Urinary Retention PostoperativeNCT05108506
Strict Need to Void After Same-day Discharge, Non-urogynecologic, Minimally Invasive Hysterectomy
A study testing No Strict need to void following surgery and Strict need to void following surgery in people with Urinary Retention Postoperative, run by Johns Hopkins University at 1 site in United States.
Trial summary
Patients who are undergoing non-urogynecologic, minimally invasive (laparoscopic, robotic) hysterectomy who are discharged the day of surgery will be randomized to a strict need to void versus no need to void prior to discharge. 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 Postoperative
- What is being tested?
- No Strict need to void following surgery and Strict need to void following surgery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 205 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2022to 1 Apr 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women 18+ undergoing minimally invasive benign, non-urogynecologic hysterectomy
- English speaking
Who cannot join
- At the surgeons discretion based on amount of bladder dissection the patient can be removed from the study at the conclusion of surgery
- Any patient with a history of prior urologic procedures
- Patients with any baseline known urinary disease
- Any bladder injury at the time of surgery
- Any combined cases with other surgical services
- Patients undergoing surgery for prolapse or incontinence symptoms
- Patients who are ultimately not discharged the same day and remain in house overnight
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Void or Not to Void After Same-day Discharge, Non-urogynecologic, Minimally Invasive Hysterectomy, That is the Question
Patients who are undergoing non-urogynecologic, minimally invasive (laparoscopic, robotic) hysterectomy who are discharged the day of surgery will be randomized to a strict need to void versus no need to void prior to discharge.
To determine if a strict versus liberal voiding trial following the aforementioned surgery in same day discharge patients increases rates of post-operative urinary retention, urinary tract infection (UTI), or re-presentation and if there is a difference in Post-Anesthesia Care Unit (PACU) time and costs.
- Conditions
- Urinary Retention Postoperative
- Being tested
- No Strict need to void following surgery, Strict need to void following surgery
- Keywords
- Minimally invasive hysterectomy, Urinary retention, Some day discharge
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Strict need to void following surgeryBehavioural
Certain patient will be randomized without a strict need to void prior to discharge following surgery.
Strict need to void following surgeryBehavioural
Certain patient will be randomized with a strict need to void prior to discharge following surgery.
| Study group | Role | What they receive |
|---|---|---|
| No strict need to void following surgery before discharge | Experimental | Participants randomized to this arm will have no strict need to void following surgery before they are discharged. Receives: Behavioral: No Strict need to void following surgery |
| Strict need to void following surgery before discharge | Placebo comparator | Participants randomized to this arm will have a strict need to void following surgery before they are discharged. Receives: Behavioral: Strict need to void following surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of time spent in PACU
This will assess the amount of time spent (in hours) in PACU.
Measured: 2 years
Secondary outcomes (4)
Rates of urinary retention
Will measure rates of urinary retention.
Measured: 2 years
Rates of UTI
Will measure rates of UTI.
Measured: 2 years
Rates of re-presentation to the ER
Will measure rates of re-presentation to ER.
Measured: 2 years
Cost of stay in PACU
This will assess the cost pertaining to the time spent in the PACU to determine if the time spent has a significant impact on the cost.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start5 Dec 2022
- Primary completion30 Mar 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Retention PostoperativeStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristin Patzkowsky, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108506
- Sponsor's protocol ID
- IRB00307084
- Status last verified
- Jul 2024
- First submitted
- 25 Oct 2021
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- 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 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Void or Not to Void After Same-day Discharge, Non-urogynecologic, Minimally Invasive Hysterectomy, That is the Question
- ClinicalTrials.gov ID
- NCT05108506
- Acronym / sponsor ID
- IRB00307084
- Conditions
- Urinary Retention Postoperative
- Keywords
- Minimally invasive hysterectomy, Urinary retention, Some day discharge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 5 Nov 2021 (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.
Patients who are undergoing non-urogynecologic, minimally invasive (laparoscopic, robotic) hysterectomy who are discharged the day of surgery will be randomized to a strict need to void versus no need to void prior to discharge.
To determine if a strict versus liberal voiding trial following the aforementioned surgery in same day discharge patients increases rates of post-operative urinary retention, urinary tract infection (UTI), or re-presentation and if there is a difference in Post-Anesthesia Care Unit (PACU) time and costs.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No strict need to void following surgery before discharge | Experimental | Behavioral: No Strict need to void following surgeryParticipants randomized to this arm will have no strict need to void following surgery before they are discharged. |
| Strict need to void following surgery before discharge | Placebo comparator | Behavioral: Strict need to void following surgeryParticipants randomized to this arm will have a strict need to void following surgery before they are discharged. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women 18+ undergoing minimally invasive benign, non-urogynecologic hysterectomy
- English speaking
Key exclusion criteria (7 listed)
- At the surgeons discretion based on amount of bladder dissection the patient can be removed from the study at the conclusion of surgery
- Any patient with a history of prior urologic procedures
- Patients with any baseline known urinary disease
- Any bladder injury at the time of surgery
- Any combined cases with other surgical services
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 |
|---|---|---|
| No Strict need to void following surgeryCertain patient will be randomized without a strict need to void prior to discharge following surgery. | Behavioural | No strict need to void following surgery before discharge |
| Strict need to void following surgeryCertain patient will be randomized with a strict need to void prior to discharge following surgery. | Behavioural | Strict need to void following surgery before discharge |
Primary outcome
Amount of time spent in PACU
Time frame: 2 years
This will assess the amount of time spent (in hours) in PACU.
4 secondary outcomes
Rates of urinary retention
Time frame: 2 years
Rates of UTI
Time frame: 2 years
Rates of re-presentation to the ER
Time frame: 2 years
Cost of stay in PACU
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- 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.
Kristin Patzkowsky principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Strict need to void following surgery and Strict need to void following surgery in people with Urinary Retention Postoperative, run by Johns Hopkins University 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 17 Jul 2024. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Amount of time spent in PACU (time frame: 2 years). 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 Jul 2024.