Postoperative CareNCT05885958
Timing of Active Void Trials After Urogynecologic Procedures
A study testing Time in people with Postoperative Care and Urinary Catheters, run by University of South Florida at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn about active void trial pass rates in patients undergoing urogynecologic surgery. The main question it aims to answer is the comparison in pass rate during active void trial between women who are given 30 minutes versus 60 minutes to void following urogynecologic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Care, Urinary Catheters, Urogynecology
- What is being tested?
- Time
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2023to 5 Jun 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
- Women undergoing a urogynecologic surgery at Tampa General Hospital and who are seen preoperatively at the University of South Florid Urogynecology clinic
- Women undergoing a urogynecologic surgery where a postoperative active void trial is indicated
- Planned for same day surgery
- Women able to consent for themselves
- Speak English and/or Spanish as preferred language
Who cannot join
- Imprisoned patients
- Females under the age of 18 years old
- Women who are unable or unwilling to consent to participation
- Women who are planning to stay inpatient overnight
- Women with history of urinary retention or neurogenic bladder
- Women undergoing procedure that is not standard of care to perform a void trial (includes sacral neuromodulation, botox to the pelvic floor, cystoscopy with hydrodistension, urethral bulking, etc)
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to learn about active void trial pass rates in patients undergoing urogynecologic surgery. The main question it aims to answer is the comparison in pass rate during active void trial between women who are given 30 minutes versus 60 minutes to void following urogynecologic surgery.
Patient will be randomized to two arms prior to scheduled surgery. During the active void trial, women will be allotted up to 30 minutes or up to 60 minutes to void depending on respective randomization.
- Conditions
- Postoperative Care, Urinary Catheters, Urogynecology
- Being tested
- Time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TimeOther
Patients will be given up to 30 minutes to void.
TimeOther
Patients will be given up to 60 minutes to void.
| Study group | Role | What they receive |
|---|---|---|
| Immediate | Experimental | Patients will be given up to 30 minutes to void during the active void trial postoperatively. Receives: Other: Time |
| Extended | Experimental | Patients will be given up to 60 minutes to void during the active void trial postoperatively. Receives: Other: Time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pass Rate
to compare the active void trial pass rate between arms
Measured: 60 minutes
Secondary outcomes (4)
Time in PACU
to compare overall time spent in the PACU between arms
Measured: 6 hours
Pass Rate After Failing
to assess the overall pass rate of active void trial after failed first attempt
Measured: 60 minutes
UTI
to assess rate of urinary tract infection after surgery
Measured: 2 weeks
Surgical Procedures Performed Prior to Active Void Trial
to compare types of surgery women are having with the rate of void trial passing
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 posted2 Jun 2023
- Study start3 Jul 2023
- Primary completion27 Aug 2024
- Study completion5 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Postoperative CareStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Fertel, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885958
- Sponsor's protocol ID
- STUDY005629
- Status last verified
- Jun 2025
- First submitted
- 22 May 2023
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barber MD, Walters MD, Karram MM, et al. Walters & Karram Urogynecology and Reconstructive Pelvic Surgery - E-Book: Elsevier Health Sciences; 2021
Lo TS, Shailaja N, Hsieh WC, Uy-Patrimonio MC, Yusoff FM, Ibrahim R. Predictors of voiding dysfunction following extensive vaginal pelvic reconstructive surgery. Int Urogynecol J. 2017 Apr;28(4):575-582. doi: 10.1007/s00192-016-3144-z. Epub 2016 Sep 19.
PubMed 27647467Kim JW, Moon du G, Shin JH, Bae JH, Lee JG, Oh MM. Predictors of Voiding Dysfunction after Mid-urethral Sling Surgery for Stress Urinary Incontinence. Int Neurourol J. 2012 Mar;16(1):30-6. doi: 10.5213/inj.2012.16.1.30. Epub 2012 Mar 31.
PubMed 22500251Mills JT, Rapp DE, Shaw NM, Hougen HY, Agard HE, Case RM Jr, McMurry TL, Schenkman NS, Krupski TL. Effect of active versus passive void trials on time to patient discharge, urinary tract infection, and urinary retention: a randomized clinical trial. World J Urol. 2020 Sep;38(9):2247-2252. doi: 10.1007/s00345-019-03005-0. Epub 2019 Nov 15.
PubMed 31732771Wang R, Won S, Haviland MJ, Von Bargen E, Hacker MR, Li J, Lefevre R. Voiding trial outcome following pelvic floor repair without incontinence procedures. Int Urogynecol J. 2016 Aug;27(8):1215-20. doi: 10.1007/s00192-016-2975-y. Epub 2016 Feb 17.
PubMed 26886553Barr SA, Thomas A, Potter S, Melick CF, Gavard JA, McLennan MT. Incidence of successful voiding and predictors of early voiding dysfunction after retropubic sling. Int Urogynecol J. 2016 Aug;27(8):1209-14. doi: 10.1007/s00192-016-2972-1. Epub 2016 Feb 19.
