: up to 30 days postoperatively
Healthcare Resource Utilization
Time frame: up to 30 days postoperatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No. This is a single-center, investigator-initiated study. There are no plans to share individual participant data at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ekaterina Grebenyuk, MD principal investigator
Dartmouth-Hitchcock Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing At-home Foley Catheter Self-Removal with Passive Void Trial and In-Office Foley Catheter Removal and Backfill Void Trial in people with Post-Operative Urinary Retention, run by Dartmouth-Hitchcock Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction with Void Trial Process (time frame: 2 weeks postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.