Urinary RetentionNCT05538273
Optimal Management of Urinary Catheter in Gyn Onc
An observational study of Urinary Retention, run by WellSpan Health at 1 site in United States.
Trial summary
This is a combined retrospective observational study that will collect data on urinary catheter removal of patients who underwent pelvic surgery by a gynecologic oncologist to assess timing safety and its implications in postoperative care. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Retention
- What is being tested?
- Early removal of urinary catheter postoperatively and Late removal of urinary catheter postoperatively
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2022to 14 Mar 2023
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients who meets the eligibility criteria, undergoing pelvic surgery by a gynecologic oncologist. Simple and radical procedures included.
Who may be able to join
- Age above 18
- female gender
- undergoing pelvic surgery for benign or malignant indications by a gynecologic oncologist
Who cannot join
- Age less than 18 years of age at the time of surgery
- pregnant
- individual is a prisoner
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimal Management and Timing of Removal of Urinary Catheter Following Pelvic Surgery by the Gynecologic Oncology Surgeon
This is a combined retrospective observational study that will collect data on urinary catheter removal of patients who underwent pelvic surgery by a gynecologic oncologist to assess timing safety and its implications in postoperative care.
- Conditions
- Urinary Retention
- Being tested
- Early removal of urinary catheter postoperatively, Late removal of urinary catheter postoperatively
- Keywords
- urinary retention, postoperative, urinary complications, pelvic surgery, hysterectomy, gynecologic oncology
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early removal of urinary catheter postoperativelyOther
removal of urinary catheter less than 24 hours after surgery
Late removal of urinary catheter postoperativelyOther
removal of urinary catheter greater than 24 hours after surgery
| Study group | Role | What they receive |
|---|---|---|
| Minimal invasive surgery | removal of urinary catheter postoperatively Receives: Other: Early removal of urinary catheter postoperatively; Other: Late removal of urinary catheter postoperatively | |
| Laparotomy | removal of urinary catheter postoperatively Receives: Other: Early removal of urinary catheter postoperatively; Other: Late removal of urinary catheter postoperatively | |
| Simple surgery | removal of urinary catheter postoperatively Receives: Other: Early removal of urinary catheter postoperatively; Other: Late removal of urinary catheter postoperatively | |
| Radical surgery | removal of urinary catheter postoperatively Receives: Other: Early removal of urinary catheter postoperatively; Other: Late removal of urinary catheter postoperatively |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary retention rate after urinary catheter removal postoperatively
urinary retention rate will be measured as need for re-catheterization postoperatively
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start8 Sep 2022
- Primary completion14 Mar 2023
- Study completion14 Mar 2023
Why it stopped: Study not activated, staff left institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary RetentionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- WellSpan Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eav Lim, WellSpan Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538273
- Sponsor's protocol ID
- 1946054-1
- Status last verified
- Mar 2023
- First submitted
- 8 Sep 2022
- Last updated
- 17 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Management and Timing of Removal of Urinary Catheter Following Pelvic Surgery by the Gynecologic Oncology Surgeon
- ClinicalTrials.gov ID
- NCT05538273
- Acronym / sponsor ID
- 1946054-1
- Conditions
- Urinary Retention
- Keywords
- urinary retention, postoperative, urinary complications, pelvic surgery, hysterectomy, gynecologic oncology
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study not activated, staff left institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- WellSpan HealthUniversity, hospital or other
- Study start
- 8 Sep 2022 (actual)
- Primary completion
- 14 Mar 2023 (actual)
- Study completion
- 14 Mar 2023 (actual)
- First posted
- 13 Sep 2022 (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.
This is a combined retrospective observational study that will collect data on urinary catheter removal of patients who underwent pelvic surgery by a gynecologic oncologist to assess timing safety and its implications in postoperative care.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Minimal invasive surgery | – | Other: Early removal of urinary catheter postoperatively, Other: Late removal of urinary catheter postoperativelyremoval of urinary catheter postoperatively |
| Laparotomy | – | Other: Early removal of urinary catheter postoperatively, Other: Late removal of urinary catheter postoperativelyremoval of urinary catheter postoperatively |
| Simple surgery | – | Other: Early removal of urinary catheter postoperatively, Other: Late removal of urinary catheter postoperativelyremoval of urinary catheter postoperatively |
| Radical surgery | – | Other: Early removal of urinary catheter postoperatively, Other: Late removal of urinary catheter postoperativelyremoval of urinary catheter postoperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients who meets the eligibility criteria, undergoing pelvic surgery by a gynecologic oncologist. Simple and radical procedures included.
Key inclusion criteria (3 listed)
- Age above 18
- female gender
- undergoing pelvic surgery for benign or malignant indications by a gynecologic oncologist
Key exclusion criteria (3 listed)
- Age less than 18 years of age at the time of surgery
- pregnant
- individual is a prisoner
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 |
|---|---|---|
| Early removal of urinary catheter postoperativelyremoval of urinary catheter less than 24 hours after surgery | Other | Laparotomy, Minimal invasive surgery, Radical surgery, Simple surgery |
| Late removal of urinary catheter postoperativelyremoval of urinary catheter greater than 24 hours after surgery | Other | Laparotomy, Minimal invasive surgery, Radical surgery, Simple surgery |
Primary outcome
Urinary retention rate after urinary catheter removal postoperatively
Time frame: 30 days after surgery
urinary retention rate will be measured as need for re-catheterization 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 17 Mar 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Retention, run by WellSpan Health at 1 site 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 3 inclusion and 3 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 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Urinary retention rate after urinary catheter removal postoperatively (time frame: 30 days after surgery). 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 17 Mar 2023.