PubMed 26894607
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Active Void Trials After Urogynecologic Procedures
- ClinicalTrials.gov ID
- NCT05885958
- Acronym / sponsor ID
- STUDY005629
- Conditions
- Postoperative Care, Urinary Catheters, Urogynecology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 27 Aug 2024 (actual)
- Study completion
- 5 Jun 2025 (actual)
- First posted
- 2 Jun 2023 (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 clinical trial is to learn about active void trial pass rates in patients undergoing urogynecologic surgery. The main question it aims to answer is the comparison in pass rate during active void trial between women who are given 30 minutes versus 60 minutes to void following urogynecologic surgery.
Patient will be randomized to two arms prior to scheduled surgery. During the active void trial, women will be allotted up to 30 minutes or up to 60 minutes to void depending on respective randomization.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate | Experimental | Other: TimePatients will be given up to 30 minutes to void during the active void trial postoperatively. |
| Extended | Experimental | Other: TimePatients will be given up to 60 minutes to void during the active void trial postoperatively. |
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)
- Women undergoing a urogynecologic surgery at Tampa General Hospital and who are seen preoperatively at the University of South Florid Urogynecology clinic
- Women undergoing a urogynecologic surgery where a postoperative active void trial is indicated
- Planned for same day surgery
- Women able to consent for themselves
- Speak English and/or Spanish as preferred language
Key exclusion criteria (6 listed)
- Imprisoned patients
- Females under the age of 18 years old
- Women who are unable or unwilling to consent to participation
- Women who are planning to stay inpatient overnight
- Women with history of urinary retention or neurogenic bladder
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 |
|---|---|---|
| TimePatients will be given up to 30 minutes to void. | Other | Immediate |
| TimePatients will be given up to 60 minutes to void. | Other | Extended |
Primary outcome
Pass Rate
Time frame: 60 minutes
to compare the active void trial pass rate between arms
4 secondary outcomes
Time in PACU
Time frame: 6 hours
Pass Rate After Failing
Time frame: 60 minutes
UTI
Time frame: 2 weeks
Surgical Procedures Performed Prior to Active Void Trial
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 1 Jul 2025.
- BackgroundBarber MD, Walters MD, Karram MM, et al. Walters & Karram Urogynecology and Reconstructive Pelvic Surgery - E-Book: Elsevier Health Sciences; 2021
- Background: PubMed 27647467Lo TS, Shailaja N, Hsieh WC, Uy-Patrimonio MC, Yusoff FM, Ibrahim R. Predictors of voiding dysfunction following extensive vaginal pelvic reconstructive surgery. Int Urogynecol J. 2017 Apr;28(4):575-582. doi: 10.1007/s00192-016-3144-z. Epub 2016 Sep 19.
- Background: PubMed 22500251Kim JW, Moon du G, Shin JH, Bae JH, Lee JG, Oh MM. Predictors of Voiding Dysfunction after Mid-urethral Sling Surgery for Stress Urinary Incontinence. Int Neurourol J. 2012 Mar;16(1):30-6. doi: 10.5213/inj.2012.16.1.30. Epub 2012 Mar 31.
- Background: PubMed 31732771Mills JT, Rapp DE, Shaw NM, Hougen HY, Agard HE, Case RM Jr, McMurry TL, Schenkman NS, Krupski TL. Effect of active versus passive void trials on time to patient discharge, urinary tract infection, and urinary retention: a randomized clinical trial. World J Urol. 2020 Sep;38(9):2247-2252. doi: 10.1007/s00345-019-03005-0. Epub 2019 Nov 15.
- Background: PubMed 26886553Wang R, Won S, Haviland MJ, Von Bargen E, Hacker MR, Li J, Lefevre R. Voiding trial outcome following pelvic floor repair without incontinence procedures. Int Urogynecol J. 2016 Aug;27(8):1215-20. doi: 10.1007/s00192-016-2975-y. Epub 2016 Feb 17.
- Background: PubMed 26894607Barr SA, Thomas A, Potter S, Melick CF, Gavard JA, McLennan MT. Incidence of successful voiding and predictors of early voiding dysfunction after retropubic sling. Int Urogynecol J. 2016 Aug;27(8):1209-14. doi: 10.1007/s00192-016-2972-1. Epub 2016 Feb 19.
- Individual participant dataSharing planned: No
Related trials for Postoperative Care
Active, not recruiting
VentilO Prospective Study
Mechanical Ventilation Complication, Respiratory Acidosis
Not yet recruitingPhase 4
Discontinuation or Continuation of SGLT-2 Inhibitors Before Cardiac Surgery
Heart Failure, Cardiac Surgery
Not yet recruitingObservational study
Comparison of IV Dexmedetomidine Versus Clonidine Versus no Alpha 2 Agonist on Emergency Delirium, PACU Length of Stay and Time to Hospital Discharge in Children Undergoing (Adeno)Tonsillectomy: a Prospective Observational Study
Emergency Delirium, Postoperative Delirium (POD)
RecruitingObservational study
Vascular Events In Patients Undergoing Same-day Noncardiac Surgery (VALIANCE) Study
Preoperative Care, Surgery--Complications
Recruiting
Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction
Postoperative Sore Throat, Nasal Obstruction
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?
A study testing Time in people with Postoperative Care and Urinary Catheters, run by University of South Florida 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 5 inclusion and 6 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 1 Jul 2025. 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 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?
Pass Rate (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05885958, which also lists 6 linked publications.
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 Jul 2025.